Feliza Mirasol is the science editor for 

Feliza Mirasol

On Aug. 15, 2023, US-based Chiesi Global Rare Diseases, a business unit of the Chiesi Group, announced that it has entered into a co-development agreement with Aliada Therapeutics, a US-based biotechnology company focused on developing a novel blood-brain barrier (BBB)-crossing platform technology. Under the collaboration, the companies will focus on multiple enzyme cargoes that have been modified using Aliada's Modular Delivery (MODEL) platform. The goal is to establish drug delivery systems that will allow large-molecule therapeutics to cross the BBB, particularly for the treatment of lysosomal storage disorders (LSDs).

Aliada’s MODEL platform harnesses the endogenous cell transport mechanisms in brain endothelial cells to efficiently move large-molecule therapeutics across the BBB. The technology enables high therapeutic exposure in the brain, according to a company press release. According to the release, the MODEL platform demonstrates advantages over competing approaches as it offers a broad design landscape that confers an ability to optimize therapeutics for both central nervous system (CNS) delivery and downstream functionality.

"Our commitment to the development of new treatment options for people living with [LSDs] is global, as evidenced by recent regulatory approvals," said Giacomo Chiesi, head of Chiesi Global Rare Diseases, in the press release. "Many LSDs have CNS involvement. With this collaboration, we are expanding our strategy and presence in BBB-crossing technologies and hope to leverage our know-how in LSDs to support the development of an effective and differentiated drug delivery platform. We are especially proud to advance this important research with Aliada, a partner with vast experience in neuro drug development and biologics delivery."

"We are excited to partner with Chiesi to develop improved therapeutics for patients living with LSDs, who currently lack treatments that can readily access the brain," said Adam Rosenberg, CEO, Aliada Therapeutics, in the release. "We admire Chiesi's continued commitment to patients, exemplified by their two recent FDA approvals. This collaboration will allow Aliada to demonstrate the diverse capabilities of our MODEL platform, which enables us to efficiently transport a diverse range of therapeutic cargoes into the brain."

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With this agreement, Chiesi Global Rare Diseases will co-develop drug delivery systems with Aliada Therapeutics for large-molecule therapeutics that can cross the blood-brain barrier.

Chiesi Global Rare Diseases and Aliada Therapeutics Partner to Advance Blood-Brain Barrier-Crossing Platform Technology for Drug Delivery

China-based HitGen, a drug discovery technology platform company, announced on Aug. 10, 2023 that it has entered into a research service agreement with Nested Therapeutics (Nested), a US-based biotechnology company specializing in a next-generation precision medicine platform for hard-to-treat cancers. Under the agreement, HitGen will use its DNA-encoded library (DEL) technology platform to identify hits against targets in which Nested is interested.

HitGen’s technology platform is centered around the design, synthesis, and screening of DELs. The company applies its technology to early stage small-molecule drug discovery. Its platform includes more than 1.2 trillion small molecules generated by its DEL technology, which streamlines the screening process.

“We look forward to working with the research teams at Nested to generate novel starting points for their research programs to help address the unmet needs of patients with cancer. As one of HitGen’s four core technology platforms, our … DEL platform is an efficient ‘engine’ to advance drug discovery and has enabled hit identification and lead generation for many innovative discovery programs by our customers and partners. We look forward to delivering useful outcome[s ]for Nested’s research programs,” said Jin Li, chairman of the board and CEO of HitGen, in the press release.

HitGen has entered into a research service agreement with Nested Therapeutics for use of HitGen’s DNA-encoded library for drug discovery.

HitGen and Nested Therapeutics Sign Research Service Agreement for DNA-Encoded Library

Alpha Teknova (Teknova), a US-based producer of critical reagents for novel therapies, vaccines, and molecular diagnostics, has opened its newest good manufacturing practice (GMP)-certified production facility in Hollister, Calif., which increases its capacity for custom, high-quality reagents for use in life sciences. The facility is expected to enable faster bioprocessing and gene therapy development, bringing products to the clinic faster, according to an Aug. 9, 2023 company press release.

The new facility, which was previously operational for research-grade production, now adds more than 10,000 ft2 of GMP-certified ISO cleanrooms. Teknova gets a three-fold increase in overall manufacturing capacity with expanded formulation, dispensing, cleanroom, and warehouse space. The facility also includes increased automation to support single-use needs and offers animal-free and endotoxin-controlled environments.

“Our team has worked tirelessly over the past two years to build our new GMP-certified production facility here in Hollister, and its opening represents a momentous milestone in our company’s evolution,” said Stephen Gunstream, Teknova’s president and CEO, in the press release. “We kept hearing from our customers that they wanted a partner who could support them with custom reagent manufacturing as they scale from research, through process development, and into clinical trials, particularly in batch volumes of less than 2000 liters. We built this facility to do just that [and] we look forward to leveraging our facility's modular manufacturing capabilities to continue supporting our customers throughout various stages of their lifecycle.”

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Teknova Opens New GMP Manufacturing Facility for Life Sciences Reagents 

Eli Lilly and Company (Lilly) has announced the completion of several previously announced acquisitions: Versanis Bio (Versanis), Sigilon Therapeutics (Sigilon), and DICE Therapeutics (DICE), all of which were concluded in August 2023.

The Versanis acquisition includes that company’s lead asset, bimagrumab, a monoclonal antibody currently in Phase IIb development for treating obesity. Under the agreement, Versanis shareholders stand to receive up to $1.925 billion in cash, which includes an upfront payment and subsequent payments based on the achievement of certain development and sales milestones, according to an Aug. 14, 2023 company press release. Lilly had announced its intent to acquire Versanis Bio in July 2023 (1).

"Combining our current incretin portfolio, including tirzepatide, with activin receptor blockers such as bimagrumab, could be the next major step in innovative treatments for those living with cardiometabolic diseases, [such as] obesity," said Ruth Gimeno, group vice-president, diabetes, obesity, and cardiometabolic research, Lilly, in the company press release. "The wealth of knowledge that our new colleagues from Versanis will bring to Lilly will propel our research and development efforts forward, ultimately benefiting patients around the world."

The Sigilon acquisition, first announced by Lilly in June 2023 (2), boosts Lilly’s R&D capabilities in encapsulated cell therapies for treating type 1 diabetes and includes a lead candidate, SIG-002. According to a company press release, Lilly offered $14.92 per share of Sigilon common stock, an aggregate of approximately $34.6 million (2).

Finally, the $2.4 billion ($48 per share) DICE acquisition, 

 (3), expands Lilly's immunology portfolio. It adds DICE's novel oral therapeutic candidates for treating chronic diseases in immunology, including oral interleukin-17 (IL-17) inhibitors, to Lilly’s pipeline. The IL-17 inhibitors are currently in clinical development, according to a company press release.

1. Eli Lilly and Company, Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases. Press Release, July 14, 2023.
2. Eli Lilly and Company, Lilly to Acquire Sigilon Therapeutics. Press Release, June 29, 2023.
3. Eli Lilly and Company, Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology. Press Release, June 20, 2023.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

Lilly Completes Spate of Acquisitions

Rakuten Medical, a US-based biotechnology company specializing in cell targeting therapies, announced on Aug. 10, 2023 that it has signed an exclusive licensing and commercialization agreement with Hikma Pharmaceuticals (Hikma), a UK-based pharmaceutical company that serves the Middle East and North Africa (MENA) region as well as Europe.

Under the agreement, Hikma gains an exclusive license to commercialize products in Rakuten Medical’s oncology pipeline to all of Hikma’s MENA markets. Rakuten Medical’s oncology pipeline was developed using its proprietary photoimmunotherapy technology platform, Alluminox. These therapies are not currently approved in MENA for investigational or commercial use. Outside of Japan, they are investigational treatments, according to a company press release.

“We are already developing Alluminox treatment in several countries and regions, including the United States, Japan, Taiwan, and India, and this agreement further accelerates our global expansion. With Hikma’s strong regional footprint and medical expertise, we expect the Alluminox platform to make significant progress in MENA,” said Mickey Mikitani, co-CEO of Rakuten Medical, in the company press release.

“This agreement allows us to work with an excellent global partner to strengthen our growing portfolio in oncology and biotechnology. Most importantly, this allows us to bring a potentially transformative technology to cancer patients in MENA, helping to put better health within reach, everyday,” said Mazen Darwazah, executive vice-chairman and president of MENA, Hikma, in the release.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

Rakuten Medical Signs Exclusive Licensing Agreement with Hikma for Cancer Treatments in MENA

On July 24, 2023, Teva Pharmaceuticals, Inc., a US-based affiliate of Teva Pharmaceutical Industries, and Alvotech, an Iceland-based biotech company specializing in biosimilars, announced that they are expanding an existing strategic partnership for the development and commercialization of several biosimilar candidates. Under the expanded agreement, Teva will also acquire subordinated convertible bonds—to be issued by Alvotech—for $40 million.

With the expanded agreement, Teva will have exclusive commercialization rights in the United States for two new biosimilar candidates and line extensions of two current biosimilar candidates. Alvotech will be responsible for the development and manufacturing of these four candidates. The agreement includes milestone payments, the majority of which will be paid upon approval of the products and upon achieving significant sales milestones. Teva and Alvotech will share the profit from the commercialization of the biosimilars.

In addition, Teva will be involved in overseeing manufacturing activities and quality control at Alvotech’s manufacturing facility in Iceland. Teva is on site in Iceland to actively support Alvotech and to help ensure that the facility is fully ready for an FDA inspection, according to a company press release.

Meanwhile, the partners will continue to work closely on the pending US approval of AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). Under the existing partnership, the companies are also collaborating on four other biosimilar candidates, including AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending FDA approval. Furthermore, Teva’s investment under the expanded agreement (i.e., the acquisition of subordinated convertible bonds) will be used by Alvotech to fund the continued development of its biosimilars pipeline in the near-term.

“We welcome Teva’s continued partnership, and this expansion of our partnership agreement,” said Robert Wessman, chairman and CEO of Alvotech, in the press release. “We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by [FDA] to be able to bring our biosimilar candidates to patients in the US with Teva as soon as possible.”

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.