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])

On January 8, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, reported that Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics will present at the 2026 Biotech Showcase being held from January 12-14, 2026 in San Francisco, CA.

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Presentation details are as follows:

Date/Time: Tuesday, January 13, 2026 at 9:30 AM PST

Location: Yosemite A (Ballroom Level)

In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

(Press release, Akari Therapeutics, JAN 8, 2026, View Source [SID1234661843])

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.

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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])

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])