Pharmaceutical Technology Editors

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.

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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. 

Boehringer Ingelheim, 3T Biosciences Join Forces to Develop Next-Generation Cancer Immunotherapies

The new oral suspending base from PCCA, called SuspendIt Anhydrous, can be used on APIs that are unstable in water or are incompatible with existing aqueous vehicles, according to a company press release.

“An anhydrous base offers many benefits to compounding pharmacies,” said Gus Bassani, PCCA chief scientific officer, in the press release. “There’s no water to support the growth of micro-organisms or cause hydrolytic degradation of an API and it opens the potential for formulations to be assigned longer beyond-use dates (BUDs). But what makes our new base really unique is its self-emulsifying properties. This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility as well.”

Many anhydrous bases are oil-based; however, many patients do not like the taste of oil-based vehicles or the oily residue left in their mouths and throats. These highlighted issues along with other problems have led to problems with medication compliance.

“We developed a unique anhydrous base that, in addition to the self-emulsifying properties, has an improved viscosity, which reduces when shaken and thickens when standing. This thixotropic effect allows for rapid redispersion of APIs with agitation and minimizes sedimentation,” said Daniel Banov, PCCA director of Research and Development, in a press release. “We added a natural sweetener, as well as the ability to mix the compounded medicine with juice or water at the moment of administration, for a better taste if desired. The technology is so unique that we have a patent pending.”

PCCA has also created formulas for the most prescribed APIs and plans to continue formula development and API testing.

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

SuspendIt Anhydrous Introduced as New Compounding Base

Spectrum Laboratory Products announced on Jan. 9, 2023 that the company is voluntarily recalling three lots of epinephrine (L-Adrenaline) USP, a bulk API used to manufacture or compound prescription products to the user level.

The L-Adrenaline USP bulk API powder is used in manufacturing and compounding of finished-dose epinephrine prescription products that can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person. The use of a finished-dose product manufactured or compounded with the recalled product could result in less-effective product and incomplete treatment of life-threatening conditions, such as low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack. Further, treatment with a less-effective product or underdosing of epinephrine could result in death.

The main customer complaints have found that the product is discolored. The doses that are included in the impacted Epinephrine USP product can be identified by Spectrum catalog number EP130.

There have not been any reports of adverse events related to this recall, according to Spectrum Laboratory Products.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

A FDA guidance was published on Jan. 4, 2023 that provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product and a biological drug product. A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

This guidance specifically provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer and more informative while supporting the submission of a REMS document in Structured Product Labeling format.

An overview of the types of information that should be included in a REMS document is provided in the new document, whereas additional and more detailed information is provided in a separate guide, titled 

REMS Document Technical Conformance Guide

, which will be updated periodically on FDA’s website.

The guide can be used for drafting a REMS document for single product and shared system REMS and includes an outline for drafting a Bifurcated4 REMS document.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Updated REMS Document for Prescription, Biological Drug Product

AstraZeneca announced a definitive agreement to acquire CinCor Pharma, a clinical-stage biopharmaceutical company focused on developing novel treatments for hypertension and chronic kidney disease, on Jan. 9, 2023. The deal, worth up to $1.8 billion, grants AstraZeneca global rights to baxdrostat (CIN-107), a novel aldosterone synthase inhibitor (ASI) currently in development as a treatment to lower blood pressure in treatment-resistant hypertension. The deal is expected to close in the first quarter of 2023.

According to a company press release, CIN-107 is highly selective for aldosterone synthase and spares the cortisol pathway in humans. AstraZeneca will also acquire the rights to farxiga (dapagliflozin), another treatment designed to prevent and delay cardiorenal disease.

“Acquiring CinCor supports our commitment to cardiorenal disease and further strengthens our pipeline with [CIN-107],” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in the press release. “Excess levels of aldosterone are associated with hypertension and several cardiorenal diseases, including chronic kidney disease and coronary artery disease and being able to effectively reduce this would offer a much-needed treatment option for these patients.”

“We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved,” said Marc de Garidel, CEO, CinCor, in the press release. “CinCor is committed to ensuring a smooth transition of the development responsibilities to AstraZeneca once the acquisition is consummated.”

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

AstraZeneca Inks $1.8 Billion Acquisition for CinCor Pharma

Chiesi Farmaceutici, a research-focused biopharmaceuticals and healthcare group, and Amryt Pharma, a commercial-stage biopharmaceutical company focused on rare diseases, announced a definitive acquisition agreement on Jan. 8, 2023. Chiesi will acquire Amryt for approximately $1.25 billion, with an additional $225 million available in contingent value rights. The transaction is expected to close before the end of the first half of 2023.

“With this Transaction, we are further expanding our commitment to people living with rare diseases, the majority of which still have no cure or approved treatment,” said Marco Vecchia, CEO, Chiesi Group, in a company press release. “This addition of the Amryt portfolio, as well as their expertise, will help us on our journey to bring medicines to patients, no matter how rare their condition may be.”

“Chiesi is aligned with Amryt’s commitment and passion, and I believe Chiesi will further maximize the value of Amryt’s current portfolio and pipeline and most importantly, will accelerate our ability to reach more patients in need globally,” said Joe Wiley, CEO, Amryt Pharma, in the press release.

Chiesi will acquire Amryt Pharma, a commercial-stage biopharmaceutical company, in a deal worth up to $1.47 billion.