On May 27, 2025 Pillar Biosciences, Inc., the leader in Decision Medicine, reported they have finalized $34.5M in funding, including a strategic investment from Illumina, structured financing from Soleus Capital and investments from existing investors (Press release, Pillar Biosciences, MAY 27, 2025, View Source [SID1234653411]).

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Proceeds from this financing will be leveraged to advance Pillar’s commercial activities including headcount and infrastructure to support biopharma partnerships and expand adoption of its distributable clinical testing kits.

"We are very pleased with our commercial growth over the past few years," said Gang Song, Founder and Executive Chairman of Pillar Biosciences. "We look forward to using this latest capital infusion to drive additional top-line growth as we move closer towards profitability."

The financial investment by Illumina further reinforces its strong partnership with Pillar which includes previous agreements announced in 2017 and 2023.

"Pillar Biosciences has become an important strategic partner to enable Illumina to provide an expanded menu of research and clinical NGS solutions, accelerating access to precision oncology," " said Ashley Van Zeeland, vice president of Corporate Development Illumina. "Pillar’s rapid NGS targeted sequencing panels alongside Illumina’s state-of-the-art sequencing and bioinformatics solutions delivers rapid, cost-effective genomic profiling of tumors, which is critical to advancing personalized therapy globally."

"Access to rapid NGS testing solutions is critical to advancing precision medicine in oncology. We see Pillar’s technology as a market leader, helping laboratories across the globe more effectively streamline and consolidate their molecular testing platforms, enabling faster time to results," said Benjamin Lund from Soleus Capital. "Pillar has demonstrated strong commercial growth over the past few years, including multiple biopharma collaborations."

On May 27, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., reported its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company’s evolution (Press release, BeiGene, MAY 27, 2025, View Source [SID1234653410]).

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"BeOne represents more than a name change—it’s not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what’s possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer," said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. "While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne."

The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company’s worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne’s presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world.

Industry-Leading Innovation and Global Scale

BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne’s hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company’s proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment.

BeOne’s entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its "Fast to Proof-of-Concept" approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers.

In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company’s rapidly growing pipeline, operational resilience, and global ambitions.

On May 27, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Candel management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET (Press release, Candel Therapeutics, MAY 27, 2025, View Source [SID1234653409]). The call will discuss the Company’s positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, which demonstrated a statistically significant 30% reduction in disease recurrence compared with placebo when combined with standard-of-care radiation therapy. The discussion will follow Dr. Theodore DeWeese’s* oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The call will also feature insights from leading prostate cancer specialists, John E. Sylvester, M.D., Atlantic Urology Clinics, Myrtle Beach, South Carolina, and Ronald F. Tutrone, Jr., M.D., FACS, CPI, National Medical Director of Clinical Research, United Urology Group, Towson, Maryland. Both physicians were principal investigators on the phase 3 clinical trial.

Dr. Sylvester is a renowned prostate cancer specialist with over two decades of experience in radiation oncology. He is widely recognized for his expertise in prostate brachytherapy and advanced radiation treatment techniques. Dr. Sylvester has played a pivotal role in pioneering innovative approaches to prostate cancer care and has authored numerous peer-reviewed publications in the field. He has trained physicians globally and continues to contribute to advancing clinical best practices. His leadership and dedication have earned him a reputation as a trusted authority in prostate cancer treatment and a passionate advocate for improving patient outcomes.

Dr. Tutrone is a leading urologist specializing in the diagnosis and treatment of prostate cancer. With over 25 years of clinical experience, he serves as Medical Director of Chesapeake Urology Research Associates and has been principal investigator in numerous clinical trials focused on urologic oncology. Dr. Tutrone is recognized for his commitment to advancing prostate cancer care through research, innovation, and patient-centered treatment. He has published extensively in peer-reviewed journals and is frequently invited to speak at national and international conferences. His work has significantly contributed to improving outcomes for men with prostate cancer.

Conference Call and Webcast

Candel will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET. The webcast can be accessed here and on the Candel website at View Source, under News & Events, in the IR section of the website.

Participants may register for the conference call here to receive dial-in numbers and 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 30 days following the presentation.

* Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. He has never received reimbursements, consulting fees, or any other fees from Candel, and he has no shares of common stock, options to purchase common stock or any other affiliation with Candel.

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies.

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, for the treatment of stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and for the treatment of localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a Special Protocol Assessment (SPA) agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC.

On May 27, 2025 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the upcoming presentation of final clinical outcomes and safety data from the investigator sponsored Phase 1 clinical study conducted at Sant Joan de Déu Barcelona Children’s Hospital evaluating the safety and tolerability of two intravitreal injections of VCN-01 (zabilugene almadenorepvec) in patients with intraocular retinoblastoma that was refractory to systemic, intra-arterial, or intravitreal chemotherapy, and for whom enucleation was the only recommended treatment (NCT03284268) (Press release, Theriva Biologics, MAY 27, 2025, View Source [SID1234653408]). These data will be featured in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL from May 30-June 03, 2025.

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Details on Poster number 161 (abstract number 10046) can be found below.

Presenting Author: Dr. Jaume Català-Mora, Pediatric Ophthalmologist, Sant Joan de Déu-Barcelona Children’s Hospital
Title: A Phase I dose-escalation study to assess the oncolytic virus VCN-01 safety and efficacy in refractory retinoblastoma patients.
Poster Session: Pediatric Oncology
Date & Time: Saturday May 31st, 2025, at 0900-1200 US CDT
Location: online at the conference portal and in person at Hall A, McCormick Place, Chicago, IL
"We are very pleased that the important work by our collaborators at Sant Joan de Déu-Barcelona Children’s Hospital is being presented at the premier international oncology conference" said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We previously reported that the Study Monitoring Committee determined the trial results to be positive. This poster presentation provides the investigators with the opportunity to discuss the detailed results on VCN-01 safety and long-term efficacy in this population with a broader clinical oncology audience and obtain feedback that may assist in refining our clinical strategy for VCN-01 in this underserved pediatric cancer population."

Guillermo Chantada, world-recognized expert in retinoblastoma and one of the investigators in the trial indicated "The oncolytic virus VCN-01 is a promising new player for the treatment of retinoblastoma. In our study, it has shown a tolerable toxicity profile and encouraging response in refractory vitreous seeds which are still the major cause of conservative therapy failure. Through its mechanism of action, we found that VCN-01 specifically targets the tumor cells and by being a non-chemotherapeutic or radiotherapeutic agent, it is of additional interest in this population with higher risk of treatment-induced malignancies".

Theriva senior management will also attend the ASCO (Free ASCO Whitepaper) conference and participate in an off-site meeting on Monday June2nd, 2025 to review the recently reported topline results of the VIRAGE Phase 2b clinical trial in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) with investigators and garner additional insights relevant to the design and execution of a Phase 3 clinical trial in this indication.

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov. VCN-01 has Orphan Drug designation from the EMA and both Orphan Drug designation and Fast Track designation from the FDA for the treatment of pancreatic cancer. VCN-01 also has Orphan Drug designation and Rare Pediatric Diseases designation from the FDA for the treatment of retinoblastoma.

About Retinoblastoma

Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 – 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (Stacey et al. 2021). Preserving life and preventing the loss of an eye, blindness, and other serious effects of treatment that reduce the patient’s life span or the quality of life remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.

On May 27, 2025 Biogen Inc. (Nasdaq: BIIB) and City Therapeutics, Inc., a privately held biopharmaceutical company leading the future of RNA interference (RNAi)-based medicine, reported a strategic collaboration to develop select novel RNAi therapies (Press release, Biogen, MAY 27, 2025, View Source [SID1234653407]).

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Through the collaboration, City Therapeutics will leverage its next-generation RNAi engineering technologies to develop an RNAi trigger molecule combined with proprietary drug delivery technology from Biogen. The collaboration will initially focus on a single target that mediates key central nervous system diseases, utilizing tissue enhanced delivery technologies with the aim of allowing for systemic administration of medicines. Biogen will be responsible for IND-enabling studies and global clinical development along with any regulatory submissions and all activities related to commercialization.

"This collaboration underscores Biogen’s new strategic research approach of balancing our differentiated internal capabilities with external investments in cutting-edge science. With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach," said Jane Grogan, Ph.D., Head of Research at Biogen. "We are excited to collaborate with City Therapeutics and their world-class scientists on key programs, as well as to invest in their company as part of this innovative effort to develop new approaches to treating disease."

"Partnering with Biogen represents a meaningful milestone in our mission to expand the therapeutic reach of RNAi, as we pioneer the next generation of RNAi technology for breakthrough medicines," said Andy Orth, Chief Executive Officer of City Therapeutics. "By combining our novel RNAi platform with Biogen’s industry-leading capabilities in global drug development, we aim to accelerate the advancement of therapies for serious diseases. We look forward to demonstrating the potential of our RNAi platform in addressing this area of significant unmet need."

Under the terms of the agreement, City Therapeutics will receive a total of $46 million in payments including a $16 million upfront payment and an investment of $30 million in exchange for a City Therapeutics convertible note, representing a minority equity interest in the company if converted. The upfront payment will be recorded by Biogen as an Acquired In-Process Research and Development expense in the second quarter of 2025. Should the initial program achieve certain development and commercial milestones, City Therapeutics is eligible to receive up to approximately $1 billion in potential milestone payments plus tiered royalties in the high single-digit to low double-digit range based on net sales. Biogen will have the option to select one additional target in the collaboration, subject to an additional payment and availability of the target.