Delta-Fly Pharma Inc.: Abstracts submission for Phase I Clinical Trial of DFP-14927 to 2024 ASCO annual meeting

On February 7, 2024 Delta-Fly Pharma reported that following the previous information on Jan. 5th. in 2024, we are excited to share our latest development status (Press release, Delta-Fly Pharma, FEB 7, 2024, View Source [SID1234639924]).

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A Phase I clinical dose-finding study of DFP-14927 in patients with solid tumors has been completed at MD Anderson Cancer Center and the University of California, Los Angeles in the United States. Subsequently, the concentration of DFP-10917, the active component of DFP-14927, delivering into cancer tissue in patients treated with DFP-14927 is being measured to confirm PK/PD relationship for the clinical efficacy of DFP-14927.

On 6th Feb. 2024, we are pleased to announce that we have submitted an abstract to the 2024 ASCO (Free ASCO Whitepaper) annual meeting to be held from May 31st this year in Chicago.

DFP-14927 is an amide bond of DFP-10917 to a carboxylic acid at the end of polyethylene glycol (PEG) with a molecular weight of 40,000, and it is extremely stable in human blood after intravenous administration, allowing for weekly treatment regimen. DFP-14927 is a drug delivery system (DDS) with a mechanism that allows selective release of DFP-10917 into cancer tissues by amidolysis of proteases that are highly expressed in them.

Compared to high molecular weight antibody-drug conjugates (ADCs), medium-sized PEG covalent conjugates are known to have retention in blood vessels around cancer and cancer cell membranes and higher permeability into tumors, and therefore, the concentration of DFP-10917 in cancer tissue can be measured by conventional analysis without the use of radioisotope technology.

Soon after the expected effective concentration of DFP-10917 in cancer tissue is confirmed in the study, we plan to conduct an expanded Phase I study, equivalent to a Phase II clinical trial, in patients with colorectal cancer who have failed existing approved drugs.

The composition of matter patent for DFP-14927 has been granted in the United States, Europe, Asian countries and others, which will enable global marketing of DFP-14927.

In collaboration with leading oncology hospitals in the U.S., we are considering the development of DFP-14927 in haematological cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in addition to solid tumors.

For our future global development and marketing strategy, we are considering collaboration with a major global pharmaceutical company that has strength and expertise in the oncology.

I-Mab Signs Agreement to Divest its Assets and Business Operations in China

On February 7, 2024 I-Mab (the "Company") (NASDAQ: IMAB), a global biotech company exclusively focused on bringing highly differentiated immunotherapies and biologics for cancer treatment to patients around the world, reported that as part of its strategy to become a U.S.-based biotech, its Chinese subsidiaries have entered into definitive agreements with I-Mab Biopharma (Hangzhou) Co., Ltd. (the "Hangzhou Company"), an unconsolidated affiliate of the Company, and a group of China-based investors to divest the Company’s assets and business operations in China (Press release, I-Mab Biopharma, FEB 7, 2024, View Source [SID1234639923]).

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"This agreement to divest our operations in China marks an important milestone for I-Mab in bringing a greater focus on the U.S. and ex-China markets," said Raj Kannan, Director and Chief Executive Officer of I-Mab. "Importantly, we believe that this transaction allows us to reduce significant operational costs and enables us to reallocate our capital on current key priorities and new potential opportunities in further strengthening our portfolio while maintaining a strong balance sheet."

Pursuant to the definitive agreements, the Company will transfer 100% of the outstanding equity interest in I-Mab Biopharma Co., Ltd. ("I-Mab Shanghai"), a wholly owned subsidiary of the Company that operates the Company’s business in China, on a cash-free and debt-free basis, to the Hangzhou Company for an aggregate consideration of the RMB equivalent of up to US$80 million, contingent on the Hangzhou Company group’s achievement of certain future regulatory and sales-based milestone events. The Company also retains a right of first negotiation outside of Greater China related to three future investigational new drug candidates.

The definitive agreements also provide that the Company’s wholly owned subsidiary, I-Mab Biopharma Hong Kong Limited ("I-Mab Hong Kong"), will transfer the equity interests it holds in the Hangzhou Company to certain participating shareholders of the Hangzhou Company in exchange for extinguishment of the existing repurchase obligations owed by I-Mab Hong Kong to those shareholders in the amount of approximately US$183 million. The total amount of potential repurchase obligations owed by I-Mab Hong Kong and the Company to the non-participating shareholders of the Hangzhou Company upon the closing of the transaction is expected to range from US$30 million to US$35 million, an amount that includes actual or potential claims in legal proceedings by the non-participating shareholders against I-Mab Hong Kong and the Company in connection with the aforementioned transaction.

The Special Committee to the Board of Directors (the "Board") of the Company, consisting of Mr. Conor Chia-hung Yang, Dr. Ruyi He, and Mr. Shuai Chen, each of whom is an independent and disinterested director of the Board, led the evaluation and negotiation of the transaction on behalf of the Company. Kroll, LLC served as an independent financial advisor to the special committee and issued a fairness opinion. The Board, acting upon the unanimous recommendation of the special committee, resolved that the proposed transaction is in the best interest of I-Mab and is fair from a financial point of view to the Company and approved the transaction. The transaction is subject to closing conditions and is expected to close by the end of March 2024.

Once the transaction is completed, the Hangzhou Company will acquire I-Mab drug assets in China, including the Greater China rights for eftansomatropin alfa, felzartamab, uliledlimab, givastomig, and lemzoparlimab; bear all future development costs of these assets; and be responsible for the operations of the research & development (R&D) center of I-Mab Shanghai and the manufacturing facility of the Hangzhou Company.

Concurrent with the entry into definitive agreements and to support the ongoing strategic partnership, the Company participated in the Series C fundraising of the Hangzhou Company for an equity interest subscription of US$19 million in cash. Immediately after the closing of the transaction, the Company will directly and through I-Mab Hong Kong own a total of less than 10% of the Hangzhou Company’s registered capital.

To further its transition to a U.S.-based biotech company, I-Mab announced certain management and personnel changes. Pamela Klein, M.D., has accepted the appointment as the Interim Chairperson of the Company, as Jingwu Zang, M.D., Ph.D., steps down from the Board, effective February 10, 2024, to lead the Hangzhou Company. Andrew Zhu, M.D., Ph.D., will step down from the Board and resign from his executive position with the Company, effective February 10, 2024. Furthermore, Mr. Joseph Skelton has been appointed by the Board to serve as the Company’s Chief Financial Officer, effective February 5, 2024, succeeding Mr. Richard Yeh, who resigned from the Board and his executive positions with the Company. Mr. Skelton brings nearly ten years of experience in investment banking and has advised on transactions with an aggregate transaction value of more than US$20 billion. Mr. Skelton most recently served as a Senior Vice President at Truist Securities, covering the biopharma sector, and previously held roles at Cantor Fitzgerald and Amneal Pharmaceuticals, Inc.

"I want to express my gratitude to Dr. Zang for his unwavering commitment to I-Mab and wish him the greatest of success as he transitions to leading the Hangzhou Company. I also want to take the opportunity to thank Dr. Zhu for his leadership in advancing our pipeline assets and to Mr. Yeh for his contributions and service," Mr. Kannan continued. "I’m pleased to welcome Mr. Skelton and look forward to partnering with him in realizing the potential of our Company to bring innovative medicines to the patients we serve."

Dr. Klein’s appointment as Interim Chairperson of the Board advances I-Mab’s plan of becoming a U.S.-based biotech. "I am delighted with the opportunity to lead the Board as I-Mab continues to progress on its strategic plan. My deep appreciation goes to Dr. Zang, Dr. Zhu, and Mr. Yeh for their dedicated service on the board," Dr. Klein commented.

Fusion Pharmaceuticals to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference

On February 7, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present virtually at the Oppenheimer 34th Annual Healthcare Life Sciences Conference on Wednesday, February 14, 2024, at 10:00 a.m. ET (Press release, Fusion Pharmaceuticals, FEB 7, 2024, View Source [SID1234639922]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

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A webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation date.

Tyra Biosciences to Present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference

On February 7, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that Todd Harris, CEO of TYRA, will present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference on Tuesday, February 13, 2024, at 2pm ET (Press release, Tyra Biosciences, FEB 7, 2024, View Source [SID1234639921]). The conference is being held in a virtual format.

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A live and archived webcast of the presentation will be available via the For Investors page on the Investor section of the TYRA website.

Theriva Biologics Announces Positive Recommendation from the Independent Data Monitoring Committee of VIRAGE, the Phase 2b Clinical Trial of VCN-01 in Combination with Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma

On February 7, 2024 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Independent Data Monitoring Committee (IDMC) recommended the continuation of enrollment as planned into VIRAGE, a multinational, Phase 2b, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Theriva Biologics, FEB 7, 2024, View Source [SID1234639920]).

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According to the IDMC’s comprehensive assessment of clinical data from patients enrolled across 6 sites open in the U.S. and 9 sites open in Spain, the ongoing Phase 2b trial will continue without any changes to the protocol. No safety concerns were raised based on the evaluation of data presented at the IDMC meeting. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials. Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01, providing the first clinical evidence of the feasibility of repeated systemic dosing. VIRAGE remains on track to complete enrollment in the first half of 2024.

"The positive IDMC review of VCN-01 safety following repeated systemic dosing marks a significant step forward for our lead program. VCN-01 is a highly differentiated, systemic, selective, stroma-degrading oncolytic adenovirus," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "With the IDMC’s recommendation, we will continue to drive forward the VIRAGE study and explore the potential of VCN-01 to improve outcomes in first-line metastatic PDAC patients treated with standard-of-care chemotherapy. We have shown that repeated systemic dosing of VCN-01 is feasible from a safety perspective, and can now focus on whether the repeated-dose VCN-01 regimen may lead to improved clinical outcomes for patients with PDAC and other solid cancers."

About VIRAGE
VIRAGE is a two-arm Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. VIRAGE is expected to enroll up to 92 adult participants at up to 25 sites across the US and Spain. In both the control and treatment arms, patients will receive gemcitabine/nab-paclitaxel standard-of-care chemotherapy over 28-day cycles. In the treatment arm only, patients will also receive systemically administered VCN-01 seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response. Since this is an open-label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by the emerging data. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24).

About VCN-01
VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).