On December 18, 2025 Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its lead program, CBI-1214. This approval enables Cartography Bio to initiate a Phase I clinical trial for CBI-1214, a T-cell engager being developed for the treatment of colorectal cancer (CRC).

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In addition to the IND approval, Cartography Bio also announced that CBI-1214 has been granted Fast Track designation by the FDA. This status is designed to facilitate the development and expedited review of drugs that treat serious conditions and fill an unmet medical need, underscoring the potential of CBI-1214 and the urgent, unmet need among patients with CRC. These milestones mark the next steps forward in bringing a potential new, highly specific, tumor antigen therapy to patients with CRC. Cartography anticipates initiating its Phase I clinical trial in the first quarter of 2026.

Kevin Parker, Cartography Bio CEO, said, "Receiving IND approval and Fast Track designation for CBI-1214 represent two important steps forward for Cartography, further validation of our ATLAS and SUMMIT discovery platforms, a tribute to the hard work and ingenuity of our entire team and crucial progress toward addressing the unmet needs of colorectal cancer patients."

Dirk Nagorsen, MD, Cartography’s CMO, added, "This IND approval allows us to advance CBI-1214, our novel T-cell engager, rapidly into clinical development. The Fast Track designation further validates the significant unmet need we are targeting in CRC and the potential impact of our approach. We look forward to expeditiously advancing our Phase I trial."

CBI-1214, Cartography’s lead program, is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating CRC patients. The target, which has minimal expression on healthy cells, is uniquely expressed within the microsatellite stable (MSS) and microsatellite instability-low (MSI-L) subtypes of CRC, which represent the vast majority of CRC patients and remains a major area of unmet medical need. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer diagnosed in both men and women in the United States, and the second leading cause of cancer-related deaths globally. According to the American Cancer Society, an estimated 153,020 new cases of colorectal cancer are diagnosed annually in the U.S., leading to approximately 52,550 deaths. Despite advances in treatment, many patients face significant challenges, particularly in advanced stages, highlighting the urgent need for innovative and more effective therapeutic options.

(Press release, Cartography Biosciences, DEC 18, 2025, View Source [SID1234661528])

On December 18, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech", or "the Company") reported the closing of its acquisition of CureVac N.V. (Nasdaq: CVAC, "CureVac") and that the subsequent offering period (the "Subsequent Offering Period") of the exchange offer (the "Offer") for all outstanding shares of CureVac expired today at 12:01 a.m. Eastern Time.

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As previously published, as of the expiration time of the Subsequent Offering Period, a total of 195,341,219 CureVac shares, collectively representing approximately 86.75% of CureVac’s issued and outstanding shares, were validly tendered in the Offer, of which 11,269,809 CureVac shares were validly tendered in the Subsequent Offering Period. Considering the final exchange ratio of 0.05363 of a BioNTech American Depositary Share ("ADS") per CureVac share as published on November 26, 2025 and the payment of cash in lieu of fractional BioNTech ADSs, in total, 10,475,287 BioNTech ADSs have been, or will be, delivered to tendering holders of CureVac shares, of which 604,201 BioNTech ADSs will be delivered to holders tendering during the Subsequent Offering Period.

(Press release, BioNTech, DEC 18, 2025, View Source [SID1234661527])

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 FoRx Therapeutics, a clinical-stage biotechnology company developing precision anti-cancer therapeutics, reported the close of an insider-led USD 50 million (CHF 40 million) Series A financing. The funding will be used to advance Phase 1 clinical development of its lead drug candidate, FORX-428, a potential best-in-class PARG (poly (ADP-ribose) glycohydrolase) inhibitor designed to target and disrupt the DNA Damage Response (DDR) in advanced solid tumors.

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Existing investors including EQT Life Sciences, Pfizer Ventures, Novartis Venture Fund and M Ventures participated in the financing including a first closing in June 2024, which provided funding through the Investigational New Drug (IND) application for FORX-428 and the initiation of the Phase 1 trial.

Tarig Bashir, CEO of FoRx Therapeutics, said: "The FoRx team is proud to have earned the continued trust and conviction of this sophisticated syndicate of leading strategic and specialist investors. The funds from this investment will allow us to achieve initial clinical readout in our ongoing Phase 1 trial of FORX-428, which has shown very strong anti-tumor efficacy in multiple preclinical in vitro and in vivo tumor models. We are looking forward to reinforcing its best-in-class PARG inhibitor characteristics and potential to make a significant difference to patients, with initial clinical data expected in mid-2026."

The discovery that distinct genetic subsets of cancer are exceptionally vulnerable to drugs that interfere with the DNA Damage Response (DDR) led to the approval of PARP inhibitors more than 10 years ago, transforming cancer treatment. FoRx is pursuing a next-generation DDR target, PARG, which shows significant potential as a new treatment for patients whose cancers are resistant to, or have become resistant to, PARP inhibitors.

Vincent Brichard (EQT Life Sciences), Board member at FoRx Therapeutics, said: "Advances in PARG inhibition hold significant potential as a therapeutic strategy in Oncology. Our syndicate’s continued support of FoRx reflects our confidence in both, the lead candidate FORX-428, and the strong progress achieved by its experienced management team."

FoRx’s ongoing first-in-human Phase 1study of FORX-428, a novel PARG inhibitor targeting the DDR in advanced solid tumors is progressing as planned, with initial data readout expected by mid-2026. The open-label study, which began recruitment in August 2025 in the United States, is evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors who have exhausted standard-of-care options.

FORX-428 is a proprietary, orally available small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG). PARG is a DNA repair enzyme considered important for the survival of certain genetically defined cancers with specific DDR deficiencies or high replication stress. In preclinical studies, FORX-428 demonstrated robust anti-tumor activity across multiple solid tumor types underscoring the novel compound’s outstanding potential in both monotherapy and combination settings. FORX-428 was well tolerated, demonstrating drug-like pharmacology and a favorable safety profile.

(Press release, FoRx Therapeutics, DEC 18, 2025, View Source [SID1234661525])

On December 17, 2025 Talus Bioscience, Inc. ("Talus Bio"), an AI-enabled regulome therapeutics company, reported a strategic collaboration with PRISM BioLab Co., Ltd. ("PRISM") to accelerate the discovery and development of novel small-molecule modulators of transcription factor (TF) and protein-protein interaction (PPI) targets. The collaboration combines Talus Bio’s pioneering regulome profiling and AI-guided drug discovery platform with PRISM’s innovative chemistry.

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"This collaboration gives us an unprecedented opportunity to pursue targets that have resisted conventional drug discovery," said Alex Federation, PhD, CEO and Co-Founder of Talus Bio. "Integrating PRISM’s chemistry with Talus’ regulome profiling and AI models allows us to see, in real time, how compounds reshape transcriptional networks in human cells. It’s a step-change in our ability to drug the undruggable."

Under the agreement, the companies will deploy PRISM’s proprietary small-molecule libraries in Talus Bio’s AI-guided regulome profiling screens to identify and optimize novel compounds against high-value TF and PPI targets. The collaboration aims to generate first-in-class chemical matter with direct functional effects on TF and PPI activity in live human cells. Talus Bio and PRISM will share the costs of discovery research and development and any profits generated from out-licensing and commercialization of discovered drug products.

"We are delighted to partner with Talus on this exciting project," commented Dai Takehara, PRISM’s President and CEO. "We at PRISM have developed chemistries for PPI targets, but because of the complex nature of these targets, it is often challenging to properly model protein-protein interactions in a biochemical assay. Even when we are successful, we can interrogate only one target at a time, whereas Talus can profile hundreds to thousands of these targets in parallel and in their native environment. We believe that the combination of PRISM’s chemistry platform and Talus’s regulome profiling platform has the potential to discover a plethora of inhibitors against previously ‘undruggable’ TF and PPI targets and open a path for the development of novel therapeutics."

This collaboration is a pivotal step in establishing a systematic, scalable strategy to address TF and PPI targets. Together, the companies are creating a unified platform capable of revealing and modulating regulatory mechanisms that have remained undruggable for decades. The approach opens the door to long-needed therapies for transcriptionally driven diseases that lie beyond the capabilities of traditional small-molecule approaches.

Talus Bio will be attending the 2026 J.P. Morgan Healthcare Conference in San Francisco, January 12–15. For information on partnership and co-development opportunities, contact the Talus Bio team here. Follow Talus Bioscience on LinkedIn for the latest news and updates.

(Press release, Talus Bioscience, DEC 17, 2025, View Source [SID1234661516])