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 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.

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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])

On January 8. 2026 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO, Dr Tim Franklin, COO, and Dr Sebastien Goudreau, CSO, will be attending both the JP Morgan Conference and the Biotech Showcase from 12-14 January 2026, in San Francisco, USA.

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The JP Morgan conference and Biotech Showcase are annual premier partnering events, designed to provide biotechnology companies with the opportunity to present to and connect with global Biopharma companies and investors.

(Press release, ImmuPharma, JAN 8, 2026, View Source [SID1234661852])

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 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).

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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])