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).

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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.

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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.

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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])

On January 8, 2026 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported following approval at its 2025 Extraordinary General Shareholders’ Meeting, that Foresee Pharmaceuticals USA Inc., the Company’s fully-owned US subsidiary, has officially signed an exclusive global licensing agreement with Primevera Therapeutics, LLC (hereinafter referred to as "Primevera") for its MMP-12 inhibitor programs. The agreement includes FP-025, FP-020 and third-generation MMP-12 inhibitors currently in the drug discovery stage.

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In return, Foresee USA will receive an upfront payment of 10 million USD, future potential milestones of up to 574.5 million USD and tiered single-digit percentage royalties. [Should Primevera sublicense its rights under the Agreement, Foresee will be entitled to a tiered percentage of all proceeds received by Primevera as part of its sublicense agreements, in lieu of the milestones and royalties]. Furthermore, Foresee USA will hold a 19% equity interest in Primevera. This transaction will have a positive and material impact on boosting Foresee’s working capital and shareholder equity, while reducing R&D expenses and reinforcing financial stability, with a focus on near to mid-term profitability.

This strategic move marks a transformative milestone for Foresee, enabling the company to streamline operations and prioritizes its SIF (Stabilized Injectable Formulation) portfolio. Foresee is at a pivotal junction in its growth trajectory, and intends on building its revenue stream by concentrating resources on CAMCEVI, and its FP-001, 6-month long-acting injectable which has recently completed a successful pivotal P3 study in central precocious puberty patients (CPP), with an NDA submission targeted in 2026. The CAMCEVI six-month formulation has demonstrated stable sales in the U.S. and the three-month formulation, which holds broader commercial potential is expected to launch in Q4 2026. Foresee is also exploring its strategic options related to the future commercialization of FP-001 in CPP. Simultaneously, the agreement with Primevera allows Foresee to maintain significant upside in its NCE (New Chemical Entity) pipeline, while maximizing capital efficiency and working towards profitability.

Going forward, Primevera will assume all subsequent costs for the MMP-12 inhibitors. The development will focus on the following key programs:

FP-020: Preparing an Investigational New Drug (IND) application for a Phase II clinical trial in asthma, with submission to the U.S. FDA expected in early 2026.

FP-025: Preparing for future Phase II clinical trials in rare disease indications.

"Over the past decade Foresee has shown unwavering commitment to the discovery and development of MMP-12 inhibitors, which has allowed us to become recognized globally as a leader in this space. Our partnership with Primevera allows us to continue this mission in a more focused and streamlined way while we foster Foresee’s path to profitability and continue to build the SIF business-" Stated Dr. Ben Chien, PhD. Foresee’s Chairman and CEO.

(Press release, Foresee Pharmaceuticals, JAN 8, 2026, View Source [SID1234661866])

On January 8, 2026 STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, reported a strategic collaboration with Alida Biosciences Inc. (AlidaBio), a company at the forefront of epitranscriptomics and RNA modification analysis. STORM will utilize AlidaBio’s advanced EpiPlex and EpiScout next-generation sequencing (NGS) platforms to detect and quantitatively measure transcript-specific N6-methyladenosine (m6A) RNA modifications resulting from METTL3 inhibition. This will be achieved using STORM’s first-in-class METTL3 inhibitor, STC-15, which is the first small molecule drug targeting an RNA-modifying enzyme to enter human clinical trials.

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Post-transcriptional modification of RNA, including N6-methyladenosine (m6A), adds a crucial layer of regulation to RNA metabolism, influencing processes like synthesis, stability, maturation, transport, and translation. The METTL3/14 methyltransferase complex catalyzes the deposition of m6A, and inhibition of METTL3 reduces global m6A levels, disrupting RNA regulation. In this collaboration, STORM and AlidaBio will focus on the impact of METTL3 inhibition on RNA regulation, specifically m6A dynamics, in clinical samples from cancer patients treated with STC-15, currently in Phase 1/2 clinical trials.

In collaboration, the teams will correlate changes in m6A modifications at the transcript level with clinical response to treatment and identify baseline m6A features that could predict sensitivity to METTL3 inhibition. The collaboration aims to validate m6A-regulated genes and cell types affected by METTL3 inhibition, exploring epitranscriptomic biomarkers to guide patient selection and enrichment strategies for future clinical trials.

Dr. Eric Martin, Chief Development Officer of STORM Therapeutics, said: "AlidaBio has demonstrated exceptional expertise and leadership in the field of RNA modification analysis, particularly through the development of advanced NGS technologies capable of detecting key epitranscriptomic modifications in both healthy and diseased settings. Through this collaboration, our shared goal is to extend our understanding of transcript-specific m6A changes in relation to clinical benefit and patient response, to improve outcomes for cancer patients treated with STC-15."

Dr. Gudrun Stengel, Chief Executive Officer of AlidaBio, commented: "By applying the advanced features of our EpiPlex and EpiScout platforms, we aim to advance the clinical development and efficacy evaluation of STC-15 through comprehensive m6A biology analysis in patient samples. Our collaborative efforts are focused on generating deeper insights to ultimately deliver greater benefits for patients."

This collaboration highlights the growing importance of epitranscriptomics in drug development, combining targeted RNA-modifying enzyme inhibition with advanced molecular profiling to inform precision oncology strategies.

(Press release, STORM Therapeutics, JAN 8, 2026, View Source [SID1234661865])