On May 4, 2026 XtalPi (2228.HK), a leading AI- and robotics-powered innovation platform, reported dual breakthroughs in its strategic partnership with PharmaEngine (4162.TWO) PEP08, a next-generation PRMT5 inhibitor discovered via XtalPi’s platform, has successfully begun enrollments in a Phase I solid tumor trial, achieving a new clinical milestone. Built upon the success of PEP08 at the drug discovery stage, the two companies initiated a second project, targeting a different undisclosed synthetic lethality mechanism.

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PEP08 received clinical clearance in June 2025 and is currently in Phase I evaluation for solid tumors in Australia and the Taiwan region. The enrollment milestone underscores XtalPi’s ability to deliver differentiated molecules with strong drug-like properties, while demonstrating the program’s steady clinical advancement.

Leveraging XtalPi’s integrated quantum physics-, AI-, and robotics-powered platform, PEP08 was designed to overcome the dose-limiting hematological toxicities seen with first-generation PRMT5 inhibitors. The molecule exploits an innovative MTA-cooperative binding mode to specifically target MTAP-deleted tumors—a genomic alteration found in 10-15% of all human cancers, with higher frequencies observed in NSCLC, pancreatic cancer, glioblastoma, and more. Preclinical data presented at 2025 AACR (Free AACR Whitepaper) show PEP08 achieving superior efficacy compared to other clinical-stage MTA-cooperative PRMT5 inhibitors across multiple MTAP-deleted tumor models, supporting a potential best-in-class profile.

Driven by the success of PEP08 at the drug discovery stage, the partnership expanded into a second project. By combining PharmaEngine’s deep oncology expertise with XtalPi’s AI and robotics molecular design engine, the duo aims to capture additional market share in the synthetic lethality space.

Synthetic lethality is widely recognized as challenging yet highly promising frontier in oncology. According to Globocan and industry data, the global market is expected to grow from $4.2 billion to $17.6 billion by 2033, at a 17.3% CAGR. In recent years, several early-stage licensing deals in this space have exceeded $1 billion USD, further underscoring the immense clinical value and commercial appetite for this category.

The clinical advancement of PEP08 and the ongoing collaboration of the second project serve as a dual validation of XtalPi’s AI+robotics discovery engine. By repeatedly meeting rigorous benchmarks in complex target spaces, XtalPi has built a reproducible innovation model that turns deep know-how into high-value clinical assets. Underpinned by a milestone-sharing structure, this model tightly aligns the platform’s evolution with clinical success, quickly translating biological insights into tangible impact for partners and patients around the world.

Dr. Shuhao Wen, Chairman of XtalPi commented, "The clinical progress of PEP08 and the ongoing collaboration of the second project are testaments to the synergy between our teams, and highlights the reliability of XtalPi’s R&D platform in tackling complex targets. We look forward to further applying this model to deliver high-quality pipeline assets for our partners and generate sustained value for our shareholders."

"PharmaEngine has been advancing its R&D capabilities, and our collaboration with XtalPi exemplifies our ability to harness innovative technologies to propel next-generation discoveries in precision oncology," said Dr. Hong-Ren Wang, CEO and President of PharmaEngine. "XtalPi’s R&D platform played a key role in the early-stage discovery of PEP08, providing a robust foundation for its clinical entry. Our collaboration of PEP08 and the second project demonstrates our ongoing efforts to advance cancer treatment development worldwide.

(Press release, XtalPi, MAY 4, 2026, View Source;enabled-pharmaengine-pep08-achieves-enrollment-milestone-with-second-synthetic-lethality-program-underway-302760846.html [SID1234665062])

On May 4, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported that data from its Phase 1A Dose Escalation Study of BTX-9341, a potent and selective CDK4/6 degrader, in combination with fulvestrant for the treatment of HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy in the advanced and/or metastatic setting, will be presented as an oral presentation at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress, taking place May 6 – 8 in Berlin, Germany.

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2026 ESMO (Free ESMO Whitepaper) Breast Cancer Presentation Details:

Title: Dose optimization of BTX-9341, a first-in-class CDK4/6 bifunctional degrader, in CDK4/6 inhibitor-pretreated HR+/HER2− advanced/metastatic breast cancer

Presenter: Dr. Matthew Goetz, MD, Mayo Clinic, Rochester, USA

Presentation #: 421RO

Session: Rapid Oral Session 2, Berlin Hall

Session Date and Time: Friday, May 8, 2026 | 8:30-10:00 AM

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 and Cyclin E transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAY 4, 2026, View Source;breast-cancer-at-the-2026-european-society-for-medical-oncology-breast-cancer-annual-congress-302760537.html [SID1234665063])

On May 4, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported that its Board of Directors has appointed Natalie Holles as Chief Executive Officer and President and member of the Board of Directors, effective April 30, 2026. Ms. Holles succeeds Elisabet de los Pinos, Ph.D., the Company’s founder, who stepped down from her roles as Chief Executive Officer and President and member of the Board of Directors on the same date.

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The Company also announced that its Phase 3 CoMpass trial with its investigational candidate belzupacap sarotalocan (bel-sar) for the treatment of early choroidal melanoma is nearing enrollment completion. As of today, 86 patients have been enrolled in the study, and more than 25 additional patients have been scheduled or identified for screening through May 2026. With this update, the Company reiterates its guidance to enrollment completion by mid-2026 and topline data from the CoMpass trial in the second half of 2027. 

"I am thrilled to join Aura to lead the Company through this next phase of its growth, including Phase 3 trial completion and the potential registration and commercial launch of bel-sar," said Ms. Holles. "With the potential to bring the first frontline, vision-preserving therapy to patients with early choroidal melanoma, I believe the Company is very well-positioned for meaningful value creation for our patients and shareholders. I look forward to working with this talented team to advance our work toward realizing the full clinical and commercial potential of bel-sar."

"We are delighted to welcome Natalie as CEO at this important moment for Aura," said David Johnson, Chairman of the Board of Directors of Aura Biosciences. "Natalie brings significant experience across late-stage development, operations, and rare disease commercialization, making her exceptionally well-suited to lead Aura as we near completion of enrollment in our Phase 3 CoMpass trial and prepare for potential commercialization. On behalf of the Board, I would like to thank Elisabet for her leadership and vision in founding Aura and advancing the Company to this critical point."

"It has truly been a privilege to found and lead Aura from the ground up and to work alongside such an extraordinary team," said Dr. de los Pinos. "I am deeply proud of what we have built together—advancing innovation in oncology, our commitment to patients and the field of ocular oncology, and bringing the CoMpass trial to this important stage. As the Company moves into its next phase, I am excited to see it continue to grow and thrive under Natalie’s leadership."

Ms. Holles has more than 25 years of executive leadership experience spanning corporate strategy, business development, operations and commercialization across multiple therapeutic areas. Prior to joining Aura, Ms. Holles served as Chief Executive Officer of Third Harmonic Bio from August 2021 through December 2025. Before that, she was President and Chief Executive Officer of Audentes Therapeutics, which was acquired by Astellas Pharma in 2020. She joined Audentes as Senior Vice President and Chief Operating Officer in 2015, was an instrumental architect of the Company’s GMP viral vector manufacturing capabilities and was subsequently promoted to President and Chief Operating Officer in 2018, and

then to Chief Executive Officer in 2020. Earlier in her career, Ms. Holles served as Senior Vice President of Corporate Development at Hyperion Therapeutics, which was acquired by Horizon Pharma in 2015, and as Vice President of Business Development at KAI Pharmaceuticals, which was acquired by Amgen in 2012. Ms. Holles holds an A.B. in Human Biology from Stanford University and an M.A. in Molecular, Cellular and Developmental Biology from the University of Colorado, Boulder.

About Bel- sar and Aura’s Ongoing Phase 3 CoMpass Trial in Early Choroidal Melanoma: CoMpass is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control. As of today, 86 patients have been enrolled in the trial and over 25 patients are scheduled or identified for screening through May 2026. The Company continues to expect to complete enrollment by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

(Press release, Aura Biosciences, MAY 4, 2026, View Source [SID1234665045])

On May 4, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported that Candel’s management will host a webcast and conference call on Friday, May 15, 2026 at 1:00 PM ET. The call will discuss the Company’s extended follow-up data from the phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with intermediate- to high-risk localized prostate cancer. The discussion will follow the oral plenary presentation of these data by Mark G. Garzatto, M.D., Professor of Urology at Oregon Health & Science University and the Portland VA Medical Center, at the American Urological Association (AUA) 2026 Annual Meeting.

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The call will feature insights from leading prostate cancer specialists, including; Neal D. Shore, M.D., FACS, START Carolinas/Carolina Urologic Research Center, Head of GU Oncology and Radiopharm, Myrtle Beach, SC, USA; Jonathan D. Tward, M.D., Ph.D., FASTRO, Professor of Radiation Oncology, Huntsman Cancer Institute, University of Utah, and Daniel J. George, M.D., Professor of Medicine, Urology and Surgery, Duke University School of Medicine, Director of Genitourinary Oncology, Duke Cancer Institute.

Dr. Shore is a renowned urologic oncologist with a focus on genitourinary oncology. He has led more than 500 clinical trials and authored over 350 peer-reviewed publications and currently serves as Editor-in-Chief of Reviews in Urology and co-Chair of both the Prostate Cancer Academy and Bladder/Kidney Cancer Academy, and the AUA International Prostate Cancer Forum. He serves on numerous advisory boards, including the Duke Global Health Institute.

Dr. Tward is a Professor of Radiation Oncology and internationally recognized pioneer in AI-driven digital and molecular oncology at the University of Utah Huntsman Cancer Institute (HCI), where he holds the Vincent P. and Janet Mancini Presidential Endowed Chair in Genitourinary Malignancies. He also serves as the director of the HCI Genitourinary Cancers Center and is a leading authority in prostate, bladder and penile cancer. Dr. Tward has authored over 100 peer-reviewed publications, serves on NCCN guideline panels and is Utah’s State Captain for the American Society of Radiation Oncology.

Dr. George is an Eleanor Easley Distinguished Professor of Medicine, Surgery and Urology at Duke University School of Medicine and a leading expert in urologic cancers with a specialized focus on prostate, kidney, bladder, and testicular cancers. He has authored over 300 peer-reviewed publications on genitourinary oncology, novel therapeutics, and clinical trials.

Conference Call and Webcast:

Candel will host a webcast and conference call on Friday, May 15, 2026, at 1:00 PM ET. The webcast can be accessed here and on the Candel website at www.candeltx.com, under News & Events, in the Investors section of the website.

Participants may register for the conference call here to receive dial-in numbers and a unique PIN to access the call. Joining 10 minutes prior to the start of the event is recommended, although you may register and dial in at any time during the call. An archived webcast will be available on Candel’s website for 90 days following the presentation.

(Press release, Candel Therapeutics, MAY 4, 2026, View Source [SID1234665064])

On May 4, 2026 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the Bank of America Securities 2026 Global Healthcare Conference on Tuesday, May 12, 2026, at 9:20 a.m. PDT. A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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(Press release, Bio-Techne, MAY 4, 2026, View Source [SID1234665046])