Grant Playter

Pfizer and Flagship Pioneering, a venture capital firm that creates bioplatform companies, announced a partnership on July 18, 2023 that is centered on creating a new pipeline of innovative medicines. The deal mentions that both companies will invest $50 million upfront to explore opportunities to develop 10 single-asset programs.

According to a Flagship press release, Pfizer will fund and have the option to acquire each selected development program, whereas Flagship and its bioplatform companies will be eligible to receive up to $700 million in milestones and royalties for each successfully commercialized program. In addition, Pioneering Medicines, a Flagship initiative, will work with Pfizer to lead the rapid portfolio creation process.

"Flagship and Pfizer enter into this strategic alliance driven by a shared sense of urgency to develop novel medicines that make a difference for patients," said Paul Biondi, president, Pioneering Medicines, and executive partner, Flagship Pioneering, in the release. "This new partnership brings together the best of our organizations to maximize discovery and development potential from inception to impact through a unique innovation supply chain that sets us on a path to potentially realize transformational medicines more quickly and effectively."

"At Pfizer, we are expanding our efforts to pursue potential breakthrough science with unique approaches and funding mechanisms designed to leverage the dynamic scientific ecosystem," said Mikael Dolsten, chief scientific officer and president, Worldwide Research, Development and Medical, Pfizer, in the release. "This collaboration is an exciting opportunity for Pfizer to bring deep scientific expertise and apply our development and regulatory strength to Flagship's diverse portfolio of technology platforms, translating early-stage innovation to potential medicines."

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The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.

Pfizer and Flagship Pioneering Enter Innovation Partnership

Scribe Therapeutics, a genetic medicines company, and Sanofi announced an expanded collaboration on July 17, 2023. The agreement will see Sanofi receive an exclusive license to use Scribe’s CRISPR X-Editing (XE) genome editing technologies for the development of in vivo therapies, including sickle cell disease.

According to a company press release, Scribe will receive $40 million in upfront payment and is eligible to potentially receive more than $1.2 billion based on the successful completion of certain development and sales milestones, as well as tiered royalties. This agreement builds on the companies’ existing collaboration, which is focused on ex vivo editing of natural killer (NK) cell therapies for cancer treatment.

“We are continually impressed by the expertise, rigor, and urgency that Sanofi has brought to our existing ex vivo collaboration, as well as their rapid advancements and innovation in non-viral delivery technologies. Now, we are thrilled to expand our work together into new areas of high unmet need,” said Benjamin Oakes, co-founder and CEO, Scribe Therapeutics, in the release. “This in vivo collaboration further demonstrates the versatility of Scribe’s design-based approaches to CRISPR, which enable greater activity, specificity, and deliverability, ultimately accelerating the development of life-changing therapeutics.”

“We are pleased to expand our work with Scribe, an illustration of our shared commitment to advance best-in-class genome editing therapies for patients in need,” said Christian Mueller, global head, Genomic Medicine Unit, Sanofi, in the release. “We’re encouraged by what we’ve accomplished to date with Scribe in creating ex vivo NK cell therapies and now look forward to accelerating our ability to effectively leverage genome editing in vivo through Sanofi’s innovative research work in targeted lipid nanoparticles, for in vivo therapies with the potential to dramatically improve treatment outcomes and ultimately to change patients’ lives.”

“Scribe’s platform holds tremendous potential to address an unprecedented number of therapeutically relevant targets across the human genome for many serious diseases,” said Svetlana Lucas, chief business officer, Scribe Therapeutics, in the release. “We are excited to partner with companies like Sanofi that offer not only disease and drug development expertise but also the resources and technologies enabling the delivery of our molecules in vivo to specific disease tissues, allowing us to develop better therapies. We look forward to our continued collaboration with Sanofi to expand the application of Scribe’s best-in-class genome editing tools and fully realize the promise of CRISPR for patients as broadly and rapidly as possible.”

The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.

Sanofi and Scribe Therapeutics Expands Genomics Collaboration 

In this episode of the Drug Solutions Podcast, Grant Playter, associate editor, speaks with Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, on the history and ongoing development of both protein- and mRNA-based vaccines. Topics of discussion include recent vaccine approvals, the broader state of the vaccine industry, and ideal use cases for both vaccine formulations.

Jeff Fischer, co-founder and president, Longhorn Vaccines and Diagnostics

Jeff Fischer, MBA, is the President of Longhorn and is responsible for oversight of all non-scientific aspects of the organization to include regulatory affairs. Jeff co-founded the company and has served as its Chief Financial Officer from 2007-2017. From 1998-2005, Jeff served as an executive vice president and CFO in the biotechnology industry. He is a former infantry officer in the United States Marine Corps and holds an MBA from the University of Texas at Austin.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, discusses the history and ongoing development of both protein- and mRNA-based vaccines.

Drug Solutions Podcast: Evaluating the Vaccine Marketplace

Westlake Village BioPartners, a Los Angeles area-based venture capital firm, announced the launch of its oversubscribed third fund of $450 million to incubate and grow early stage next-generation biotechnology companies on July 17, 2023. The new fund will be managed by Beth Seidenberg, founding managing director; Mira Chaurushiya, managing director; and David Allison, recently appointed managing director.

According to a company press release, the new fund brings the total raised since the company’s launch in 2018 to approximately $1.3 billion. The full list of companies in Westlake’s current investment portfolio can be found 

“This new fund will enable us to continue to do what we do best – build great companies from the ground up that make a difference for patients and generate outsized returns for investors regardless of market conditions,” said Seidenberg in the release. “Our investors recognize our strategy is working and have demonstrated their commitment through this new investment.”

Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.

Westlake Village BioPartners Announces $450 Million Venture Capital Funding Pool

FDA announced approval of Opill (norgestrel) tablet for nonprescription use to prevent pregnancy on July 13, 2023. This approval marks the first time a daily oral contraceptive will be available without a prescription, according to an agency press releaes. The approval was granted to Laboratoire HRA Pharma, a pharmaceutical company specializing in products for women in the fields of reproductive health and endocrinology.

According to the press release, norgestrel was granted its original approval for prescription use in 1973. For approval of a product for use in a nonprescription setting, FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively without any assistance from a healthcare professional. FDA based the current approval on studies that demonstrated that consumers had a high overall understanding and a high proportion of individuals who understood the label instructions.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said PatriziaCavazzoni, director, Center for Drug Evaluation and Research, FDA, in the release. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.

FDA Approves First Nonprescription Daily Oral Contraceptive 

FDA announced on July 6, 2023, that it had converted its approval of Eisai’s Leqembi (lecanemab-irmb), indicated to treat patients with Alzheimer's Disease, from an accelerated approval to a traditional approval. Originally granted approval in 

, the conversion followed a confirmatory trial which FDA determined verified clinical benefit. Lecanemab-irmb is an amyloid beta-directed therapy that is designed to reduce amyloid plaques that form in the brain, which is a defining pathophysiological feature of Alzheimer’s Disease.

The confirmatory study, Study 301, was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 Alzheimer’s patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. According to the release, lecanemab-irmb demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, relative to placebo. Statistically significant differences between treatment groups were also demonstrated on all secondary endpoints.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director, Office of Neuroscience, Center for Drug Evaluation and Research, FDA, in the release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.