Pharmaceutical Technology Editors

Predictive Oncology, a biopharma company specializing in drug discovery, and Cvergenx, a genomics information company, announced the launch of a strategic partnership on Feb. 23, 2023. The goal of this partnership is to develop a genomics-based artificial intelligence (AI) approach to personalized radiotherapy and drug discovery.

The collaboration will utilize Predictive Oncology’s drug discovery, AI, and machine learning capabilities with Cvergenx’s precision genomics radiation therapy (pGRT) platform to pursue novel ways of optimizing radiotherapy (RT). According to a company press release, the companies believe this could potentially lead to the repurposing of existing compounds or the development of an entirely new class of drugs.

“The central principle in precision medicine is that cancer therapy should be tailored to the individual tumor biology. Even so, radiation therapy, the most commonly utilized therapeutic agent in clinical oncology, has yet to enter the era of precision therapy,” said Raymond F. Vennare, CEO, Predictive Oncology, in the release. “We believe that the next and most significant paradigm shift in the field of radiation oncology will come from exploiting tumor genomics to optimize RT prescription dose and to identify drug targets for the development of radiosensitizers and radioprotectors for biopharma and industry.”

“Today, RT is prescribed based on a one-size-fits-all approach where all tumors are treated with uniform doses of RT. pGRT provides the first clinically validated approach to optimize RT prescription dose for each individual patient,” explained Javier F. Torres-Roca, co-founder and acting CEO, Cvergenx, in the release. “The pGRT platform has been shown to correctly identify radiosensitizers and radioprotectors from large pharmacogenomic screens. We believe this knowledge can improve the clinical outcome of patients treated with radiotherapy.”

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The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.

Predictive Oncology and Cvergenx Enter Genomics-Based Personalized Therapy Collaboration

FDA is warning consumers and health care professionals of the use of Delsam Pharma’s Artificial Eye Ointment because of potential bacterial contamination. This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

These over-the-counter products are manufactured by Global Pharma Healthcare Private Limited and are intended to be sterile. The use of the ointment can increase the risk of eye infections that can result in blindness according to FDA, and patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately warns the agency. FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment on February 22, 2023.

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. 

FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination 

CRB announced on Feb. 17, 2023 that it will be providing design support for Agilent’s manufacturing facility expansion in Frederick, Colo. The expansion will double Agilent’s manufacturing capacity of nucleic acid therapeutics.

Agilent’s two new manufacturing lines will help the company meet rapid growth within the nucleic acids market and strong demand for its APIs. CRB is working under Flour Corporation to deliver process design, process utilities, current good manufacturing practices architecture, and equipment procurement support for the facility’s new therapeutic nucleic acid manufacturing lines.

“Agilent’s facility will be a powerful tool in the effort to deliver these critical, life-saving therapies to patients,” said Jake Adams, senior project manager and RNA therapies market sector lead for CRB, in a company press release. “We are thrilled to help deliver Agilent’s difference-making solution.”

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Agilent Gains Design Support from CRB for Manufacturing Facility Expansion

Pfizer announced positive results from its Phase III study (TALAPRO-2) of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) on Feb. 16, 2023. The combination treatment was found to demonstrate a statistically significant improvement in radiographic progression-free survival (rPFS) compared to placebo in men with metastatic castration-resistant prostate cancer (mCRPC). FDA has granted the treatment a priority review status.

According to a company press release, the combination treatment reduced the risk of disease progression or death by 37% relative to placebo plus enzalutamide.These findings held independent of the presence of homologous recombination repair (HRR) gene mutations. Preliminary results found that overall survival rate also favored the treatment, but these results were immature at the time of the announcement.

“Novel hormone therapies dramatically changed outcomes for patients with mCRPC in the last decade, and the results from the TALAPRO-2 study show that the addition of talazoparib to the existing standard of care adds significant clinical benefit,” said Neeraj Agarwal, professor of Oncology and presidential endowed chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and lead investigator for TALAPRO-2, in the release. “In addition to delaying disease progression, this combination delayed prostate-specific antigen progression and time to chemotherapy without adversely impacting patient quality of life. The TALAPRO-2 results support the potential for this combination to be practice-changing, with strong, highly consistent efficacy and observations in mCRPC patients both with or without HRR gene mutations, and across clinically relevant sub-populations.”

“Patients with mCRPC need new treatment approaches that can improve outcomes, and the rPFS results from TALAPRO-2, which appears to be the longest observed in a randomized trial in this setting, demonstrate the potential of the [talazoparib] and [enzalutamide] combination, if approved, to become a new standard of care,” said Chris Boshoff, chief development officer, Oncology and Rare Disease, Pfizer Global Product Development, in the release. “We are pleased that the FDA has granted [p]riority [r]eview for our application, and we look forward to working with the [a]gency and global regulatory authorities to bring this treatment to men with mCRPC.”

Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.

Pfizer Announces Positive Data for Prostate Cancer Combination Treatment

Apellis Pharmaceuticals, a global biopharmaceutical company, announced FDA approval of Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on Feb. 17, 2023. The first and only FDA-approved treatment for GA, according to a company press release, approval of pegcetacoplan injection was based on positive Phase III clinical trial results from two studies (OAKS and DERBY) that found it reduced the rate of GA lesion growth compared to sham.

GA is an advanced form of AMD that is characterized by the growth of lesions that destroy the retinal cells responsible for vision. According to the press release, it is a leading cause of blindness affecting more than one million people in the United States and five million worldwide.

“The approval of [Syfovre] is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center, in the press release. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With [Syfovre], we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

“Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that [Syfovre] will make a meaningful difference in the lives of people with GA,” said Cedric Francois, co-founder and CEO, Apellis, in the release. “GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.”

The treatment is expected to be available in the US via specialty distributors and pharmacies by the beginning of March 2023. Similar regulatory applications are currently under review by the European Medicines Agency and Health Canada.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

FDA Approves First Treatment for Geographic Atrophy

Quotient Sciences, a company specializing in accelerating drug development, recently announced the completion of its expansion to its Nottingham, United Kingdom, facility. The expansion is geared toward increasing the capacity of its early-phase formulation development capabilities for oral solid dosage forms. The goal of this, according to a Feb. 8, 2023 press release, is to increase support for the company’s fully integrated drug development programs.

“With these expanded capabilities, we can start formulation development work even earlier for our customers, allowing for projects to start faster and turnaround times to be reduced, which in turn will speed up development timelines,” said Andy Lewis, global vice-president, Integrated Pharmaceutical Services, Quotient Sciences, in the release. “Importantly, the new equipment and process trains are fully integrated with our existing capabilities, so at the appropriate point we can quickly transition drug programs downstream into [Good Manufacturing Practice] clinical trial manufacturing, saving our customers precious time in advancing innovative medicines into the clinic.”

“Quotient Sciences’ mission is to help get new medicines to patients faster and over the course of the last decade we’ve been investing in capabilities to support that,” said Mark Egerton, CEO, Quotient Sciences, in the release. “We place a great importance on supporting customer demand and will continue to actively increase our formulation tool kit to provide more integrated solutions under a single organization to streamline the outsourcing paradigm for our customers.”

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.