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).

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 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

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).

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!

"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])

On January 8, 2026 Kazia Therapeutics (NASDAQ: KZIA) reported that its Chief Executive Officer, John Friend, MD, will be in San Francisco next week to participate in meetings during the annual J.P. Morgan Healthcare Conference week (JPM Week).

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!

During the week, Kazia will connect with existing and prospective institutional investors, sell-side analysts, and strategic collaborators, including both established partners and potential new industry counterparties, as part of ongoing investor relations and business development outreach.

"We are entering JPM Week with strong strategic and clinical momentum," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "Following the successful completion of our recent financing, we are well capitalized to execute across multiple near-term catalysts, including an anticipated triple negative breast cancer clinical and biomarker update before the end of the month. At the same time, renewed industry focus on the PI3K/mTOR pathway—particularly in hormone receptor–positive, HER2-negative breast cancer—underscores the growing relevance of approaches that are designed to be differentiated and patient-friendly, such as paxalisib."

Anticipated Clinical and Program Updates

Kazia expects to provide a clinical and translational update before the end of the month from its ongoing Phase 1b trial evaluating paxalisib in advanced triple-negative breast cancer (TNBC). The update is anticipated to include additional clinical response observations, together with expanded circulating tumor cell (CTC) and CTC cluster biomarker analyses, further evaluating paxalisib’s potential impact on metastatic disease biology.

As previously reported, paxalisib treatment in advanced TNBC has been associated with rapid and sustained reductions in CTCs and CTC clusters, biomarkers increasingly linked to metastatic potential and adverse clinical outcomes. Notably, prior observations in the patient demonstrated that temporary interruption of paxalisib dosing was accompanied by a rebound increase in CTC clusters, with subsequent re-initiation again suppressing overall CTC count and cluster formation, supporting a mechanistically distinct and pharmacodynamically consistent contribution beyond that of immunotherapy alone.

The impending update could meaningfully expand the clinical and biological dataset supporting paxalisib in metastatic breast cancer, providing further context around treatment response, biological consistency, and translational relevance, and may further inform the broader development strategy for paxalisib across breast cancer subtypes.

In addition, Kazia plans to provide the first update on its potential first-in-class PD-L1 protein degrader program. This program is designed to leverage a novel and differentiated mechanism of action, reflecting evolving scientific strategies aimed at addressing biological complexity, resistance, and durability challenges in immune-based cancer therapies.

(Press release, Kazia Therapeutics, JAN 8, 2026, View Source [SID1234661869])

On January 8, 2026 Astellas Pharma U.S., Inc. (Head of US Commercial: Mike Petroutsas, "Astellas") reported the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in ESMO (Free ESMO Whitepaper) Open, characterizing the management of adverse events on treatment adherence and efficacy of VYLOY (zolbetuximab) plus chemotherapy and evaluating strategies for managing these side effects.

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 exploratory analyses, which included 1,072 patients, reported higher mPFS and mOS estimates for patients treated with zolbetuximab plus chemotherapy after censoring data from patients who discontinued early or had inadequate treatment exposure due to nausea and/or vomiting.1

Pooled data from the analyses show that mPFS with zolbetuximab plus chemotherapy was 10.4 months (95% confidence interval [CI]: 8.8-12.2), and 8.2 months (95% CI: 7.7-8.4) with placebo plus chemotherapy. The hazard ratio [HR] versus placebo was 0.65 (95% CI: 0.56-0.76).1

Similarly, mOS with zolbetuximab plus chemotherapy was 17.9 months (95% CI: 16.4-19.5) and 13.7 months (95% CI: 12.4-15.3) with placebo plus chemotherapy with a HR versus placebo of 0.69 (95% CI: 0.60-0.80).1

Sam Klempner, MD, Gastrointestinal Medical Oncologist, Massachusetts General Hospital, Boston:

"Nausea and vomiting are important symptoms that can affect patient comfort and treatment continuity for advanced gastric or GEJ cancer, particularly during early cycles when these symptoms are most common. Supportive care measures are therefore an important part of managing patients receiving cancer therapy."

Zolbetuximab (VYLOY) is an FDA approved monoclonal antibody for patients with HER2-negative, CLDN18.2-positive advanced gastric or GEJ cancer. In combination with chemotherapy, zolbetuximab demonstrated statistically significant improvements in PFS and OS compared with placebo plus chemotherapy in the SPOTLIGHT and GLOW Phase 3 clinical trials.2,3 In SPOTLIGHT and GLOW, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared with placebo plus chemotherapy. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.2,3

The ad-hoc analyses in these studies showed an association between nausea and vomiting and higher treatment discontinuation rates compared with placebo.

Timothy Forrest, RN, BSN, Massachusetts General Hospital, Boston:

"Early cycles are a critical window for supporting patients starting treatment for advanced gastric or GEJ cancer. Since we know nausea and vomiting are common in this setting, preparing patients, monitoring closely, and using guideline-aligned supportive care can make a meaningful difference to their comfort and ability to continue treatment as planned."

Within the published exploratory analyses, the effect of guideline-aligned supportive care on early nausea and vomiting associated with zolbetuximab plus chemotherapy was assessed.1 Data indicate that use of a guideline-recommended three-drug antiemetic regimen was associated with a higher proportion of patients who did not experience nausea or vomiting at cycle 1 dose 1 (C1D1; 60.8% and 75.3%, respectively).1

Additionally, across the SPOTLIGHT and GLOW trials, 57.9% of patients who received steroids at C1D1 did not experience nausea (versus 49.7% without steroids) and 63.7% did not experience vomiting at C1D1 (versus 62.6% with no steroids).1

Finally, results from the combined analysis suggest that a faster initial infusion may have contributed to adverse events such as nausea and vomiting observed during the first infusion. The authors noted that infusion-rate modifications may help mitigate these symptoms.1

Exploratory ad hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value.

Astellas is committed to supporting patients and the oncology care community by continuing to generate insights that enhance the patient and healthcare professional experience and better understand supportive care needs and treatment experiences.

About the SPOTLIGHT Phase 3 Clinical Trial

SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced, unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint was progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.

Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in The Lancet on April 14, 2023. The final analyses of SPOTLIGHT and GLOW, including additional supporting data in the appendix, were later published as a Letter to the Editor in the New England Journal of Medicine in 2024.

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

About the GLOW Phase 3 Clinical Trial

GLOW is a Phase 3, global, multi-center, double-blind, randomized study assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint was PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints included OS, ORR, DOR, safety and tolerability, and quality-of-life parameters.

Data from the GLOW study were initially presented at the March 2023 ASCO (Free ASCO Whitepaper) Plenary Series with an updated oral presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3, 2023, and were subsequently published in Nature Medicine on July 31, 2023.

For more information, please visit clinicaltrials.gov under Identifier NCT03653507.

About VYLOY

VYLOY (zolbetuximab) is a monoclonal antibody (mAb) specifically designed to target tumor cells that express claudin 18.2 (CLDN18.2), a transmembrane protein. By binding to CLDN18.2, zolbetuximab induces cancer cell death and inhibits tumor growth by activating two distinct immune system pathways – antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), as demonstrated in preclinical studies.

In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18.2 immunohistochemical staining.

Astellas collaborated with Roche on the Ventana CLDN18 (43-14a) RXDX assay which, where approved, can be used by pathologists or laboratories to identify patients eligible for targeted treatment with zolbetuximab.

(Press release, Astellas, JAN 8, 2026, View Source [SID1234661868])

On January 8, 2026 MediLink Therapeutics ("MediLink") reported that it has entered into a new collaboration and exclusive licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the development and commercialization of YL201, an investigational novel antibody-drug conjugate (ADC) asset targeting B7H3 across numerous solid tumor types.

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!

Under the terms of the agreement, MediLink will grant Roche an exclusive license to develop, manufacture, and commercialize YL201 worldwide, excluding the mainland of China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. MediLink will receive upfront and near-term milestone payments of US$ 570 million, together with additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales of YL201 outside of China, once approved.

This new agreement for YL201 builds on the successful collaboration initiated in January 2024 for the YL211 (c-Met ADC) program. MediLink and Roche are now deepening their collaboration through the development of YL201. Through this new agreement, the two companies will leverage their complementary strengths to accelerate YL201’s path to global regulatory approvals. United by a shared commitment to scientific innovation and patient benefit, MediLink and Roche strive to bring this potentially transformative therapy option quickly to patients.

Dr. Tongtong Xue, Ph.D., Founder, Chairman and CEO of MediLink, stated "We are thrilled to again enter into collaboration with our valued partner Roche. We are impressed by Roche’s unparalleled expertise in global clinical development for oncology assets and look forward to working jointly to expedite worldwide patient access to YL201 once approved."

"YL201 has demonstrated promising clinical data, and this collaboration with Roche marks a transformative step for its global development. This agreement provides YL201, a key asset from our innovative TMALIN platform, with the necessary worldwide reach and resources to potentially become a new treatment option, addressing critical unmet needs for patients with various solid tumors," said Dr. Jiaqiang Cai, Ph. D., Co-founder, co-CEO and CSO of MediLink.

Boris L. Zaïtra, Head of Corporate Business Development at Roche, commented on the agreement: "Our deepening collaboration with MediLink on YL201 reflects Roche’s commitment to leveraging cutting-edge innovation from around the globe to address unmet patient needs, particularly within oncology and lung cancer as one of our strategic priorities. We are excited to combine MediLink’s and Roche’s expertise in ADCs with our well established global development and commercial presence to bring this promising potential therapy option to patients."

About YL201

YL201 is a B7H3-targeting ADC developed using MediLink’s proprietary Tumor Microenvironment-Activatable LINker-payload (TMALIN) platform. YL201 is currently under investigation in multinational clinical trials for a variety of advanced solid tumors. In China, it has advanced into two Phase III registrational trials for small cell lung cancer (SCLC) and nasopharyngeal carcinoma (NPC). Preliminary clinical data have demonstrated promising objective response rates and survival benefits in 2L SCLC patients. In June 2025, the FDA granted Breakthrough Therapy Designation for YL201 for the treatment of SCLC, following its previous conferral of three Orphan Drug Designations, including SCLC, NPC and Esophageal Squamous Cell Carcinoma (ESCC).

(Press release, Hoffmann-La Roche, JAN 8, 2026, View Source [SID1234661867])