Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors

On February 28, 2025 Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy (Press release, Fapon Biopharma, FEB 28, 2025, View Source [SID1234650762]).

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FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation.

PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability.

This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization.

"Global collaboration is central to our vision," stated President Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy."

BridgeBio Oncology Therapeutics (BBOT) and Helix Acquisition Corp. II Announce Business Combination Agreement to Create Publicly Listed Biotechnology Company Advancing a Pipeline of RAS and PI3Kα-Targeting Medicines

On February 28, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT"), a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies, and Helix Acquisition Corp. II (Nasdaq: HLXB) ("Helix"), a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, reported that they have entered into a definitive business combination agreement (Press release, BridgeBio, FEB 28, 2025, View Source [SID1234650763]). Upon closing of the transaction, the combined company will be renamed "BridgeBio Oncology Therapeutics, Inc." The combined company’s common stock is expected to be listed on Nasdaq under the ticker symbol BBOT.

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"Management—Directors’ Fiduciary Duties and Conflicts of Interest"

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In addition to approximately $196 million held in Helix Acquisition Corp. II’s trust account (assumed as of the closing and assuming no redemptions by Helix’s public shareholders), the transaction also includes commitments for an approximately $260 million PIPE from a group of premier institutional investors. The PIPE is led by Cormorant Asset Management and includes ADAR1 Capital Management, BC Capital, investment funds affiliated with Deerfield Management Company, Enavate Sciences, Eventide Asset Management, Novo Holdings A/S, Octagon Capital, Omega Funds, Paradigm BioCapital Advisors, StemPoint Capital LP, Surveyor Capital (a Citadel company), Wellington Management, and another leading mutual fund.

Eli Wallace, PhD, Chief Executive Officer of BBOT, said, "This financing and transaction mark a significant milestone for our company. We are profoundly grateful to the patients who participate in our trials, our dedicated BBOT team members, and our investors. We believe this transaction is the optimal path to advance our programs and make a meaningful impact on patients affected by deadly cancers."

Net proceeds from the transaction are expected to provide BBOT with the capital needed to accelerate the development of three lead programs: BBO-8520, BBO-10203, and BBO-11818. BBO-8520 is a direct inhibitor of KRASG12C in both the "ON" and "OFF" states and is currently being evaluated in the Phase 1 ONKORAS-101 trial (NCT06343402) for patients with KRASG12C mutant non-small cell lung cancer. BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action that is designed to inhibit the physical interaction between RAS and PI3Kα, resulting in the inhibition of RAS-driven PI3Kα-AKT signaling in tumors. BBO-10203 is being evaluated in the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locally advanced and unresectable or metastatic HER2+ breast cancer, HR+/HER2- breast cancer, KRAS mutant colorectal cancer and KRAS mutant non-small cell lung cancer. BBO-11818 is a pan-KRAS inhibitor targeting mutant KRAS in both the "ON" and "OFF" states with strong potency against KRASG12D and KRASG12V mutants. BBOT expects to dose the first patient with BBO-11818 in the first half of 2025.

Bihua Chen, Founder and Chief Executive Officer of Cormorant, and Chief Executive Officer of Helix, said, "BBOT’s team has some of the brightest minds in oncology, with a proven track record of developing new medicines. The company’s pipeline has the potential for paradigm-shifting impact on the treatment of some of the highest prevalence malignancies and we look forward to seeing patient impact further materialize as the clinical trials move forward."

Transaction Overview

Upon the closing of the business combination, BBOT expects it will have access to approximately $550 million in cash (prior to the payment of transaction costs of BBOT and Helix and assuming no redemptions by Helix’s public shareholders and existing BBOT cash at closing of $100 million). The proceeds will be funded through a combination of approximately $196 million held in a trust account by Helix (assumed as of the closing and assuming no redemptions by Helix’s public shareholders) and an approximately $260 million concurrent PIPE financing of common stock issued at the SPAC redemption price per share to leading institutional investors. Assuming a share price of $10.36 per share and no redemptions of Helix shares by Helix’s public shareholders, BBOT (as a combined entity) is expected to have an implied pro forma equity value of approximately $949 million at closing. BBOT shareholders will not receive any cash proceeds as part of the transaction and will roll 100% of their equity into the combined company.

The boards of directors of both BBOT and Helix have approved the proposed transaction, which is expected to be completed in the third quarter of 2025. The transaction is subject to, among other things, the approval of the stockholders of both BBOT and Helix, and satisfaction or waiver of the conditions stated in the definitive business combination agreement.

Leerink Partners, Morgan Stanley, Cantor, and Oppenheimer & Co. acted as placement agents for Helix in connection with the PIPE transaction. Leerink Partners also acted as lead capital markets advisor to Helix. Piper Sandler acted as capital markets advisor to BBOT. Goodwin Procter acted as legal counsel to BBOT. White & Case LLP acted as legal counsel to Helix. Kirkland & Ellis LLP acted as legal counsel to the placement agents.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by Helix with the SEC and will be available at the SEC’s website at www.sec.gov.

AMGEN TO PRESENT AT THE 45TH ANNUAL TD COWEN HEALTH CARE CONFERENCE

On February 28, 2025 Amgen (NASDAQ: AMGN) reported that it will present at the 45th Annual TD Cowen Health Care Conference at 9:10 a.m. ET on Wednesday, March 5, 2025 (Press release, Amgen, FEB 28, 2025, View Source [SID1234650749]). Jay Bradner, executive vice president of Research and Development at Amgen, will participate in a fireside chat at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Delta-Fly Pharma, Inc.: Progress of Development Status of the Combination Study of DFP-10917 with Venetoclax

On February 28, 2025 Delta-fly Pharma reported that following to the previous information on Dec. 9th. in 2024, it is excited to share its latest development status (Press release, Delta-Fly Pharma, FEB 28, 2025, View Source [SID1234650764]).

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Regarding the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) in second-line therapy (NCT06382168), the Data Management Committee (DMC) has approved the tolerability of all six patients in the Phase I (dose finding) portion of the Phase I/II study, and we are moving to the Phase II portion of the trial for efficacy testing as of today, on 28th Feb., 2025. We are pleased to inform that we already have multiple potential patients waiting to participate in the trial.

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Eisai Enters into License Agreement for the Development and Distribution of Fibroblast Growth Factor (FGF) Receptor Selective Tyrosine Kinase Inhibitor Tasurgratinib in Greater China Region (Mainland China, Hong Kong, Macau, and Taiwan) with SciClone

On February 28, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the company has entered into a license agreement granting the exclusive development and distribution rights for the fibroblast growth factor (FGF) receptor selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, Japan brand name: TASFYGO, "tasurgratinib") in the Greater China region (mainland China, Hong Kong, Macau, and Taiwan, "licensed regions") to a subsidiary of SciClone Pharmaceuticals (Holdings) Limited (Headquarters: Shanghai, China, "SciClone") (Press release, Eisai, FEB 28, 2025, View Source [SID1234650748]). Eisai will maintain the rights to tasurgratinib worldwide outside of the licensed regions and continue to manufacture and market it in Japan, where it has been already launched.

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Under the terms of this agreement, Eisai will receive a contractual upfront payment. Additionally, Eisai will receive milestone payments based on the progress of development and regulatory approval, as well as sales milestone payments and certain royalties based on sales revenue after the product launch.

Tasurgratinib is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against FGFR1, FGFR2 and FGFR3. Tasurgratinib was approved in Japan for the treatment of patients with unresectable biliary tract cancer with FGFR2 gene fusions or rearrangements that progressed after cancer chemotherapy. The medicine was launched in Japan in November 2024. A Phase I clinical trial (ClinicalTrials.gov, NCT04572295(New Window)) is underway in Japan for patients with estrogen receptor-positive and HER2-negative breast cancer.

SciClone is a global biopharmaceutical company with an integrated platform for the development and commercialization of innovative therapies for cancer and severe infection, and a strong presence in the Greater China region. Through the conclusion of this agreement, Eisai expects to maximize the value of tasurgratinib in licensed regions, ensuring the earliest possible contribution to patients in need of the medicine.