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FDA issued a recommendation on June 30, 2022 to COVID-19 vaccine manufacturers that indicated that they should include an Omicron subvariant BA.4/5 component in their vaccines. This move follows the recommendation of the Vaccines and Related Biological Products Advisory Committee, an independent advisory board that met publicly to discuss the necessity of this course of action ahead of an anticipated COVID-19 surge in fall and winter.

According to an agency press release, the official recommendation states that vaccine manufacturers intending to update their COVID-19 vaccines should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition. The goal behind this is to create bivalent booster vaccines that can potentially be used by early-to-mid fall 2022. FDA also noted that it is not advising changes to primary vaccine series because they have been shown to provide a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.

“As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19,” said FDA in the release. “Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the [United States] beginning in fall 2022.”

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Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses 

Ipsen, a biopharmaceutical company, announced that it had entered into a definitive merger agreement to acquire Epizyme, a biopharmaceutical company focused on oncology, on June 27, 2022. The $247 million deal will grant Ipsen access to Epizyme’s oncology portfolio, including their lead medicine Tazverik (tazemetostat), which was granted accelerated approval by FDA in 2020 as a treatment for relapsed or refractory (R/R) follicular lymphoma (FL).

Tazemetostat is an enhancer of zeste 2 polycomb repressive complex 2 subunit (EZH2) inhibitor indicated for:

R/R FL patients whose tumors are positive for EZH2 mutation

R/R FL patients who have no satisfactory alternatives

Patients 16 years or older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

According to a company press release, tazemetostat is currently in Phase III of a registrational confirmatory study in combination with rituximab and lenalidomide in patients with R/R FL who have received at least one prior therapy. Results from this study are expected to be read out in 2026.

As part of the deal, Ipsen will also acquire Epizyme’s oral suvar, enhancer of zeste, trithorax-domain containing 2 (SETD2) inhibitor development candidate, EZM0414. EZM0414 was granted fast track status by FDA and is currently under evaluation in a recently initiated Phase I/Ib trial in adult patients with relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma, as well as various preclinical programs focusing on epigenetic targets.

“Ipsen’s capabilities and resources in oncology combined with Epizyme’s will accelerate the growth of [tazemetostat] to achieve its full potential in [FL] patients,” said David Loew, CEO, Ipsen, in a company press release. “The strength of data support [tazemetostat’s] positioning in patients with both EZH2 mutation positive and wild-type [FL]. We are compelled by the potential of its efficacy and tolerability profile, especially for elderly and/or frail patients who are treated in the community-based setting. Furthermore, we are excited to bring on board epigenetic expertise and the SETD2 inhibitor, as well as several preclinical compounds into our portfolio.”

“I am incredibly proud of what our team has accomplished over the past 15 years, from the approval of [tazemetostat] to advancing our next novel investigational agent, EZM0414, to the clinic, as well as the progress made on our preclinical compounds focused on both hematologic malignancies and solid tumors,” said Grant Bogle, president and CEO, Epizyme, in the press release. “We expect that this acquisition and Ipsen’s commitment to invest in the oncology space will ensure our epigenetic pipeline continues to advance in a way we could not have done on our own to bring transformative cancer therapies to patients in need.”

Ipsen will acquire Epizyme, who recently had their lead medicine Tazverik (tazemetostat) approved by FDA for treatment of relapsed or refractory follicular lymphoma.

Ipsen Expands Oncology Portfolio with $247 Million Epizyme Acquisition

On June 30, 2022, Inceptor Bio, a US-based biotechnology company specializing in cell therapies for difficult-to-treat cancers, announced a collaboration with the University of Minnesota. Under the collaboration, the two parties plan to build a novel induced pluripotent stem cells (iPSC) platform to accelerate Inceptor Bio’s next-generation cell therapies platforms.

Inceptor Bio will receive an exclusive license to the technology developed under this collaboration. The company plans to advance multiple cell therapy products into clinical studies by incorporating the iPSC platform into its proprietary K62 platform for chimeric antigen receptor macrophage (CAR-M) therapy. CAR-M therapy increases the phagocytic capabilities of macrophages and supports a macrophage 1 (M1) anti-tumor phenotype as well as its novel co-stimulatory domain, M83, for CAR-natural killer cell therapies.

"iPSC-derived cell therapies have the potential to enable the next frontier of cell therapies. We are excited to work with [Beau] Webber at University of Minnesota and his team to develop this unique platform," said Mike Nicholson, president and chief operating officer, Inceptor Bio, in a company press release.

"The team at University of Minnesota is confident that Inceptor Bio is the right partner for building a differentiated iPSC platform to advance novel cell therapies," said Beau Webber, assistant professor in the Department of Pediatrics, Division of Hematology and Oncology, University of Minnesota, in the press release. "We are deeply encouraged by Inceptor Bio’s progress in the cell therapy arena, and we look forward to being part of future developments to help cure difficult-to-treat cancers."

Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.

Inceptor Bio Collaborates with University of Minnesota to Develop Cell Therapy Platform

On June 29, 2022, MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced it has signed a non-binding memorandum of understanding (MoU) with the Lotte Group.

Under the MoU, MilliporeSigma will collaborate with the new biologics business of Lotte to establish Lotte’s biologics manufacturing capabilities in the United States. MilliporeSigma will be a preferred supplier who will provide Lotte with technical consulting, training and expertise, products, technologies, and manufacturing solutions.

“Novel modalities are changing the landscape of medicine and are expected to rapidly expand in the coming years to support development of customized, next-generation therapies, drugs, and vaccines,” said Andrew Bulpin, head of process solutions, Life Science, Merck KGaA, Darmstadt, Germany, in a company press release.

“We are delighted to announce our collaboration with MilliporeSigma. We believe such a relationship is a perfect fit for our mutual growth and business value and we look forward to strengthening and fostering this partnership not only in the US, but further on a global level to place both parties on the best path for consistent success,” said Richard Lee, CEO, Lotte Biologics, in the release.

MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.

MilliporeSigma to Supply Lotte Biologics with Biologics Manufacturing Capabilities in US

Avantor has entered into an agreement with GeminiBio, a US-based supplier of cell culture products, instruments, and solutions, to deliver custom hydrated solutions and cell culture media, the companies announced on June 23, 2022.

Under the agreement, Avantor's manufacturing platforms will complement GeminiBio's small-to-medium-scale product offering, with the goal of supplying customized current good manufacturing practice (cGMP) products through the full development lifecycle—from early stage research to scale-up and commercialization. Custom hydrated solutions and cell culture media are critical components in the bioproduction workflow, particularly for emerging modalities such as gene therapy.

"With the imperative to meet patient needs quickly, our customers require custom solutions to accelerate their bioproduction goals," said Ger Brophy, executive vice president, Biopharma Production, Avantor, in a company press release. "Customized media is critical in optimizing cell line productivity, and hydrated solutions offer efficiency to biomanufacturers as they optimize their downstream processes. Our collaboration with GeminiBio will drive increases in product yields, helping bring efficiency and speed to our customers as they scale."

"Enabling customers to optimize their upstream and downstream liquid manufacturing workflows by offering custom solutions, built around a strong quality foundation, has been an essential part of GeminiBio's success. Collaborating with Avantor, who shares our focus on quality, will allow us to expand our ability to address customer needs for both small- and large-volume process liquids," said Brian Parker, CEO of GeminiBio, in the press release.

Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.

Avantor Partners with GeminiBio on Custom Hydrated Solutions and Cell Culture Media

Novartis announced on June 27, 2022 that the European Commission (EC) has approved Cozentyc (secukinumab), used alone or in combination with methotrexate, for the treatment of various childhood arthritic conditions. The conditions include juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA). The treatment has been approved for patients aged 6 years and older who either have not responded adequately to, or cannot tolerate, conventional therapy.

ERA and JPsA are progressive, debilitation autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may include lower back and hip pain. JPsA is characterized by joint swelling and skin psoriasis and may present with nail changes, inflammation of fingers and/or toes, or psoriatic skin changes. These diseases can lead to high levels or pain and disability if left untreated.

“The approval of Cosentyx is very positive news for children affected by JPsA and ERA across Europe. We are now able to offer a new therapeutic target, which was not on the market for this disease in children and also offers a lower frequency of administration. Cosentyx adds to the body of other approved treatments that may provide children and adolescent patients, with the opportunity to participate in all daily activities, and even sports,” said Ivan Foeldvari, MD, Hamburg Centre for Pediatric Rheumatology, Germany, in a press release.

“Cosentyx could now provide a treatment option for eligible patients who continue to struggle with the painful symptoms which negatively impact their quality of life, such as inflammation of the joints, swollen fingers and toes,” added Todd Fox, global head of medical affairs immunology at Novartis, in the release. “This approval represents an important step in our ambition to expand Cosentyx to 10 indications for children and adults living with rheumatic and dermatologic diseases.”

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.