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Transgene Publishes Phase I Data Supporting TG4050’s Potential in Preventing Head and Neck Cancer Relapse

On January 9, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the preprint publication on medRxiv of a comprehensive analysis of both the clinical and translational data from the Phase I part of its randomized Phase I/II trial of TG4050, an individualized neoantigen therapeutic vaccine (INTV).

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The manuscript is now available on medRxiv – a preprint platform that enables early scientific visibility by sharing research ahead of journal peer review.

In parallel, the article has been submitted to a peer-reviewed journal and is currently under evaluation.

TG4050: an individualized therapeutic cancer vaccine shows 100% two-year disease-free survival as monotherapy in the adjuvant treatment of operable head and neck cancers

Despite the availability of current treatments, including immune checkpoint inhibitors, about one-third of patients with head and neck squamous cell carcinoma (HNSCC) experience recurrence within two years after surgery. Transgene’s trial with TG4050 was designed to assess whether inducing neoantigen-specific T-cell responses following treatment with an INTV encoding up to 30 predicted tumor neoantigens delivered via a Modified Ankara Virus (MVA) vector could help reduce the risk of relapse.

Half of the participants received TG4050 immediately after completing primary adjuvant treatment, while the other half were administered the vaccine at the time of disease recurrence, as an additional therapy alongside the standard of care.

With 100% disease-free survival at two years, the data suggest that individualized treatment with TG4050 does have the potential to prevent cancer relapses when administered as monotherapy in an adjuvant treatment regimen in patients with high risk, resected, locally advanced HPV-negative HNSCC. In addition, TG4050 was well-tolerated and showed no unexpected safety signals.

Detailed translational findings from patients treated with TG4050 confirm durable, neoantigen-specific T-cell responses

The translational data show that TG4050 induced neoantigen-specific T cell responses in the majority of treated patients (73% of 15 evaluable patients). These responses were durable, with cytotoxic and effector phenotype markers expressed up to one year after the end of treatment.

An overview of these data were first presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (see press release) and support TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy in patients with HNSCC.

TG4050 is currently under further evaluation in a randomized Phase I/II clinical trial (NCT04183166), in patients with HNSCC.

"The publication of TG4050’s Phase I results on medRxiv is an important step for Transgene. Making these data available to the global scientific community underscores our commitment to transparency and scientific rigor. The findings show encouraging evidence of TG4050’s ability to induce durable, neoantigen-specific immune responses and its potential in preventing relapse in patients with HPV-negative operable head and neck cancer. We look forward to advancing TG4050 through Phase II with the same determination and patient-centered approach" said Katell Bidet-Huang, Head of translational medicine at Transgene.

The preprint on medRxiv provides early access to these important clinical findings ahead of peer-reviewed journal publication.

Title: "Viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: immunogenicity and efficacy from a randomized Phase I trial"

(Press release, Transgene, JAN 9, 2026, View Source [SID1234661862])

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.

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.

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).

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.

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])