Grant Playter

Verve Therapeutics, a clinical-stage genetic medicines company, announced an exclusive research collaboration with Eli Lilly & Company on June 15, 2023. The deal, which centers around Verve’s preclinical stage, 

 gene editing program targeting lipoprotein(a) (Lp(a)), will see Lilly take over development, manufacturing, and commercialization of Verve’s Lp(a) program following Phase I clinical development. Lilly will pay Verve $60 million upfront, with an additional $465 million plus tiered royalties contingent on various research, development, and commercial milestones.

According to a company press release, Lp(a) is a genetically validated, independent risk factor for atherosclerotic cardiovascular disease (ASCVD), ischemic stroke, thrombosis, and aortic stenosis; this increased risk is most pronounced in individuals with very high Lp(a) concentrations. Verve’s LP(a) gene editing program is evaluated as a treatment for ASCVD.

“Verve was created with a singular focus to protect the world from ASCVD by developing single-course gene editing medicines that address the underlying causal drivers of the disease. Lp(a) is validated as one of these key drivers, and as such, this program represents another important step in our efforts to transform the care of ASCVD,” said Sekar Kathiresan, co-founder and CEO of Verve Therapeutics, in the release. “Blood concentrations of Lp(a) are determined almost entirely by inheritance, and unfortunately, lifestyle and currently approved lipid-lowering therapies have minimal to no impact. In patients with established ASCVD and elevated blood Lp(a), we believe there is a substantial opportunity for a single-course gene editing medicine to permanently lower Lp(a) levels, and we are thrilled to have joined forces with Lilly, an industry leader in cardiometabolic disease, to accelerate this program toward patients.”

“We are pleased to establish this collaboration with Verve, a company uniquely positioned to develop gene editing medicines for common cardiovascular conditions such as elevated Lp(a), a lipoprotein particle that has been established as an important causal and modifiable driver of ASCVD,” said Ruth Gimeno, group vice-president, Diabetes, Obesity, and Cardiometabolic Research, Eli Lilly & Company, in the release. “We look forward to working with Verve to develop a much-needed treatment option for patients with elevated levels of Lp(a).”

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Eli Lilly & Company will pay Verve Therapeutics up to $525 million to advance a lipoprotein gene editing research program.

Lilly Enters Gene Editing Collaboration with Verve Therapeutics

Advanco, a global pharmaceutical and life sciences track and trace solutions provider, announced the acquisition of Vantage Consulting Group, a manufacturing company specializing in automation, on June 15, 2023. The acquisition will strengthen Advanco’s position in providing serialization solutions for the pharmaceutical and life sciences sector, according to a company press release.

With the acquisition, Advanco will be now able to provide integrated design, implementation, and validation engineering services along the entire supply chain, from raw material handling through to distribution and warehousing services. Furthermore, Advanco will be able to provide these services in compliance with the most updated regulatory requirements specific to geographic regions.

Advanco will retain its training and support services and will continue to offer on-site and remote training in serialization. The company’s 24/7 global support services will also remain in effect for all systems.

Under the transaction, John Jordon, president of Vantage, will join the Advanco leadership team, and the Vantage staff will be folded into Advanco’s operations. Alf Goebel, CEO of Advanco, will retain his position.

“Advanco’s acquisition of Vantage is a strategic move, designed to offer clients a sophisticated suite of products and services across the full spectrum of the supply chain,” said Goebel in the press release. “Advanco’s established ARC platform and software expertise is now fully bolstered by the design, implementation, and validation expertise offered by the team from Vantage.”

“Vantage prides itself on designing and implementing complex manufacturing and automation solutions, delivered in a way that fosters trust, transparency, and honesty with every client in every transaction,” said John Jordon, president, Vantage, in the release. “Advanco has an identical pedigree and shares a track record of client excellence across all that it does. We are therefore looking to the future with excitement as we continue to provide the entire supply chain with all that it needs for future success.”

Advanco’s acquisition of Vantage Consulting Group boosts its position as a provider of independent pharmaceutical serialization solutions.

Advanco Acquires Vantage Consulting Group

The Pistoia Alliance, a global not-for-profit alliance in life sciences R&D, announced a new partnership with Matador Japan, a software development company, on June 14, 2023, under which the two entities will accelerate research and promote Japan’s access to the global pharmaceutical ecosystem.

Through the partnership, Pistoia Alliance and Matador expect to create further networking and interest groups in the Japanese language and in a time-zone from which member organizations in the region can directly benefit. R&D activities by Japanese pharmaceutical companies have significantly focused in areas such as targeted immunotherapy, the human microbiome, and neurology. Member organizations can gain access to global expertise in these fields with this partnership between Pistoia Alliance and Matador, according to a company press release.

“This partnership marks an exciting stage in the Pistoia Alliance’s evolution. Japan is the second largest pharmaceutical market in the world, and we believe it can benefit from the pre-competitive collaboration the Alliance has long been offering members in regions including Europe and North America,” said Becky Upton, president, Pistoia Alliance, in the press release. “We’ve already had Japanese members, including Takeda, QunaSys, Chugai, and National Cancer Hospital East, benefit from being part of the Alliance and contribute to advances in exciting areas such as quantum computing. Our work alongside Matador will offer even more Japanese companies the same opportunities.”

“The … pre-competitive collaboration happening within the Pistoia Alliance presents great opportunity for the vibrant Japanese life sciences sector,” said John Bolger, CEO, Matador, in the press release. “Matador was founded to build a bridge between overseas technology firms and Japanese pharmaceutical companies, and collaboration is critical to this aim. We work to accelerate the implementation of the latest technologies and innovations to support R&D in Japan and bringing Matador under the Pistoia Alliance umbrella will help us further that mission.”

The collaboration between the Pistoia Alliance and Matador Japan will work to accelerate research and promote access to a global pharmaceutical ecosystem.

Pistoia Alliance and Matador Japan Collaborate to Accelerate Research

Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, and NorthX Biologics, a contract development and manufacturing organization that serves as the National Swedish Innovation Hub for the good manufacturing practice (GMP) manufacture of biologics used in vaccines, gene therapies, and other advanced medicinal products, announced a manufacturing alliance on June 8, 2023. The companies will co-establish cell therapy manufacturing capabilities in Sweden for use in late-stage development and commercial manufacturing of Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

In conjunction with this collaboration, Mendus has also entered into an agreement with Flerie Invest, a Swedish investment firm specializing in pharma and biotech companies, who will invest approximately $8.4 million in support of the alliance. According to a company press release, this investment will allow Mendus and NorthX to construct a cell therapy facility for the large-scale production of vididencel. In return, Flerie will receive an unspecified amount of shares in Mendus. Ted Fjällman, CEO of Flerie, is expected to join Mendus’ Board of Directors, subject to shareholder approval.

According to the release, vididencel is currently being evaluated in a Phase II clinical study for treatment of acute myeloid leukemia. Mendus plans to soon launch further clinical studies for this indication, and is also evaluating the vaccine as a treatment for ovarian cancer.

“Establishing large-scale manufacturing is a key element of our development strategy for vididencel,” said Erik Manting, CEO, Mendus, in the release. “The alliance with NorthX as Sweden’s emerging center of excellence for manufacturing of this drug class, supported by an investment by Flerie, is a major step for Mendus in this regard, as it brings together the required funding and the opportunity to establish a dedicated facility to manufacture vididencel for the next stage of clinical development and, eventually, commercialization.”

“This strategic alliance not only paves Mendus’ path to commercializing vididencel for the benefit of cancer patients, but ensures NorthX strengthens its positioning as the premier GMP manufacturing hub for advanced therapies in the Nordics, attracting regenerative medicine innovators worldwide,” said Helena Strigård, CEO, NorthX, in the release. “We are proud to be working with Mendus to hone both teams’ skills in this rapidly developing area of cell therapies.”

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

Mendus and NorthXBiologics Enter Cell Therapy Manufacturing Alliance

Charles River Laboratories, a pharmaceutical company specializing in cell and gene therapies, announced the launch of its lentiviral vector (LVV) packaging plasmids on June 13, 2023. According to a company press release, the immediate availability of these off-the-shelf plasmids is intended to provide a streamlined solution for challenges associated with plasmid sourcing for cell and gene therapies, including capacity bottlenecks, timeline pressures, and process development optimization.

“We are thrilled to announce this addition to our product offering,” said Kerstin Dolph, corporate senior vice-president, Biologics Solutions, Charles River, in the release. “Our LVV packaging plasmids allow us to further support advanced therapy programs and most importantly, help expedite the delivery of safe, effective therapies to those who need them most."

“Charles River’s LVV packaging plasmids offer researchers and manufacturers a high-quality, reliable tool to support their LVV viral vectors production,” said Andrew Frazer, associate director, Scientific Solutions, Charles River, in the release. “The new plasmids will be a valuable resource to develop new treatments for a wide range of programs in preclinical and clinical development with the continuity of supply for commercial use”

Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.


Charles River Laboratories Launches LVV Packaging Plasmids

AstraZeneca announced an exclusive option and license agreement with Quell Therapeutics, a UK-based biotechnology company, on June 9th, 2023. Per the terms of the agreement, Quell will develop T-regulatory (Treg) cell therapies for Type 1 diabetes (T1D) and inflammatory bowel disease. According to a company press release, AstraZeneca will pay Quell $85 million upfront for the rights to these treatments, but Quell’s total payout could come to more than $2 billion plus tiered royalties if various development and commercialization milestones are met.

“We are extremely pleased to have AstraZeneca on board as our first major partner,” said Iain McGill, CEO, Quell Therapeutics, in the release. “This collaboration builds on our pioneering work to develop exquisitely engineered, multi-modular Treg cell therapies for immune disorders and provides excellent validation for the technologies and capabilities we have established. We are proud and incredibly excited to partner our leading science with the deep experience of AstraZeneca to accelerate the application of our Treg cell therapy platform in major autoimmune disease, where we believe there is a broad opportunity to reset immune tolerance and drive durable responses for patients.”

“This is a very exciting collaboration with Quell as we look to expand our next-generation therapeutic toolbox and explore the untapped potential with Treg cell therapies in autoimmune indications,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the release. “This is aligned with our strategy to target underlying disease drivers to stop or slow disease progression and ultimately accelerate the delivery of transformative care to patients with chronic autoimmune conditions.”

In addition to the previously disclosed terms, Quell retains an option to co-develop Treg cell therapies from the T1D program with AstraZeneca in the United States in exchange for additional milestone payments and increased royalties on US net sales. This can be exercised either after approval of an Investigational New Drug application or at the end of the Phase I/II clinical study.

The deal, valued at more than $2 billion dollars, will see Quell Therapeutics develop various T-regulatory cell therapies for AstraZeneca.