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TROPION-Lung07 Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in Patients with Previously Untreated Metastatic Non-Small Cell Lung Cancer

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) today announced that the first patient has been dosed in the global, randomized TROPION-Lung07 phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with PD-L1 expression less than 50% (TPS<50%) and without actionable genomic alterations.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

 

Among patients with NSCLC, nearly half are diagnosed at an advanced stage and generally have a poor prognosis.1,2,3 While first-line treatment with pembrolizumab or other checkpoint inhibitors, with or without chemotherapy, has improved outcomes in patients with NSCLC without actionable genomic alterations, disease progression still occurs in the majority of patients.4,5

 

“Metastatic non-squamous non-small cell lung cancer remains a challenge because the majority of patients experience disease progression following their initial treatment, underscoring the need for more effective treatment options in the first-line setting,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “The TROPION-Lung07 trial will assess the potential of the combination of datopotamab deruxtecan and pembrolizumab with and without chemotherapy, to evaluate whether this combination may be a more effective standard treatment option than the current standard of care for patients in the first-line setting.”

 

“The combination of datopotamab deruxtecan with a checkpoint inhibitor with or without chemotherapy, has shown increased activity and a manageable safety profile in early trials, including TROPION-Lung02,” said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. “With this initiation, TROPION-Lung07 becomes the third phase 3 trial in our evaluation of these investigational combinations for the first-line treatment of patients with non-small cell lung cancer, across PD-L1 segments and tumor histologies.”

 

TROPION-Lung07 is the third clinical trial collaboration and supply agreement between Daiichi Sankyo and AstraZeneca with a subsidiary of Merck & Co., Inc., Rahway, NJ., USA to evaluate the combination of datopotamab deruxtecan and pembrolizumab. Previous clinical trial collaboration agreements were entered in October 2021 for the TROPION-Lung08 phase 3 trial and May 2020 for the TROPION-Lung02 phase 1b trial.

 

About TROPION-Lung07

TROPION-Lung07 is a global, randomized, open-label, phase 3 trial assessing the efficacy and safety of datopotamab deruxtecan in combination with pembrolizumab with or without platinum chemotherapy compared with pembrolizumab and platinum chemotherapy in patients with previously untreated, advanced or metastatic non-squamous NSCLC with less than 50% programmed death-ligand (PD-L1) expression (tumor proportion score [TPS] < 50%) and without actionable genomic alterations. Eligible participants in the three-arm study will be randomized in a 1:1:1 ratio to the following intervention arms: Arm A (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV plus platinum chemotherapy every three weeks), Arm B (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV every three weeks), and Arm C (pembrolizumab 200 mg IV plus pemetrexed [500 mg/m2] plus platinum chemotherapy every three weeks).

 

The primary endpoints of TROPION-Lung07 are progression-free survival (PFS) as assessed by blinded independent central review and overall survival. Secondary endpoints include objective response rate, duration of response, time to response, disease control rate as assessed by both investigator and blinded independent central review, PFS as assessed by investigator, PFS2 and safety.

 

TROPION-Lung07 will enroll approximately 975 patients at sites in North America, South America, Europe, Asia and Oceania. For more information visit ClinicalTrials.gov.

 

About Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide.1 NSCLC is diagnosed at an advanced stage in nearly 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.6,7,8

 

While the introduction of targeted therapies and checkpoint inhibitors in recent years have improved outcomes for patients with advanced NSCLC, the majority of tumors do not have known actionable genomic alterations.7,8,9,10 The current standard of care in the first-line treatment of patients with advanced NSCLC without actionable genomic alterations consists of checkpoint inhibitors with or without platinum-based chemotherapy based on PD-L1 expression. While these therapies may improve survival, at least 40% to 60% of patients experience disease progression, underscoring the need for new therapeutic approaches and options.11,12,13,14

 

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is widely expressed in several types of tumors, including NSCLC.15,16,17,18 TROP2 is expressed across all lung cancer subtypes with the highest expression seen in the majority of adenocarcinoma and squamous cell carcinoma (the most common forms of NSCLC).19 No TROP2 directed therapies are currently approved for the treatment of patients with NSCLC.19,20,21

 

About Datopotamab Deruxtecan (Dato-DXd)

Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

 

A comprehensive development program called TROPION is underway globally with more than 10 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple tumors including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer. Trials in combination with other anticancer treatments are also underway.

 

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of five ADCs in clinical development across multiple types of cancer. The company’s clinical trial stage DXd ADCs include ENHERTU, a HER2 directed ADC and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca; and patritumab deruxtecan (HER3-DXd), a HER3 directed ADC. Two additional ADCs including ifinatamab deruxtecan (I-DXd; DS-7300), a B7-H3 directed ADC, and DS-6000, a CDH6 directed ADC, are being developed through a strategic early-stage research collaboration with Sarah Cannon Research Institute.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan and DS-6000 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com.

 

References:

1

Siegel R, et al. CA Cancer J Clin. 2021;71:7-33.

2

Centers for Disease Control and Prevention. U.S. Cancer Statistics Data Visualizations Tool. Accessed January 2023.

3

Hardstock F, et al. BMC Cancer. 2020;20(1):260.

4

Shields MD, et al. Am Soc Clin Oncol Educ Book. 2021;41:1-23.

5

Walsh RJ, et al. Ther Adv Med Oncol. 2020;12:1758835920937902.

6

World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed January 2023.

7

Chen R, et al. J Hematol Oncol. 2020;13(1):58.

8

Majeed U, et al. J Hematol Oncol. 2021;14(1):108.

9

Adib E, et al. Genome Med. 2022;14(1):39.

10

Bubendorf L, et al. Eur Respir Rev. 2017;26(144):170007.

11

Paz-Ares L, et al. J Thorac Oncol. 2020 Oct;15(10):1657-1669.

12

Mok TSK, et al. Lancet. 2019 May 4;393(10183):1819-1830.

13

Brahmer J.R. et al. KEYNOTE-024 5-year OS update. ESMO 2021 Virtual Congress. 2021 Sept 16 – 20; Abstract LBA51.

14

Rodríguez-Abreu D et al. Ann Onc. 2021 Jul;32(7):881-895.

15

McDougall ARA, et al. Devel Dynamics. 2015;244:99-109.

16

Shvartsur A, et al. Genes Cancer. 2015;6(3-4):84-105.

17

Inamura K, et al. Oncotarget. 2017; 8(17):28725-28735.

18

Goldenberg DM, et al. Oncotarget. 2018;9(48):28989-29006.

19

Mito R, et al. Pathol Int. 2020;70(5):287-294.

20

Zaman S, et al. Onco Targets Ther. 2019;12:1781-1790.

21

American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer. Accessed January 2023.

Contacts

Global/US:
Rose Talarico

Daiichi Sankyo, Inc.

rtalarico@dsi.com
+1 973 775 0838 (mobile)

Japan:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business Lifestyle

5 New contracts for Knightscope (Nasdaq: KSCP)

Public Safety Innovator Continues to Build Strong Growth Curve

 

MOUNTAIN VIEW, Calif. — (BUSINESS WIRE) — $KSCP #SecurityRobot—Knightscope, Inc. (Nasdaq: KSCP) “(Knightscope” or the “Company),” a leading developer of autonomous security robots and emergency systems, announces 5 customer expansion orders adding to the Company’s ongoing sales growth. Knightscope’s new suite of K1 Emergency Communication Systems continue to be big sellers across multiple industries.


  • A New York college upgraded two of its devices with K1 Upgrade Kits and a 1-year maintenance plan.
  • A private university in California purchased 5 K1 Upgrade Kits.
  • A New Jersey Airport added a K1 E-Phone and parts kit.
  • A North Carolina town purchased another K1 Upgrade Kit.
  • A city in Colorado added a K1 Call Box to its existing network.

 

Anyone looking for an innovative security solution or advanced communication devices for properties in the U.S. may book a discovery call or meeting now at www.knightscope.com/discover to learn more about Knightscope’s autonomous security robots and blue light emergency communication systems.

 

About Knightscope

Knightscope is an advanced security technology company based in Silicon Valley that builds fully autonomous security robots that deter, detect and report. Knightscope’s long-term ambition is to make the United States of America the safest country in the world. Learn more about the Company at www.knightscope.com. Follow Knightscope on Facebook, Twitter, LinkedIn and Instagram.

 

Forward-Looking Statements

This press release may contain “forward-looking statements” about Knightscope’s future expectations, plans, outlook, projections and prospects. Such forward-looking statements can be identified by the use of words such as “should,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” “proposes” and similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements about the Company’s path to profitability, the Company’s targeted annualized revenue run rate, the Company’s plans for top-line growth, the Company’s ability to deliver on its backlog of new orders, the benefits of the Company’s planned streamlining of its operations and rightsizing of its combined workforce and the Company’s ability to achieve improved margins. Although Knightscope believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These risks and uncertainties include, among other things, the risk that the restructuring costs and charges may be greater than anticipated; the risk that the Company’s restructuring efforts may adversely affect the Company’s internal programs and the Company’s ability to recruit and retain skilled and motivated personnel, and may be distracting to employees and management; the risk that the Company’s restructuring efforts may negatively impact the Company’s business operations and reputation with or ability to serve customers; the risk that the Company’s restructuring efforts may not generate their intended benefits to the extent or as quickly as anticipated. Readers are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in Knightscope’s Annual Report on Form 10-K for the year ended December 31, 2021. Forward-looking statements speak only as of the date of the document in which they are contained, and Knightscope does not undertake any duty to update any forward-looking statements, except as may be required by law.

Contacts

Public Relations:
Stacy Stephens
Knightscope, Inc.
(650) 924-1025

Corporate Communications:

IBN (InvestorBrandNetwork)

Los Angeles, California

www.InvestorBrandNetwork.com
310.299.1717 Office

Editor@InvestorBrandNetwork.com

Categories
Business

Elmer Bancorp, Inc. announces Fourth Quarter and 2022 Annual Financial Results

ELMER, N.J. — (BUSINESS WIRE) — ELMER BANCORP, INC. “(Elmer Bancorp” or the “Company)” (OTC Pink: ELMA), the parent company of The First National Bank of Elmer (the “Bank),” announces its operating results for the fourth quarter and full year ended Dec. 31, 2022.

 

For the three months ended Dec. 31, 2022, Elmer Bancorp reported net income of $1.025 million, or $0.89 per common share compared to $412,000, or $0.36 per common share for the quarter ended Dec. 31, 2021. For the twelve months ended Dec. 31, 2022, net income totaled $2.604 million, or $2.26 per common share compared to $1.949 million, or $1.70 per common share for the twelve months ended Dec. 31, 2021.

 

Net interest income for the three months ended Dec. 31, 2022 totaled $3.720 million, an increase of $922,000 from the three months ended Dec. 31, 2021 total of $2.798 million. For the twelve months ended Dec. 31, 2022, net interest income totaled $12.795 million, an increase of $923,000 from the twelve months ended Dec. 31, 2021 total of $11.872 million. The increase in net interest income for the three-month period results from higher interest income on our overnight investments and higher interest income on loans resulting from core loan growth year-over-year. For the twelve-month period, the increase in interest income on our overnight investments was partially offset by lower loan interest income and net loan fee income recognized on PPP loans. The loan loss provision was reduced by $87,000 for the three months and $174,000 for the twelve months ended Dec. 31, 2022 compared to no loan loss provision for the three months ended Dec. 31, 2021 and a $300,000 provision for the twelve months ended December 31, 2021. The $174,000 represents a reversal of the provision that was specifically allocated to the COVID-19 pandemic ($87,000 reversal in the third quarter and $87,000 reversal in the fourth quarter of 2022). The allowance for loan losses was 1.57% of total core loans at Dec. 31, 2022 compared to 1.83% of total core loans at Dec. 31, 2021.

 

Non-interest income for the three months ended Dec. 31, 2022 was $29,500 lower than the same three-month period a year ago and $9,000 higher than the twelve-month period last year. For the three-month period, a decrease in premiums on sold mortgages and no gains on the sale of Other Real Estate Owned (“OREO”) were partially offset by higher service fee income. For the twelve-month period, increases in service fee income more than offset a decline in premiums on sold mortgages and a decrease in gains on the sale of OREO.

 

Non-interest expenses were higher for the three and twelve months ended Dec. 31, 2022 versus the prior year periods by $103,600 and $466,400, respectively. Increases in employment costs, occupancy and equipment expenses, data processing costs and miscellaneous expenses were partially offset by lower professional fees, loan related expenses and OREO expenses.

 

Elmer Bancorp’s total assets at Dec. 31, 2022 totaled $371.5 million, a decrease of $4.2 million from the Dec. 31, 2021 level of $375.7 million. Total core assets (excluding PPP related assets) totaled $371.5 million, an increase of $1.3 million over Dec. 31, 2021. Total loans were $278.9 million at Dec. 31, 2022, an increase of $24.9 million from the Dec. 31, 2021 total of $254.0 million. Excluding Dec. 31, 2021 PPP loan related balances of $5.5 million, total core loans at Dec. 31, 2022 were $30.4 million higher than Dec. 31, 2021. In addition, overnight investments decreased $26.6 million and investment securities decreased $3.5 million year-over-year.

 

Deposits totaled $340.3 million at Dec. 31, 2022, a decrease of $4.2 million from the Dec. 31, 2021 level of $344.5 million. The negative variance from Dec. 31, 2021 resulted from decreases in certificates of deposit ($6.1 million), demand deposits ($2.3 million) and IRA accounts ($1.5 million) partially offset by an increase in savings deposits ($3.1 million) and an increase in interest-bearing checking and money market accounts ($2.6 million). This decrease in deposits is reflective of runoff that is starting to occur on deposits of government stimulus programs that have been artificially inflating our deposit totals. Stockholders’ equity totaled $29.3 million at Dec. 31, 2022 compared to $29.5 million at Dec. 31, 2021, a decrease of $169,300. Elmer Bancorp’s book value per common share at Dec. 31, 2022 was $25.45 per share compared to $25.62 per share at Dec. 31, 2021. The book value of the Company at Dec. 31, 2022 was affected by the unrealized comprehensive loss on the balance sheet which is largely a function of the significant increases in interest rates. This loss is a book entry and would not be incurred unless, in the unlikely event, the Bank had to liquidate securities. The Company and the Bank met all regulatory capital requirements at Dec. 31, 2022.

 

Brian W. Jones, President and Chief Executive Officer, commented, “As the bank enters 2023, we celebrate 120 years of serving the public and record earnings of over $2.6 million. It should also be noted that our 2022 fourth quarter net income figure of $1.025 million was the best single quarter in the bank’s history. Contributing to our 2022 results was an increase in our core loans, net of PPP loans, of $30.4 million or over 12%, which will prove to be a driving force in our continued effort to penetrate our target markets. Moving forward, we recognize the challenges ahead of us in 2023. A rising interest rate environment supplies both opportunities and challenges to our balance sheet, income statement, and our general operations. COVID-19 continues to present intermittent issues to our bank and to the general public. The economic environment remains uncertain as recessionary pressures must be accounted for and managed. The overriding good news is that we have positioned our institution to remain a strong and significant financial partner within our communities in 2023 and beyond. In summary, this past year proved to be an outstanding year, not just in terms of income, but in our ability to serve our clients and to make significant improvements in our infrastructure. I would like to thank you, our loyal customer base, and our outstanding team members who continue to provide unparalleled service to our clients. I would also like to thank our Board of Directors, specifically Chairman Boyer, for their consistent support and guidance, without such, our exceptional results would be impossible.”

 

Chairman, P. Scott Boyer, stated, “The Bank had a truly outstanding year in 2022. I would like to thank all of our employees for their hard work and service to our banking community which allowed us to achieve these great results.”

 

The First National Bank of Elmer, a nationally chartered bank headquartered in Elmer, New Jersey, has a long history of serving the community since its beginnings in 1903. We are a community bank focused on providing deposit and loan products to retail customers and to small and mid-sized businesses from our six full-service branch offices located in Cumberland, Gloucester and Salem Counties, New Jersey, including our main office located at 10 South Main Street in Elmer, New Jersey. Deposits at The First National Bank of Elmer are insured up to the legally maximum amount by the Federal Deposit Insurance Corporation (FDIC).

 

For more information about Elmer Bank and its products and services, please visit our website at www.ElmerBank.com or call toll free 1-877-358-8141.

 

Forward-Looking Statements

This press release and other statements made from time to time by the Company’s management contain express and implied statements relating to our future financial condition, results of operations, credit quality, corporate objectives, and other financial and business matters, which are considered forward-looking statements. These forward-looking statements are necessarily speculative and speak only as of the date made, and are subject to numerous assumptions, risks and uncertainties, all of which may change over time. Actual results could differ materially from those expected or implied by such forward-looking statements. Risks and uncertainties which could cause our actual results to differ materially and adversely from such forward-looking statements include economic conditions affecting the financial industry: changes in interest rates and shape of the yield curve, credit risk associated with our lending activities, risks relating to our market area, significant real estate collateral and the real estate market, operating, legal and regulatory risk, fiscal and monetary policy, economic, political and competitive forces affecting our business, our ability to identify and address cyber-security risks, and management’s analysis of these risks and factors being incorrect, and/or the strategies developed to address them being unsuccessful. Any statements made that are not historical facts should be considered forward-looking statements. You should not place undue reliance on any forward-looking statements. We undertake no obligation to update forward-looking statements or to make any public announcement when we consider forward-looking statements to no longer be accurate, whether as a result of new information of future events, except as may be required by applicable law or regulation.

 

ELMER BANCORP, INC. AND SUBSIDIARIES
SELECTED FINANCIAL DATA
(unaudited)
Twelve Months Ended Three Months Ended

12/31/2022

12/31/2021

12/31/2022

9/30/2022

6/30/2022

3/31/2022
Statement of Income Data: (dollars in thousands, except per share data)
Interest income

$

13,562

$

12,736

$

3,902

$

3,518

$

3,195

$

2,948
Interest expense

767

863

182

186

198

202
Net interest income

12,795

11,873

3,720

3,332

2,997

2,746
Provision for loan losses

(174

)

300

(87

)

(87

)

–

–
Net interest income after provision
for loan losses

12,969

11,573

3,807

3,419

2,997

2,746
Non-interest income

1,042

1,033

253

258

269

262
Non-interest expense

10,393

9,927

2,622

2,618

2,564

2,589
Income before income tax expense

3,618

2,679

1,438

1,059

702

419
Income tax expense

1,014

730

413

300

193

108
Net income

$

2,604

$

1,949

$

1,025

$

759

$

509

$

311
Earnings per share:
Basic

$

2.26

$

1.70

$

0.89

$

0.66

$

0.44

$

0.27
Diluted

$

2.26

$

1.70

$

0.89

$

0.66

$

0.44

$

0.27
Weighted average basic shares outstanding

1,147,678

1,146,453

1,147,150

1,149,771

1,148,418

1,146,867
Weighted average diluted shares outstanding

1,149,701

1,148,483

1,149,443

1,151,600

1,149,954

1,149,266
Statement of Condition Data (Period End):

12/31/2022

12/31/2021

12/31/2022

9/30/2022

6/30/2022

3/31/2022
Total investments

$

24,244

$

29,698

$

24,244

$

24,469

$

25,910

$

27,521
Total gross loans

$

278,889

$

254,021

$

278,889

$

267,090

$

263,109

$

262,994
Allowance for loan losses

$

4,379

$

4,556

$

4,379

$

4,466

$

4,554

$

4,532
Total assets

$

371,530

$

375,693

$

371,530

$

385,630

$

392,923

$

380,846
Total deposits

$

340,330

$

344,527

$

340,330

$

355,365

$

363,042

$

350,534
Total stockholders’ equity

$

29,297

$

29,466

$

29,297

$

28,350

$

28,215

$

28,640
Book value per share

$

25.45

$

25.62

$

25.45

$

24.63

$

24.51

$

24.88

Contacts

Cynthia L. Volk

Senior Vice President

Financial Officer

1-856-358-8141

Categories
Business Lifestyle

AM Best withdraws Credit Ratings of St. Charles Insurance Company Risk Retention Group

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Financial Strength Rating of B++ (Good) and the Long-Term Issuer Credit Rating of “bbb” (Good) of St. Charles Insurance Company Risk Retention Group (St. Charles) (Charleston, SC). The outlook of these Credit Ratings (ratings) is stable. Concurrently, AM Best has withdrawn these ratings as the company has requested to no longer participate in AM Best’s interactive rating process.

 

The ratings reflect St. Charles’ balance sheet strength, which AM Best assesses as strong, as well as its adequate operating performance, very limited business profile and appropriate enterprise risk management.

 

St. Charles’ surplus size and insurance capacity were significantly reduced in 2021, due to a stockholder dividend that was paid to the parent. This came on the heels of management’s decision to discontinue writing new contract liability business in the risk retention group and place its existing policies into runoff.

 

The stable rating outlooks reflect AM Best’s expectation that the company will maintain solid risk-adjusted capitalization with adequate operating results, which are supported by modest levels of net investment income as the company operates through the runoff of its remaining service contract liabilities.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Robert Gabriel
Financial Analyst
+1 908 439 2200, ext. 5725
robert.gabriel@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Daniel Teclaw
Associate Director
+1 908 439 2200, ext. 5394
daniel.teclaw@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Lifestyle

Turkish consumer finance company Quick Finans selects Provenir AI-Powered Data and Decisioning Platform

Provenir’s no-code platform delivers rapid deployment, flexibility and scalability for a growing company

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — #AI—Provenir, a global leader in data and AI-powered risk decisioning software, announced today that Quick Finans, a consumer finance company located in Turkey, has selected Provenir’s AI-Powered Data and Decisioning Platform to quickly approve and onboard new customers.

Quick Finans, a wholly owned subsidiary of Quick Insurance, which is under the umbrella of Maher Holding, offers solutions for consumer finance loans (GPL), auto financing, mortgages, agricultural financing, and small business lending. They were looking for a low/no code platform that could be deployed quickly, modified in real-time and scale as the company expands its offerings.

 

“After evaluating several options, we determined that Provenir best met our requirements and could support our aggressive growth strategies,” said Cumhur Taş – Deputy General Manager responsible for Credit & Operations in Quick Finans. “The platform provides the flexibility we need to power our business now and in the future. Another key differentiator was the ability to easily access and integrate new data sources to help us gain a more holistic view of our applicants and customers.”

 

“We are pleased to partner with Quick Finans to develop real-time decisioning solutions that will provide a superior customer experience,” said Emre Unlusoy, Regional Manager for Provenir. “Provenir’s no-code, visual UI eliminates vendor and development team reliance, and will provide Quick Finans the flexibility and agility needed to rapidly make changes, test new strategies and get products to market faster.”

 

Provenir’s industry-leading AI-Powered Data and Decisioning Platform is data fueled and AI driven for smarter risk decisioning. The solution, managed through a single UI, empowers organizations to innovate further and faster than ever before, driving the continuous optimization they need to power growth and agility, without increasing risk. With the unique combination of universal access to data, embedded AI and world-class decisioning technology, Provenir provides a cohesive risk ecosystem to enable smarter decisions across the entire customer lifecycle – offering diverse data for deeper insights, auto-optimized decisions, and a continuous feedback loop for constant improvement both at onboarding when assessing risk and monitoring ongoing transactions for fraud.

 

About Provenir

Provenir helps fintechs and financial services providers make smarter decisions faster with our AI-Powered Data and Decisioning Platform.

 

Provenir brings together key data, AI and decisioning capabilities to help organizations provide world-class consumer experiences. This unique offering gives organizations the ability to power decisioning innovation across the full customer lifecycle, driving improvements in the customer experience, access to financial services, business agility, and more.

 

Provenir works with disruptive financial services organizations in more than 50 countries and processes more than 3 billion transactions annually.

Contacts

Viali Munteanu

Cognito Media (for Provenir)

viali.munteanu@cognitomedia.com
+44 (0) 7547 819 438

Categories
Business Culture Perks

Campbell appoints Carrie Anderson Chief Financial Officer

CAMDEN, N.J. — (BUSINESS WIRE) — Campbell Soup Company (NYSE:CPB) today announced the appointment of Carrie L. Anderson as Executive Vice President and Chief Financial Officer, effective Feb. 6.

 

Anderson will lead Campbell’s finance function, including controllership, corporate financial planning and analysis, corporate strategy and development, tax, treasury, internal audit, investor relations, transactional services and financial systems. She will report to Campbell’s President and Chief Executive Officer Mark Clouse and become a member of the company’s Operating Committee and a Corporate Officer. Anderson succeeds Mick Beekhuizen, who was appointed President of Campbell’s Meals & Beverages division in November 2022.

 

“I am delighted to welcome Carrie to our leadership team. She brings a wide range of diverse, strategic experience and financial discipline, and her expertise in capital management and deployment will help us continue to drive our growth plans and enhance our performance,” said Clouse.

 

“Her collaborative approach combined with a track record of driving transformation, delivering results and developing strong finance teams will be invaluable as we continue to build momentum in the business.”

 

Anderson brings a wealth of financial experience working in a variety of complex industries, as well as a background in manufacturing and engineering. She joins Campbell from Integra LifeSciences (NASDAQ:IART), a leading global medical technology company, where she has served as Executive Vice President and Chief Financial Officer since 2019. Before Integra, Anderson spent seven years with Dover Corporation in several leadership roles, including Chief Accounting Officer/Corporate Controller, and Vice President and CFO for the company’s engineered systems and printing and identification businesses. Previously, Anderson spent six years as Vice President and Chief Financial Officer of Delphi Product & Service Solutions, a division of Delphi Corporation. While at Delphi, she also held leadership positions in finance, treasury and investor relations. Anderson started her career with General Motors.

 

Anderson earned her B.S. in chemical engineering from Purdue University and an MBA from Ball State University. She serves on the board of directors of Embecta Corp. (NASDAQ:EMBC) and is a member of its Audit and Nominating & Governance committees.

 

About Campbell Soup Company

For more than 150 years, Campbell (NYSE: CPB) has been connecting people through food they love. Generations of consumers have trusted Campbell to provide delicious and affordable food and beverages. Headquartered in Camden, N.J. since 1869, Campbell generated fiscal 2022 net sales of nearly $8.6 billion. Our portfolio includes iconic brands such as Campbell’s, Cape Cod, Goldfish, Kettle Brand, Lance, Late July, Milano, Pace, Pacific Foods, Pepperidge Farm, Prego, Snyder’s of Hanover, Swanson and V8. Campbell has a heritage of giving back and acting as a good steward of the environment. The company is a member of the Standard & Poor’s 500 as well as the FTSE4Good and Bloomberg Gender-Equality Indices. For more information, visit www.campbellsoupcompany.com or follow company news on Twitter via @CampbellSoupCo.

Contacts

Investor:
Rebecca Gardy

(856) 342-6081

Rebecca_Gardy@campbells.com

Media:
James Regan

(856) 219-6409

James_Regan@campbells.com

Categories
Business Lifestyle

Best’s Review’s popular stories focus on Insurer Balance Sheets, growth in specialization

OLDWICK, N.J. — (BUSINESS WIRE) — In the last 60 days, Best’s Review readers have been most interested in the following stories:

 

Best’s Review is AM Best’s monthly insurance magazine, covering emerging issues and trends and evaluating their impact on the marketplace. Access to the complete content of Best’s Review is available here.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Patricia Vowinkel
Executive Editor, Best’s Review®
+1 908 439 2200, ext. 5540
patricia.vowinkel@ambest.com

Categories
Business Environment Lifestyle

Offshore Wind Innovation Hub announces opening in Brooklyn

Brooklyn-based Hub seeking start-up applicants to unleash the potential of offshore wind in New York.

 

NEW YORK — (BUSINESS WIRE) — The Offshore Wind Innovation Hub (OWIH) is open for business and announced its first call for applications. The Brooklyn-based Hub was founded in mid-2022 to identify and help develop promising start-ups to drive new innovations in the offshore wind industry. The three-year initiative is backed by Equinor and bp, partners developing the Empire Wind and Beacon Wind offshore wind projects, together with Urban Future Lab (UFL), the NYU Tandon School of Engineering, and the National Offshore Wind Research & Development Consortium (NOWRDC) and is supported by the New York City Economic Development Corporation (NYCEDC).

 

Designed to facilitate testing opportunities, fast-track commercialization, and developing strategic partnerships, startups will have access to the co-working space and programming at the Offshore Wind Innovation Hub located in Industry City. An Accelerator Program will allow selected cohort companies to begin a six-month intensive mentoring and business development program in June 2023.

 

“We’re thrilled to launch the Accelerator Program at our Offshore Wind Innovation Hub with our esteemed partners to accelerate innovation in New York’s burgeoning offshore wind industry,” said Molly Morris, President of Equinor Wind US. “The demand for offshore wind is rapidly increasing, and innovative ideas and technological advancement are needed to help the industry develop in the U.S. and beyond.”

 

The first call for applications is focused on finding start-ups that provide innovative technology and solutions related to the development phase of offshore wind in New York. The application can be found here and the deadline for submission is March 27, 2023.

 

The Offshore Wind Innovation Hub will also offer membership to stakeholders outside the Accelerator Program. Interested parties can apply for access to the co-working facilities in Industry City, community programming, as well as workshops and networking opportunities with industry peers. Applications to become a Community Member are open year-round.

 

“We’re looking for New York’s best,” said Dave Lawler, chairman and president of bp America. “We know innovation is in New Yorkers’ DNA. It’s at the core of bp, too, as we transform ourselves to reach net-zero by 2050 or sooner and help the world get there too. At this incredible moment for growing offshore wind in our country, we want to empower New York’s startups to lead the nation.”

 

Lyndie Hice-Dunton, Executive Director of NOWRDC said, “We are delighted to be a part of this exciting partnership. The Accelerator Program is a unique opportunity to help support innovative solutions for offshore wind in the U.S., as well as help build strategic partnerships within this growing industry. We are looking forward to working with this outstanding group of leaders to achieve our mutual goal of accelerating offshore wind innovation.”

 

“Equinor’s Innovation Hub will call on New York’s world-class entrepreneurial talent to develop cutting-edge technologies, and accelerate advances in the offshore wind industry,” said NYCEDC Chief Operating Officer Melissa Román Burch. “We are thrilled the Hub will partner with Venture Access NYC – an NYCEDC initiative to create a more inclusive and representative tech startup ecosystem. Together with our industry and community partners, we are building a nation-leading offshore wind ecosystem and a more inclusive future for New Yorkers.”

 

Doreen M. Harris, President and CEO, New York State Energy Research and Development Authority (NYSERDA) said, “As we solidify New York’s leadership in offshore wind, we must bolster innovation in an end-to-end ecosystem–from concept to commercialization–that supports this game-changing industry. The launch of Equinor’s Offshore Wind Innovation Hub will build a strong network that allows new cleantech businesses, investors, and entrepreneurs to accelerate the time to market for their technologies, overcome industry barriers and bring forward economic opportunity for all New Yorkers.”

 

Pat Sapinsley, Managing Director of Cleantech Initiatives at the Urban Future Lab, said, “Our program will help to build an offshore wind industry in New York state. Equinor and bp will need to rely on smaller players to provide innovative solutions to local issues such as permitting, data collection, modeling, and more. These companies will be in the unique position of working with Equinor to devise and deploy the best solutions for this nascent US industry.”

 

Equinor is the operator on behalf of its 50-50 strategic partnership with bp. Together, the companies are developing the Beacon Wind and Empire Wind projects, which will supply 3.3 gigawatts (GWs) of renewable energy to New York — enough to power nearly two million homes.

 

To learn more, visit the OWIH website at www.offshorewindnyc.com.

 

About the Offshore Wind Innovation Hub (OWIH)

Catalyzing startups to unleash the potential of offshore wind in New York.

 

We leverage our New York City hub to grow the US offshore wind industry by harnessing the entrepreneurial powers of both global industry-leading startups and the local community. Our innovative programming and strong networks connecting innovators, local partners, investors, and industry will foster demonstration opportunities, safety awareness, knowledge transfer, innovation, and job creation. Through collaborative partnerships, we accelerate the local development of new technologies for the national offshore wind industry, to facilitate cost-efficiency gains. Our commitment to diversity and equity will advance inclusive supply chain and business development and accelerate the green economy in New York.

 

About Equinor

Equinor is one of the largest offshore wind developers in the United States.

Equinor is actively developing three projects: Empire Wind 1, Empire Wind 2, and Beacon Wind 1. Once completed, these projects will produce enough electricity to power about 2 million New York homes and will help generate more than $1 billion in economic output to New York State. Equinor is also a provisional winner of a lease area on the Outer Continental Shelf off California.

 

The United States is an attractive growth market for Equinor, with an ambition to install 12-16 GW of renewables capacity globally by 2030.

 

About bp

bp’s ambition is to become a net-zero company by 2050 or sooner, and to help the world get to net-zero. bp is America’s largest energy investor since 2005, investing more than $130 billion in the economy and supporting about 230,000 jobs. For more information on bp in the US, visit www.bp.com/us.

 

About the National Offshore Wind Research and Development Consortium (NOWRDC)

The National Offshore Wind Research and Development Consortium, established in 2018, is a not-for-profit public-private partnership focused on advancing offshore wind technology in the United States through high-impact research projects and cost-effective and responsible development to maximize economic benefits. Funding for the Consortium comes from the U.S. Department of Energy and the New York State Energy Research and Development Authority (NYSERDA), with each providing $20.5 million, as well as contributions from the Commonwealths of Virginia and Massachusetts and the States of Maryland and Maine, and New Jersey, bringing total investment to approximately $47 million. For more information, please visit nationaloffshorewind.org.

 

About New York City Economic Development Corporation (NYCEDC)

New York City Economic Development Corporation is a mission-driven, nonprofit organization that creates shared prosperity across New York City by strengthening neighborhoods and creating good jobs. We work with and for communities to bring emerging industries to New York City; develop spaces and facilities for businesses; empower New Yorkers through training and skill-building; and invest in sustainable and innovative projects that make the city a great place to live and work. To learn more about what we do, visit us on Facebook, Twitter, LinkedIn, and Instagram.

 

About the Urban Future Lab at the NYU Tandon School of Engineering

The Urban Future Lab (UFL) at NYU Tandon School of Engineering is New York City’s premier innovation hub for smart cities, the smart grid, and clean energy. As an integral part of Tandon’s Sustainable Engineering Initiative and NYU Tandon Future Labs network, the UFL is home to programs focused on policy, education, and market solutions for the green economy. Due to generous funding from our sponsors, UFL provides unmatched access to industry stakeholders, strategic advice, marketing and branding support, investor networks, and a community of like-minded founders. Our portfolio includes industry-leading startups in the areas of renewable energy, smart buildings, transportation, and resource-efficiency. The Urban Future Lab is leading the way to a more sustainable world by connecting people, capital, and purpose to advance market-ready solutions to address climate change. For more information about UFL, visit ufl.nyc and follow us on Twitter and LinkedIn. For more information about NYU Tandon, visit engineering.nyu.edu.

Contacts

Lauren Shane, Senior Communications Manager, Equinor Renewables US

Laush@equinor.com
+1 (917) 392 4252

Sayar Lonial, Associate Dean for Communications & Public Affairs, NYU Tandon School of Engineering

sayar.lonial@nyu.edu
+1 (646) 997-3721

Kori Groenveld, Program Manager, National Offshore Wind Research & Development Consortium

Kori.groenveld@nationaloffshorewind.org
+1 (805) 657 7197

Categories
Business

AM Best comments on Credit Ratings of Elevance Health, Inc. and its subsidiaries following acquisition announcement

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has commented that the Credit Ratings (ratings) of Elevance Health, Inc. (Elevance) (Indianapolis, IN) [NYSE: ELV] and its insurance subsidiaries entities remain unchanged following the Jan. 23, 2023, announcement that Elevance will be acquiring Louisiana Health Service and Indemnity Company dba Blue Cross and Blue Shield of Louisiana (BCBSLA). BCBSLA is an independent licensee of the Blue Cross Blue Shield Association and offers a diversified portfolio of health products that are similar to the core insurance subsidiaries of Elevance. BCBSLA serves more than 1.9 million members with approximately $1.8 billion in capital and surplus as of year-end 2021.

 

AM Best will continue to monitor developments as BCBSLA, a mutual company, goes through various legal, regulatory and financial steps needed to be acquired by Elevance, a publicly traded company. In addition, it has been over a decade since Elevance last added a Blue plan to the enterprise and it is unclear how long it will take to obtain the necessary approvals in the current environment. While Elevance recently stressed its focus on joint ventures and partnerships with various Blue plans, the announcement indicates that there may be an interest toward a full merger of additional Blue plans into the organization. In AM Best’s opinion, there is a possibility that this acquisition, if successful, may prompt other transactions of a similar nature, especially given that a number of Blue plans that have converted to a mutual holding company from a nonprofit structure over the past decade. Following the transaction, AM Best anticipates Elevance’s financial leverage to increase slightly above its long-term target of 40%. However, Elevance has shown an ability to manage the financial leverage down to below 40% following temporary fluctuations due to debt issuances and acquisitions. Elevance also has a high level of financial flexibility, supported by its large commercial paper program, parent company cash and a revolving credit facility. AM Best notes that BCBSLA is well-capitalized with a history of profitable, albeit fluctuating, results and the acquisition will be accretive to earnings. Elevance plans to maintain its current business strategy and the transaction is expected to close in the second half of 2023 following regulatory approval.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jennifer Asamoah
Senior Financial Analyst
+1 908 439 2200, ext. 5203
jennifer.asamoah@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Doniella Pliss
Director
+1 908 439 2200, ext. 5104
doniella.pliss@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Science

Tevogen Bio announces positive Proof-of-Concept clinical trial results of its off-the-shelf, allogeneic cytotoxic CD8+ T Cell therapy for treatment of acute high-risk COVID patients, first clinical product of company’s precision cell therapy platform

  • The primary study endpoints were related to safety. No dose-limiting toxicities or significant adverse events related to TVGN 489, including Cytokine Release Syndrome, were observed in any patient at any dose level.
  • Secondary endpoints measuring the reduction of viral load and the presence of cellular and humoral anti-COVID-19 responses after treatment were met.
  • Fifty percent (50%) of treatment arm patients were immunocompromised versus six percent (6%) of observational arm patients.
  • Treatment arm patients were infected by a variety of COVID variants ranging from Delta through Omicron BA.5.2.
  • Observational arm patients were treated with standard of care including monoclonal antibodies.
  • Key observational findings: All treatment arm patients returned to their baseline level of health within 14 days of treatment. No incidence of COVID reinfection or Long COVID was observed in any treated patient at the time of the six (6) month follow up.

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio today announced positive topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company’s first clinical product of its precision T Cell therapy platform, for the treatment of acute high-risk COVID-19 patients. TVGN 489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with precise targets across the SARS-CoV-2 genome, not just the Spike protein. To date, TVGN 489 targets, identified early in the pandemic, persist in the most recent SARS-CoV-2 variants. The open label comparative trial was conducted at Thomas Jefferson University Hospital in Philadelphia to assess the safety and feasibility of TVGN 489 when given at one of four escalating doses. Twelve ambulatory patients with newly diagnosed COVID-19 infection who were at higher risk for infection-related complications due to advanced age or CDC-defined comorbid conditions such as heart, lung, liver, and kidney disease, hypertension, diabetes, cancer, or obesity were treated on the trial. Eighteen patients, who also met these criteria but did not receive TVGN 489 because of lack of HLA matching, were enrolled on an observational arm in the study and treated with standard of care including monoclonal antibodies.

The treated patients had between 2 to 5 comorbidities each and 6 out of 12 (50%) were immunocompromised due to treatment for cancer or autoimmune disease. Multiple COVID-19 variants were detected in the group. Safety endpoints included infusion reactions, grade 4 adverse events, GVHD, marrow aplasia, neurotoxicity and CRS.

 

Table 1. Treatment arm (n=12)

Safety Criteria as Defined in the Study Protocol

Trial Result

Infusion Reactions (≥ Grade 3)

0/12

Cytokine release syndrome, (Grade ≥ 2)

0/12

Neurotoxicity (Grade ≥ 2)

0/12

Graft versus Host Disease

0/12

Grade ≥4 Adverse Events

(Related to the CTL therapy & outside the spectrum of identified COVID related adverse events)

0/12

 

Safety endpoints were reviewed after each dose level and confirmed by an independent Data and Safety Monitoring Committee at Jefferson and by both internal and external Medical Monitors who provided permission to escalate to the next dose level. Based on the data in Table 1, safety was confirmed with the minimum required number of patients per dosing level. In addition to safety endpoints, secondary endpoints measuring the reduction of viral load and the presence of cellular and humoral anti-COVID-19 responses after treatment were also met.

 

Enrollment was completed in nine months, and six-month follow-up for all patients concluded on January 19, 2023. In the treatment arm, no patient experienced progression of their COVID-19 infection and all patients returned to their baseline level of health within 14 days of treatment. There were no incidences of COVID-19 reinfection or Long COVID observed in any treated patient through the 6-month follow-up period. While patients in the treatment group experienced COVID-19 symptom relief in a rapid, consistent timeframe as self-reported and confirmed by the investigators, patients on the observation arm showed improvement in a less consistent, and in some cases, longer time frame.

 

The study investigators plan to submit the full data for publication in a peer-reviewed journal in the upcoming weeks.

 

“The highly encouraging data of TVGN 489 allows us to turn our attention to the critical unmet need in the COVID-19 landscape. Immunocompromised and the elderly and infirm usually do not benefit from currently available prevention or treatment strategies for COVID-19 and remain highly vulnerable to poor outcomes with a COVID-19 infection. These patients, as well as those individuals with Long COVID, urgently require new treatment options,” said Dr. Dolores Grosso, DNP, the Principal Investigator of the trial.

 

“I’m greatly encouraged by the POC trial experience of TVGN 489 and hopeful that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of patients,” said Dr. Neal Flomenberg, MD, Tevogen’s Chief Scientific Officer.

 

“Tevogen’s goal is to provide access to the vast and unprecedented potential of personalized immunotherapies for large patient populations impacted by common cancers and viral infections. The ability to administer TVGN 489 in the outpatient setting and the ongoing work by Tevogen scientists to use this product in diverse patient populations, highlights Tevogen Bio’s commitment to patient accessibility,” said Tevogen founder and CEO Dr. Ryan Saadi, MD, MPH.

 

Tevogen’s research pipeline includes treatment for other serious viral infections and cancers using their precision T Cell platform.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T-cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple, precise candidate targets on viral or malignant cells are selected in advance for T cell sensitization and effector functions with the goal of overcoming the mutational escape capacity of cancer cells and viruses while limiting cross-reactivity.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to provide access to the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections. The ability to administer TVGN-489 in the outpatient setting and the ongoing work by Tevogen scientists to use this product in diverse patient populations, highlights Tevogen Bio’s commitment to patient accessibility.

 

About Tevogen Bio

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 701

Communications@Tevogen.com