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])

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.

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"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])

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.

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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])

On January 8, 2026 Noetik, an AI-native biotech company pioneering self-supervised machine learning and high-throughput spatial data to develop next-generation cancer therapeutics, reported a five-year strategic collaboration and AI model licensing agreement with GSK.

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The partnership provides GSK’s AI and Therapeutics teams with a direct, non-exclusive license to access Noetik’s OCTO-VC virtual cell foundation models in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The collaboration combines GSK’s leadership in AI and tumor immunology with Noetik’s industry-first virtual cell simulation technology to accelerate the development of novel medicines. Additionally, the companies will collaborate to generate bespoke human spatial datasets, applying human-first biological simulation to areas of strategic interest.

Noetik’s platform is powered by the largest spatial biology dataset in oncology, specifically engineered to train self supervised AI. Comprising hundreds of millions of spatially resolved human cells, this data powers Noetik’s virtual cell foundation models capable of simulating gene expression, cell states, and tumor-immune interactions. "Simulation of patient biology with world models like OCTO-VC will drive the next wave of discovery and therapeutic development. These models let us go beyond the limited data available from any one patient to ask ‘What if?’ questions about patient genes, proteins, cells, and tissue," said Daniel Bear, Ph.D, Vice President of AI at Noetik.

"We built Noetik to move the industry from probabilistic ‘shots on goal’ to deterministic engineering of cancer drugs," said Ron Alfa, M.D., Ph.D., CEO & Co-Founder of Noetik. "This agreement validates a new paradigm in biotech: the licensing of human foundation models. GSK is now equipped with one of the most extensive oncology multimodal spatial training sets in existence, allowing them to query tumor biology with a level of resolution that was previously impossible. We are proud to partner with their team to find better medicines, faster."

Kim Branson, SVP Global Head of Artificial Intelligence and Machine Learning at GSK added: "Foundation models are only as good as the underlying training data they are built upon. Noetik’s approach to generating high-quality spatial data at scale to train foundation models is novel. Integration of these models in GSK’s drug discovery and development process has the potential to deepen our understanding of biology and support our development of novel medicines."

Under the terms of the agreement, GSK receives a non-exclusive license to Noetik’s OCTO-VC foundation models in NSCLC and CRC. This collaboration includes $50 million in upfront capital and near-term milestones. Additionally, the deal establishes a subscription-based framework, with GSK paying annual licensing fees to access the models, validating Noetik’s platform as a scalable, revenue-generating engine.

"This deal defines a new asset class in biotech," said Shafique Virani, M.D., Chief Business Officer of Noetik. "We are moving the industry from AI services collaborations to licensing AI infrastructure. To our knowledge, this is among the first and largest transactions monetizing a biological foundation model as a scalable enterprise asset."

This partnership reflects a growing industry shift toward AI-guided discovery and development frameworks that integrate real human biology, enabling improved translation and more confident therapeutic development.

(Press release, GlaxoSmithKline, JAN 8, 2026, View Source [SID1234661874])

On January 8, 2026 RefleXion Medical, an external-beam theranostic oncology company, reported the U.S. Food and Drug Administration has cleared its next generation, autonomously-guided oncology platform, the RefleXion X2 with SCINTIX therapy, for the treatment of primary and metastatic lung and bone tumors.

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The X2 platform delivers a 20-fold increase in positron emissions tomography (PET) sensitivity, significantly increasing the biological signal for tumor detection. This increased sensitivity aims to expand the number of patients eligible for SCINTIX therapy.

"Clinical outcomes data1 from our first-generation platform showed that SCINTIX biology-guided radiotherapy enables tumors to autonomously direct their own treatment," said Sam Mazin, Ph.D., CTO and co-founder of RefleXion. "The goal of the X2 platform is to scale applicability of SCINTIX therapy to a broader patient population, including those with early-stage or metastatic disease."

The key innovation of the X2 platform is its wide field-of-view PET detector technology, which quadruples the imaging field of view to generate sharper images with less noise and improve visualization of moving tumors. The X2 expands the field of view of the first-generation system from 5 to 20 centimeters, expanding autonomous delivery of SCINTIX therapy to a much larger area.

"We have effectively expanded the ‘eyes’ of the machine to generate more real time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment," continued Mazin.

Design advancements also allow upgrades across the existing installed base, enabling current RefleXion customers to transition to the full capabilities of the new X2 platform with minimal disruption.

The company will leverage its participation in the 44th annual J.P. Morgan Healthcare Conference to be held Jan. 12-15 in San Francisco to discuss the newly cleared X2 platform and other commercialization milestones with select investors.

(Press release, RefleXion, JAN 8, 2026, View Source [SID1234661873])