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GSK Licenses Noetik’s AI Foundation Models in Anchor Partnership to Transform Cancer Therapeutic Research and Development

On January 8, 2026 Noetik, an AI-native biotech company pioneering self-supervised machine learning and high-throughput spatial data to develop next-generation cancer therapeutics, reported a five-year strategic collaboration and AI model licensing agreement with GSK.

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The partnership provides GSK’s AI and Therapeutics teams with a direct, non-exclusive license to access Noetik’s OCTO-VC virtual cell foundation models in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The collaboration combines GSK’s leadership in AI and tumor immunology with Noetik’s industry-first virtual cell simulation technology to accelerate the development of novel medicines. Additionally, the companies will collaborate to generate bespoke human spatial datasets, applying human-first biological simulation to areas of strategic interest.

Noetik’s platform is powered by the largest spatial biology dataset in oncology, specifically engineered to train self supervised AI. Comprising hundreds of millions of spatially resolved human cells, this data powers Noetik’s virtual cell foundation models capable of simulating gene expression, cell states, and tumor-immune interactions. "Simulation of patient biology with world models like OCTO-VC will drive the next wave of discovery and therapeutic development. These models let us go beyond the limited data available from any one patient to ask ‘What if?’ questions about patient genes, proteins, cells, and tissue," said Daniel Bear, Ph.D, Vice President of AI at Noetik.

"We built Noetik to move the industry from probabilistic ‘shots on goal’ to deterministic engineering of cancer drugs," said Ron Alfa, M.D., Ph.D., CEO & Co-Founder of Noetik. "This agreement validates a new paradigm in biotech: the licensing of human foundation models. GSK is now equipped with one of the most extensive oncology multimodal spatial training sets in existence, allowing them to query tumor biology with a level of resolution that was previously impossible. We are proud to partner with their team to find better medicines, faster."

Kim Branson, SVP Global Head of Artificial Intelligence and Machine Learning at GSK added: "Foundation models are only as good as the underlying training data they are built upon. Noetik’s approach to generating high-quality spatial data at scale to train foundation models is novel. Integration of these models in GSK’s drug discovery and development process has the potential to deepen our understanding of biology and support our development of novel medicines."

Under the terms of the agreement, GSK receives a non-exclusive license to Noetik’s OCTO-VC foundation models in NSCLC and CRC. This collaboration includes $50 million in upfront capital and near-term milestones. Additionally, the deal establishes a subscription-based framework, with GSK paying annual licensing fees to access the models, validating Noetik’s platform as a scalable, revenue-generating engine.

"This deal defines a new asset class in biotech," said Shafique Virani, M.D., Chief Business Officer of Noetik. "We are moving the industry from AI services collaborations to licensing AI infrastructure. To our knowledge, this is among the first and largest transactions monetizing a biological foundation model as a scalable enterprise asset."

This partnership reflects a growing industry shift toward AI-guided discovery and development frameworks that integrate real human biology, enabling improved translation and more confident therapeutic development.

(Press release, GlaxoSmithKline, JAN 8, 2026, View Source [SID1234661874])

FDA Clears Next-Generation RefleXion Platform That Improves Tumor Detection

On January 8, 2026 RefleXion Medical, an external-beam theranostic oncology company, reported the U.S. Food and Drug Administration has cleared its next generation, autonomously-guided oncology platform, the RefleXion X2 with SCINTIX therapy, for the treatment of primary and metastatic lung and bone tumors.

The X2 platform delivers a 20-fold increase in positron emissions tomography (PET) sensitivity, significantly increasing the biological signal for tumor detection. This increased sensitivity aims to expand the number of patients eligible for SCINTIX therapy.

"Clinical outcomes data1 from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment," said Sam Mazin, Ph.D., CTO and co-founder of RefleXion. "The goal of the X2 platform is to scale applicability of SCINTIX therapy to a broader patient population, including those with early-stage or metastatic disease."

The key innovation of the X2 platform is its wide field-of-view PET detector technology, which quadruples the imaging field of view to generate sharper images with less noise and improve visualization of moving tumors. The X2 expands the field of view of the first-generation system from 5 to 20 centimeters, expanding autonomous delivery of SCINTIX therapy to a much larger area.

"We have effectively expanded the ‘eyes’ of the machine to generate more real time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment," continued Mazin.

Design advancements also allow upgrades across the existing installed base, enabling current RefleXion customers to transition to the full capabilities of the new X2 platform with minimal disruption.

The company will leverage its participation in the 44th annual J.P. Morgan Healthcare Conference to be held Jan. 12-15 in San Francisco to discuss the newly cleared X2 platform and other commercialization milestones with select investors.

(Press release, RefleXion, JAN 8, 2026, View Source [SID1234661873])

Enodia Therapeutics Secures €20.7M to Advance a Small-Molecule Platform for Targeted Protein Degradation Enabled by Proteomics and Machine Learning

On January 8, 2026 Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, reported it has raised €20.7 million (US$25 million) in a Seed financing. The round was co-led by Elaia, Pfizer Ventures and Bpifrance, as part of the InnoBio investment strategy, with participation from Wallonie Entreprendre, Argobio Studio, MACSF, The Institut Pasteur, InvestSud, Sambrinvest and Mission BioCapital.

Enodia’s proprietary discovery platform, built on Institut Pasteur science, uses machine learning to selectively modulate the SEC61 translocon, where secreted and transmembrane proteins are directed into the secretory pathway at the point of synthesis. This enables intervention upstream of disease, without compromising vital physiological functions, and before damage occurs. Leveraging a large chemical space spanning several families of well-characterized inhibitors, together with a tailored library of signal-peptide cell lines, the company integrates machine-learning-driven selectivity, proteomics-based secretome analysis and structural validation to guide rational drug design. This innovative strategy allows Enodia to unlock previously undruggable secreted and membrane protein targets to treat high-unmet-need conditions.

"We are grateful for the strong support and confidence from our investors, which reflects their conviction in our scientific approach and team," said Yves Ribeill, Chief Executive Officer of Enodia Therapeutics. "This financing supports the advancement of our small-molecule approach to modulating the SEC61 translocon, with machine learning enabling greater selectivity in targeted protein degradation than previous approaches. Over the next year, we plan to progress our lead program toward preclinical candidate selection, thereby establishing a key value inflection point and the foundation for subsequent IND-enabling development."

Florian Denis, Partner at Elaia, commented: "Enodia’s rational, proteomics-enabled drug design approach provides strong confidence in the team’s ability to repeatedly translate complex SEC61 biology into truly differentiated drug candidates, supported by a highly experienced management team. Beyond individual programs, the platform unlocks exceptionally deep and expandable therapeutic opportunities across a broad range of disease areas, creating significant long-term pipeline and partnering potential."

"Our investment reflects strong interest in Enodia’s differentiated approach addressing disease by controlling protein secretion and enabling precise targeting of pathogenic proteins," said Irena Melnikova, Partner at Pfizer Ventures. "We are pleased to support Enodia’s efforts to rapidly advance a broad pipeline of SEC61-targeted small-molecule medicines across inflammatory diseases and autoimmune disorders, and beyond."

Enodia Therapeutics was created by Argobio Studio and The Institut Pasteur, with early platform and translational validation further supported by the Mission BioCapital Platinum Program.

"Enodia is tackling a significant unmet medical need by targeting the secretion pathway at the initiation of protein synthesis," said Olivier Martinez, Senior Investment Director at Bpifrance. "Built on strong scientific foundations from the Institut Pasteur and further developed within France’s Argobio ecosystem, the company’s selective approach to pathogenic secreted and membrane-associated proteins illustrates the type of rigorous, translational innovation we want to support."

Valentin Tonnel, Investment Manager, WE Venture Life Sciences on behalf of the Walloon public investor consortium: "This investment in Enodia reflects WE Venture Life Sciences’ strategy to support breakthrough biology at a very early stage, in close collaboration with leading specialized investors. Enodia’s SEC61 platform, selected by Argobio, illustrates how cutting-edge scientific discoveries can be translated into transformative therapeutic solutions. We are pleased to contribute to the development of this program alongside our partners Sambrinvest and InvestSud within the Walloon region, where a mature life sciences ecosystem offers strong conditions for successful execution."

(Press release, Enodia Therapeutics, JAN 8, 2026, View Source [SID1234661872])

Biomunex Pharmaceuticals will showcase its MAIT Engager Platform during the 11th Annual Oncology Innovation Forum in San Francisco

On January 8, 2026 Biomunex Pharmaceuticals, a biopharmaceutical company specializing in the development of next generation immunotherapies based on the discovery and development of bispecific and multispecific antibodies, today announces its participation at the 11th Annual Oncology Innovation Forum, organized by Sachs Associates, on the 10th of January at the Marines’ Memorial Club in San Francisco (USA).

The 2026 Oncology Innovation Forum programme is designed to discuss key industry trends and milestones; it will feature high-level keynotes and panel discussions covering the latest trends in Pharma and Biotech business development, modalities, targets, and investment. Biomunex’s invitation highlights the company’s commitment to innovative therapeutic approaches in oncology.

Invited for an oral communication, Dr. Simon Plyte, Biomunex CSO (Chief Scientific Officer), will present the Company and its unique and highly differentiated MAIT engager Platform. MAIT engagers are expected to overcome some of the limitations of current CD3+ TCEs, including activation of regulatory T cells (Tregs) and cytokine release syndrome, serious side effects that are difficult to manage for cancer patients.

MAIT engagers, that are as potent as classical CD3+ TCE, have the potential to bring significantly improved safety, providing a larger therapeutic window in solid tumor types. Moreover, MAIT engagers can effectively induce the "SPARK effect" (tumor cytotoxicity with induced secondary immune response), enabling long-term durable anti-cancer response.

Biomunex is notably developing a portfolio of MAIT engager drug candidates, a new therapeutic class in immuno-oncology, that are highly differentiated from classical CD3+ TCEs. MAIT engagers are bispecific antibodies that identify, mobilize and bridge MAIT cells (Mucosal-Associated Invariant T cells), present in all body and particularly in mucosal and barrier tissues, to cancer cells, resulting in MAIT cell activation and directed killing of tumors.

MAIT engagers could become a breakthrough approach in the treatment of many cancers, particularly in solid tumors, significantly widening the therapeutic window.

Based on the proprietary "Plug-and-Play" BiXAb bispecific antibody platform that enables the generation of breakthrough immunotherapies faster than most other bispecific platforms in the field and with excellent drug-like properties and high industrial yield, the Biomunex’ MAIT engager programmes will pave the way for a series of innovative new immunotherapeutics for the treatment of several cancers.

Dr. Pierre-Emmanuel Gerard, Biomunex’s founder and President, concludes: "Our presentation during the 11th Annual Oncology Innovation Forum will enable us to illustrate the differentiation of MAIT engagers and how this innovative and highly promising approach for the treatment of cancer could potentially redefine the standard of care for solid tumors."

Details about Biomunex’ presentations at 11th Annual Oncology Innovation Forum

Oral presentation:
Saturday 10th January 2026, 2:55 PST
Room: Heritage

Marines’ Memorial Club, San Francisco, USA

Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones

On January 8, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported positive initial data from the ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

"We are excited about these initial Phase 1b data, the progress we made throughout 2025 and the year ahead. Our data continue to demonstrate that ELVN-001 has the potential to be the best-in-class active-site TKI for the treatment of CML and an important treatment option across all lines of therapy," said Helen Collins, M.D., Chief Medical Officer of Enliven. "Momentum has been building over the last year leading to significant interest in our Phase 3 clinical trial from sites all around the world. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026."

ELVN-001 Program Updates

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with CML.

Encouraging ELVN-001 Phase 1b Data by 24 Weeks

As of the cutoff date of December 22, 2025, 60 patients were enrolled in the initial cohorts of the Phase 1b trial. Patients were first enrolled in the 80 mg once daily (QD) cohort. Subsequent patients were randomized to either 60 mg QD or 120 mg QD.
Patients enrolled were heavily pretreated, consistent with patients from previously reported datasets. In these 60 patients:
53% of patients received four or more unique prior TKIs.
67% of patients received prior asciminib and 32% received prior ponatinib.
Despite the heavily pretreated patient population, the efficacy data below highlights that ELVN-001 continues to demonstrate the profile of a best-in-class active-site TKI.
Dose (number of patients)

80 mg QD (n=19)

60/120 mg QD (n=41)

Cumulative MMR

47% (n=19)

69% (n=26)

Achieved MMR

38% (n=16)

53% (n=17)

Maintained MMR

100% (n=3)

100% (n=9)

Deep Molecular Response (DMR)

16% (n=19)

35% (n=26)

As of the data cutoff in December:

In the 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. In these mature data, rates of MMR achievement (38%) and DMR (16%) compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs, including asciminib.
In the randomized 60 mg and 120 mg cohorts (n=41), 26 patients were evaluable for efficacy by 24 weeks, reflecting their more recent enrollment. In this cohort, highly encouraging rates of MMR achievement (53%) and DMR (35%) were observed.
Across all Phase 1b cohorts, 100% of evaluable patients in MMR at enrollment maintained, or deepened, their response.
As expected, robust clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response (efficacy or safety) within this range.
ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all evaluated doses. The safety profile observed in these Phase 1b cohorts remained consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified.
Expected 2026 Clinical Milestones for ELVN-001

Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial
Regulatory alignment with the FDA on dose selection and Phase 3 trial design
Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, in the second half of 2026
About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active-site TKI, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

(Press release, Enliven Therapeutics, JAN 8, 2026, View Source [SID1234661870])