Pharmaceutical Technology Editors

Flow Eighteen38, a protein sciences company, announced a €5 Million (US$5.58 million)investment into its protein production and biophysical characterization capabilities on March 8, 2022. The investment comes from its parent company, FairJourney Biologics, a company specializing in the discovery and optimization of antibodies.

According to a company press release, the investment will be used to develop a new laboratory that will be designed to double the company's protein purification capacity. These facilities will accommodate 15+ high-end fast protein liquid chromatography systems, all of which will be individually optimized to scale-up custom production, support unique partner requirements, and fast-track standard productions.

The investment will also be used to purchase:

LabChip’s GX Touch for capillary electrophoresis sodium dodecyl sulfate (CE-SDS)

Thermo Scientific’s Vanquish ultra high-performance liquid chromatography (UHPLC)

Endosafe nexgen-MCS for endotoxin testing

Two BioAccord liquid chromatography–mass spectrometry (LC–MS) systems.

The funding will also drive further recruitment for production and characterization services and cold storage and logistics solutions. It will also contribute to continued supply of quality antibody reagents that comply with new European Union recommendations.

“This investment is further commitment to our partners to ensure we remain on the cutting-edge of protein production and biophysical solutions and to continue to deliver quality results our diverse portfolio of partners have come to know and expect,” said António Parada, CEO, FairJourney Biologics, in the press release.

“We are thrilled for this new stage of Flow Eighteen38,” said Teresa Barata, head of Protein Science Division, Flow Eighteen38, in the press release. “The new investment will enable us to continue to support our clients at the various stages of the discovery process and extend it to pre-[chemistry, manufacturing, and controls] stages, for faster and successful biotherapeutics development.”

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Flow Eighteeen38 is receiving a €5 million (US$5.58 million) investment from its parent company, FairJourney Biologics.

Flow Eighteen38 Receives €5 Million (US$5.58 Million) to Expand Production and Biophysical Capabilities

evitria, a transient chinese hamster ovary (CHO) expression service provider, announced the closing of a license agreement with mAbsolve, a biotechnology company, on March 10, 2022. The agreement will grant evitria access to mAbsolve’s gene silencing technology for use in their antibody cells.

Per the terms of the agreement, evitria will supply clients with antibodies bearing STR silencing modifications, which clients will then be able to use in their experiments without needing to secure additional R&D licenses. These clients will also have access to technical support and commercial-term certainty from mAbsolve.

“We are excited to add the STR technology into our antibody engineering and modification capabilities,” said Christian Eberle, CEO, evitria, in a company press release. “STR has been shown to outperform all other modifications for generating truly silent Fc-domains and fits perfectly with our best-in-class approach at evitria.”

“We cannot wait to get STR into the hands of more researchers,” said Geoff Hale, CEO, mAbsolve, in the press release. “evitria’s focus on high quality CHO expression means that it is perfectly positioned to offer our technology to the therapeutic market, and we look forward to supporting their clients with this technology.”

Evitria has entered into an agreement with mAbsolve that will allow the company to use mAbsolve’s gene silencing technology in their antibody cells.

evitria Licenses mAbsolve Gene Silencing Technology

C4 Therapeutics announced on March 9, 2022 that FDA has granted orphan drug designation (ODD) to CFT8634 for the treatment of soft tissue sarcoma. The company specializes in developing a new generation of small-molecule medicines to change how diseases are treated.

CFT8634 targets cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1 deleted cancers. It is orally bioavailable, selective degrader of BRD9, which was formerly considered an “undruggable” target because inhibitors of the bromodomain of BRD9 are not effective in treating cancers.

Orphan drug designation is granted to treatments for rare diseases that affect fewer than 200,000 people in the United States. The treatments are intended for the safe and effective treatment of patients with unmet medical needs due to these rare diseases.

“Patients living with synovial sarcoma currently have limited treatment options. After first-line treatment with chemotherapy, the benefit of which is typically of limited durability, patients with metastatic synovial sarcoma tend to do poorly,” said Adam Crystal, M.D., Ph.D., and chief medical officer of C4 Therapeutics, in a press release. “The FDA’s decision to grant orphan drug designation to CFT8634 is an important recognition of the potential of our targeted protein degrader to address this dire unmet medical need faced by patients and their families.”

C4 Therapeutics has been granted orphan drug designation by FDA for CFT8634 for the treatment of soft tissue sarcoma.

FDA Grants Orphan Drug Designation to Soft Tissue Sarcoma Treatment

SCG Cell Therapy, a Singapore-based biotechnology company, announced on March 10, 2022 that it has signed a collaboration agreement with A*STAR’s Bioprocessing Technology Institute (BTI) to advance the development of multi-specific antibodies for infectious diseases and cancer treatments.

The collaboration between the companies will aid in discovering novel therapeutic antibodies and chemistry, manufacturing, and control (CMC) process development to produce more effective, safe, and affordable treatments for patients with infectious diseases and related cancers. There is a specific focus on the hepatitis B virus (HBV) and human papillomavirus (HPV), motivated by the 33 million people in Southeast Asia that have chronic hepatitis B virus, along with the nearly 200,000 deaths in Asia caused by cervical cancer.

Multi-specific antibodies can target multiple antigens on the same or separate cells, which is crucial in the treatment of cancers. These types of antibodies disrupt cancer development or progression by increasing tumor killing selectivity and promoting immune activities.

“The collaboration builds on SCG’s strong international network and capabilities in product development, and BTI’s in-depth expertise in biotherapeutics technology and manufacturing process development,” said Frank Wang Shuli, CEO of SCG Cell Therapy, in a press release. “Together we look forward to accelerating breakthroughs in new antibody-based therapeutics, revolutionizing how we treat chronic infections and cancer.”

SCG Cell Therapy has signed a collaboration agreement with A*STAR’s BTI to advance the development of antibodies for infectious diseases and cancer treatments.

SCG Cell Therapy and A*STAR’s BTI Collaborate to Advance Multi-Specific Antibody Development 

Voyager Therapeutics, a gene therapy company, announced on March 8, 2022 that it had entered into a licensing agreement with Novartis, under which Novartis will license Voyager’s TRACER adeno-associated virus (AAV) capsids for potential use with three central nervous system (CNS) targets. Novartis will also have the future option to access the capsids for two additional targets.

Under agreement, Novartis will pay Voyager $54 million upfront for access to TRACER. Additional payments totaling up to $1.7 billion are contingent on Novartis exercising potential options and the drug targets reaching various development, regulatory, and commercial milestones.

According to a company press release, an initial set of proprietary AAV capsids derived from the TRACER platform demonstrated:

Superior blood–brain barrier penetration

Increased transduction in the brain and spinal cord

Increased transgene expression in target tissues compared to conventional AAV capsids when dosed intravenously in non-human primates.

“Overcoming the substantial toxicity risk frequently observed with high doses of AAV-based gene therapies remains a critical challenge to realizing the full, curative potential of this breakthrough modality,” said Glenn Pierce, interim chief scientific officer, Voyager, in a company press release. “Voyager’s growing and maturing library of proprietary TRACER-derived capsids have demonstrated markedly enhanced expression in non-human primates with more precise targeting of desired tissue and cell types, creating the potential for superior delivery and fewer off-target risks than conventional AAV.”

“This transaction further validates the potential of the Voyager TRACER capsid discovery platform to broadly enable a next generation of AAV gene therapies,” said Allen Nunnally, chief business officer, Voyager, in the press release. “Our collaboration with Novartis expands the array of therapeutic programs in which our proprietary capsids may be deployed and highlights the potential of our TRACER platform to generate future business development opportunities as our novel capsid library expands and initial TRACER-derived capsids are further refined to enhance desirable characteristics.”

Novartis will pay Voyager up to $1.75 billion for access to Voyager’s novel Tracer AAV capsids for potential use with three CNS targets.

Voyager Therapeutics Announces License Agreement with Novartis Worth Up to $1.75 Billion

Various life sciences executives, including representatives from Ovid Therapeutics, Nkarta Therapeutics, and Alnylam Therapeutics, released a paper calling for fellow businesses to cease all business involvement with Russia. Until such a time that “restoration of peace and democracy [is achieved] in a sovereign Ukraine,” the authors ask that fellow businesses:

Halt collaboration or service agreements with Russian companies

Halt trade in goods and services with Russian companies (except for food and medicines).

“We cannot look back in the future wondering whether we could have taken stronger measures.” reads the statement. “This justifies the strongest possible economic disengagement now.”

The authors encourage all industry professionals, not just executives or those working in the life sciences industry, to sign the agreement. As of March 9, 2022, more than 850 individuals have signed the agreement. The full list of co-signatories can be found 

Various executives in the life sciences industry have started a petition calling for “complete economic disengagement” with Russia.