On January 8, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors. A2B543 contains a membrane-tethered IL-12 booster, designed to enhance potency and persistence of Tmod cells and address the immunosuppressive tumor microenvironment. It will be evaluated as a second arm of the EVEREST-2 master protocol (NCT06051695) in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express mesothelin (MSLN) and have lost HLA-A*02 expression.

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!

"FDA clearance of our IND for A2B543 is an important milestone for A2 Bio. Our ability to launch four clinical programs in just four years highlights the adaptability and robustness of the Tmod platform and the promising clinical pipeline of Tmod-based cell therapies. We are committed to speeding the clinical development of our therapies to help patients with solid tumors who need new treatment options," said Jim Robinson, chief executive officer of A2 Bio.

A2 Bio continues to advance its clinical development of A2B694, A2B395, the BASECAMP-1 prescreening study, and other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and beyond.

Enabling Efficient Patient Identification for A2 Bio Precision Medicine Studies

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1,2

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2B543

A2B543 is designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. A2B543 is comprised of autologous Tmod cells transduced with two lentiviral vectors: one expressing both the HLA-A*02-targeted blocker and the MSLN-targeted CAR activator; and a second expressing a membrane-tethered IL-12 (memIL-12) booster. The inducible memIL-12 booster, which activates only upon engagement with tumor antigens, is designed to reduce toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of Tmod.3

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added memIL-12 booster. The EVEREST-2 study is recruiting participants with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, JAN 8, 2026, View Source [SID1234661882])

On January 8, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported a business update and anticipated milestones for 2026.

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 to build on our transformational progress at CytomX with Varseta-M and will be focused on advancing this novel, potential first-in-class ADC towards a registrational study in late-line CRC. Varseta-M was specifically designed to address a broad, unselected CRC patient population based on the universally high and uniform expression of EpCAM. The promising initial clinical activity we have presented to date in Phase 1 dose escalation underscore this potential. We look forward to providing CRC Phase 1 expansion data later this quarter," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued, "Given our highly encouraging start in late line CRC we aim to move rapidly towards a potentially registrational trial and advance Varseta-M into earlier lines of CRC treatment to maximize impact in this area of high unmet medical need. We also plan to capitalize on our platform leadership by progressing our broader pipeline of PROBODY Therapeutics, including our masked interferon-alpha-2b program, CX-801, in combination with KEYTRUDA in advanced melanoma."

Clinical Program Updates and 2026 Milestones:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Varseta-M Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing with a focus on selecting a dose or doses for a potential registrational study in advanced CRC.
Total Phase 1 study enrollment is projected to reach approximately 100 patients by the planned Varseta-M Phase 1 update in Q1 2026.
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
A Phase 1 Varseta-M combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC.
Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
CX-801 monotherapy biomarker data in advanced melanoma patients were presented at the 2025 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is anticipated by the end of 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

CytomX JP Morgan Healthcare Conference Presentation
Dr. Sean McCarthy will present at the JP Morgan Healthcare Conference on January 14, 2026, at 9 a.m. PST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source

(Press release, CytomX Therapeutics, JAN 8, 2026, View Source [SID1234661851])

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])

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.

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 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.

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 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])