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A2 Biotherapeutics Announces FDA Clearance of IND for A2B543 for Treatment of Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors that Express Mesothelin and Have Lost HLA-A*02 Expression

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.

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"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])

Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

On January 8, 2026 Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer.

Fast Track designation is granted by the FDA to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

"Receiving Fast Track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today," said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. "We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences."

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the potential side effects of systemic anti-androgen and testosterone-lowering drugs, including sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events.

Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the potential negative side effects which can result from systemic exposure.

Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to present initial findings from the study in 2026.

(Press release, Alessa Therapeutics, JAN 8, 2026, View Source [SID1234661881])

EpiBiologics Closes $107M Series B to Advance Pipeline of Novel Bispecific Antibodies to Selectively Degrade Extracellular Protein Targets in Oncology and Immunology

On January 8, 2026 EpiBiologics, a leader in tissue-selective extracellular protein degradation, reported the completion of a $107 million Series B financing co-led by GV (Google Ventures) and Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc (JJDC).

Novartis Venture Fund (NVF), Aulis Capital, Avego BioScience Capital, and Samsara BioCapital joined JJDC as new investors. In addition to GV, existing investors Polaris Partners, Digitalis Ventures, Taiho Ventures, Vivo Capital, Codon Capital, and Mission BioCapital participated in the round.

"We’re delighted to work with this distinguished group of investors as we enter the next stage of EpiBiologics’ growth. This financing allows us to advance our pipeline of novel bispecific antibodies to selectively degrade disease-driving membrane and soluble targets in oncology and immunology," said Ann Lee-Karlon, Ph.D., Chief Executive Officer of EpiBiologics. "Our lead program, EPI-326, is moving rapidly to the clinic as a highly differentiated therapeutic to address substantial unmet needs for patients with EGFR-driven cancers."

EPI-326 is a tissue-selective bispecific antibody that degrades all oncogenic forms of EGFR, is mutation-agnostic, and overcomes limitations of existing EGFR therapies by localizing degradation to the tumor while sparing normal healthy tissue. In preclinical studies, EPI-326 drives strong and durable efficacy with favorable safety and pharmacokinetics, enabling both monotherapy and combination approaches for multiple cancer types.

EpiBiologics plans to initiate a first-in-human clinical trial of EPI-326 in early 2026 for non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). The company continues to build key capabilities as it moves towards the clinic and appointed two new executives in 2025, Eric Humke, M.D. Ph.D., Chief Medical Officer, and Aaron Mishel, Chief Financial Officer, who both have deep biopharma leadership expertise.

Concurrent with Series B financing, the company welcomes new Board members: Anika Gupta Vatsa, Ph.D. (GV), Laura Brass, Ph.D. (NVF), Gaurav Aggarwal, M.D. (Vivo), and a representative from JJDC. Nisa Leung (Aulis), Eric Pham, Ph.D. (Avego), and Mitchell Mutz, Ph.D. (Samsara) will join as Board observers.

"As an early investor, I’ve been impressed by EpiBiologics’ rapid scientific and operational progress as they’ve built the EpiTAC platform and portfolio in oncology, immunology, and beyond," said David Schenkein, M.D., General Partner at GV. "Anika and I are excited to co-lead this financing as the company translates this innovation into transformative medicines for patients."

(Press release, EpiBiologics, JAN 8, 2026, View Source [SID1234661880])

Osel Enters Agreement with SWOG Cancer Research Network for First-Ever Pivotal Trial of a Microbiome-Based Therapy in Oncology

On January 8, 2026 Osel Inc., a clinical-stage biopharma company pioneering live biotherapeutic products (LBPs), reported a clinical trial agreement with SWOG Cancer Research Network for a pivotal Phase 3 clinical trial of its lead oncology candidate, MO-03, in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma (mRCC). This marks the first-ever pivotal trial of a microbiome-based oral therapy in oncology.

The BIOFRONT trial will build on promising results from two prior clinical studies led by Dr. Sumanta Kumar Pal, MD, FASCO at City of Hope. In those studies, prior formulations of the product were added to nivolumab and ipilimumab or to cabozantinib and nivolumab and showed statistically significant improvements in response rates and progression free survival, without added toxicity.1,2 A recent dose-escalation study confirmed favorable safety across higher dose levels, with no increase in immune-related adverse events, leading to a new high-potency capsule formulation, MO-03, specific for oncology.

"The study represents a major advance for patients with advanced RCC," said Dr. Pal. "While other combination approaches in the front-line setting add significant toxicity, MO-03 could possibly augment the efficacy of immunotherapy-based regimens without compromising quality of life."

The Phase 3 randomized, double-blind study will enroll approximately 700 patients across up to 150 SWOG sites in the United States, comparing MO-03 plus approved IO therapy versus placebo plus IO. The trial is supported by the National Cancer Institute (NCI), part of the National Institutes of Health. Trial initiation is slated for Q1 2026.

MO-03 is a high-potency capsule formulation of Clostridium butyricum Miyairi 588 (CBM588), developed specifically for oncology by Osel and Japan’s Miyarisan Pharmaceutical Co., which will supply the GMP product. Osel holds the Investigational New Drug applications (INDs) for CBM588 and MO-03 in the United States and has exclusive marketing rights to CBM588 and MO-03 pharmaceutical products in the United States, Canada, and Europe.

"We appreciate the investment that SWOG/NCI is making in this pivotal trial, which will position MO-03 as a first-in-class LBP in oncology," said Peter P. Lee, MD, Chairman of Osel. "We are actively working with Miyarisan to engage partners who are interested in commercializing MO-03, pending positive Phase 3 results. Recent market research among US oncologists and payers shows strong interest in MO-03 and a high likelihood of coverage in the mRCC setting."

The BIOFRONT trial, formally titled "S2419, Phase III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic CBM588 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma," is led by Principal Investigator (PI) Pedro C. Barata, MD, MSc, at University Hospitals Seidman Cancer Center. Co-PIs are Ulka Vaishampayan, MD, at University of Michigan Rogel Cancer Center, and Sumanta K. Pal, MD, at City of Hope.

Osel holds the exclusive worldwide intellectual property rights for the use of Clostridium butyricum in oncology in combination with immune checkpoint inhibitors (ICIs) including the PD-1, PD-L1 and CTLA-4 inhibitors nivolumab, ipilimumab, pembrolizumab, cemiplimab, durvalumab, daclizumab, avelumab, or atezolizumab. The allowed claims specifically cover Clostridium butyricum as the sole live biotherapeutic product in combination regimens with ICIs and other anti-cancer agents. The intellectual property includes not only renal cell cancer but also extends to other major malignancies and microsatellite-instability high (MSI-H) cancers, including non-small cell lung cancer, melanoma, sarcoma, lymphoma, breast cancer, bladder cancer, cervical cancer, colon cancer, head and neck cancer, liver cancer, stomach cancer, or rectal cancer, supporting the broad clinical potential of MO-03.

(Press release, Osel, JAN 8, 2026, View Source [SID1234661879])

BostonGene Announces Collaboration with Ottimo Pharma to Optimize and Accelerate Development of First-in-Class PD-1/VEGFR2 Immuno-Oncology Therapy Using AI

On January 8, 2026 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported a strategic collaboration with Ottimo Pharma Limited ("Ottimo"), an innovative, clinical-stage biotech company developing one-of-a-kind PD-1/VEGFR2 dual paratopic antibodies to extend the lives of patients living with cancer. The partnership will utilize BostonGene’s advanced artificial intelligence (AI) platform to apply multiomic analytics and expedite the clinical development of Ottimo’s novel therapeutic candidate, OTP-01. OTP-01 is a first-in-class, bifunctional, dual paratopic antibody therapeutic that maintains a conventional IgG architecture while being engineered to simultaneously inhibit two critical signaling pathways, PD-1 and VEGFR2, with the goal of enhancing anti-tumor immunity and overcoming both primary and acquired resistance that limit the effectiveness of current immuno-oncology approaches.

"The challenge of immune resistance in cancer treatment requires clinically precise solutions that address not only immune suppression, but also immune exclusion," said Robert Tighe, SVP Preclinical and Translational Sciences at Ottimo Pharma. "OTP-01’s novel dual mechanism is designed to address both by combining immune checkpoint blockade with VEGFR2-targeted vascular normalizing activity to improve immune cell access and enable more effective antitumor immune responses. Our collaboration with BostonGene provides a promising opportunity to establish a robust, data-driven development blueprint by helping us identify the patients most likely to benefit from this differentiated therapy."

Under the collaboration, BostonGene will synthesize preclinical datasets, early clinical signals, multiomic analyses, and tumor microenvironment insights to generate foundational biological hypotheses, define optimal first-in-man strategies, refine translational and correlative elements, and develop patient selection approaches that directly support Phase I/IIA progress. This analysis is intended to support early clinical decision-making and significantly de-risk and accelerate the path to market.

"Ottimo is at the forefront of engineering next-generation I-O molecules, and OTP-01 represents a significant advancement," said Ferran Prat, PhD, JD, Chief Commercial Officer at BostonGene. "Our powerful analytical engine is ideally suited to process the complexity of multiomic data generated by a dual-mechanism drug like OTP-01. By leveraging our AI foundation model, we will deliver the precision insights necessary for optimal patient stratification and clinical execution, ensuring this highly promising therapy reaches patients as efficiently as possible."

The agreement reflects a strong alignment of interests, featuring a shared-upside structure tied to clinical, regulatory, and commercial milestones.

(Press release, BostonGene, JAN 8, 2026, View Source [SID1234661878])