Pharmaceutical Technology Editors

AbbVie and US-based Anima Biotech (Anima) have formed a collaboration to discover and develop messenger RNA (mRNA) biology modulators for three targets across oncology and immunology. In the collaboration, Anima will use its mRNA Lightning technology platform to discover novel mRNA biology modulators against the collaboration targets. The company will provide AbbVie exclusive rights to license and further develop and commercialize these programs, according to a Jan. 10, 2023 company press release.

Under the agreement, Anima receives $42 million in an upfront payment and may be eligible to receive up to $540 million in option fees and R&D milestones in the aggregate across the three targets. The company will also have the potential to receive further commercial milestones and tiered royalties on net sales. AbbVie has an option to expand the collaboration with up to three additional targets under the same terms as the initial collaboration, which may increase the potential value of the collaboration.

"This collaboration will give AbbVie access to Anima's leading technology platform and deep expertise in mRNA biology and will help further strengthen AbbVie's [capabilities] in discovering and developing drugs to make a difference in patient[s’] lives," said Jonathon Sedgwick, vice-president and global head of discovery research, AbbVie, in the press release. "Modulating mRNA biology with small molecules is a new approach and has the potential to address 'undruggable' targets with implications across multiple therapy areas."

"Anima's differentiated approach in the field of small-molecule mRNA drugs combines phenotypic screening with AI [artificial intelligence]-driven elucidation of the mechanisms of action. The power of our mRNA Lightning platform is validated by our multiple partnerships and a growing internal pipeline," said Yochi Slonim, co-founder and chief executive officer, Anima, in the release.

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The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

AbbVie and Anima Biotech Partner on Discovery and Development of mRNA Biology Modulators

FDA published a guidance document on Jan. 16, 2023 intended to assist applicants in developing the Dosage and Administration section of labeling as described in 21 

201.57, a regulation governing the content and format of the section of human prescription drug and biological product labeling. The applicants should follow the recommendations in the new guidance when developing the Dosage and Administration section for a new drug submitted to FDA under a new drug application under section 505(b) of the Food, Drug, and Cosmetic Act or a biologics license application under section 351(a) of the Public Health Service Act.

The guidance provides examples of required and recommended information in the Dosage and Administration section.

FDA Publishes Guidance on Labeling Drugs and Biological Products 

FDA signed an agreement on Mutual Recognition between the Swiss Confederation and the United States Relating to pharmaceutical good manufacturing practice (GMP). The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

The Food and Drug Administration Safety and Innovation Act, enacted 2012, permits FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements. Mutual Recognition Agreements (MRAs) are already in place by FDA with the European Union and the United Kingdom. The MRA with Swissmedic includes veterinary drugs, in addition to covering GMP inspections of facilities making human drugs.

Further, FDA’s Office of Global Policy and Strategy has been negotiating the US-Switzerland MRA for several years. Before the MRA is in control, FDA must determine whether Swissmedic can conduct inspections that meet US requirements. Similarly, Swissmedic must decide with respect to FDA meeting Swiss requirements.

“In today’s global pharmaceutical market, MRAs offer a way for the FDA to work more efficiently and maximize its resources,” said Andi Lipstein Fristedt, FDA deputy commissioner for Policy, Legislation, and International Affairs, who signed the agreement on behalf of the FDA, in a company press release. “Once the MRA enters into force, the FDA will be able to rely on the factual findings of Swissmedic experts in many cases, thus avoiding duplicate inspections and allowing the FDA to expand its inspectional reach.”

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

FDA Signs Mutual Recognition Agreement with Swiss Confederation

At the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) meeting on Jan. 12, 2023, the members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. According to the PRAC, the use of lower dose of Olumiant (baricitinib) for patients at higher risk of blood clots, cardiovascular conditions, and cancer is in line with the dosing recommendations for other JAK inhibitors subject to the review are Rinvoq (updacitinib), Cibinqo (abrocitinib), and Jyseleca (filgotinib). 

As for new safety information for healthcare professionals, the PRAC focused on direct healthcare professional communication (DHPC) containing important information on Zolgensma (onasemnogene abeparvovec).

Zolgensma, a gene therapy medicine for the treatment of spinal muscular atrophy, has recently reported fatal cases of acute liver failure in patients treated with it. The DHPC lets healthcare professionals know of the fatal cases of liver failure and the updated recommendations for monitoring liver function, assessing suspected liver injury after infusion, and further advice regarding narrowing the corticosteroid treatment.

The updated DHPC for Zolgensma will be sent to EMA’s committee for advanced therapies and to EMA’s human medicines committee. After being adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorization holders and published on the direct healthcare professional communications’ page and in national registers in EU Member States.

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Pharmacovigilance Risk Assessment Committee Meeting Highlights

Veeva Systems announced on Jan. 13, 2023 that Adare Pharma Solutions, a contract development and manufacturing (CDMO) with expertise in oral dosage forms, chose Veeva Vault Quality Suite to harmonize quality systems across the organization. This choice can help Adare streamline quality processes, work more effectively with partners and suppliers, and deliver greater visibility into operations to customers.

“As Adare expands its business, standardizing on the technology many of our customers use is a top priority to streamline collaboration,” said Audrey Butler, vice president, global head of quality at Adare Pharma Solutions, in a press release. “Veeva Vault Quality Suite will bring together our global teams on one platform for seamless processes and real-time data access that can help us improve how we work with clients and deliver differentiated services.”

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy. Further, Adare will use Veeva Vault QMS to manage all quality processes, Veeva Vault QualityDocs to control documents and ensure quality, and Veeva Vault Training to drive employee qualifications. This new collaboration helps Adare to manage content, data, and training in a single end-to-end quality system.

“We’re proud to partner with Adare Pharma Solutions to help support their goals of improving services for clients and delivering transformational medicines for patients,” said Ashley Wentworth, senior director, Veeva Vault Quality strategy, in a press release. “With the Veeva Vault Quality Suite, Adare will have a scalable cloud platform that can keep up with evolving industry and customer requirements.”

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy. 

Adare Pharma Solutions Coordinating Quality with Veeva Vault Quality Suite

Boehringer Ingelheim and 3T Biosciences announced on Jan. 13, 2023 that they have entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs.

The partnership is meant to unite 3T Biosciences’ best-in-class 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform with Boehringer Ingelheim’s two-pronged research strategy combining cancer cell-directed and immune cell-targeting compounds, further strengthening the pipeline.

The platform from 3T platform aims to address this challenge by identifying novel shared T-cell receptor (TCR) targets of productive immune responses and comprehensively screening TCRs and TCR mimetics for specificity and off-target cross-reactivities. It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. This could lead to tumor-specific, safer therapies that can be delivered at high doses.

“At Boehringer Ingelheim, we are committed to transforming patients’ lives. Through our new partnership with 3T Biosciences, we aim at accelerating and expanding our pipeline of first-in-class T-cell based therapies for patients affected by cancer,” said Lamine Mbow, PhD, global head of Cancer Immunology + Immune Modulation, Boehringer Ingelheim, in a press release.

Stefan J. Scherer, MD, PhD, president and CEO of 3T Biosciences, added that 3T’s 3T-TRACE discovery platform has the potential to transform the treatment of cancers and beyond. “By using data from patients for patients we aim to discover the best immunogenic targets for multiple tumor indications and across patient populations,” he said in a press release.

The agreement notes that Boehringer Ingelheim will provide patient-derived TCR data to fuel 3T’s target discovery efforts to identify antigens using its 3T TRACE discovery platform. Additionally, 3T will receive an upfront payment and research and development support, while still being eligible for discovery, preclinical, clinical, regulatory, and commercial milestones for a total of $268 million and royalties on future Boehringer Ingelheim product sales.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. 