Feliza Mirasol is the science editor for 

Feliza Mirasol

On Jan. 30, 2024, Regeneron Pharmaceuticals (Regeneron) announced the formation of a new R&D unit, Regeneron Cell Medicines, founded on an agreement with 2seventy bio, a US-based immuno-oncology cell therapy company. Under the agreement, Regeneron acquires full development and commercialization rights to 2seventy bio’s pipeline of investigational novel immune cell therapies, in addition to that company’s discovery and clinical manufacturing capabilities.

The financial terms include an upfront payment of $5 million. Regeneron will also pay a single milestone payment to 2seventy bio for the first major market approval of the first approved product. In addition, Regeneron will pay 2seventy bio a low single-digit percent royalty on revenues generated by the products. The transaction is expected to close in the first half of 2024, pending certain closing conditions.

2seventy bio was spun out from bluebird bio in 2021. Prior to the spinout, Regeneron and bluebird bio entered into an agreement in 2018 to leverage their complementary technologies. The aim was to discover novel cell therapy approaches to address cancer. Under that original agreement, Regeneron had the right to opt-in to a co-development/co-commercialization arrangement for collaboration targets. Now, under the new agreement, Regeneron will acquire full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage pipeline. Regeneron will also assume ongoing program, infrastructure, and personnel costs related to these programs.

Approximately 150 employees will transition from 2seventy bio to Regeneron to continue work on cell therapy programs. These employees will remain in the company’s Cambridge, Mass., and Seattle, Wa., sites. 2seventy bio’s current chief scientific officer, Philip Gregory, will be appointed senior vice-president and head of Regeneron Cell Medicines upon the close of transaction.

The divestment frees up 2seventy bio to focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its B cell maturation antigen (BCMA)-targeted chimeric antigen T-cell (CAR-T) therapy for treating multiple myeloma.

“Together with the [b]oard, we have completed a thorough assessment of our business and strategic options. Based on this process, 2seventy has decided to focus our mission on the growth and success of Abecma,” said Nick Leschly, outgoing chief kairos officer and incoming 2seventy bio board chair, in a Jan. 30, 2024 company press release. “As part of this decision, we will divest our research and development programs, with the majority of our … R&D team transitioning to Regeneron. While the decision to reshape 2seventy was driven by a series of challenging realities, it has resulted in an outcome that we believe is right for patients, employees, and our shareholders.”

“Moving forward, 2seventy will be sharply focused on Abecma, with a streamlined team and a dramatically different cost structure and financial profile,” said Chip Baird, incoming chief executive officer, 2seventy bio, in the press release. “We believe this approach will give 2seventy the financial runway to continue to work closely with our partners at BMS [Bristol Myers Squibb] to support a potential third-line launch of Abecma later this year and a return to growth for the commercial business.”

According to the press release, 2seventy bio’s go-forward organization will include approximately 65 employees, primarily in quality and supporting functions. Through its partnership with Bristol Myers Squibb, 2seventy bio intends to return Abecma to commercial growth in 2024. The company expects a final Prescription Drug User Fee Act action following a planned Oncologic Drugs Advisory Committee meeting on the supplemental biologics license application (sBLA) for Abecma based on a Phase III clinical study (KarMMA-3). If the sBLA is approved, it would expand the therapy’s label into the larger third line setting of treatment.

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With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition

Podcast will give an overview of the biosimilars market. Industry experts will discuss regulatory controls, pricing pressure, the state of the healthcare industry, and other factors affecting the uptake of biosimilars in the market. Manufacturing challenges as well as current and future needs will also be discussed. Experts will also highlight technological innovations, such as digitalization technologies, and their role in facilitating analytical characterization and manufacturing controls for biosimilars.

Zara Bukhari, PhD student, Biochemistry, University of the Pacific, Stockton, California

Zara Bukhari completed a master’s degree in engineering at Birla Institute of Technology and Sciences, India, with an internship at Biocon Biologics, focusing on Semglee (insulin glargine-yfgn). This experience sparked Bukhari’s interest in the pharmaceutical industry. Subsequently, she worked as a bioprocess engineer at Biocon Biologics for six years, contributing to the design of purification platforms for biosimilars and innovator biologics. Notably, she was involved in a validation study leading to the successful biologics license application filing of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), offering her insights into regulatory requirements and the biosimilars market. Bukhari is currently pursuing a PhD in biochemistry, specializing in ubiquitin biology at the University of the Pacific, Stockton, Calif. Through her PhD, Bukhari aspires to contribute valuable insights into the role of ubiquitination in regulating the cellular proteome and its broader implications in diseases to advance scientific understanding and potentially aid the scientific community in identifying novel drug targets.

John Gabrielson, Senior Vice-President, Biosimilars, and Head of Business, JSR Life Sciences

John Gabrielson is senior vice-president, Biosimilars, and head of Business for JSR Life Sciences. He is a seasoned executive, company builder, and strategist with nearly 20 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading contract development and manufacturing organization, Gabrielson is now focused on accelerating biosimilar adoption across the industry.

 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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In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

Pharmapack Europe announced the winners of the 2024 Pharmapack Awards on Jan. 24, 2024 at the Paris Expo in France. The winners comprised four categories across two dedicated awards: the Health Product Awards and the Exhibitor Awards.

The Health Product Awards are open to the pharma industry as a whole. Winners fell into the categories of “eco-design” and “patient-centric design”. The Exhibitor Awards went to excellence “packaging” and “start-up” innovation. Judges also granted Highly Commended honors to two second-place entries because of the high standards exhibited in the packaging innovation and eco-design categories.

Two of the awards were given for a new injection molding technology designed to use pulp instead of plastics and an innovative dispenser that “revolutionizes the way medications are delivered intra-nasally”, according to a Pharmapack press release. Both were both recognized for their innovative approach to product development. The other awards were bestowed for a system that affords quick and easy administration of combinations of lyophilized injectable drugs and for a mono material, recyclable stick for pharmaceutical products.

The two Highly Commended honors were given for a needleless vial and cap system and a dispenser that offers more precise dispensing.

 Nissha Europe won for developing a pulp-injection autoinjector component, a new injection molding technology that uses pulp instead of plastics. Pulp-injection, used for device components and secondary packaging, mainly uses pulp and starch, which significantly reduces plastic use. In addition, components made using this technology can be recycled within a standard paper recycling system. Due to its rigidity, pulp-injection can also be used for complex designs and high dimensional accuracy.

 Coradin was honored for its GREENIS dispenser, which is designed for the accurate dispensing of serums and creams. The dispenser is made from 75% post-consumer recycled plastic.

Capa Valve Ltd won for its system, the Capa Valve, which allows for the compartmentalization of a standard syringe into a dual-chamber device. The Capa Valve consists of the installation of two small parts within existing standard syringes that are suitable for prefilled applications. According to Pharmapack, there are currently only a few companies that offer dual-chamber syringes for either sequential delivery of liquids or premixing of a diluent and lyophilized drug; this is largely due to cost and perceived complexity of such dual-chamber syringes. The advantage of the Capa Valve system is that it can be produced at a comparatively low cost for any standard size syringe using known fill/finish technology to provide a range of functionality.

 Dr. Ferrer Biopharma, a US-based company specializing in the development of intranasal medication therapies, won for its GentleMist Technology (GMT), an innovative drug delivery device that is expected to revolutionize the way medications are delivered intranasally. The device is designed to offer enhanced comfort, targeted drug delivery, and therapeutic benefits. Because traditional nozzles often generate discomfort and pain due to the pressure exerted during administration, patients often find it difficult to comply with their therapy, adversely affecting the overall treatment experience. GMT addresses this challenge by using advanced fluid dynamics principles and engineering expertise that focus on a more gentle and effective nasal spray nozzle.

 Rotor Print won for its development of a recyclable stick suitable for a wide range of current pharma products and applications. The Pharmapack press release points out that most conventional sticks are composed of three, four, or even five layers of different materials, which typically come in combinations of polyester, aluminum, paper, and polyethylene. As such, these structures cannot be recycled because of the difficulty in separating the different layers. Rotor Print addressed this problem by creating a new stick comprising three same-material layers, making the stick completely recyclable. The new design can also be used in the same processes as current, non-recyclable sticks—meaning laboratories can make a beneficial switch without any significant investment in new machinery. This is Rotor Print’s second consecutive win based on its innovative approach to pharma packaging. In 2023 the company received an award for developing a high grade 100% polyethylene teraphthalate blister that provides an equal barrier to the traditional aluminum lid or polyvinyl chloride.

Klim-Loc Medical was honored for its needleless medical vial, which is the only vial-and-cap system that can be packaged during the fill/finish process and be delivered as a completely needleless package. With its patented composition, the system features a medical-grade polymer-threaded nipple affixed to an elastomer septum. The design requires a simple flip of the flip-off cap and a twist of the Luer-lock (threaded) syringe to gain access to the contents.

“What [is] so impressive about our 2024 winners is that all the entries are advancing technologies that either bring about vital improvements in greener production, or are putting the patient front and center of the development process. I congratulate all our winners on their commitment and contributions to the industry,” said Tara Dougal, content director—Pharma, Informa, in the press release.

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.

Winners of the 2024 Pharmapack Europe Awards are Announced

Takeda has received FDA approval for HYQVIA (immune globulin infusion 10% [Human] with recombinant human hyaluronidase) for treating chronic inflammatory demyelinating polyneuropathy (CIDP), a rare, acquired, immune-mediated neuromuscular disorder. A subcutaneous immunoglobulin (IG), HYQVIA is meant for the maintenance treatment of CIDP to prevent the relapse of neuromuscular disability and impairment in adults.

According to a Jan. 16, 2024 company press release, HYQVIA is the only FDA-approved combination of IG and hyaluronidase, making it a facilitated subcutaneous IG (SCIG) infusion. With the hyaluronidase component, the therapy can be infused for adults with CIDP up to once monthly (every two, three, or four weeks). The hyaluronidase component facilitates the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle, according to the press release.

Because of its subcutaneous delivery method, HYQVIA can be administered by a healthcare professional in a medical office, infusion center, or in the home. It can also be self-administered with proper training of the patient or caregiver.

HYQVIA first received US approval in 2014 to treat primary immunodeficiency in adults. This indication has since been expanded to include children two to 16 years old.

“With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” said Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit, in the press release. “Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for HYQVIA is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”

“While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG [intravenous immunoglobulin] infusions may be challenging for some patients and their caregivers,” said Lisa Butler, executive director, GBS-CIDP Foundation International, in the release. “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder

KBI Biopharma (KBI), a JSR Life Sciences company, and Argonaut Manufacturing Services (Argonaut), announced on Jan. 16, 2024 that they have entered into a strategic alliance with the goal of offering end-to-end drug substance and drug product manufacturing solutions. The arrangement is expected to provide integration of drug substance and drug product manufacturing by combining KBI’s drug development and biologics manufacturing services with Argonaut’s expertise in sterile fill/finish.

“At KBI Biopharma, we have always been committed to delivering innovative solutions that accelerate the development and manufacturing of life-saving therapeutics,” said J.D. Mowery, president and CEO of KBI Biopharma, in a company press release. “Our … facilities and … team have consistently pushed the boundaries of what is possible in biopharmaceutical development. Similarly, Argonaut has established itself as a trusted provider in the industry, known for its cutting-edge technologies and … track record in drug product manufacturing. Their commitment to quality and efficiency aligns perfectly with our own values and vision. This collaboration represents a new era of collaboration and innovation in the biopharma industry.”

“We believe this strategic alliance resolves a key issue for biopharmaceutical organizations as it greatly improves the alignment and integration between two complex and critical aspects of drug development and manufacturing,” said Wayne Woodard, founder and CEO of Argonaut, in a company press release. “Biopharmaceutical companies will benefit from an integrated solution that is faster, more flexible, and leverages the unique expertise of our two organizations.”

“Argonaut’s fill/finish capabilities are scalable from first-in-human clinical material for rare diseases through commercial batches of approved products. With this collaboration, biopharmaceutical organizations can now seamlessly move from development to full-scale manufacturing, saving both time and capital expenditures,” Woodard also said in the release.

Argonaut had previously announced a capital investment in January 2023 for the significant expansion of its Carlsbad, Calif., manufacturing facilities. The expansion includes increased capacity and scale.

Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.

KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions

Abzena announced on Jan. 16, 2023 the launch of AbZelect and AbZelectPRO, its new cell line development (CLD) platforms, designed to speed up the generation of production cell lines for the manufacture of antibodies and recombinant proteins. The platforms are intended to enable the rapid progress of complex biologic drug programs towards clinical trials and investigational new drug (IND) application filing.

According to a company press release, the CLD platforms enable the rapid generation and selection of high-yielding mammalian Chinese hamster ovary cell lines for producing therapeutic proteins and recombinant vaccines. AbZelect was designed for traditional protein programs, such as antibodies. Based on this design, it is optimized across three key areas: vector, host cell line, and process.

AbZelectPRO combines AbZelect with ProteoNic Biosciences’ 2G UNic vector technology, which boosts expression levels and generates higher-producing, stable cell lines that express proteins such as bispecifics, fusion proteins, and other novel modalities, according to the press release. These platforms are expected to shorten timelines from DNA to research cell banks to 15 weeks.

“The higher productivity that’s achievable with the AbZelect and AbZelectPRO platforms means we can produce more drug substances per manufacturing run. These efficiencies will not only expand our capacity and help to reduce the cost of goods for our customers but also reduce the time it takes to get new and critical therapies to patients in need,” said Matthew Stober, CEO, Abzena, in the press release.

Abzena has launched its AbZelect platforms, designed for improving cell line development.