Alligator Bioscience to present new OPTIMIZE-1 data on mitazalimab at ASCO Gastrointestinal Cancers Symposium 2026

On January 9, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8–11 January 2026.

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The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator’s continued preparations for mitazalimab’s pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.

Presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final efficacy analysis of the OPTIMIZE-1 study.
Abstract number: 708
Session/Time: Friday, 9 January 2026, 11:30 – 1:00 pm PST ; poster board J4
Presenter: Teresa Macarulla, Dept. of Medical Oncology, Vall d´Hebrón University Hospital, Vall d´Hebrón Institute of Oncology (VHIO), Barcelona, Spain

"The OPTIMIZE-1 program continues to deliver compelling data supporting the potential of mitazalimab in metastatic pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "ASCO GI is one of the most important meetings for gastrointestinal oncology, bringing together leading clinicians and decision-makers in the field. We look forward to sharing these new analyses and to discuss the continued development of mitazalimab with key opinion leaders and clinical advisors."

(Press release, Alligator Bioscience, JAN 9, 2026, View Source [SID1234661844])

Mabqi & Syndivia announce the execution of an exclusive licensing agreement for their jointly discovered ADC

On January 9, 2026 Mabqi reported that Syndivia had exercised an option with Mabqi on a jointly discovered antibody-drug conjugate (ADC) acquired by a Pharma company.

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This option was exercised as part of a research collaboration launched in 2023 between Mabqi and Syndivia to discover and develop a new ADC drug candidate with indications in Prostate Cancer.

This step marked a major milestone in the collaboration between the two companies, combining their complementary strengths: Mabqi’s LiteMab Antibody Discovery Studio and Syndivia’s GeminiMab ADC platform. The antibody was discovered through the LiteMab discovery studio, tailored to meet the precise functional requirements of the final drug candidate, including affinity, developability, and pharmacological properties. Syndivia subsequently designed the final ADC candidate and carried out the full preclinical characterization.

"We are delighted that Syndivia has exercised this option and successfully demonstrated the potency of this candidate within such a short timeframe", said Sylvain Yon, CEO of Mabqi. "The combination of our LiteMab Antibody Discovery Studio with Syndivia’s cutting-edge conjugation platform has proven to be a highly effective approach, enabling the rapid discovery of a drug candidate with strong clinical potential. Through this collaboration, Mabqi reinforces its focus on advancing research in areas of significant medical need by joining forces with partners who contribute complementary expertise and technologies, creating synergies that accelerate the discovery of new treatments for patients."

(Press release, Mabqi, JAN 9, 2026, View Source [SID1234661841])

32 Biosciences to Launch $40 Million Series A at J.P. Morgan to Advance First-in-Class GI Mucosal-Immune Therapeutics

On January 8, 2026 32 Biosciences, a gastrointestinal (GI)-focused biotechnology company pioneering gut mucosal-immune science to prevent and treat GI diseases, reported that it will officially launch its $40 million Series A financing during the 2026 J.P. Morgan Healthcare Conference (January 12–15, 2026).

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The Series A financing is intended to advance CS-0003, a first-in-class Mucosal-Immune Modulator (MIM) designed to buffer the GI tract by coating and protecting the mucosal barrier, suppressing bacterial virulence, and modulating the mucosal-immune system. The lead indication is prevention of gastrointestinal surgical site infections (GI SSI), with potential expansion into inflammatory bowel disease (IBD) and prevention of colon cancer recurrence, where mucosal barrier dysfunction and immune dysregulation play a central role.

"Launching our Series A at JPM is a key step as we advance CS-0003 into the clinic and build our GB discovery platform," said Peter Farmakis, Chairman & Chief Executive Officer of 32 Biosciences. "We’re restoring and protecting the gut mucosal-immune system—an overlooked but central driver of surgical outcomes and chronic disease—with the goal of meaningfully improving outcomes for patients facing serious GI disease."

A differentiated therapeutic and platform built around gut mucosal-immune biology

32 Biosciences is advancing a first-in-class therapeutic and a metabolomics-based discovery platform to identify and enable new approaches to restore and protect the GI mucosal-immune system across multiple high-unmet-need indications, starting with GI surgical site infection.

CS-0003, a first-in-class Mucosal-Immune Modulator (MIM) being advanced through IND-enabling studies and into Phase I clinical development, with plans to advance through Phase II efficacy in GI SSI; and
GB: the GI Discovery Platform, a metabolomics-based platform designed to quantify signatures of gut mucosal function and host-microbe interactions to enable therapeutic discovery, development, and future clinical decision support.
Together, CS-0003 and GB are designed to support a differentiated pipeline across high-unmet-need GI indications.

Series A launch at JPM

At the J.P. Morgan Healthcare Conference, 32 Biosciences will meet with prospective investors and strategic partners to discuss the Series A financing and its planned use of proceeds, including advancing CS-0003 into the clinic and progressing GB partnerships and validation.

(Press release, 32 Biosciences, JAN 8, 2026, View Source [SID1234661884])

Parabilis Medicines Announces Oversubscribed $305 Million Financing to Support Ongoing FOG-001 (zolucatetide) Clinical Development Across a Broad Range of Tumors and Advance Pioneering Pipeline and Helicon Platform

On January 8, 2026 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer using its Helicon peptide platform to drug historically undruggable targets, reported the successful closing of a $305 million Series F financing.

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The round was co-led by RA Capital Management, Fidelity Management & Research Company and Janus Henderson Investors, with participation from new investors including Frazier Life Sciences, Soleus Capital, and a life science-dedicated investment fund. There was also strong participation from existing investors, including venBio Partners, Cormorant Asset Management, Nextech Invest, ARCH Venture Partners, Milky Way Investments, GV, accounts advised by T. Rowe Price Associates, Inc., Marshall Wace, General Catalyst, Invus, Farallon Capital Management, Foresite Capital, Rock Springs Capital, HBM Healthcare, Samsara BioCapital, Catalio Capital Management, Sixty Degree Capital, Alderline Group and others. The financing was completed at an increased valuation relative to the company’s prior financing.

The financing will support the continued clinical development of FOG-001 (zolucatetide) – the company’s lead investigational Helicon peptide and first and only direct inhibitor of the elusive β-catenin:TCF interaction – including progression toward a registrational trial in desmoid tumors and continued evaluation across a range of genetically simple and more complex tumor types. The financing will also support the progression of the company’s targeted discovery pipeline, including its promising prostate cancer franchise, and additional efforts to leverage the company’s Helicon platform to unlock disease targets long considered "undruggable."

"Our goal at Parabilis is to develop medicines with the potential to deliver truly life-changing impact for patients who urgently need new treatment options," said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "We are deeply grateful for the support and confidence of our world-class investors, which will enable us to advance zolucatetide across a range of rare and common tumor types – creating the opportunity for a pipeline within a product – while continuing to build a unique and differentiated pipeline through our Helicon platform designed to address biology that has remained out of reach for decades."

This financing follows presentations of compelling preliminary data in the fourth quarter of 2025 from Parabilis’s ongoing Phase 1/2 trial of zolucatetide, a first-in-class therapy targeting the key downstream node within the Wnt/β-catenin pathway. This pathway is implicated in millions of cancer cases annually yet remains unaddressed by any approved therapies.

Early data demonstrated meaningful single-agent activity of zolucatetide across five low complexity tumor types driven by Wnt/β-catenin alterations – including desmoid tumors, an indication granted Fast Track Designation from the U.S. Food & Drug Administration, and adamantinomatous craniopharyngioma (ACP). The findings also showed strong scientific rationale for combination approaches in more biologically complex cancers, including microsatellite-stable colorectal cancer (MSS CRC). At next week’s J.P. Morgan Healthcare Conference, Parabilis will share additional data in desmoid tumors, as well as early clinical evidence of zolucatetide’s potential in hepatocellular carcinoma (HCC) and familial adenomatous polyposis (FAP). Parabilis plans to provide additional data readouts in 2026.

In parallel, Parabilis continues to demonstrate the broad applicability of its Helicon platform beyond zolucatetide, with encouraging data from its preclinical Helicon degrader programs targeting ERG and allosteric ARON, two historically intractable targets in prostate cancer. Together, these programs highlight the platform’s ability to repeatedly generate multiple differentiated therapeutic candidates against high-value targets.

"Successfully drugging a target long considered undruggable requires both deep biological insight and a differentiated technological approach. With Helicons, Parabilis has established a platform with the potential to generate a robust pipeline of impactful therapies," said Jake Simson, Ph.D., Partner at RA Capital. "We believe this financing positions the Parabilis team to build enduring value by translating the company’s recent data and breakthroughs into multiple development opportunities."

Despite decades of progress, the vast majority of the human proteome remains "undruggable" with today’s modalities. Many key disease drivers are intracellular—out of reach for antibodies—and have only flat protein surfaces that small molecules can’t effectively bind. Parabilis’s α-helical Helicon peptides, designed based on the pioneering work of Greg Verdine, are engineered to overcome these limitations, creating a new path to selectively engage disease-driving targets long considered out of reach.

(Press release, Parabilis Medicines, JAN 8, 2026, View Source [SID1234661883])

A2 Biotherapeutics Announces FDA Clearance of IND for A2B543 for Treatment of Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors that Express Mesothelin and Have Lost HLA-A*02 Expression

On January 8, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors. A2B543 contains a membrane-tethered IL-12 booster, designed to enhance potency and persistence of Tmod cells and address the immunosuppressive tumor microenvironment. It will be evaluated as a second arm of the EVEREST-2 master protocol (NCT06051695) in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express mesothelin (MSLN) and have lost HLA-A*02 expression.

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"FDA clearance of our IND for A2B543 is an important milestone for A2 Bio. Our ability to launch four clinical programs in just four years highlights the adaptability and robustness of the Tmod platform and the promising clinical pipeline of Tmod-based cell therapies. We are committed to speeding the clinical development of our therapies to help patients with solid tumors who need new treatment options," said Jim Robinson, chief executive officer of A2 Bio.

A2 Bio continues to advance its clinical development of A2B694, A2B395, the BASECAMP-1 prescreening study, and other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and beyond.

Enabling Efficient Patient Identification for A2 Bio Precision Medicine Studies

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1,2

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2B543

A2B543 is designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. A2B543 is comprised of autologous Tmod cells transduced with two lentiviral vectors: one expressing both the HLA-A*02-targeted blocker and the MSLN-targeted CAR activator; and a second expressing a membrane-tethered IL-12 (memIL-12) booster. The inducible memIL-12 booster, which activates only upon engagement with tumor antigens, is designed to reduce toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of Tmod.3

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added memIL-12 booster. The EVEREST-2 study is recruiting participants with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, JAN 8, 2026, View Source [SID1234661882])