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.

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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])

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).

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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])

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.

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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])

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.

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"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])

On January 8, 2026 858 Therapeutics, a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETX-19477, the company’s internally discovered PARG inhibitor. The designation has been granted for the treatment of adult patients with BRCA-mutated, platinum-resistant, high-grade serous ovarian cancer (HGSOC).

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"Patients with platinum-resistant ovarian cancer have a poor prognosis, and treatment options remain extremely limited, highlighting a substantial unmet need for new therapies," said Jeffrey Stafford, Ph.D., CEO of 858 Therapeutics. "We are pleased that the FDA has granted Fast Track designation to ETX-19477 and we are committed to working closely with the FDA to accelerate its development. This designation was based on preclinical data and emerging clinical data from our ongoing Phase 1/2 trial of ETX-19477, including anti-tumor activity at tolerable doses."

FDA Fast Track status is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions with unmet medical need. Under the Fast Track designation, the ETX-19477 development program will have access to more frequent interactions with the FDA and may be eligible for accelerated approval and/or priority review if certain criteria are met.

ETX-19477 is being evaluated in an ongoing Phase 1/2, open-label, multicenter study in patients with advanced solid tumors, designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. The trial is currently enrolling patients in Phase 1 backfill cohorts at multiple dose levels and enriching for select solid tumors harboring BRCA mutations, including HGSOC.

About ETX-19477

Poly(ADP-ribose) glycohydrolase (PARG) is an enzyme that catalyzes the removal of poly-ADP-ribose (PAR) chains from proteins during the DNA damage response. PARG inhibition leads to selective cell death in tumors with underlying replication fork defects, including BRCAm tumors, through a mechanism distinct from PARP inhibition. ETX-19477 is an oral, potent, and selective PARG inhibitor that shows robust preclinical activity in mouse models of ovarian, breast, and gastric cancers. 858 Therapeutics is evaluating ETX-19477 in a Phase 1/2 study in patients with advanced solid tumors at multiple sites in the U.S. For more information on the Phase 1/2 study, please visit: View Source

(Press release, 858 Therapeutics, JAN 8, 2026, View Source [SID1234661877])