On April 22, 2024 Bristol Myers Squibb (NYSE: BMY) and Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, reported a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M in upfront and milestone payments (Press release, Bristol-Myers Squibb, APR 22, 2024, View Source [SID1234642189]). As part of the agreement, Cellares will optimize, automate, and tech-transfer select Bristol Myers Squibb CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle. Cellares will dedicate multiple Cell Shuttle and Cell Q systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use. The Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories in the U.S., EU, and Japan.

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Manufacturing cell therapies is both operationally and technically complex. Because cell therapies are rapidly transforming the way many different diseases are treated, the demand for these treatments is increasing significantly. This collaboration enables Bristol Myers Squibb to expand its manufacturing capacity, meeting the growing demand for its diverse range of cell therapies through a platform that is scalable and has the potential to improve turnaround time, bringing the promise of cell therapies to more patients faster.

"The agreement with Cellares is our latest step forward in support of our comprehensive strategy to unlock the full potential of CAR T therapy to deliver transformative treatments to as many patients as possible, as quickly as possible," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "Our collaboration with Cellares strengthens our existing internal manufacturing capabilities for CAR T cell therapies by giving us access to the first end-to-end fully automated cell therapy manufacturing platform, to help ensure we meet the high demand for these differentiated treatments, now and in the future."

This agreement expands upon the existing collaborations between Bristol Myers Squibb and Cellares. In August 2023, Bristol Myers Squibb participated in Cellares’ Series C financing to launch the first IDMO Smart Factory in an effort to meet the demand for cell therapies globally. That same month, Bristol Myers Squibb joined Cellares’ Technology Adoption Partnership (TAP) Program to evaluate the Cell Shuttle’s automated manufacturing capabilities.

"This agreement with Bristol Myers Squibb is aligned with our strategy of establishing a global network of high-throughput, automated Smart Factories to meet the growing and worldwide demand for cell therapies," said Fabian Gerlinghaus, CEO and co-founder of Cellares. "We look forward to demonstrating how our innovative technology’s emphasis on standardization will accelerate commercial-scale manufacturing and worldwide deployment. Our collaboration with Bristol Myers Squibb and our collective expertise furthers our mission to accelerate access to life-saving cell therapies for patients globally."

On April 22, 2024 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported preclinical data from the Company’s platform and pipeline (Press release, Azitra, APR 22, 2024, View Source [SID1234642188]). The data will be presented on Friday, May 10, 2024, in two oral sessions entitled "Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases" and "Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome."

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"We are thrilled to announce new preclinical data for our precision dermatology platform that demonstrate proof-of-concept data supporting the use of genetically engineered skin commensals to deliver proteins to the skin," said Travis Whitfill, Azitra’s co-founder and COO. "These data show the robust preclinical activity of ATR-12 in Netherton syndrome models and further supports the rationale behind our Phase 1b clinical trial in Netherton syndrome patients."

ATR-12 is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial in adult patients (NCT06137157).

The data in the abstracts released online today show that topical application of ATR-12 in preclinical models reduced produced reduced IL-36γ by 93% compared to skin extracts induced to overexpress IL-36γ. Additionally, topical application of ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Finally, ATR-12 produced higher amounts of LEKTI compared to topical application of LEKTI protein alone (6.0 µg vs. 2.3 µg, respectively, p<0.01) after 24 hours and resulted in deeper skin penetration of LEKTI.

On April 22, 2024 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber, "Takeda"), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome, "SMBC") reported that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company (Press release, Astellas, APR 22, 2024, View Source [SID1234642187]). The new company will be dedicated to the incubation*1 of early drug discovery programs, primarily originating from Japan and toward the creation of innovative therapeutics.

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1. Background
Japan, as one of the world’s leaders in drug discovery and development, is home to both world-class academic institutions conducting innovative basic research in drug discovery and global pharmaceutical companies, with extensive expertise in early drug research and development. Both possess a wealth of early drug discovery programs with breakthrough potential. However, in recent years, advancing academic discoveries from bench to bedside, known colloquially as the "valley of death", has presented a major challenge when it comes to unleashing the full potential of innovative technologies and seed assets originating in Japan. In response to this challenge, the three companies have been engaged in discussions to establish a joint venture company that will seamlessly cover the entire drug discovery process, spanning early drug discovery research through the inception of drug discovery startups.

2. Joint Venture Company: Planned Overview

Name To be determined
CEO Toshio Fujimoto, MD, MBA*
Location Shonan Health Innovation Park (Fujisawa, Kanagawa, Japan)
Capital Approximately 600 million yen (including capital reserve)
Capital Structure Takeda 33.4%, Astellas 33.4%, SMBC 33.2%
Establishment Mid-2024
Business Incubation of early discovery programs to develop innovative therapeutics primarily originated from Japan
*Toshio Fujimoto will concurrently serve as President and Representative Director of the iPark Institute Co., Ltd.

3. Business Focus
The joint venture company will focus on the following three aspects:

Advancing innovative drug discovery programs primarily originating in Japan into the global pharmaceutical market.
Incubating globally competitive drug discovery technology and fostering entrepreneurship.
Unleashing the potential of drug discovery ecosystem in Japan through the creation of high caliber start-up companies.
In addition to establishing the joint venture company, Takeda and Astellas will provide support to the joint venture company leveraging their expertise gained from global drug discovery research and development, aiming to accelerate open innovation in early-stage drug discovery, and toward the creation of start-up companies for the benefit of society.

The joint venture company plans to begin incubation activities by collaboratively working with academia, pharmaceutical companies, and start-up companies across Japan to enable access to potentially transformative early drug discovery programs.

4. Future Plans
The three companies will further discuss the details of the agreement to complete the inception of the joint venture company and commence operations, aiming for a swift launch of the new incubation activities.

On April 21, 2024 WuXi Biologics reported its interim results for the year 2024 (Presentation, WuXi Biologics, APR 21, 2024, View Source [SID1234646082]).

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On April 19, 2024 The Crossfire team reported that it has attended this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting with three posters (Press release, Crossfire Oncology, APR 19, 2024, View Source [SID1234642182]).

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On Tuesday the Crossfire team unveiled its highly innovative degrader-based payload targeting an essential cell cycle kinase. Its sophisticated design is expected to dramatically reduce off-tumor related toxicity observed with classical payloads. This will increase the therapeutic window for this novel Degrader Antibody Conjugate technology versus currently approved ADCs (see poster link).

On the same day, Crossfire’s proprietary EPriL platform was presented, that enables rapid identification of potent kinase degraders. EPriLs contain a unique macrocyclic scaffold that binds the ATP-binding pocket of kinases and which have several exit vectors suitable for attachment of E3 ligase binders. In this way, potent BTK degraders were established with potent activity on all clinically relevant BTK inhibitor resistance mutants (see poster link).

The day before, our best-in-class non-covalent BTK inhibitor (CFON-026) was presented. The macrocyclic nature of CFON-026 endows it with high potency, not only on BTK wild-type, but also BTK[C481S] and BTK[T474I], making it a unique non-covalent BTK inhibitor with cytotoxicity to all clinically relevant BTK mutant variants. Because of Crossfire’s strategic decision to fully focus on the development of Degrader Antibody Conjugates, an out-licensing process was recently initiated for this exciting program that is mid-way preclinical development (see poster link).