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The FDA approves PharmaMar’s Investigational NewDrug (IND) application for the combination of PM54with immunotherapy in solid tumors

On December 18, 2025 PharmaMar (MSE:PHM) reported that it has received an investigational new drug (IND) approval from the U.S Food and Drug Administration (FDA), to start a Phase 1/2 multicenter clinical trial for the combination of PM54 with immunotherapy for the treatment of advanced stage solid tumors.

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This refers a Phase 1 study for the evaluation of the safety, followed by a Phase 2 to evaluate the safety and efficacy profile in patients affected by tumors with significant unmet medical needs such as advanced-stage melanoma, endometrial cancer, extrapulmonary neuroendocrine cancer and mesothelioma.

The approval of this IND allows, after the positive evaluation of the dossier with the preclinical data, manufacturing information and the protocol of the proposed clinical trial, the beginning of the activities related to the study in the United States.

PM54 is a novel inhibitor of the oncogenic transcription of the ecteinascidin family, currently being evaluated as a monotherapy in Phase 1/1b studies, in patients with advanced solid tumors to assess safety, tolerability, pharmacokinetics and preliminary antitumor activity.

Preliminary data from ongoing studies, together with evidence from preclinical studies and the mechanism of action, support the advancement of the clinical development plan for PM54 and the initiation of the study in combination with immunotherapy.

(Press release, PharmaMar, DEC 18, 2025, View Source [SID1234661531])

Orum Therapeutics Secures Approximately US$100 Million to Accelerate Development of Leading Degrader Antibody Conjugate Programs to Treat Serious Diseases

On December 18, 2025 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that it secured 145 billion KRW (approximately US$100 million) in convertible referred stock investments. This round is led by returning investor KB Investment and includes other existing investors, IMM Investment, Woori Venture Partners and Stassets Investment. New investors include Weiss Asset Management, a Boston-based global investment firm, and Korea Investment Partners, a major institutional venture investor with a strong track record in biotech investment. Additional new investors in this round are DSC Investment, Company K Partners, AON Investment, and DAYLI Partners.

"Our mission is to deliver degrader-antibody conjugate therapeutics that apply powerful degrader payloads with antibody-targeted precision to improve the treatment of cancer and other serious diseases," said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of Orum. "This investment supports the next stage of our growth as we prepare to advance our next therapeutic programs towards clinical evaluation, develop additional novel payloads, and continue to build platforms that can generate differentiated drug candidates across oncology and beyond. We appreciate the confidence of both new and existing investors who share our commitment to delivering meaningful innovation for patients."

This investment supports the advancement of ORM-1153 and additional programs in Orum’s pipeline and continued refinement of the Company’s DAC platforms, including development of additional novel payload classes beyond GSPT1. It also supports the expansion of Orum’s scientific and operational infrastructure as the Company advances additional targeted DAC programs based on principles of selectivity, potency, and rational payload design. These efforts are foundational to Orum’s strategy to generate differentiated therapeutic DAC programs for oncology and other serious diseases.

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, DEC 18, 2025, View Source [SID1234661530])

Crinetics Pharmaceuticals to Participate in The 44th Annual J.P. Morgan Healthcare Conference

On December 18, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, will present at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 13, 2026 at 9:45 a.m. Pacific Time.

To access the live audio-only webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

(Press release, Crinetics Pharmaceuticals, DEC 18, 2025, View Source [SID1234661529])

Cartography Receives FDA Investigational New Drug (IND) Approval and Fast Track Designation for Lead Program CBI-1214 for Colorectal Cancer

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).

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])

BioNTech Publishes Final Results of the Exchange Offer for CureVac

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.

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])