Duvelisib

Appointments strengthen the leadership team and deepen expertise in drug discovery, oncology research, and strategic partnerships Dr. Brian Jones appointed to Scientific Advisory Board LEXINGTON, MA / ACCESSWIRE / September 12, 2023 / Triana Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and rational molecular glue discovery platform to address difficult to drug disease targets, today announced the appointments of Dr. Vito Palombella as Chief Scientific Officer and Dr. Reza Mazhari as Chief Business Officer. Additionally, Dr. Brian Jones is appointed to the growing Scientific Advisory Board (SAB). "I am thrilled to have Vito and Reza join the team at such a pivotal time for the company. As we rapidly advance our discovery pipeline currently focused on targeted protein degradation, Vito's oncology and drug development expertise and Reza's prowess in business development and portfolio strategy complement and strengthen our growing team. Both share a depth in translational sciences that will play a central role in the development of TRIANA's future molecular glue products," said Dr. Patrick Trojer, President and CEO of TRIANA. "Also, I am delighted to welcome Dr. Brian Jones to our Scientific Advisory Board. We are privileged to have the opportunity to work with a premier group of molecular glue thought leaders on drug development initiatives from discovery through drug commercialization. Their insights will help advance our efforts to build our world class molecular glue discovery platform and a robust pipeline of innovative molecular glue therapeutics." "I joined TRIANA because of its high powered scientific team and its product-focused approach to exploit this exciting new modality to tackle undrugged cancer targets," said Dr. Vito Palombella. "We are at the cusp of creating transformative medicines for patients." "I am very pleased to join the TRIANA team as we explore opportunities which leverage the company's proprietary scientific platform and discovery pipeline," said Dr. Reza Mazhari. "There is a growing interest in unlocking the full potential of molecular glues to develop precision medicines for a broad range of indications, allowing TRIANA to consider various value-creating asset- and/or platform-focused business development opportunities in the months and years ahead." "This is an exciting time for TRIANA as they deliver on the potential of molecular glue therapies. I look forward to working with the company and the other members of the SAB in guiding the company to address the undruggable dilemma facing many patients with first-in-class therapies," said Dr. Brian Jones. Vito J. Palombella, PhD, joins TRIANA with 30 years of scientific leadership and experience advancing first-in-class therapeutic programs, as well as a successful track record of building drug discovery and development organizations. Prior to joining TRIANA, he was the Chief Scientific Officer (CSO) at Surface Oncology, where he led the non-clinical research and development organization. Prior to that, Dr. Palombella was EVP and CSO at Infinity Pharmaceuticals, where he was responsible for drug discovery and preclinical development. He held roles of increasing scientific responsibility at Syntonix Pharmaceuticals, Millennium Pharmaceuticals, LeukoSite Inc, and ProScript. Dr. Palombella was involved in the discovery and development of bortezomib and duvelisib, both for cancer therapy. Dr. Palombella holds a PhD in Viral Oncology and Immunology from the New York University Medical Center and completed his postdoctoral fellowship at Harvard University. Reza Mazhari, PhD, brings to TRIANA more than twenty years of business development as well as drug discovery and development experience. Prior to joining TRIANA, he was the Head of Search and Evaluation for Oncology at Novartis, where he led numerous successful in-licensing deals that contributed to the early-stage oncology pipeline and expanded the portfolio of enabling technologies. Dr. Mazhari was also responsible for out-licensing and divestment efforts at Novartis Institutes for BioMedical Research (NIBR). Previously, Dr. Mazhari was the Vice President of Translational Medicine at Rexahn Pharmaceuticals. Prior to that, he held dual responsibilities for leading drug discovery and early development in addition to leading the company's business development efforts at Cerecor. He was the co-founder of Cardioxyl Pharmaceuticals which was acquired by Bristol-Myers Squibb for $1.8 billion. He began his career as a faculty member at the School of Medicine in The Johns Hopkins University. Dr. Mazhari holds a PhD in Bioengineering from University of California at San Diego and a post-doctoral research fellowship in Cardiovascular Medicine from The Johns Hopkins School of Medicine. Brian Jones, PhD, is a seasoned drug discovery leader with over 30 years of industry experience. He is responsible for over 20 INDs across a broad spectrum of therapeutic indications. Most recently, he incubated, launched and was the CSO at Cedilla Therapeutics, which successfully discovered distinctive conditional modulators of targeted cancer biology. He was Entrepreneur in Residence at Third Rock Ventures, with active involvement in a wide variety of therapeutic areas and responsible for the incubation and launch of several private biotech companies. Previously, he was Head of Discovery Chemistry and Chemical Biology at Novartis Institute for Biomedical Research. Dr. Jones holds a PhD in Organic Chemistry from Imperial College of Science at University of London and a NATO post-doctoral research fellowship from Yale University. About TRIANA Biomedicines, Inc. TRIANA Biomedicines is a private biotechnology company, headquartered in Lexington, Massachusetts and focused on building the leading molecular glue discovery platform to regulate disease targets that are difficult to address with any other modality. TRIANA's drug discovery engine is powered by high-resolution structural insights, state-of-the-art AI and computational tools, and bespoke chemical libraries. TRIANA's target first and rational approach to molecular glue discovery is currently focused on inducing or enhancing the degradation of high-pro targets. The therapeutic approach pioneered by TRIANA has the potential to fundamentally change the paradigm of small molecule drug discovery and bring significant therapeutic benefits to patients. Contact IR@trianabio.com SOURCE: TRIANA Biomedicines, Inc. View source version on accesswire.com:

Secura Bio says it has no plans to change the marketing status of its PI3K inhibitor Copiktra (duvelisib), which won full approval in September 2018 as a third-line treatment for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Updated pivotal trial results raised fresh safety questions about that approval, and the FDA’s outside oncology experts last September voted 8-4 against the drug’s benefit-risk profile. But unlike other approvals that have gone before ODAC in recent memory that was for accelerated approvals with negative confirmatory trials, Copiktra’s third-line indication in r/r CLL and SLL doesn’t come with any confirmatory trials. In fact, the ODAC meeting was a result of the final data linked to the full approval. The company has an “obligation related to the original approval to report the follow-on overall survival (OS) data generated in the pivotal trial supporting approval that was not available at the time of original approval,” a spokesperson for Secura told Endpoints News via email . The trial in question, known as DUO, was a Phase III, open-label, randomized trial that began in 2014 and compared Copiktra with the mAb ofatumumab in 319 patients with relapsed or refractory CLL or SLL who received at least one prior line of therapy. The primary endpoint was progression-free survival. At the time of initial, full approval, OS data were limited, FDA said, noting that it required a final analysis of OS at five years to evaluate Copiktra’s longer-term efficacy and safety. While the study met its primary endpoint by significantly improving PFS when compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P < .0001), Nicholas Richardson from FDA’s division of hematologic malignancies followed up at the September adcomm to explain that the final data show there was not only a higher number of deaths in the Copiktra arm of DUO when compared to ofatumumab, but a higher rate of deaths due to adverse events with duvelisib. Prior to that meeting, FDA last June sent a warning out explaining that Copiktra may increase the risk of death and severe side effects for this third-line indication. FDA’s ODAC met three months later and voted 8-4 against the benefit-risk profile of the drug, with the chair of the committee, Jorge Garcia of Cleveland’s University Hospitals Seidman Cancer Center, saying that ultimately the data did not support the notion that this drug prolongs life. FDA and company officials also got into heated arguments over whether the cancer or the side effects of the drug killed more people in the trial. Secura’s spokesperson said the drug’s benefit-risk profile has not changed since initial approval, “as the OS data were confounded by a high rate of crossover in the study. We are in favor of updating the COPIKTRA prescribing information to include the new OS data. Additionally, at the request of the FDA, we have sent a ‘Dear Doctor’ letter to all prescribers of COPIKTRA that reviews these data in detail.” That letter from last May explained the results of the trial as: Regarding Copiktra’s approval in r/r CLL and SLL moving forward, the company said it remains on the market, adding that “there are no additional requirements for clinical trials to support that indication.” And trying to pull a full approval is not common and can be difficult if the sponsor is unwilling. “I don’t know of any cases when the FDA has withdrawn a drug/indication for a full approval over a manufacturer’s objection,” Harvard Medical School professor Aaron Kesselheim told Endpoints.