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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.

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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])

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])

858 Therapeutics Announces FDA Fast Track Designation for PARG Inhibitor ETX-19477 for the Treatment of Patients with BRCA-Mutated, Platinum-Resistant Ovarian Cancer

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).

"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])

Tempus Announces Eight Abstracts Accepted for Presentation at the 2026 ASCO® Gastrointestinal Cancers Symposium

On January 8, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that eight abstracts have been accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The meeting is being held on January 8–10 in San Francisco, California.

"The research Tempus is presenting at ASCO (Free ASCO Whitepaper) GI reflects our ongoing commitment to advancing progress in gastrointestinal cancers and demonstrates the power of utilizing our multimodal database to uncover novel insights in oncology," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Across a variety of GI cancers, these studies show how our de-identified clinical and molecular data can be used to better characterize tumors, identify new biomarkers, and in some cases, find patient populations that may benefit from targeted therapies. We are proud to collaborate with all of the investigators who are helping to advance precision medicine."

Tempus will highlight its latest scientific and clinical research findings via the following poster presentations:

Genomic Profiling of Epithelial Neoplasms of the Appendix: Insights Across Histological Subtypes and Histological Grades
Date/Time: Thursday, January 8, 11:30 a.m.–1:00 p.m. and 6:00 p.m.–7:00 p.m. PT
Abstract Number: 847
Summary: Tempus Lens was utilized to analyze de-identified clinical genomic, and transcriptomic information for patients diagnosed with different subtypes of appendiceal epithelial neoplasms (AENs). AENs showed unique DNA alterations by histological subtype, with mutations occurring most frequently in KRAS, TP53, SMAD4, and GNAS. Grade 2 mucinous adenocarcinoma closely resembled Grade 1, not Grade 3, in survival and genomics, supporting a three-tier grading system over a high-grade (G2/G3) grouping in this subtype. Furthermore, patients with KRAS/GNAS co-mutations had better survival and a favorable immune profile in the AEN population overall, supporting further immunotherapy research in this disease.
Impact of Claudin-1 (CLDN1) Expression on Molecular Correlates and Clinical Outcomes in Patients with Advanced Biliary Tract Cancers (BTCs)
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. PT
Abstract Number: 602
Summary: Dysregulation of CLDN1 is associated with invasiveness and migration of cells in many cancers. We examined the molecular and clinical correlates of CLDN1 expression in a real-world cohort of patients (pts) with advanced BTCs across subtypes. We analyzed a cohort of patients with BTC who received xT and xR testing. High CLDN1 expression was associated with immune cell infiltration in this cohort of advanced BTC with improved survival in pts treated with 1L chemo+IO. Furthermore, relevant molecular alterations in BTC differed with high vs low CLDN1 expression. Larger studies are warranted to evaluate the predictive and prognostic role of CLDN1 in BTC to identify novel therapeutic strategies.
Molecular and Immune Landscape of Early-Onset Versus Average-Onset Well-Differentiated Enteropancreatic Neuroendocrine Tumors
Date/Time: Friday, January 9, 11:30 a.m.–1 p.m. PT
Abstract Number: 643
Summary: In the current study, the authors sought to characterize the molecular and immune landscape of early (EO)- versus average-onset (AO) pancreatic (pNETs) and small intestinal NETs (siNETs) by leveraging Tempus Lens. EO pNETs exhibited a significantly lower prevalence of KRAS, TP53, SMAD4 and RB1 alterations and a higher prevalence of LRP1B alterations compared to AO pNETs. EO siNETs showed a significantly higher prevalence of PAX5 and HDAC2 alterations. EO-pNETs were significantly enriched in certain gene sets (VEGF, hedgehog signaling, myogenesis, apical junction) and depleted in others (MYC, E2F, DNA repair, G2M checkpoint), and showed enriched infiltration of M2 macrophages. The findings, from the largest analysis of its kind to date, highlight key molecular and immune differences between age sub-groups in enteropancreatic NETs, suggesting that age at diagnosis may be an important determinant of tumor biology.
Advanced Pancreatic Adenocarcinoma Outcomes in Patients with DDR Deficiencies Outside of BRCA1/2 and PALB2
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 759
Summary: Tempus Lens was used to analyze de-identified clinical, genomic and transcriptomic data for patients diagnosed with advanced pancreatic adenocarcinomas with mutations in the DNA damage repair (DDR) pathway other than BRCA1/2 and PALB2. We compared the outcomes of patients treated with platinum- versus non-platinum chemotherapy regimens in the first line (1L). Patients treated with platinum regimens showed a trend toward improved survival starting around 5 months of treatment (median rwOS 11.7 vs 9.8 months, p=0.471), but this was not statistically significant.
Multiomic Analysis and Oncologic Outcomes in Pancreatic Cancer by PIN1 Expression
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 784
Summary: PIN1 is a novel investigational target and is associated with desmoplastic stroma, an immunosuppressive tumor immune microenvironment (TIME) and worse outcomes in pancreatic ductal adenocarcinoma (PDAC). We characterized PIN1 expression and its impact on the TIME and survival in PDAC patients sequenced with xT and/or xR. Our results demonstrated that PIN1 RNA expression was higher in NLP disease sites and is associated with pro- and anti-tumor immune subsets and a favorable OS, which is contrary to previously published literature.
Molecular Characterization of Resected Non-Metastatic Pancreatic Cancer (PC) Based on KRAS Status
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6:00 p.m. PT
Abstract Number: 776
Summary: This study assessed whether next-generation sequencing (NGS)–based tumor profiling can guide tailoring of CT strategies in resectable pancreatic cancer (PC). Tempus Lens was used to identify PC patients sequenced with xT or xF assays. KRAS mutations did not predict survival benefit from mFOLFIRINOX or gem-nab in resected PC, however we identified distinct profiles of potentially targetable co-alterations in KRAS mutated vs. KRAS WT patients. These findings may suggest the integration of genomic profiling in clinical trials to develop new biomarker-driven targeted strategies in the early stage disease.
Transcriptomic Signatures of RAD51 and GATA6 Predict Improved Real-World Overall Survival with Platinum Therapy in BRCA/PALB2 Wild-Type Metastatic Pancreatic Cancer
Date/Time: Friday, January 9, 11:30 a.m.–1:00 p.m. and 5:00 p.m.–6 p.m. PT
Abstract Number: 679
Summary: In this study the authors postulated that BRCA/PALB2 wildtype mPC may exhibit platinum sensitivity driven by altered HRR gene expression. Tempus Lens was used to identify and analyze mPC pts with wildtype somatic BRCA1/2 and PALB2 who had Tempus xT DNA and xR RNA testing. In BRCA/PALB2wt mPC, transcriptomic profiling identified low RAD51 and high GATA6 expression as predictors for improved rwOS when treated with 1L platinum therapy. Integrating these biomarkers may improve development of DNA-damaging therapies beyond canonically defined HRD.
Coupling Tumor Genomics, Whole Transcriptome Sequencing, and Patient Outcomes to Define the Tumor Microenvironment in Receptor Tyrosine Amplified Gastrointestinal Cancers: Analysis from 24,598 Cases
Abstract Number: 427
Summary: Amplifications of receptor tyrosine kinases (RTKs) such as ERBB2, EGFR, MET, and FGFR2 have been previously linked to an immunosuppressive tumor microenvironment (TME). To further map TME features to tumor genomics across gastroesophageal adenocarcinoma, colorectal carcinoma, and cholangiocarcinoma, researchers utilized Tempus Lens to analyze patients with RTK-amplified and RTK non-amplified GI cancers, leveraging xT and xR testing. RTK amplifications were present in approximately 10% of all samples, consistent with known tumor-specific prevalences. These RTK-amplified tumors were also found to be enriched for MYC and CCNE1 genomic alterations and were associated with altered expression of immunosuppressive regulatory genes, including IDO1, TIM-3, and LAG3.

(Press release, Tempus, JAN 8, 2026, View Source [SID1234661876])

Acuitas Therapeutics Expands Collaboration with RNA Technologies & Therapeutics Through Strategic Investment

On January 8, 2026 Acuitas Therapeutics, the global leader in lipid nanoparticle (LNP) delivery systems for nucleic acid therapeutics, reported that it has acquired a majority stake in RNA Technologies & Therapeutics (RNA T&T), a company specializing in the design, optimization and manufacture of high-quality RNA constructs. This investment will support the growth and development of RNA T&T, allowing it to further develop and scale its operations.

Clinical development of RNA therapeutics requires optimization of both the mRNA payload and the LNP carrier to maximize efficacy and safety. An integrated approach for these two key components derisks clinical programs and supports accelerated availability to patients in need.

While the companies will continue to operate independently, this investment will give partners of each company streamlined access to complementary world-class RNA optimization and manufacturing know-how and LNP delivery expertise. By integrating these capabilities, partners can take a more holistic approach to RNA-LNP therapeutics, helping to reduce development complexity, accelerate clinical timelines and preemptively mitigate risk across multiple programs.

"As genetic medicines expand into more complex areas such as personalized therapies, biotechnology and pharmaceutical companies are seeking efficient access to RNA and LNP design and engineering expertise," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Having worked extensively with RNA T&T over the last number of years, we are impressed with their scientific approach and technical know-how, which brings a level of precision and consistency that is critical in RNA drug development. Ultimately, this investment gives our partners a coordinated way to engage experts from both companies as they develop next-generation RNA-LNP therapies."

"The synergy between our organizations is a natural result of our shared commitment to scientific integrity and technical excellence," said Pierrino Torbey, Board Member and interim CEO of RNA T&T. "Acuitas is the ideal partner for our next phase of growth, as both companies are deeply rooted in science and equally committed to advance the next generation of RNA-LNP medicines. Acuitas has collaborated with RNA T&T since its inception, and together the two companies have collaborated at both the research and clinical level. This investment deepens the relationship between Acuitas and RNA T&T, while also allowing the latter to grow its operational footprint, further develop its proprietary algorithmic platform for RNA sequence optimization and expand its capabilities in small-batch GMP-grade production of personalized and n-of-few therapies."

"From the beginning, it was clear that both teams are aligned in scientific ethos and in their approach to advancing RNA-LNP therapeutics," said RNA T&T co-founder and Scientific Advisor Mohamad-Gabriel Alameh, Ph.D., who provided the RNA design for the first personalized CRISPR therapy administered to baby KJ Muldoon. "This investment strengthens RNA T&T’s ability to support highly complex and personalized RNA programs, while allowing partners to benefit from seamless access to select the right LNP delivery vehicle from Acuitas’ extensive portfolio of clinically validated LNP."

(Press release, Acuitas Therapeutics, JAN 8, 2026, View Source [SID1234661875])