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Halozyme Announces Global Collaboration and License Agreement with Takeda to Develop and Commercialize Vedolizumab with ENHANZE

On January 8, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) reported the Company entered into a global collaboration and exclusive license agreement with Takeda in December 2025. The agreement provides Takeda with access to Halozyme’s ENHANZE drug delivery technology, the leading proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20), for use with vedolizumab. Vedolizumab is marketed globally as ENTYVIO.

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"Our collaboration with Takeda reflects our ongoing commitment to delivering innovative solutions that enhance the patient experience, with the goal of helping patients spend less time managing their therapy and more time living their lives," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Our new collaboration reinforces the broad applicability and value of the ENHANZE technology across multiple therapeutic areas."

"People living with ulcerative colitis and Crohn’s disease, as well as their health care providers, need flexible treatment options that match evolving needs and priorities in disease management," said Robert Hollowell, M.D., Head of Global Product and Launch Strategy, GI and Inflammation at Takeda. "Our collaboration is another example of our commitment to the IBD community and leadership in this therapeutic area. It is an exciting opportunity to potentially enable vedolizumab to benefit even more patients around the world, and integrate even more seamlessly into patients’ lives."

Under the terms of the agreement, Takeda will make an upfront payment to Halozyme, and potential future development and commercial milestone payments. Halozyme will also be entitled to up to low-mid single digit royalties on sales of products containing vedolizumab in combination with ENHANZE.

Crohn’s disease and ulcerative colitis are the two main forms of inflammatory bowel disease (IBD), characterized by chronic inflammation of the gastrointestinal tract. Both conditions can result in serious complications. It is estimated that more than 10 million people across the globe will be living with IBD within the next decade, reflecting a growing burden of IBD.

Vedolizumab is a biologic therapy approved (under the trade name ENTYVIO) for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market). ENTYVIO is approved for use in adults with moderately to severely active Crohn’s disease or ulcerative colitis. Please click for Entyvio Full U.S. Prescribing Information and for SmPC.

(Press release, Halozyme, JAN 8, 2026, View Source [SID1234661860])

Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases

On January 8, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.

Highlights of FDA responses to the Company’s key enquiries:

Accelerated approval – FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications.
Primary and key endpoints – FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint.
Trial design and comparator group – FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.
Treated populations – FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial.
"Our recent FDA end of phase meeting was constructive, and we hope will help us speed up our clinical development timelines and facilitate faster submission of an application for the approval of REYOBIQ for patients with LM," said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. "As there are no approved drugs for LM, this discussion with the FDA early in clinical development will allow us to make relevant amendments to our current trial protocol and to begin meaningful planning for an anticipated pivotal trial. Furthermore, based in part on this meeting, we will plan to accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline."

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, JAN 8, 2026, View Source [SID1234661859])

Rakovina Therapeutics and Variational AI Expand Collaboration to Advance Next-Generation ATR Inhibitors

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.

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])

Xilio Therapeutics Highlights Upcoming Milestones and Recent Corporate Updates

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.

"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:

•
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])

Xencor Highlights Corporate Priorities and 2026 Pipeline Milestones

On January 8, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported corporate priorities and 2026 pipeline advancement milestones for its clinical-stage portfolio of novel XmAb drug candidates.

"Xencor designs proteins that enable potential first-in-class and best-in-class medicines for patients, and we are building on momentum from 2025, when we presented encouraging clinical data from our portfolio of T-cell engagers and TL1A antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We are excited to be evaluating a pipeline of five wholly owned clinical-stage XmAb drug candidates and have plans this year to begin the first-in-human study of our TL1A x IL23p19 bispecific antibody for development in inflammatory bowel disease."

"Throughout 2026, we plan to present key clinical data and program updates as we advance our oncology programs toward late-stage development and present clinical proof-of-concept data for our autoimmune programs. We are also starting the year with a strong balance sheet to execute our plans, and we look forward to several updates, potential regulatory achievements and milestones across multiple partner programs."

Four Novel XmAb T-Cell Engagers in Solid Tumor Oncology and B-Cell Depletion for Autoimmune Disease

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). Initial results from an ongoing Phase 1 study in advanced ccRCC indicated that XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (RECIST v1.1) as best response with a 70% disease control rate. The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-escalation continues. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) during 2026
Initiate a pivotal study of XmAb819 in ccRCC during 2027
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. In 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541. Nine patients had received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses (RECIST v1.1) were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate a pivotal study of XmAb541 during 2027
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in an ongoing Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. We plan to:

Provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in development for patients with idiopathic inflammatory myopathies (IIM). In the fourth quarter of 2025, Xencor initiated a Phase 1 proof-of-concept study of XmAb657 for patients with IIM. We plan to:

Provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26
Two Differentiated, Potentially Best-in-Class Therapeutic Options for Inflammatory Bowel Disease

XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Patient enrollment in the study is ongoing. We plan to:

Present final results from the Phase 1 study of XmAb942 in healthy volunteers in 1H26
Provide an update on progress achieved in the XENITH-UC study near year-end 2026
XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. XmAb412 was selected as the lead candidate in 2025. We plan to:

Present preclinical characterization of XmAb412 in 1H26
Initiate a first-in-human study of XmAb412 in 2H26
Preliminary Cash Position and Financial Guidance

Xencor’s broad development portfolio is supported by a strong financial position. Xencor ended the fourth quarter of 2025 with unaudited cash, cash equivalents and marketable debt securities expected to be approximately $611 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2028.

(Press release, Xencor, JAN 8, 2026, View Source [SID1234661856])