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MediLink Has Signed an Additional Exclusive Licensing Agreement with Roche

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])

Foresee Pharmaceuticals announces Global Licensing Agreement for MMP-12 Inhibitors with Primevera Therapeutics LLC

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.

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])

STORM Therapeutics and AlidaBio Announce Strategic Collaboration to Accelerate Development of Cancer Therapies Targeting RNA Modifications

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.

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])

KAHR Bio Announces Strong Topline Phase 2 Results for DSP107 in Combination with Anti-PD-L1 Therapy in Colorectal Cancer

On January 8, 2026 KAHR Bio (KAHR or the Company), a clinical-stage biotechnology company developing DSP107, a first-in-class, bispecific 4-1BB–targeted, next-generation T-cell engager, reported topline results from its Phase 2a dose-expansion cohort in late-line metastatic microsatellite stable colorectal cancer (MSS-CRC). DSP107 was evaluated in combination with atezolizumab (Tecentriq), an anti–PD-L1 therapy. The combination demonstrated favorable safety, clinical evidence of antitumor activity, and extended survival, including in patients with liver metastases.

KAHR also announced the closing of a $22 million round in equity financing. The equity investment was led by Flerie AB, Peregrine Ventures, Oriella Ltd. of the Consensus Business Group, aMoon Growth Fund, and the Cancer Focus Fund, with participation from certain additional existing investors and new investors including SPRIM Global Investments. The proceeds are expected to fully fund KAHR’s randomized, controlled Phase 2b trial of DSP107 in combination with atezolizumab versus fruquintinib (Fruzaqla) in fourth-line metastatic MSS-CRC. The trial was initiated in December 2025 following the U.S. Food and Drug Administration (FDA) investigational new drug (IND) clearance. In addition to the equity financing, KAHR has entered into a $10 million on-demand debt facility with SPRIM Global Investments, which the Company can draw down based on eligible research and development (R&D) activity under the Australian Government’s R&D tax rebate scheme. Additional equity commitments are under discussion as the Company continues to attract new investor interest.

The topline Phase 2a (NCT04440735) data demonstrated a median overall survival of 17.5 months, exceeding outcomes reported for currently approved therapies in this setting (6.4–10.8 months). Notably, approximately 75% of enrolled patients had liver metastases, a population historically refractory to immunotherapy. Across more than 130 patients treated with DSP107 to date in a variety of solid tumors and hematological malignancies, the therapy continues to demonstrate a favorable safety and tolerability profile.

Based on these encouraging results, KAHR has initiated a randomized, controlled, multicenter Phase 2b clinical trial in fourth-line metastatic, chemo-refractory MSS-CRC. The trial is expected to enroll at 18 sites across Australia and the United States, with the first patient having been enrolled in December 2025. Interim results are expected in late 2026, with topline data anticipated in the second half of 2027. Additional information about the study is available at clinicaltrials.gov (NCT07235293).

Anwaar Saeed, M.D., Chief of GI Oncology at the University of Pittsburgh and Co-Leader of the Cancer Therapeutics Program at UPMC Hillman Cancer Center, who co-led the Phase 2a trial said, "Observing efficacy with an immunotherapy approach in late line MSS-CRC patients with liver metastases is unexpected. DSP107’s mechanism is particularly suited to this setting as it utilizes CD47 overexpression on cancer cells to anchor a 4-1BB ligand to those cells, thereby attracting and activating T cells. CD47 expression increases in liver metastases following chemotherapy, creating a therapeutic window uniquely addressable by DSP107."

"Following these compelling topline results demonstrating anti-tumor activity and meaningful survival outcomes in heavily pretreated MSS-CRC patients, including those with liver metastases, we have made MSS-CRC our primary development focus and look forward to advancing the Phase 2b trial," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR.

Dr. Pereg added, "We highly appreciate the continued support from our existing and new investors. Their commitment reflects confidence in the clinical potential of DSP107 and the opportunity to meaningfully improve outcomes in MSS-CRC, a disease with a significant unmet medical need, and in our team’s ability to execute as we move toward our next milestones."

About DSP107
DSP107, KAHR Bio’s lead drug candidate, is a first-in-class, bispecific CD47×4-1BB targeting, next-generation T-cell engager. DSP107 utilizes tumor-expressed CD47 as an anchor, selectively binding CD47 on cancer cells while sparing red blood cells, thereby overcoming the safety challenges previously seen with other CD47-directed agents. Once bound, DSP107 converts the tumor’s immune-evasion signal into a potent 4-1BB co-stimulatory activation signal, recruiting and activating CD8 cytotoxic T cells and orchestrating engagement of both the innate and adaptive immune systems to generate a coordinated anti-tumor response. This approach is particularly relevant in colorectal cancer, where more than 70% of metastatic patients develop liver metastases that commonly upregulate CD47 following earlier-line chemotherapy. Unlike prior immunotherapy approaches in MSS-CRC, which have demonstrated limited benefit due to poor immune cell infiltration and low immunogenicity, DSP107 is designed to leverage tumor CD47 overexpression to enhance immune engagement within the tumor microenvironment, transforming it from immunosuppressive to immune-responsive and enabling productive anti-tumor immunity.

About Microsatellite Stable Metastatic Colorectal Cancer
Colorectal cancer (CRC) is one of the most common cancers worldwide and a leading cause of cancer mortality. Globally, CRC ranks among the top three most frequently diagnosed cancers, with approximately 1.9 million new cases and nearly 900,000 deaths annually, making it the second leading cause of cancer-related death and the third most common cancer overall. Among metastatic colorectal cancer (mCRC) cases, approximately 85–90 % are microsatellite stable (MSS). MSS-CRC is characterized by low tumor mutational burden and limited inherent immune activation, and as a result, tumors are typically unresponsive to current immunotherapies, including immune checkpoint inhibitors. Standard treatment for MSS-CRC continues to rely on cytotoxic chemotherapy, targeted agents, and VEGF inhibition. Despite advances in systemic therapy, there remains a significant unmet medical need for more effective treatment options, and ongoing research is focused on novel approaches, including immune-based and mechanism-driven combination strategies, to improve outcomes for patients with this challenging disease.

(Press release, KAHR Medical, JAN 8, 2026, View Source [SID1234661864])

Whitehawk Therapeutics Advances to Clinical Stage with IND Clearance for HWK-007 and Announces IND Submission for HWK-016

On January 8, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HWK-007, its PTK7-targeted ADC. Whitehawk’s Phase 1 trial for HWK-007 is now actively recruiting and will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.

The company also announced the submission of an IND for HWK-016, its MUC16-targeted ADC, to the FDA in December 2025. A Phase 1 trial is anticipated to start recruiting this quarter and is expected to initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

Both next-generation ADC programs leverage Whitehawk’s advanced ADC technology platform consisting of a highly stable yet cleavable linker that delivers a DNA Topoisomerase I (TOP1) inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.

"These are important regulatory and execution milestones, underscoring the strength of our preclinical data and our ability to advance multiple programs in parallel," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "At Whitehawk, we are taking a unique approach to the development of next-generation ADCs, combining validated tumor biology with a differentiated ADC architecture. Our platform’s design features are intended to maximize tumor targeting while minimizing off-target toxicity, enabled by highly selective antibodies, a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing, and controlled delivery of a potent TOP1 inhibitor payload. As our lead programs enter the clinic, our focus will be on efficient clinical execution to generate data that validates this approach with meaningful outcomes for patients."

About HWK-007
HWK-007 is a differentiated next-generation ADC targeting Protein Tyrosine Kinase 7 (PTK7). PTK7 is an oncofetal transmembrane pseudokinase that drives early embryonic development, has restricted expression in adult tissues and frequent overexpression in a wide range of cancers. PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. There are no approved PTK7-directed ADCs.

HWK-007-101 is a Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

About HWK-016
HWK-016 is a differentiated next-generation ADC targeting the membrane-bound portion of Mucin 16 (MUC16). MUC16 is a glycoprotein with low level of expression in normal adult tissues, and broad overexpression in gynecological tumors including ovarian, cervical and endometrial. In ovarian cancer, for example, MUC16 is present at rates up to 3-10 times higher than clinically validated and emerging ADC targets.

Shed MUC16 (CA125) is a validated biomarker for cancer screening and disease monitoring in gynecologic cancers. When ADCs bind to this cleaved portion of the MUC16 protein in circulation, it is cleared from the patient systemically rather than reaching the tumor. HWK-016 is designed to overcome this by directly targeting the membrane-bound, non-shed portion of MUC16.

HWK-016-101 is a planned Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HWK-016 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

(Press release, Whitehawk Therapeutics, JAN 8, 2026, View Source [SID1234661863])