On March 7, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that the company has taken steps to focus its clinical strategy on the planned future FDA trials for TCB-008 in AML as a monotherapy and other oncology indications in combination with additional assets (Press release, TC Biopharm, MAR 7, 2023, View Source [SID1234628278]).

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The pending protocol submission will be a Phase 1b safety trial, with a relatively small patient population and a short timeline to completion. In conjunction with refocusing the clinical team’s efforts on the USA, the Company intends to file the first IND in the third quarter of 2023 with an expected additional IND to be filed in the fourth quarter or early 2024. At this juncture, the Company is anticipating a dose escalating study of approximately 9 patients with an expansion cohort at the optimal dose.

"Our business development efforts over the last 12 months have generated multiple research collaborations and strategic relationships, the majority of which are US based and beginning to come to fruition," said Bryan Kobel, Chief Executive Officer. "Prioritizing US trials realigns us with our long term goal of becoming a leading commercial stage company, with a myriad of oncological treatment applications for TCB-008 (Omnimmune) as both a monotherapy and as a combination therapeutic. We firmly believe in the potential of our asset and the best way to position the Company for success is to commence with this proposed US trial protocol and to pursue future trials through the FDA pathways. Our partnership with MD Anderson will be valuable, both for this study and future FDA trials, and I anticipate that we’re now better positioned for near term success and sustainability, including potentially multiple data readouts in 2024."

TC BioPharm expects this US clinical trial enrollment to be relatively rapid due to the the fact that America offers a significantly greater pool of patients with more than 20,000 AML diagnoses each year. This transition will allow TC BioPharm to become more economically efficient by simplifying its strategy and reducing manufacturing and production efforts.

On March 7, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported a corporate update and reported financial results for the fourth quarter and year-end of 2022 (Press release, Corbus Pharmaceuticals, MAR 7, 2023, View Source [SID1234628277]).

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"The fourth quarter and recent weeks have been a productive period for Corbus as we continue to evolve into a precision oncology company," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "With the execution of our exclusive licensing agreement for CRB-701, a next generation Nectin-4 ADC, we are excited to have a compelling, differentiated asset in the clinic. Concurrently, we continue on-track to the clinic with CRB-601 supported by our latest pre-clinical data presented at SITC (Free SITC Whitepaper) 2022".

Key Corporate and Program Updates:

CRB-701 next generation Nectin-4 ADC

Acquired CRB-701 through licensing agreement with CSPC Pharmaceutical Group granting exclusive development and commercialization rights in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia.

CRB-701 is designed to achieve an improved therapeutic index and patient convenience and could act on a broad range of Nectin-4 expressing tumors.

Clinical development is underway and will focus on urothelial cancer and other Nectin-4-positive solid tumors potentially including lung, breast and prostate cancer.

CRB-601 blocking the activation of TGFβ

CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block the activation of latent TGFβ within the tumor microenvironment.

CRB-601 significantly inhibits tumor growth as a single agent and enhances the efficacy of anti-PD-1 immunotherapy in checkpoint inhibitor (CPI) sensitive and CPI-resistant tumor models.

Pre-clinical data presented at SITC (Free SITC Whitepaper) 2022 indicate that anti-tumor activity of CRB-601 as a monotherapy correlates with protein expression of αvβ8. CRB-601 is scheduled for IND submission in the second half of 2023 in solid tumor cancer patients with the first patient treated by the end of 2023.

Additions to the Board and Management Changes

Dr. Yong Ben joined the Corbus Board of Directors on March 1, 2023. Dr Ben is a distinguished oncology researcher and pharma industry executive, with multiple drug approvals to his credit. This appointment augments our Board with his extensive oncology experience both in the United States and China.

Craig Millian, the Company’s Chief Operating Officer, will be departing Corbus on April 14, 2023 to pursue other opportunities. "We are very grateful for Craig’s contributions over the past four years. We thank him for his efforts and leadership and wish him well in his future endeavors", stated Yuval Cohen Ph.D., Chief Executive Officer of Corbus.
Financial Results for Fourth Quarter Ended December 31, 2022:

The Company reported a net loss of approximately $10.9 million, or a net loss per diluted share of $2.61, for the three months ended December 31, 2022, compared to a net loss of approximately $10.3 million, or a net loss per diluted share of $2.46, for the same period in 2021. For the year ended December 31, 2022, the Company reported a net loss of approximately $42.3 million, or a net loss per diluted share of $10.15, compared to a net loss of approximately $45.6 million, or a net loss per diluted share of $11.15 for the same period in 2021.

Operating expenses for Q4 2022 increased by $0.8 million to approximately $10.8 million for the three months ended December 31, 2022, compared to $10.0 million in the comparable period in the prior year. The increase was primarily attributable to pre-clinical costs to support IND filing for CRB-601 offset by decreased clinical trial and drug manufacturing costs, as well as an overall reduction in compensation expense. A reverse stock split of 1-for-30 was effected on February 14, 2023 and all per share amounts except the authorized shares have been retroactively adjusted to reflect the reverse split.

As of December 31, 2022, the Company has $59.2 million of cash and investments on hand which is expected to fund operations through the second quarter of 2024, based on the current planned expenditures.

On March 7, 2023 Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, and Sesen Bio, Inc. ("Sesen Bio"), reported the closing of their previously announced merger (Press release, Carisma Therapeutics, MAR 7, 2023, View Source [SID1234628276]). The combined company will operate under the name Carisma Therapeutics Inc. and shares of its common stock will commence trading under the ticker symbol "CARM" on March 8, 2023 on the Nasdaq Global Market.

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"This merger represents a very exciting opportunity for stockholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy," said Steven Kelly, President and Chief Executive Officer of Carisma. "It will provide us with the financial strength to not only continue to develop our lead candidate CT-0508 but also accelerate the growth of our platform and pipeline within and outside of oncology and continue to develop additional strong strategic partnerships."

Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, "I want to thank the entire Sesen Bio team for their steadfast commitment to our mission to save and improve lives. Patients, caregivers and investigators around the world have been important advocates of Sesen Bio and I want to thank them for their support. I am confident in the potential of Carisma’s promising technology and through the combined company, we can continue to advance our shared mission of saving and improving the lives of patients with cancer. I know the future of Carisma is bright and I am optimistic for their continued success."

Concurrent with the closing of the merger, Carisma completed a $30 million financing from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio. The projected cash and cash equivalents as of the close of the business combination are expected to be approximately $140 million, providing anticipated operating runway at least through the end of 2024.

In connection with the closing of the merger, a one-time special cash dividend of $75 million, or approximately $0.36 per share, will be paid no later than March 10, 2023 to Sesen Bio stockholders of record at the close of business on March 7, 2023. Under the terms of the merger, Sesen Bio stockholders also received one Contingent Value Right, which entitles the holder to receive a cash payment related to any potential proceeds from the sale of Sesen Bio’s legacy assets, including Vicineum, and the potential $30 million milestone payment under the Roche Asset Purchase Agreement.

The combined company will be headquartered in Philadelphia, Pennsylvania, and will be led by Steven Kelly, President and Chief Executive Officer of Carisma. The board of directors of the combined company will be composed of seven members, including Sanford Zweifach (Chair), Regina Hodits, Briggs Morrison, Björn Odlander, Chidozie Ugwumba, Steven Kelly (Carisma President & Chief Executive Officer) and Michael Torok.

"The successful completion of this merger marks an important milestone in Carisma’s journey and significantly strengthens its cash resources to advance the company’s differentiated pipeline and platform," said Chairman of the Board Sanford Zweifach. "The dedication of the Carisma team, as well as the support and guidance of our advisors and stockholders, have been instrumental in bringing us to this moment. The Board and I look forward to the opportunities that lie ahead."

SVB Securities acted as the exclusive financial advisor to Sesen Bio for the transaction, and Hogan Lovells US LLP served as Sesen Bio’s legal counsel. Evercore served as lead financial advisor to Carisma for the transaction, and BofA Securities, Inc. also served as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore served as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel.

On March 7, 2023 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the fourth quarter of 2022 after the market closes on Wednesday, March 15, 2023 (Press release, MacroGenics, MAR 7, 2023, View Source [SID1234628275]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Wednesday, March 15, 2023, at 4:30 pm ET.

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Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On March 7, 2023 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a virtual presentation at the Oppenheimer 33rd Annual Healthcare Conference on Tuesday, March 14, 2023 at 2:00 pm (ET) (Press release, Mannkind, MAR 7, 2023, View Source [SID1234628274]).

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Interested parties can access a link to the webcast from the News & Events section of the Company’s website at Events & Presentations. The webcast replay will remain available for 14 days following the live presentation.