On January 8, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported upcoming milestones and recent corporate updates.

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"2025 was marked by robust execution at Xilio as we delivered on key priorities across our deep portfolio of differentiated I-O therapies, demonstrated additional clinical validation of our masking technology and further strengthened our financial position through strategic partnerships and our recent equity financing," said René Russo, Pharm.D., president and chief executive officer of Xilio. "In the year ahead, we have a strong foundation to advance our potential best-in-class bispecific PD-1/IL-2 and T cell engager programs toward the clinic and maximize the value of our vilastobart and efarindodekin alfa programs through strategic partnerships."

Xilio also announced the appointment of Sara Bonstein as chair of the board of directors, following the retirement of Paul Clancy. Dr. Russo continued, "Sara has been an invaluable member of our board since 2021 and brings more than two decades of executive leadership in finance, corporate strategy and business operations in the biotechnology industry, as well as extensive experience advancing novel therapies from discovery through commercialization. I look forward to continuing to partner with Sara as we advance our pipeline of masked immuno-oncology therapies through development. On behalf of the entire board, I’d also like to express my gratitude to Paul for his leadership and contributions as chair, which have been instrumental in helping shape Xilio over the past five years."

Ms. Bonstein added, "During my tenure, Xilio has made significant progress demonstrating validation for its novel masking technology through strategic partnerships with Gilead and AbbVie as well as promising clinical data for its most advanced programs. I am excited to chair the board and look forward to working closely with the management team to advance the company’s deep portfolio of differentiated I-O therapies."

Corporate Updates

In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc. The Series B warrants were issued in connection with a follow-on public offering in June 2025.

Xilio today announced:

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The achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.
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The nomination of a development candidate for its masked T cell engager program targeting the tumor-associated antigen for CLDN18.2, which has broad potential as a target for gastric, pancreatic, esophageal and lung cancers.
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The appointment of Sara M. Bonstein as chair of the board of directors of Xilio. Ms. Bonstein has served as a member of Xilio’s board of directors since August 2021 and succeeds Paul Clancy, who retired from the board of directors on January 6, 2026. Ms. Bonstein has more than 10 years of experience as a chief financial officer for public biotechnology companies, and she currently serves as chief financial officer of Insmed, Inc. where she oversees key financial functions including capital raising, investor relations, accounting, treasury, financial planning and analysis and procurement. Earlier in her career, Ms. Bonstein held finance roles of increasing responsibility at Eli Lilly & Company and Johnson & Johnson. Ms. Bonstein holds a B.S. in finance from The College of New Jersey and an M.B.A. from Rider University.

Anticipated Milestones

Xilio’s anticipated upcoming milestones include:

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Submit an investigational new drug (IND) application for XTX501 in the middle of 2026
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Report initial Phase 1 data for XTX501 in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration
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Nominate a development candidate for the STEAP1 program (masked T cell engager with co-stimulation) in the first half of 2026
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Advance at least two masked T cell engager programs into IND-enabling studies and submit IND applications for those programs in 2027
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Deliver the Phase 1/2 option data package to Gilead for the efarindodekin alfa program in the first half of 2027

Financial Guidance

As of December 31, 2025, Xilio estimates that it had cash and cash equivalents of $137.5 million, including $35.8 million in gross proceeds received in the fourth quarter of 2025 from the exercise of Series B warrants.

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.

The cash and cash equivalents information provided above is based on preliminary unaudited information and management estimates for the year ended December 31, 2025, is not a comprehensive statement of the company’s financial results as of and for the fiscal year ended December 31, 2025 and may change. Xilio’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, this preliminary estimate.

(Press release, Xilio Therapeutics, JAN 8, 2026, View Source [SID1234661857])

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])

On January 8, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported corporate updates and highlights from its ZYNLONTA clinical program.

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"During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This year, we look forward to multiple clinical catalysts including full results from our LOTIS-5 and LOTIS-7 2L+ DLBCL trials, as well as potentially from the ongoing Phase 2 indolent lymphoma IITs. Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow. Taken together, we anticipate we will see an acceleration in net product revenue growth beginning in 2027."

Recent Highlights and Developments

Preliminary unaudited 2025 selected financial results. ZYNLONTA net product revenue is expected to be approximately $73 million for full year 2025 compared with $69.3 million for full year 2024. Fourth quarter 2025 ZYNLONTA net product revenue is expected to be approximately $22 million, as compared to $16.4 million in the fourth quarter of 2024, primarily reflecting variability in customer ordering. Underlying demand for ZYNLONTA in the current 3L/3L+ DLBCL indication remained broadly stable year-over-year. The Company ended 2025 with cash and cash equivalents of approximately $261 million which, based on current plans, is expected to provide a cash runway at least to 2028.

Reported updated data from LOTIS-7 in December 2025. Updated data from the LOTIS-7 Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) demonstrated an 89.8% best overall response rate (ORR) and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of 6 months follow-up. Enrollment in the LOTIS-7 trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 µg/kg dose expected during the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. In addition, the Company plans to assess regulatory and compendia strategies in the first half of 2027.

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of approximately 262 progression-free survival (PFS) events is reached and data are available. Publication of the full results is anticipated by the end of 2026. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.

Investigator-initiated trials (IITs) of ZYNLONTA in indolent lymphomas ongoing. Initial data from the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) and the Phase 2, single-arm, open-label, multicenter trial of ZYNLONTA to treat r/r marginal zone lymphoma (MZL) led by the Sylvester Comprehensive Cancer Center at University of Miami have shown promising efficacy and manageable safety results. The Company anticipates publication of both data sets as early as the end of 2026. Assuming positive data, the Company plans to assess regulatory and compendia strategies.

IND-enabling activities completed for PSMA-targeting ADC. IND-enabling activities for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC were completed at the end of 2025. The Company continues to explore partnership opportunities.

(Press release, ADC Therapeutics, JAN 8, 2026, View Source [SID1234661842])

On January 8, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) ("Rakovina"), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery and Variational AI, a leader in generative artificial intelligence for small-molecule design, reported the expansion of their collaboration focused on the continued optimization of Rakovina’s kt-5000 series of ATR inhibitors.

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Building on their existing collaboration, the companies have signed a new agreement to focus on lead optimization of drug candidates identified by Variational AI’s Enki generative AI platform and selected by Rakovina for further evaluation in the kt-5000 ATR inhibitor program. Under the expanded scope of work, Variational AI will apply its generative AI platform to iteratively optimize the initial leads with the goal of identifying a clinical candidate in months versus the industry standard of years.

Variational AI will generate and prioritize multiple optimized compound designs, while Rakovina will retain full control over which candidates to advance into laboratory testing and further development. The expanded collaboration is intended to accelerate the identification of high-quality development candidates while reducing the time and cost typically required in early-stage drug discovery.

Rakovina’s kt-5000 program comprises a series of small-molecule inhibitors targeting ATR (ataxia telangiectasia and Rad3-related), a central regulator of the DNA damage response that enables cancer cells to survive replication stress and DNA damage. ATR inhibition has emerged among big pharma companies as a promising therapeutic strategy in solid tumors, including cancers with DNA repair deficiencies such as ovarian, breast, and prostate cancer.

Rakovina recently reported results from the kt-5000 series, including compounds with dual ATR/mTOR activity and designed to achieve central nervous system (CNS) penetration at the Society for NeuroOncology annual meeting. These preclinical findings highlight efforts to address known limitations of existing ATR inhibitors and support continued optimization of the compounds.

"ATR is a proven oncology target, but real differentiation comes from optimizing the drug itself," said Jeffrey Bacha, executive chairman of Rakovina Therapeutics. "This expanded collaboration with Variational AI enables a highly focused, AI-driven refinement of kt-5000 compounds identified for further evaluation, with particular attention to potency, selectivity, and CNS penetration. The result is a more efficient path to identifying high-quality candidates while maintaining strategic flexibility for development and partnering."

"Our Enki generative AI platform efficiently explores novel chemical space and has already generated promising leads for Rakovina," said Handol Kim, Co-Founder and CEO of Variational AI. "With this expanded collaboration, we are now applying Enki to exploit these novel leads through local chemical search to efficiently perform lead optimization and enable Rakovina to get to human trials faster."

(Press release, Rakovina Therapeutics, JAN 8, 2026, View Source [SID1234661858])

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])