On December 18, 2025 Niowave Inc., a U.S.- based global leader in medical radioisotope production, reported the expansion of its existing supply agreement with AstraZeneca, a global biopharmaceutical company, to a 10-year commitment to deliver Actinium-225 (Ac-225), following AstraZeneca’s decision to exercise its option to increase capacity. The agreement secures a reliable and scalable supply of this critical isotope to advance AstraZeneca’s growing portfolio of radioconjugates (RCs). RCs are a type of cancer treatment that use radioactive particles to target and destroy cancer cells.

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"Our expanded agreement with AstraZeneca underscores Niowave’s central role in scaling high-quality production of medical radioisotopes for the development of targeted cancer treatments," said Mike Zamiara, CEO of Niowave. "We are pleased to play a role in ensuring that AstraZeneca’s promising pipeline of radioconjugates have the isotope supply they need."

Ac-225 is one of the most promising radioisotopes in oncology as its emitted alpha particles deliver highly potent, DNA-damaging energy, enabling precise destruction of tumor cells while limiting harm to surrounding healthy tissue with targeted modalities like RCs. Despite its potential, global supply of Ac-225 remains limited. Niowave’s proprietary superconducting linear accelerator technology and radiochemistry provide sustainable, U.S.-based production to address this need.

As AstraZeneca advances RCs for prostate and other difficult-to-treat cancers, the agreement highlights the critical importance of securing dependable isotope supply.

(Press release, AstraZeneca, DEC 18, 2025, View Source [SID1234661543])

On December 18, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib tablets have been included in the List of Products for Priority Review and the List of Breakthrough Therapy Designation for this indication.

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About Tinengotinib

Tinengotinib is an internally discovered, NDA stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials conducted globally have revealed the potential of tinengotinib to be efficacious in various solid tumors, such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA), the Priority Review and Approval Procedure and the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China for the treatment of CCA.

(Press release, TransThera Biosciences, DEC 18, 2025, View Source [SID1234661542])

On December 18, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.

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"The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options," said Julie Lepin, Senior Vice President and Chief Regulatory Affairs Officer at BeOne.

BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab).

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death.1 HCC accounts for 80% of all primary liver cancers, with the number of new cases expected to double between 2022 and 2050.2 The rising burden of HCC is primarily attributed to the high prevalence of the hepatitis B and hepatitis C viruses (HBV/HBC) and lifestyle factors such as obesity, tobacco, and alcohol consumption.3 With approximately 80% of patients diagnosed in advanced stages and five-year survival rates for this patient population lower than 20%, new treatment options are needed beyond currently available systemic therapy.

About BGB-B2033

BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC5, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.6 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.

(Press release, BeOne Medicines, DEC 18, 2025, View Source [SID1234661541])

On December 18, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, reported that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase shares of common stock. In addition, Cue Biopharma intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of its common stock and/or warrants to purchase shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the securities are being offered by Cue Biopharma.

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H.C. Wainwright & Co. is acting as sole book-running manager for the proposed offering. Newbridge Securities Corporation is acting as co-manager for the proposed offering.

The securities are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023, and declared effective on May 26, 2023. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Cue Biopharma, DEC 18, 2025, View Source [SID1234661540])

On December 18, 2025 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it has entered into the second phase of a research collaboration with Korean preclinical drug screening company Next & Bio. This follows a successful initial engagement that demonstrated the powerful capability of the Next & Bio technology as well as promising preliminary data from the study.

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The collaboration has been investigating the ability of Amplia’s FAK inhibitors to suppress the growth of patient-derived pancreatic cancer cells that possess genetic mutations in the kRAS gene known to be present in >90% of pancreatic cancers. Amplia’s best-in-class FAK inhibitor narmafotinib showed promising activity in these initial tests and this data will be presented at a forthcoming scientific conference.

Building on this promising data, further studies investigating the activity of a combination of narmafotinib with known inhibitors of the mutant kRAS gene will now be undertaken. kRAS inhibitors are an exciting new class of drug in development for a range of cancers including pancreatic cancer, and there is strong scientific rationale for a combination of FAK and kRAS inhibition to provide improved responses.

Next & Bio, a global leading Preclinical research biotech in Seoul, Korea, offers advanced drug screening by testing treatments on cancer cells taken directly from patients. The company has developed these patient-derived cell models specifically for pancreatic cancer. Importantly, these cells are grown to closely replicate the tumour environment for more accurate and predictive results.

Amplia’s Chief Executive Officer and Managing Director, Dr Chris Burns, commented, "The initial phase of our collaboration successfully demonstrated the activity of Amplia’s FAK inhibitors on patient-derived pancreatic cancer cells. Building on these promising results, we are eager to further investigate the potential synergy between narmafotinib and kRAS inhibitors. This next phase of the collaboration is expected to strategically position Amplia for expanded partnering opportunities and commercial growth."

Next and Bio’s Chief Executive Officer Mr. SangWook Park, stated, "We are delighted to build on the success of our initial collaboration and to advance into a second phase of partnership with Amplia Therapeutics. In this collaboration, Next & Bio will leverage its preclinical research platform to investigate synergistic effects with kRAS inhibitors, with the ultimate goal of delivering new therapeutic options for pancreatic cancer patients with high unmet medical needs."

(Press release, Amplia Therapeutics, DEC 18, 2025, View Source [SID1234661539])