Pharmaceutical Technology Editors

LifT Biosciences, a British pharmaceuticals company, and Minaris Regenerative Medicine, a German contract development and manufacturing service provider specializing in cell and gene therapies, announced a manufacturing and development partnership on Feb. 16, 2023. Per the terms of the agreement, the companies plan to develop a Good Manufacturing Practice (GMP)-compliant manufacturing process to supply LIfT’s clinical trial programs for its N-LifT cell therapy in Europe; these trials are currently slated to begin in the first quarter of 2024.

N-LifT is a neutrophil progenitor-based leukocyte infusion therapy which is being evaluated for pancreatic cancer, lung cancer, and other solid tumor cancers. According to a company press release, the drug's unique mechanism of action allows it to work through the innate immune pathway while also activating multiple other factors of the adaptive immune system.

“Following very strong preclinical results, we are now moving into producing GMP grade product as we prepare for clinical trials early next year. Our mission to destroy all solid tumors irrespective of where the tumor is or how it adapts is looking more and more achievable,” said Alex Blyth, CEO, LIfT BioSciences, in the release. “We are confident that Minaris’ extensive track record in process development, clinical, and commercial manufacturing will generate a scalable and cost-effective GMP-process and accelerate our clinical readiness.”

“We are excited about our partnership with LIfT BioSciences and to be contributing to scientific progress in a new field,” said Dusan Kosijer, CEO of Minaris Regenerative Medicine, in the release. “We share LIfT’s enthusiasm about their unique (immunomodulatory alpha neutrophils) and their demonstrated enhanced cytotoxic and immunomodulatory properties.”

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LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.

LIfT BioSciences and Minaris Regenerative Enter Cell Therapy Partnership

On Feb. 16 2023, FDA published a new set of product-specific guidance documents that provide recommendations for developing generic drugs and creates evidence to support abbreviated new drug application (ANDA) approvals, which helps to streamline generic product and ANDA assessment.

The FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower-cost treatments. Additionally, improving access to high-quality, affordable medicines helps the agency’s mission to advance public health.

21 PSGs for products with no approved ANDAs, including 13 complex products

19 PSGs for complex products (14 new and 5 revised PSGs), and 13 new PSGs for complex products with no approved ANDAs

PSGs for products used for treatment of Human Immunodeficiency Virus (HIV), achondroplasia, migraines, hypoglycemia, and other conditions.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The FDA also updated their “Upcoming Product-Specific Guidances for Generic Drug Product Development” website to include PSG revision categories and brief descriptions of the revisions that will help applicants in determining if a PSG revision may impact their generic drug development program.

FDA Publishes New Product-Specific Guidelines for Generic Drug Development

FDA published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that improve biosimilars, interchangeable biological product development, and regulatory science. The Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023–2027 (BsUFA III) highlights that FDA will start a regulatory science program to facilitate biosimilar and interchangeable biological product development. The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Increasing the accuracy and capability of analytical characterizations, like physical, chemical, and biological function, and chemistry, manufacturing, and controls

Creating alternatives to and/or reducing the size of studies involving human subjects.

Further, the FOA provides details on projects of particular interest to support the overall research, such as the use of analytical device information, identification of user interface differences, and development of methods and/or principles to help determine acceptable differences.

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

FDA Announces BsUFA III Regulatory Science Program to Support Future Research

Takeda and Nimbus Therapeutics, a clinical-stage pharmaceutical company, announced the completion of an acquisition agreement on Feb. 8, 2023. Announced in December 2022, the agreement includes Takeda’s acquisition of Nimbus Lakshmi, a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor TAK-279, formerly known as NDI-034858. Four billion dollars were paid upfront, with two additional billion-dollar payments to be made contingent on TAK-279 reaching net sales of $4 and $5 billion, respectively.

According to a company press release, TAK-279 is being evaluated for psoriasis as well as multiple other immune-mediated diseases. Takeda is expected to present Phase IIb data in the fourth quarter of the 2022 fiscal year, while a Phase III study in psoriasis is expected to begin sometime in 2023.

“With our plan to acquire announced in December [2022], we are excited to have promptly added TAK-279, a highly selective oral TYK2 inhibitor with truly transformative potential for patients in multiple diseases, to our late-stage pipeline,” said Ramona Sequeira, president, global portfolio division, Takeda, in the release. “This program closely aligns with our strategy and expertise in immune-mediated diseases, and we look forward to sharing more details of our development plans soon.”

Takeda’s acquisition of Nimbus Lakshmi will grant them rights to NDI-034858, an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases.

Takeda Completes $6 Billion Acquisition of Nimbus Therapeutics Subsidiary

Bayer AG announced on Feb. 8, 2023 that Bill Anderson will take over as CEO on June 1, 2023. Anderson, the former CEO of Roche’s pharmaceutical division, has also held senior leadership positions with Biogen and Genentech.

“We are very excited to welcome Bill Anderson as the new CEO of Bayer. Bill has an outstanding track record of building strong product pipelines and turning biotech breakthroughs into products,” said Norbert Winkeljohann, chairman, Supervisory Board, Bayer AG, in a company press release. “Beyond that, he is a truly transformational leader who creates a culture that propels innovation, boosts productivity and performance, and allows people to thrive.”

“Bayer is an innovative company that is already delivering tremendous benefits for the nutrition, health and environmental protection of the world,” said Anderson in the release. “I look forward to working with the people of Bayer to accelerate innovation, increase performance, advance sustainability and unleash the full potential of the company.”

In addition to this appointment, Anderson is also slated to join Bayer’s board of management on April 1, 2023. Current CEO Werner Baumann is expected to aid in the transition through the end of May 2023.

Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.

Bayer Names Bill Anderson as CEO

GenScript ProBio, a US-based contract development and manufacturing organization specializing in biologics, and Bio Immunitas, a UK-based pharmaceutical company, announced a joint collaboration on Feb. 8, 2023. The aim of this partnership is to develop and fast track manufacturing of a novel therapeutic platform for Bio Immunitas’ novel human recombinant protein (hRPP) platform.

According to a company press release, GenScript will provide investigational new drug-enabling chemicals, manufacturing, and controls services for Bio Immunitas. These are intended to accelerate the preclinical development of two recombinant protein products that will use Bio Immunitas’ hRPP platform.

“This relationship will help us realize our commitment to creating innovative, differentiated treatments for millions of patients.” said Syed Haq, CEO and chief manufacturing officer, Bio Immunitas, in the release.

“We're delighted to collaborate with Bio Immunitas to accelerate its novel therapeutic platform and expect more patients will benefit from this superior treatment.” said Brian Min, CEO, GenScript ProBio, in the release.

GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.