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 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on Thursday, January 15, 2026 at 11:15am PT / 2:15pm ET, in San Francisco, CA, and will host institutional investor meetings at the event.

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Event: J.P. Morgan 2026 Healthcare Conference
Format: Presentation and 1-on-1 Meetings
Date: January 15, 2026
Time: 11:15AM PT – 11:55AM PT
Location: Westin St. Francis, San Francisco, CA

Webcast: Link will be posted on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source

Please reach out to your J.P. Morgan representative to schedule 1-on-1 meetings with Mr. Sofer and Mr. Levy.

(Press release, Alpha Tau Medical, DEC 18, 2025, View Source [SID1234661526])

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 17, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that it has agreed with AstraZeneca to monetize a portion of Compugen’s rilvegostomig future royalties. Compugen has amended the exclusive license agreement with AstraZeneca, previously entered into in March 2018, to strengthen Compugen’s balance sheet and advance its innovative and differentiated immuno-oncology pipeline.

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Key Transaction Highlights:
•
$65 million upfront payment and a potential additional $25 million upon the next milestone payment on BLA acceptance, for a portion of Compugen’s existing royalty interest in rilvegostomig
•
Compugen shall retain the majority of its future royalties and remain eligible for tiered royalties of up to mid-single digits on future sales and potential future regulatory and commercial milestones of up to $195 million (amount includes the $25 million stated above)

About Rilvegostomig:
•
AstraZeneca is developing rilvegostomig, a first-in-class dual-checkpoint bispecific that delivers co-ordinated PD-1 and TIGIT blockade on the same immune effector cell, restoring antitumor immune activity and supporting the potential for durable, long-term outcomes. The TIGIT component of rilvegostomig is derived from Compugen’s fully owned COM902 which is one of only two clinical-stage Fc-reduced anti-TIGIT monoclonal antibodies currently in development
•
AstraZeneca is advancing rilvegostomig in a broad development program including 11 ongoing Phase 3 trials in patients with lung, gastrointestinal, and endometrial cancers

"This strategic agreement with AstraZeneca reflects the potential significant value of rilvegostomig and Compugen’s differentiated Fc-reduced approach to TIGIT inhibition," said Eran Ophir, Ph.D., President and CEO of Compugen. "This non-dilutive transaction strengthens our financial position and is expected to extend our cash runway into 2029 assuming no further cash inflows. This agreement enables us to continue advancing our innovative and differentiated immuno-oncology pipeline, while retaining significant upside from rilvegostomig’s potential success, representing a key long-term value driver for Compugen and our shareholders."

(Press release, Compugen, DEC 17, 2025, View Source [SID1234661501])

On December 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone.

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Notably, the company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the company’s proposed Phase 3 trial.

"We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib," said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. "Importantly, the regulators’ feedback supports our trial design and key primary endpoint of overall survival, and we are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026. We are also thrilled to expand the planned trial to 510 patients, which gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness. In addition, we are excited to provide an update on overall survival in the Phase 2a trial in the coming weeks."

MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. Immuneering plans to enroll a total of approximately 510 patients in the Phase 3 trial.

The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028. Immuneering also reiterated management’s belief that the company’s current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029.

"The constructive guidance from both agencies validates our scientific approach and our understanding of the unmet need in first-line metastatic pancreatic cancer," said Igor Matushansky, M.D., Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib into Phase 3 and working with investigators worldwide to bring this potentially transformative therapy to patients as expeditiously as possible."

"New therapies for pancreatic cancer are urgently needed," said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center. "The phase IIa data of atebimetinib and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation."

(Press release, Immuneering, DEC 17, 2025, View Source [SID1234661502])