On October 1, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (OTCMKTS: RKVTF) a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, reported a research collaboration with Boston-based Celvion Therapeutics ("Celvion") to leverage Celvion’s proprietary EMphora artificial intelligence platform to identify novel precision medicine strategies designed to accelerate the development of Rakovina’s ATR inhibitor program.

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The collaboration will initially focus on indications where EMphora will analyze large-scale clinical outcomes and real-world patient data to identify therapeutic targets that may enhance the activity of Rakovina’s ATR inhibitor. In addition to evaluating potential drug combinations, the analysis will search for previously unrecognized therapeutic opportunities, predictive biomarkers, and patient subgroups most likely to benefit from ATR-targeted therapies.

Unlike conventional preclinical discovery approaches, the collaboration will utilize artificial intelligence to interrogate real-world clinical evidence, helping identify the most promising drug combinations and patient populations before advancing into further development. By combining Rakovina’s expertise in synthetic lethality and DNA damage response therapeutics with Celvion’s AI-powered clinical discovery platform, the companies aim to improve development efficiency, reduce clinical risk, and accelerate the delivery of precision medicines to patients with difficult-to-treat cancers.

The companies expect the analysis to generate clinically actionable hypotheses that will help prioritize future combination studies, guide biomarker-driven patient selection strategies, and inform the design of subsequent clinical development programs.

"We have learned how to use multiple specialized AI platforms to accelerate the drug discovery and development process rather than relying on a single platform. Our team selects the right tool for each challenge, from generative design to large-scale screening, to develop molecules that exploit vulnerabilities in how cancer cells repair DNA damage," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "Working with Celvion extends that approach into clinical strategy, using advanced AI to identify the patient populations and drug combinations where our ATR inhibitor program can have the greatest impact."

"EMphora was built to uncover meaningful therapeutic insights directly from clinical outcomes and existing patient data," said Mi Yang, Chief Executive Officer of Celvion Therapeutics. "By collaborating with Rakovina, we have an opportunity to identify combination therapies and biomarkers that may not be apparent through conventional research methods. Our objective is to generate actionable evidence that helps guide smarter clinical development and ultimately benefits patients."

"Synthetic lethality offers tremendous promise in oncology, but its greatest impact will come from identifying the right combinations for the right patients," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "This collaboration gives us the opportunity to rigorously evaluate ATR-based combination strategies while exploring additional biomarkers and therapeutic targets that could further enhance clinical benefit. These insights will help shape the next generation of our development strategy."

Rakovina and Celvion intend to commit appropriate scientific, technical and other resources to support the collaboration and advance the resulting opportunities. As the work progresses and promising development opportunities are identified, the companies expect to explore appropriate co-development and economic arrangements to support subsequent stages of development.

The collaboration reflects Rakovina’s broader strategy of integrating cutting-edge computational biology, translational science, and precision oncology to build a smarter, faster, and more targeted approach to cancer drug development. By leveraging artificial intelligence alongside world-class science, Rakovina continues to position itself at the forefront of precision oncology innovation with the goal of delivering transformative therapies for patients facing significant unmet medical needs.

(Press release, Rakovina Therapeutics, OCT 1, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-partners-with-boston-based-celvion-therapeutics-to-leverage-ai-and-real-world-clinical-data-for-precision-cancer-drug-development [SID1234671215])

On October 1, 2026 Quest Diagnostics reported a new study published in The Journal of Molecular Diagnostics showed that the Haystack MRD test is highly accurate at detecting residual and recurrent disease, demonstrating clinical performance in specimens from the landmark DYNAMIC colorectal cancer trial series. The study also validated the test’s analytical performance across 23 solid tumor types. Haystack MRD is an ultrasensitive circulating tumor DNA (ctDNA) liquid biopsy test for identifying residual or recurrent disease in patients with solid tumor cancers.

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The study evaluated the clinical performance of the commercially available Haystack MRD test by retrospectively testing residual specimens from patients enrolled in the DYNAMIC and DYNAMIC-III trials, which evaluated the use of ctDNA-based MRD results (generated with an earlier version of the Haystack MRD technology) to guide chemotherapy decisions in stage II and III colorectal cancer. In this cohort, Haystack MRD results were highly associated with recurrence, demonstrating 100% sensitivity and 100% specificity at 3-year follow-up and 83.3% sensitivity and 100% specificity at 5-year follow-up. Haystack MRD also substantially outperformed carcinoembryonic antigen (CEA), a standard blood-based biomarker, detecting recurrence with 88.9% sensitivity versus 11.1% for CEA (median follow-up 60 months).

Scientists from Quest and Haystack Oncology conducted the study together with investigators from the two institutions that led the DYNAMIC trials: The Walter and Eliza Hall Institute of Medical Research and the Peter MacCallum Cancer Center in Melbourne, Australia.

"The DYNAMIC trial demonstrated the potential for ctDNA to guide more individualized treatment decisions in stage II colon cancer but realizing that potential depends on a highly sensitive assay that can reliably detect the extremely small amounts of tumor DNA that may remain after treatment, while maintaining high specificity," said Professor Jeanne Tie,* a medical oncologist at Peter MacCallum Cancer Centre and lead investigator for the DYNAMIC trial series. "This study helps bridge the gap between clinical research and real-world patient care."

In other key findings, Haystack MRD:

Demonstrated ultrasensitive detection of residual disease, with a 95% limit of detection (LoD95) of 0.063 mean ctDNA molecules per milliliter (mL) of plasma. Earlier validation established an LoD95 of 6 parts per million (PPM), a metric commonly reported for tumor-informed MRD assays1.
Achieved sub-PPM detection of 0.8 PPM, and as low as 0.2 PPM in some samples, with no false positives in cancer-free controls using an investigational whole-genome version of the test. This whole-genome version is currently only available to clinical investigators and biopharma partners while the commercial test uses whole-exome sequencing.
Established a limit of quantitation (LOQ) suitable for response monitoring of 0.25 mean ctDNA molecules per mL. Establishing the LOQ allows a change in a patient’s ctDNA level between serial tests to be interpreted as a real change in tumor burden rather than assay variability.
Demonstrated analytical performance across the complete testing process, starting from plasma collection and including cell free (cf) DNA extraction, rather than starting with already extracted cfDNA. As a result, analytical performance can be directly translated to clinical performance, versus assay validations that begin with extracted cfDNA and do not account for extraction variability.
"To our knowledge, this is the first time that the full ctDNA MRD testing process, starting from plasma collection and including cfDNA extraction, has been characterized for the limit of detection (at 95%) and quantitative analytical performance," said study co-author Dan Edelstein, Vice President and General Manager, Haystack Oncology. "The precise quantitative measurements demonstrated in this validation provide confidence that the Haystack MRD test accurately measures changes in ctDNA levels over time and can be used for serial ctDNA monitoring during and after treatment. With these insights, clinicians can understand the degree of change in ctDNA levels related to tumor biology in an individual patient, supporting earlier evaluation of treatment response and detection of molecular progression or recurrence."

In addition, the study examined a real-world clinical cohort from an Early Experience program in which Haystack MRD detected ctDNA across 27 solid tumor types, including at ultra-low concentrations, with 42% of positive results below 0.5 mean ctDNA molecules/mL.

The new study adds to the growing body of evidence supporting the clinical value of Haystack MRD, following two studies published in The New England Journal of Medicine. Published in 2022, DYNAMIC was the first prospective, interventional study to demonstrate the clinical utility of ctDNA-based MRD testing to reduce the use of chemotherapy in stage II colon cancer without compromising recurrence-free survival. In 2025, a study on response to immunotherapy in mismatch repair-deficient cancers found that the Haystack MRD test was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared with more than 6 months using imaging.

(Press release, Quest Diagnostics, OCT 1, 2026, View Source [SID1234671214])

On October 1, 2026 mAbxience reported that Fresenius SE & Co. KGaA has acquired the remaining 45% of mAbxience from Insud Pharma, building on the successful partnership established between the two companies in 2022 and marking the beginning of a new phase of growth for the company.

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Fresenius acquired a 55% majority stake in mAbxience in August 2022 and has consolidated the business since then. Full ownership completes that structure: mAbxience biosimilars platform is now wholly owned within Fresenius Kabi’s Biopharma business, which covers the full value chain from development and manufacturing through to commercialization.

The acquisition builds on a successful partnership that has already delivered important development, manufacturing, technology-transfer and regulatory milestones. This collaboration has contributed to the expansion of manufacturing capabilities, the advancement of technology transfer programs and the strengthening of mAbxience’s position as a global biopharmaceutical company. Bringing the organizations together under full ownership creates a stronger platform to enhance quality and supply resilience, while supporting future innovation and broader patient access to high-quality biosimilars at a time when a large wave of biologics is losing exclusivity.

Michael Sen, Chief Executive Officer of Fresenius, said: "Completing the acquisition of mAbxience marks the next milestone in building a leading, vertically integrated biopharma business at scale. When we first invested in mAbxience four years ago, the market opportunity was promising but still evolving. Our initial majority stake gave us access to a highly competitive platform while managing risk. Since then, the market has developed strongly, mAbxience has delivered, and Fresenius now has the financial strength to take this next step. Full ownership gives us complete control over cost, capacity and launch timing, and full economic benefit, as the next wave of biologics loses exclusivity. For patients, that means dependable access to high-quality biosimilars; for shareholders, it is a disciplined investment in a business we know well."

Jurgen van Broeck, Chief Executive Officer of mAbxience, said: "mAbxience was founded to serve patients, while proving that world-class biologics could be developed and manufactured at a cost the world could afford. Since 2022, our partnership with Fresenius has demonstrated the strength of combining our people, expertise and capabilities. I would also like to recognize and thank Insud Pharma for its support and commitment over the past decade. The success of mAbxience today is built on the vision, dedication and hard work of many people who have contributed to this journey from the very beginning. Full ownership is the natural next step and creates an even stronger platform for innovation, growth and long-term impact for patients, customers, and partners. As we begin this next chapter together, we will continue to build on the entrepreneurial spirit, scientific expertise and commitment to patients that have driven mAbxience’s success."

mAbxience will continue to support its existing customers and partners, and the company remains fully committed to maintaining quality, reliable supply and the delivery of its ongoing commitments worldwide.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business, reporting to Dr. Sang-Jin Pak, President Biopharma at Fresenius.

(Press release, Fresenius, OCT 1, 2026, View Source [SID1234671213])

On October 1, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum platform, reported its participation in the 17th World ADC San Diego, taking place October 12–15, 2026, in San Diego, California.

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World ADC San Diego is a leading global forum dedicated to antibody-drug conjugates ("ADCs"), bringing together leaders from pharmaceutical and biotechnology companies, emerging innovators, academia and the clinical community to exchange scientific insights, foster collaboration and advance the development of next-generation ADCs.

Defence to Lead Discussion on the Next Frontier in ADC Development:

As part of the conference program, Dr. Amie Phinney, President and Chief Executive Officer of Defence Therapeutics, will take the stage on Wednesday, October 14, at 12:30 p.m. for a presentation and fireside discussion entitled "Beyond Antibody, Linker & Payload – Is Intracellular Delivery the Next Frontier for ADCs?"

The discussion will explore how intracellular trafficking and processing can influence ADC activity; whether improving intracellular delivery could enhance the performance of existing ADCs or create opportunities for ADCs in development; and how emerging technologies may help address these challenges.

The session provides an opportunity for Defence to introduce the scientific rationale underlying its proprietary Accum intracellular delivery platform within the broader evolution of ADC technology and to engage with industry leaders on potential applications and collaborations.

"The ADC field has made remarkable advances in antibody engineering, linker chemistry and payload development, but intracellular delivery represents another important dimension of ADC performance," said Dr. Amie Phinney, President and Chief Executive Officer of Defence Therapeutics. "World ADC provides an ideal forum to bring together different perspectives on where the field goes next. We look forward to contributing to that discussion while exploring how Accum may complement existing and emerging ADC technologies."

In addition to its on-stage participation, Defence will present its latest Accum-ADC research during the conference scientific poster session on Tuesday afternoon. The poster, entitled "Accum: A Plug-In Intracellular Trafficking Platform for Next-Generation ADCs," will be presented by Dr. Guillaume Lefrançois, Senior Scientist at Defence Therapeutics, and will highlight the Company’s ongoing work evaluating Accum as an intracellular trafficking platform for ADCs.

Defence’s team will be available throughout the conference to meet with researchers, pharmaceutical and biotechnology companies interested in learning more about the Accum platform and Defence’s ADC-enhancement profiling programs. Those interested in connecting with Defence during World ADC San Diego are encouraged to contact the Company at [email protected]

(Press release, Defence Therapeutics, OCT 1, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-take-the-stage-at-world-adc-san-diego-to-discuss-the-next-frontier-in-antibody-drug-conjugates [SID1234671212])

On October 1, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing disrupting payload, reported the filing of PCT/US2026/45955, expanding the Company’s growing intellectual property portfolio around its novel splicing-modulating payload, PH1 and PH1-based ADCs.

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Alternative splicing enables cells to generate different proteins from a single gene. Cancer cells can exploit this process to produce protein variants called ‘isoforms’ that support tumor growth, proliferation and survival and promote resistance to therapy. This PCT filing expands Akari’s current patent portfolio relating to its proprietary Thailanstatin payload ADCs and the payload’s ability to disrupt alternatively spliced protein isoforms that many cancers use to survive, proliferate and spread. Accordingly, Akari’s payload PH1 uses a differentiated approach compared with traditional ADC payloads that primarily rely on tubulin inhibition (i.e., vedotin) or DNA damage as (i.e., topoisomerase I Inhibitors) mechanisms of action.

The new PCT application includes claims relating to PH1’s modulation of alternative splicing involving multiple genes associated with tumor progression, including pathways involved in:

Inhibiting Angiogenesis: PH1 altered VEGF-A splicing, shifting cancer cells from a VEGF-A isoform with the ability to supply tumors with blood vessels bringing in nutrients and oxygen (pro-angiogenic) toward the VEGF-165b isoform that prevented blood vessel recruitment to tumors (anti-angiogenic). This switch may disrupt the ability of tumors to recruit the blood vessels necessary to support their growth and spread.
Facilitating programmed cell death of the tumor: Cancer cells produce soluble versions of the death receptor FAS to prevent immune cells expressing the FAS ligand from recognizing the cancer cell and killing it. PH1 altered the splicing of FAS to a version that would be anchored on cell surfaces (transmembrane isoform) making the cancer cells susceptible to immune cell-mediated cell death.
Disrupting hormone and oncogenic signaling in prostate cancer: In prostate cancer cells, PH1 demonstrated reductions in both wild-type androgen receptor (WT-AR) and the oncogenic splice variant AR-V7. WT-AR plays an important role in hormone-dependent prostate cancer, while AR-V7 is a signaling oncogene that drives tumor growth in metastatic castration-resistant prostate cancer (after hormone ablation therapy fails).
Together, these collective findings further demonstrate the versatility of PH1’s mechanism of action and its potential to disrupt different alternative splicing pathways that different cancers rely upon for survival, growth and metastasis.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, commented, "This PCT filing represents another important expansion of our intellectual property portfolio and further demonstrates the differentiated potential of PH1 as a novel ADC payload with unique properties vs. current ADC payloads. These claims illustrate PH1’s potential to impact multiple fundamental mechanisms that cancer tumors use to survive and spread, including angiogenesis, oncogene signaling and avoiding programmed cell death. We believe the breadth of this biology further supports the potential of PH1 as a platform payload for the development of differentiated ADCs across multiple tumor targets and cancer types. As we continue to expand our understanding of PH1, we are building an increasingly robust intellectual property foundation for our novel PH1 payload and ADC portfolio."

(Press release, Akari Therapeutics, OCT 1, 2026, View Source [SID1234671211])