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Sanofi and Recludix Pharma, a pharma company specializing in inflammatory diseases and cancer, announced a strategic collaboration on July 20, 2023. The partnership focuses on developing and commercializing small-molecule signal transducer and activator of transcription 6 (STAT6) inhibitors for patients with immunological and inflammatory (I&I) diseases. Under the agreement, Sanofi will pay Recludix $125 million in near-term payments and $1.2 billion in additional payments contingent on various development, regulatory, and sales-based milestones.

According to a company press release, Recludix will advance various STAT6 inhibitors from preclinical research and development until the start of Phase II clinical trials, after which Sanofi will handle further development and commercialization of the candidate. Sanofi will retain global rights to any small-molecule STAT6 inhibitors produced from the partnership, although Recludixhas the opportunity to participate in profit/loss share and certain co-promotion opportunities in the United States. Recludix will also be eligible for double-digit royalties on future product sales.

“This collaboration for the advancement of a preclinical oral STAT6 inhibitor speaks to our ability to successfully solve the challenge of drugging this attractive, yet elusive, therapeutic target,” said Nancy Whiting, CEO, Recludix, in the press release. “We are proud of the breakthroughs we have made in drugging SH2 [Src homology 2] domains as demonstrated by the STAT6 program, and we are excited to partner with Sanofi … who shares our vision for advancing an oral STAT6 inhibitor forward quickly for the benefit of patients. This strategic collaboration empowers the program while ensuring meaningful development participation and economic value for Recludix.”

“Recludix’s approach to targeting STAT6 has significant potential for a number of I&I diseases, especially where a precisely tailored oral therapy could best fit within the patient’s needs at various stages of disease,” said Frank Nestle, global head, Research, and chief science officer, Sanofi, in the release. “We are excited to partner with the Recludix team to continue to advance innovative strategies for targeting this previously considered undruggable target, aligned with our mission to best serve patients with inflammatory disease.”

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Sanofi and Recludix Pharma’s deal centers on developing treatments for various immunological and inflammatory diseases.

Sanofi and Recludix Enter STAT6 Inhibitor Partnership Worth More Than $1.3 Billion 

WuXi STA, a contract research development and manufacturing organization (CRDMO) that functions as a subsidiary of WuXi AppTech, announced the launch of its first high potency (HP) fully automated sterile injectable manufacturing line at its drug product site in Wuxi City, China on July 17, 2023. According to a company press release, the new HP injectable line has an annual capacity of 12 million units, and will enhance the company’s manufacturing capabilities and capacity for injectable dosage forms.

The line uses fully enclosed isolation systems and automated filling machines, which is intended to minimize human intervention, prevent cross-contamination, and ensure quality assurance for sterile products; according to the release, the new line meets Occupational Exposure Limits as low as 10 nanograms per cubic meter. Additionally, the line is equipped with two 20 meters squared lyophilizers with a filling rate of up to 200 units per minute, which are designed to support liquid and lyophilized vials of various specifications.

"I'm thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone," said Minzhang Chen, co-CEO, WuXi AppTec, and CEO, WuXi STA, in the release. "In addressing the growing needs of high potency drugs, WuXi STA... will continue to strengthen our CRDMO platform capabilities. With our proven track record of consistent quality and [environment, health, and safety] systems across all sites globally, we are committed to accelerating pharmaceutical development and bringing new therapeutics for patients worldwide."

According to the release, WuXi STA plans to add two more injectable manufacturing lines at the same site by 2024. In that timeframe, additional lines are also set to be added to the Couvet site in Neuchâtel, Switzerland and the upcoming Middletown site in Delaware, USA.

WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.

WuXi Sta Launches High Potency Manufacturing Line in Wuxi City Location

Feliza Mirasol is the science editor for 

US-based biotechnology company Crossbow Therapeutics announced an $80 million Series A funding round that was led by investment company MPM BioImpact and Pfizer Ventures. The funding will allow Crossbow to advance the development of novel antibody therapies that target peptide-loaded major histocompatibility complexes on cancer cells. The antibodies are T-cell receptor (TCR)-mimetics, according to a July 11, 2023 company press release.

The company uses its proprietary technology to develop TCR-mimetic antibodies with both high affinity and specificity for cancer cells. These TCR-mimetics are incorporated into off-the-shelf, easy-to-assemble T-cell engagers and other immunotherapies. The resulting products are known as tumor-bolts (T-Bolt) molecules, which can be adapted to address a broad range of cancers. The company can thus leverage these molecules to target the vast landscape of cancer proteins, according to the press release.

“We aim to cure cancer,” said Briggs Morrison, CEO, Crossbow Therapeutics, in the release. “ … [O]ur revolutionary T-Bolt products strike cancer cells like a crossbow shoots bolts at its target. The influx of additional capital enables us to scale our efforts to build an arsenal of TCR-mimetic-based immunotherapies designed to overcome the limitations of current treatments.”

“Our continued investment in Crossbow Therapeutics reflects our confidence in the team’s differentiated approach to vastly expand the range of targets for immunotherapies,” said Todd Foley, managing director of MPM BioImpact and co-founder and chair of the Crossbow board of directors, in the release.

The Series A funding was also supported by Polaris Partners, BVF Partners, Eli Lilly and Company, Mirae Asset Venture Investment, and Mirae Asset Capital.

Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.

Crossbow Therapeutics Debuts with $80 Million in Series A Financing to Advance Antibody Therapeutics

Bristol Myers Squibb has exercised its option to enter into an exclusive global license agreement with Germany-based Evotec, a drug discovery company, for selected late-stage discovery programs that were developed and progressed from a collaboration between the companies.

According to a July 11, 2023 press release, the companies originally formed a neurodegeneration partnership in 2016, which proved to be highly productive. Under the collaboration, Evotec and Bristol Myers Squibb generated a pipeline of discovery-to-clinical-stage programs. The current licensing agreement expands on that original collaboration, extending the partnership to another eight years.

Under the license agreement, Bristol Myers Squibb has selected a number of programs (not disclosed) that were developed and progressed in a short time frame using Evotec’s precision medicine platforms. Based on this achievement, Evotec get a $40 million payment and is eligible to earn performance-based milestone payments. The company is also eligible to receive tiered royalties up to low double-digit percentages based on product sales, according to the press release.

“This license agreement will further bolster our joint pipeline of programs targeting several neurodegenerative conditions. We are confident that the strong collaboration of the experienced teams at Evotec and Bristol Myers Squibb will make novel innovative treatment options available to patients living with a broad range of neurodegenerative conditions,” said Cord Dohrmann, chief scientific officer, Evotec, in the release.

Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.

Bristol Myers Squibb and Evotec Extend Neuroscience Pact

On Jul 18, 2023, Novartis announced in its 2023 second quarter (Q2) earnings that its board of directors has unanimously endorsed the 100% spin-off of Sandoz, the company’s generics and biosimilars division, into a standalone, publicly traded entity. Novartis had previously announced its intent to separate the Sandoz business in August 2022 (1). The proposed spin-off is expected to happen early in the 2023 fourth quarter.

According to a company press release, the next step involves Novartis shareholders voting on the proposed spin-off and a related reduction of the share capital of Novartis AG at a general meeting planned on Sept. 15, 2023. The plan is for Sandoz to be listed on the SIX Swiss Exchange, with an American Depositary Receipt program in the United States.

Novartis reported in its Q2 earnings that Sandoz sales grew 8% for the quarter, with net sales of $2.4 billion. Growth was primarily driven by Europe, which totaled $1.3 billion. Global sales of biosimilars grew 13% to $531 million for the quarter.

According to Novartis’ Q2 earnings release, the spin-off of Sandoz is part of the company’s new strategy to transform itself into a “pure-play” innovative medicines business. It will now focus on five core therapeutic areas: cardiovascular, immunology, neuroscience, solid tumors, and hematology. The company also intends to prioritize three emerging technology platforms for cell and gene therapy, radioligand therapy, and xRNA (i.e., ribonucleosides). The company plans to prioritize continued investment into R&D capabilities and manufacturing scale for these three platforms.

1. Novartis, Novartis Announces Intention to Separate Sandoz Business to Create a Standalone Company by Way of a 100% Spin-Off. Press Release, Aug. 25, 2022.

The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.

Sandoz Spin-off Gets Green Light from Novartis Board

Pfizer and Flagship Pioneering, a venture capital firm that creates bioplatform companies, announced a partnership on July 18, 2023 that is centered on creating a new pipeline of innovative medicines. The deal mentions that both companies will invest $50 million upfront to explore opportunities to develop 10 single-asset programs.

According to a Flagship press release, Pfizer will fund and have the option to acquire each selected development program, whereas Flagship and its bioplatform companies will be eligible to receive up to $700 million in milestones and royalties for each successfully commercialized program. In addition, Pioneering Medicines, a Flagship initiative, will work with Pfizer to lead the rapid portfolio creation process.

"Flagship and Pfizer enter into this strategic alliance driven by a shared sense of urgency to develop novel medicines that make a difference for patients," said Paul Biondi, president, Pioneering Medicines, and executive partner, Flagship Pioneering, in the release. "This new partnership brings together the best of our organizations to maximize discovery and development potential from inception to impact through a unique innovation supply chain that sets us on a path to potentially realize transformational medicines more quickly and effectively."

"At Pfizer, we are expanding our efforts to pursue potential breakthrough science with unique approaches and funding mechanisms designed to leverage the dynamic scientific ecosystem," said Mikael Dolsten, chief scientific officer and president, Worldwide Research, Development and Medical, Pfizer, in the release. "This collaboration is an exciting opportunity for Pfizer to bring deep scientific expertise and apply our development and regulatory strength to Flagship's diverse portfolio of technology platforms, translating early-stage innovation to potential medicines."

The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.

Pfizer and Flagship Pioneering Enter Innovation Partnership

Scribe Therapeutics, a genetic medicines company, and Sanofi announced an expanded collaboration on July 17, 2023. The agreement will see Sanofi receive an exclusive license to use Scribe’s CRISPR X-Editing (XE) genome editing technologies for the development of in vivo therapies, including sickle cell disease.

According to a company press release, Scribe will receive $40 million in upfront payment and is eligible to potentially receive more than $1.2 billion based on the successful completion of certain development and sales milestones, as well as tiered royalties. This agreement builds on the companies’ existing collaboration, which is focused on ex vivo editing of natural killer (NK) cell therapies for cancer treatment.

“We are continually impressed by the expertise, rigor, and urgency that Sanofi has brought to our existing ex vivo collaboration, as well as their rapid advancements and innovation in non-viral delivery technologies. Now, we are thrilled to expand our work together into new areas of high unmet need,” said Benjamin Oakes, co-founder and CEO, Scribe Therapeutics, in the release. “This in vivo collaboration further demonstrates the versatility of Scribe’s design-based approaches to CRISPR, which enable greater activity, specificity, and deliverability, ultimately accelerating the development of life-changing therapeutics.”

“We are pleased to expand our work with Scribe, an illustration of our shared commitment to advance best-in-class genome editing therapies for patients in need,” said Christian Mueller, global head, Genomic Medicine Unit, Sanofi, in the release. “We’re encouraged by what we’ve accomplished to date with Scribe in creating ex vivo NK cell therapies and now look forward to accelerating our ability to effectively leverage genome editing in vivo through Sanofi’s innovative research work in targeted lipid nanoparticles, for in vivo therapies with the potential to dramatically improve treatment outcomes and ultimately to change patients’ lives.”

“Scribe’s platform holds tremendous potential to address an unprecedented number of therapeutically relevant targets across the human genome for many serious diseases,” said Svetlana Lucas, chief business officer, Scribe Therapeutics, in the release. “We are excited to partner with companies like Sanofi that offer not only disease and drug development expertise but also the resources and technologies enabling the delivery of our molecules in vivo to specific disease tissues, allowing us to develop better therapies. We look forward to our continued collaboration with Sanofi to expand the application of Scribe’s best-in-class genome editing tools and fully realize the promise of CRISPR for patients as broadly and rapidly as possible.”

The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.

Sanofi and Scribe Therapeutics Expands Genomics Collaboration 

Novartis has acquired DTx Pharma, a US-based, preclinical-stage biotechnology company, for an upfront payment of $500 million plus additional payments of up to $500 million, dependent on the completion of pre-specified milestones, the companies announced in their respective July 17, 2023 press releases.

DTx Pharma focuses on RNA-based therapeutics with its proprietary Fatty Acid Ligand Conjugated OligoNucleotide (FALCON) technology platform, which conjugates small interfering RNAs (siRNAs) to naturally occurring fatty acids to enhance biodistribution and cellular uptake throughout the body. Under the acquisition, Novartis will gain access to the FALCON platform as well as DTx Pharma’s lead program, DTx-1252, a product candidate that targets the root cause of a subtype of Charcot-Marie Tooth disease (CMT)—CMT1A.

CMT1A is the overexpression of peripheral myelin protein 22 (PMP22), a protein that causes the myelin sheath insulating the nerves in the peripheral nervous system to function abnormally. DTx-1252 has been shown to decrease the expression of PMP22 in Schwann cells (target cell type), allowing for the development, maintenance, and function of peripheral nerves, according to DTx Pharma’s company press release.

Also under the acquisition, Novartis will gain two additional preclinical programs for other neuroscience indications. Together with DTx-1252 and the FALCON platform, these assets will expand Novartis’ siRNA toolkit and allow the company to build on its xRNA (i.e., ribonucleosides) capabilities, according to Novartis’ press release.

“I am thrilled that Novartis will be moving forward with our CMT1A therapeutic program and the FALCON platform. With its resources and capabilities in neuromuscular diseases, Novartis is well positioned to accelerate the development of DTx-1252 and provide hope to patients, who are desperately in need of therapy,” said Artie Suckow, co-founder and CEO of DTx Pharma, in that company’s press release.

“We look forward to continuing the development of DTx’s therapeutic programs and bringing new hope to patients with neuromuscular and other neurological disorders for which there have historically been few treatment options,” said Fiona Marshall, president of the Novartis Institutes for BioMedical Research, in the Novartis press release. “We are also excited to bring DTx’s FALCON technology to Novartis and explore its potential to deliver drugs to extrahepatic tissues.”

Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.

Novartis Acquires DTx Pharma in Deal Worth Up to $1 Billion

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The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) issued recommendations on July 17, 2023 for actions to prevent shortages of antibiotics (e.g., amoxicillin, amoxicillin/clavulanic acid, penicillin V, azithromycin, clarithromycin, ceftriaxone, cefotaxime and piperacillin-tazobactam) crucial in the treatment of respiratory infections . The recommendations were made to help prevent infections next winter in the European Union and were developed by the Executive Steering Group on Shortages and Safety in Medicinal Products (MSSG). The recommendations will be followed up on by the European Commission.

These recommendations reflect a new mandate for EMA (Regulation on EMA’s Reinforced Role (Regulation (EU) 2022/123)) which gives EMA new responsibilities on preventing critical medicine shortage crises. These responsibilities include monitoring events such as medicine shortages that may cause public health emergencies, reporting shortages to EU countries and coordinating responses with said countries, monitoring the supply and demand of medicinal products, and setting up two groups (MSSG and the Executive Steering Group on Shortages of Medical Devices).

EMA and the European Health Emergency Preparedness and Response Authority (HERA) will work with marketing authorization holders to ensure first and second-line antibiotics for respiratory infections will match demand. EMA and HERA recommended that marketing authorization holders increase production on these key antibiotics and take early action in the autumn and winter season to give sufficient time to manufacturers. EMA and the Commission, along with Member States, reminded stakeholders to order medicines as normal and to not stockpile medications. They also urged medical professionals to only prescribe antibiotics for bacterial infections in order to avoid antimicrobial resistance. Citizen awareness-raising initiatives were also recommended.

“Based on the data received we are working to ensure that we are better prepared for the upcoming winter season,” said Professor Karl Broich, chair of the HMA. “These early projections will allow the European medicines regulatory network to work with stakeholders to take measures in advance and prevent potential shortages for patients in the upcoming winter season.”

Going forward, EMA and HERA will continue to monitor supply and demand of key antibiotics throughout the rest of the year. “It is important that manufacturers take early action, ahead of the winter season, so that they can ramp up manufacturing capacity where necessary,” said Emer Cooke, EMA’s executive director in a EMA press release. A HERA Board meeting with representatives of the EU Member States’ Ministries of Health, the Commission, and the industry took place on July 20, 2023 to further discuss the issue and agree on future steps.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

EU Takes Steps to Prevent Antibiotic Shortages Next Winter

FDA published a draft guidance document on July 13, 2023 outlining recommendations for manufacturing of products related to human cellular therapy or gene therapy (CGT). Recommendations included product compatibility and manufacturing changes regarding investigational and licensed CGT products. The draft guidance document reflected FDA’s current view on “management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.”

The guidance specifically talks about considerations for the management of manufacturing changes related to risk management, stability and delivery device compatibility, nonclinical studies, and clinical students. It then covers regulatory reporting of manufacturing changes. This included chemistry, manufacturing, controls (CMC) changes requiring a new Investigational New Drug Application (IND) submission, and reporting manufacturing changes to an IND and to a Biologics License Application (BLA). Comparability assessment and reporting are also discussed, touching on risk assessment, analytical comparability study design, analytical methods, results, and statistics. There is also a section for special considerations for tissue-engineered medical products.

Due to the complexity of CGT products and the unique factors present in manufacturing and control of CGT products, making changes to their management and manufacturing may be more of a challenge than for other biological products. While product manufacturers may seek to make a manufacturing chance for many reasons, it is important that the risks to product quality be properly assessed beforehand. The guidance states, “Risk assessment should be performed for all types of manufacturing changes, regardless of the stage of product development. If a risk assessment indicates that a manufacturing change has the potential to adversely affect product quality, comparability studies should be performed to evaluate the impact of the proposed manufacturing change.”

Sponsors and applicants of CGT products were recommended to discuss significant manufacturing changes with FDA’s Center for Biologics Evaluation and Research, especially if the changes would take place in later stages of the product lifecycle.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach