Pharmaceutical Technology Editors

On Nov. 16, 2022, Theragent, a newly emerged, US-based cell therapy contract development and manufacturing organization (CDMO), announced that CellVax Therapeutics, a French late-stage clinical-trial company, selected it to provide manufacturing and testing services for CellVax’s novel cancer immunotherapy candidate, FK-PC101. FK-PC101 is entering Phase II clinical trials.

The immunotherapy candidate is a cell based autologous cancer vaccine for prostate cancer. It is intended for patients who have a high risk of recurrence after prostatectomy. Under the agreement, the two companies have begun preparations for the manufacturing partnership, including project planning and analytical method tech transfer. Manufacturing services will start in late 2022. Theragent has agreed to supply autologous cell-derived doses to support CellVax’s early and pivotal trials in the United States.

“Theragent is a newer CDMO, but we have assembled a team that brings decades of experience in the development and production of autologous cell-based products around the world,” said Jeff Masten, chief operating officer, Theragent, in a company press release. “We are thrilled to support CellVax and their promising Phase [II] cancer vaccine candidate. Not only does this project fit seamlessly into our new … [C]GMP [current good manufacturing practice] manufacturing facility in Southern California, but the incredible science behind FK-PC101 is a harmonious fit with our company mission of delivering advanced medicines to cancer patients in need.”

“With our proprietary immunotherapy platform, we modify the patient’s tumor cells 

, inducing them to behave as antigen-presenting cells, which are then formulated into a personalized cancer vaccine for that individual. We look forward to partnering with Theragent on the further development of this truly novel modality,” said Fernando Kreutz, CEO of CellVax, in the press release.

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CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

CellVax and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate

Sanofi and Insilico Medicine, a clinical-stage biotechnology company, announced a multi-year strategic research collaboration on Nov. 8, 2022. The agreement will see Sanofi use Insilico’s AI platform, Pharma.AI, to advance drug development in up to six new targets.

According to a company press release, Sanofi will pay $21.5 million in upfront and target nomination fees. Additional payments for various research, development, and sales milestones reach as high as $1.2 billion, as well as mid-single to low double-digit tiered royalties for any products developed.

“We look forward to working with Insilico Medicine, a demonstrated leader in AI-powered drug discovery,” said Changchun Xiao, head of China Research, Sanofi, in the release.“This collaboration will leverage our complementary capabilities, as well as the co-location of our scientific teams, to boost the drug discovery efforts of the Sanofi Institute for Biomedical Research (SIBR), Sanofi’s R&D center in China.”

“We are very happy to collaborate with Sanofi, a company with a clear strategy in AI-powered drug discovery,” said Alex Zhavoronkov, CEO and founder, Insilico Medicine, in the release. “This close collaboration will allow Sanofi to immediately gain the capabilities of one of the top AI startups in addition to enriching their drug discovery pipeline."

The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.

Sanofi and Insilico Medicine Ink $1.2 Billion Drug Development Deal

Indiviaor, a pharmaceutical company focused on treatments for addiction and serious mental illnesses, announced its acquisition of Opiant Pharmaceuticals, a company developing treatments for addiction and drug overdose, for approximately $145 million on Nov. 12, 2022. This acquisition grants Indivior the rights to OPNT003, an investigational opioid overdose reversal agent, as well as other treatments in their pipeline.

According to a company press release, OPNT003 is an intranasal nalmefene formulation that utilizes an absorption-enhancing technology (Intravail) to enhance its pharmacodynamic profile, allowing it to act more quickly and relative to certain naloxone-based rescue agents such as NARCAN Nasal Spray. OPNT003 received fast track designation from FDA in November 2021 and Opiant is expected to complete its new drug application submission in the fourth quarter of 2022. Should it receive FDA approval, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months.

"Our work in combating addiction has never been more critical, with overdose deaths in the US occurring at near record numbers,” said Mark Crossley, CEO, Indivior, in the release. “Opiant’s portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior’s strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery.”

“We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines,” said Roger Crystal, president and CEO, Opiant, in the release. “This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees, and our stockholders. It will enable us to leverage Indivior’s global scale, commercial strength, and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose.”

In addition to OPNT003, two other key treatments are in Opiant’s pipeline, PONT002 and OPNt004. OPNT002, or nasal naltrexone, is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings. OPNT004 is a cannabinoid receptor type 1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose.

Indivior’s acquisition of Opiant grants them access to the company’s portfolio of investigational opioid overdose reversal agent, OPNT003.

Indivior Acquires Opiant for $145 Million

ReiThera announced on Nov. 3, 2022 that it has received operational authorization from the Italian Medicines Agency (AIFA) to open the new production area at its new facility at the Castel Romano Technopole. The 1500-m2 facility will focus on the large-scale production of viral vectors for vaccines and gene therapy.

The new facility will serve as ReiThera’s client base and offer maximum flexibility in processing scale, able to accommodate good manufacturing practice productions based on adenovirus, adeno-associated virus, and lentivirus. The construction of the facility began in May 2020 with an investment of more than 15 million euros by ReiThera.

“Thanks to the operational authorization of this expanded facility, the ReiThera team, which combines high-level scientific knowledge with extensive experience in the engineering and bioprocessing of viral vectors, will be able to support companies engaged in the development of products in the field of vaccines and advanced therapies, from the fine-tuning of small-scale production processes to production on a commercial scale,”

said StefanoColloca, chief technology officer and co-founder of ReiThera, in a company press release.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production. 

ReiThera Expands Viral Vector Production Capabilities with Opening of New Manufacturing Facility

Avantor announced on Nov. 3, 2022 the opening of a new 69,000-ft2 distribution center in Dublin, Ireland. The facility is the most advanced distribution center in the company’s global network and enhances supply security due to its location to customers, according to a company press release.

The new facility will offer certified good manufacturing practice warehousing, on-site cleanrooms, batch-to-batch traceability, custom palletization, inbound and outbound product quality inspections, and vendor managed inventory solutions. The facility will also create 40 new jobs, adding to the 200 employees the company currently employs in Ireland.

"Avantor's value to the biopharma industry is our ability to support customers from discovery to delivery," said Ger Brophy, executive vice-president, Biopharma Production, in the release. "As a leading materials provider to the growing bioproduction industry, it is vital that we are responsive to customer needs in key markets such as Ireland while also having the capacity to meet growing demand in the region. This investment reflects our commitment to the industry and our anticipation of continued growth."

Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland. 

Avantor Opens New Distribution Center in Dublin, Ireland

Salipro Biotech announced on Nov. 8, 2022 that it has entered into a research collaboration and license agreement with Sanofi on the discovery of therapeutic biologics against a challenging drug target.

The collaboration will combine Salipro Biotech’s expertise and its Salipro platform technology to develop stable antigens of GPCRs, ion channels, and transporters with Sanofi’s drug discovery programs to move forward the generation of biologics.

“We are excited to work closely with the innovative team at Sanofi to accelerate their drug discovery efforts against a selected membrane protein drug target,” said Jens Frauenfeld, CEO of Salipro Biotech, in a press release. “Combining our expertise and platform technology to generate Salipro-stabilized drug targets with Sanofi’s expertise in biologics discovery and development will open up entirely new possibilities to make the undruggable druggable for Sanofi’s biopharmaceutical pipeline.”

Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.