BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | March 27, 2023
Massive Bio, Inc., a private AI-enabled oncology startup that provides virtual and in-person concierge services for cancer patients, and NeoGenomics, Inc. a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announced a collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world. NeoGenomics will identify patients in real time who may be eligible for clinical trials based on biomarker status. Following initial contact and outreach provided directly from NeoGenomics to the treating physician, Massive Bio will help obtain patient consent and expediate additional screening and potential enrollment. This partnership will help to quickly identify patients eligible for clinical trials and help patients and providers make an informed decision regarding their potential treatment avenue.
By combining their respective strengths in biomarker testing, data analysis, machine learning, and biomarker and genomic profiling, the collaboration between NeoGenomics and Massive Bio have achieved a significant milestone in the oncology industry.
"Our mission at Massive Bio is to provide cancer patients with the best possible care and treatment options,” said Selin Kurnaz, PhD, CEO and co-founder of Massive Bio. “By partnering with NeoGenomics, a leading player in the cancer diagnostics industry that shares Massive Bio’s commitment to advancing cancer research and improving patient outcomes, we can leverage their expertise in oncology diagnostics to accelerate the identification of patients who may be eligible for clinical trials."
“NeoGenomics’ advanced diagnostic tools and U.S. footprint, combined with Massive Bio's AI capabilities and concierge services in oncology, will enable us to match patients to clinical trials faster and more efficiently, resulting in improved outcomes and reduced costs,” said Vishal Sikri, President of the Advanced Diagnostics Division of NeoGenomics. “We are thrilled to partner with Massive Bio to advance precision medicine and improve the delivery of healthcare services to patients, pharmaceutical partners, and healthcare providers."
Dr. Arturo Loaiza-Bonilla, MD, co-founder and Chief Medical Officer of Massive Bio, added, "This collaboration between NeoGenomics and Massive Bio will enable us to provide patients with personalized care and support throughout their cancer journey, and move the needle forward in precision oncology and research."
Massive Bio empowers cancer patients to find their best treatment options, using artificial intelligence to improve equitable access and precision targeting for clinical trial matching, drug matching, and drug development. Massive Bio combines its best-in-class AI platform with technology-enabled services to remove barriers in clinical trial enrollment, value-based oncology decisions, and data-driven cancer treatment. The company serves more than two dozen pharmaceutical companies, contract research organizations, and hospital networks, and has been awarded an SBIR contract by the National Cancer Institute. Massive Bio was founded in 2015 by clinical, technology, and M&A executives, and has a global presence with nearly 100 people in 12 countries.
BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 28, 2023
EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control.
“We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.”
“We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker.
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety.
“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.”
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
RESEARCH, PHARMA TECH
Biocytogen | March 09, 2023
On March 8, 2023, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen) announced a non-exclusive license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The deal was facilitated by Johnson & Johnson Innovation LLC.
Under the agreement, Janssen and its affiliates have been granted a global, non-exclusive license to utilize Biocytogen's RenLite® platform and its underlying intellectual property to research, discover, develop, manufacture and commercialize fully human antibody therapeutics, as well as other biological therapeutics, for unlimited drug targets and indications.
RenLite® is a part of Biocytogen's RenMiceTM family of completely human antibodies. RenLite® mice can produce fully human antibody candidates with high affinity, specificity, variety, and druggability, as well as a common light chain for further assembly of multispecific and bispecific antibodies with minimal mismatch and high success rate. In addition, the multispecific and bispecific antibodies assembled following the discovery of RenLite® feature a conventional antibody structure and good physiochemical characteristics that are beneficial for downstream CMC development.
Biocytogen is a leading biotech company that offers comprehensive solutions to the global biomedical community for developing next-generation antibody drugs. It has created a streamlined platform for efficient antibody drug discovery and validation using advanced gene editing technology and modern animal facilities. This includes animal model creation, therapeutic antibody discovery through their RenMab™ mice, and preclinical validation studies in vivo and in vitro. Biocytogen partners with over 70% of the leading biotech and pharmaceutical companies worldwide to develop innovative medicines for a healthier world. The company is a leading figure in the field of biomedical research, pushing the boundaries of what is possible in this critical area of study.