On January 9, 2026 AnaptysBio presented its corporate presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, AnaptysBio, JAN 9, 2026, View Source [SID1234661887])

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

On January 8, 2026 Topos Bio, a biotechnology company pioneering AI-driven drug discovery for intrinsically disordered proteins (IDPs), reported the company emerged from stealth with $10.5M in seed funding from Boldstart, Threshold, and Neo, with participation from notable angel investors including Dara Khosrowshahi (CEO of Uber) and Naveen Rao (CEO of Unconventional AI). The company is also releasing a technology report demonstrating state-of-the-art performance of its AI model on this challenging protein class.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Problem: Drugging the Undruggable
Traditional drug discovery relies on the "lock-and-key" model: proteins fold into stable 3D structures, and drugs are designed to fit precisely into their binding pockets. Intrinsically disordered proteins (IDPs) break this paradigm entirely. Rather than adopting a single fixed shape, IDPs rapidly fluctuate through many different conformations. Without stable binding pockets, traditional drugs have nowhere to anchor. Current computational tools fail here because they predict static structures, not dynamic ensembles of constantly shifting shapes. This leaves roughly one-third of the human proteome – including the primary drivers of Alzheimer’s, Parkinson’s, and many aggressive cancers – effectively undruggable by conventional methods.

"Disordered proteins represent one of the last major frontiers in drug discovery – they’re central to devastating diseases but nearly impossible to target with existing methods," said Ryan Zarcone, co-founder and CEO of Topos Bio. "Our platform tackles this by modeling protein dynamics as ensembles rather than static structures. This approach enables rational drug design and opens up an entirely new category of previously undruggable biology."

Topos Bio’s Solution: Frontier AI for disordered proteins
Topos Bio has developed an AI-native integrated discovery platform specifically designed for intrinsically disordered proteins. The company’s AI models generate ensembles that capture how these proteins fluctuate through millions of conformations, then identify binding opportunities within these dynamic structures. Using generative chemistry, the platform designs small molecules optimized to modulate these disordered regions. An integrated wet lab validates and refines these predictions, generating experimental data that continuously improves model accuracy and expands the platform’s capabilities. The company’s initial programs focus on neurodegenerative disorders, followed by oncology and metabolic diseases.

Alongside the announcement, Topos Bio released its first technical report detailing the development and validation behind Topos-1, its foundation model for intrinsically disordered proteins. Across a broad benchmarking suite, Topos-1 outperformed every leading protein foundation model, including AlphaFold, Chai, and Boltz.

"We invested in Topos at inception because Amir and Ryan can solve a fundamental computational problem that’s blocking progress on many of medicine’s most important targets," said Ellen Chisa, Partner at Boldstart. "No one else has the AI and wet lab infrastructure to model disordered proteins, and a reliable model unlocks therapeutic opportunities that no one else can access."

Strategic Collaboration with Gladstone Institutes
To validate its platform in established disease models, Topos Bio is partnering with Gladstone Institutes. The collaboration will focus on discovering novel modulators for α-synuclein, a disordered protein central to Parkinson’s disease pathology.

Steven Finkbeiner, MD, PhD, Director of Gladstone’s Center for Systems and Therapeutics said: "This partnership embodies the spirit of translational collaboration. By combining advanced imaging and disease modeling from our lab with Topos Bio’s novel computational methods, we’re taking a powerful step toward tackling intrinsically disordered proteins, one of the greatest frontiers in neurodegenerative disease biology."

(Press release, Topos Bio, JAN 8, 2026, View Source [SID1234663735])