On July 23, 2024 ForDoz Pharma Corp., a private specialty pharmaceutical company focused on product development, manufacturing and commercialization of complex injectables, like liposomes, microspheres, nano-suspensions, etc., reported the ANDA approval of DOXOrubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) from the United States Food and Drug Administration (US FDA) (Press release, ForDoz Pharma, JUL 23, 2024, View Source [SID1234645024]). DOXOrubicin Hydrochloride Liposome Injection is indicated for the treatment of patients with ovarian cancer and AIDS-related Kaposi’s sarcoma. Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma.

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"The approval of DOXOrubicin Hydrochloride Liposome Injection marks a major milestone for ForDoz Pharma as our 1st liposomal injectable pharmaceutical product to enter the US market. It will be distributed by Lupin Pharmaceuticals, Inc.," said James He, Founder and CEO of ForDoz Pharma.

On July 23, 2024 Orange Grove Bio, a leading integrated biopharmaceutical company, and the University of Chicago’s Polsky Center for Entrepreneurship and Innovation reported a strategic partnership to catalyze the successful commercialization of novel therapeutics and life sciences technologies (Press release, Orange Grove Bio, JUL 23, 2024, View Source [SID1234645078]).

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This collaboration will combine Orange Grove Bio’s expertise in evaluating and financing novel therapeutics with the University of Chicago’s cutting-edge research capabilities. Orange Grove Bio plans to license promising life sciences technologies from the University of Chicago, developing them into new products to enhance human health. The company will provide its scientific expertise and business acumen to support early company formation.

"The University of Chicago boasts superior academic prowess and researchers who are at the top of their field," said Rich Ganz, Senior Venture Partner at Orange Grove Bio. "Our shared resources will maximize the chances of moving groundbreaking work from the lab to the clinic with the goal of benefiting patients in need."

The partnership encompasses several key aspects designed to foster innovation and collaboration. This includes new educational opportunities, such as workshops, seminars, networking events, and mentoring. Additionally, Orange Grove Bio will lead a PhD internship program, offering students valuable career exploration opportunities.

"This partnership will give the team at Orange Grove Bio an inside look at the novel work being done at the University of Chicago and provide our researchers with opportunities to gain industry-informed perspectives on their innovations," said Samir Mayekar, managing director of The University of Chicago’s Polsky Center. "We share a commitment to advancing scientific discoveries and strengthening the biotech ecosystem in Chicago, particularly on the South Side."

This strategic partnership represents a significant step forward in bridging regional gaps in venture capital funding and accelerating the translation of scientific breakthroughs into life-changing treatments. To further these goals, Orange Grove Bio plans to establish a presence on the South Side of Chicago, enabling close interaction with the academic teams at the University and amplifying its commitment to the Midwest biotech ecosystem.

"This partnership is a valuable addition to the University’s resources," said Jeffrey Hubbell, Professor at the University of Chicago’s Pritzker School of Molecular Engineering and founder of several life science companies. "The detailed feedback the Orange Grove Bio team is able to provide helps inform what additional studies or data we should pursue to empower successful external financing."

On July 23, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported multiple updates for its taletrectinib program (Press release, Nuvation Bio, JUL 23, 2024, View Source [SID1234645025]). Data from the global, pivotal Phase 2 TRUST-II study has been accepted for an oral presentation at WCLC 2024 taking place September 7-10 in San Diego, California. Pooled data from both pivotal Phase 2 studies, TRUST-I and TRUST-II, has been accepted for a poster presentation at ESMO (Free ESMO Whitepaper) 2024 taking place September 13-17, in Barcelona, Spain. The pooled data presented at ESMO (Free ESMO Whitepaper) will support the Company’s NDA in the United States. Additionally, the U.S. FDA has granted Orphan Drug Designation to taletrectinib for the treatment of multiple NSCLC indications, including ROS1-positive NSCLC.

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"We are excited to share these program updates as we continue toward our goal of bringing taletrectinib to patients with ROS1-positive NSCLC. We look forward to sharing the latest TRUST-II data at WCLC 2024 and pooled TRUST-I and TRUST-II data at ESMO (Free ESMO Whitepaper) 2024. The pooled data to be presented at ESMO (Free ESMO Whitepaper) will support our NDA in the U.S. and, we believe, position us to commercialize taletrectinib in 2025," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Further, we are pleased with the FDA’s recent determination that taletrectinib qualifies for Orphan Drug Designation, which represents another key regulatory milestone for this important program."

Taletrectinib was granted Orphan Drug Designation for the treatment of ROS1- positive, NTRK-positive, ALK-positive, LTK-positive, ACK1-positive, or DDR1-positive NSCLC. The FDA’s Office of Orphan Drug Products grants this designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and potential market exclusivity for seven years upon FDA approval.

Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two pivotal Phase 2 studies, TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global pivotal study.

WCLC Presentation Overview:

Title: Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non–Small Cell Lung Cancer: The Global TRUST-II Study
Presenter: Geoffrey Liu, MD
Date: September 10, 2024
Session Time: 11:15 a.m. – 12:30 p.m. PDT
Session: MA06 – New Strategies in ALK, ROS1, NTRK, BRAF, and MET NSCLC
Abstract: 1752

ESMO Presentation Overview:

Title: Pooled Efficacy and Safety From 2 Pivotal Phase 2 Trials of Taletrectinib in Patients (Pts) With Advanced or Metastatic ROS1+ Non–Small Cell Lung Cancer (NSCLC)
Presenter: Maurice Perol, M.D.
Date: September 14, 2024
Session Time: Poster Lunch, 12:00-1:00 p.m. CEST (on display from 9:00 a.m. – 5:00 p.m. CEST)
Session: Poster Display, NSCLC, Metastatic
Abstract: 1289P

The materials will be made available on the Publications section of nuvationbio.com the day of the respective presentations.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive NSCLC and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors (TKIs).

About ROS1-positive NSCLC

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 1-3% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.

On July 23, 2024 Triastek Inc. ("Triastek"), a global leader in 3D printing pharmaceuticals, reported that it has entered into a research collaboration and platform technology license agreement with BioNTech SE ("BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, BioNTech, JUL 23, 2024, View Source [SID1234645026]). Under the agreement, the companies will develop RNA therapeutics for oral delivery based on 3D printing technology. The collaboration aims to provide groundbreaking therapies to address unmet medical needs in an easy to administer oral formulation.

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Triastek will contribute to the collaboration its expertise in innovative oral tablet designs made possible by 3D printing aimed at optimizing delivery of RNA therapeutics across the gastrointestinal mucosa, minimizing degradation in the gastrointestinal tract, and delivering RNA therapeutics to the portion of the gastrointestinal tract where absorption will potentially be the greatest. Triastek’s ability to create tablet structures with unique external and internal tablet geometries, including multiple-layer and multi-compartment designs, will be leveraged, aiming to optimize delivery of novel RNA therapeutics.

"We are immensely honored to announce our collaboration with BioNTech, a leader in revolutionizing patient care with transformative medicines," stated Dr. Senping Cheng, Founder, and CEO of Triastek. "We believe this collaboration stands as a promising milestone in advancing oral RNA therapeutics using 3D printing technology and aims to set new benchmarks in the development of large molecule oral drugs. We are committed to working diligently together to make breakthroughs in oral delivery of RNA therapeutics."

Under the terms of the agreement, Triastek will receive an upfront payment of $10 million, and will be eligible to receive development, regulatory and commercial milestone payments potentially totaling over $1.2 billion as well as tiered royalties on potential future product sales.

On July 23, 2024 Flagship Pioneering, the bioplatform innovation company, today unveiled Abiologics, a company reimagining biologics with the creation of a new class of supranatural and programmable medicines, called Synteins (Press release, Abiologics, JUL 23, 2024, View Source [SID1234645011]). Synteins are computationally-generated and synthesized with novel building blocks, endowing them with extraordinary properties to bring life-changing treatments to patients across a wide range of diseases. Flagship has initially committed $50 million to advance the company’s platform and develop a diverse pipeline of medicines, with an initial focus on oncology and immunology indications.

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"Biologics have transformed medicine in the past forty years, but only a fraction of their potential has been realized because we’ve been limited by the boundaries of nature," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and Chairman of the Strategic Oversight Board of Abiologics. "With the convergence of advancements in generative artificial intelligence, automated polymer synthesis and chemical functionalization coupled with a vision to develop more powerful medicines with unprecedented diversity, we asked, what if we could design biologics entirely from new building blocks that could overcome the most critical limitations of today’s medicines?"

The Abiologics platform is a fully integrated digital and automated wet-lab infrastructure to create supranatural biologics with powerful, desirable pharmacological properties. The platform leverages state-of-the-art generative artificial intelligence (AI) to computationally-design Synteins de novo using a broad set of artificial building blocks, far beyond the 20 naturally occurring amino acids that form the basis of today’s biologic medicines. These include biologics built with D-amino acids, chemically identical mirror images of standard amino acids. Once designed, Abiologics chemically synthesizes its digitally-optimized Synteins with pioneering new technologies. As a result, Synteins can be programmed to interact with virtually any therapeutic target while evading the body’s natural defenses. By surpassing the limitations of traditional biologics discovery tools, Abiologics is the first to discover, prototype and scale-up polymers composed solely of artificial building blocks, and to date, has successfully generated Synteins made entirely of D-amino acids that bind a diversity of therapeutically relevant targets while remaining ultrastable.

"For the first time, we are able to imagine and generate chemically synthesized biologics at scale and with increasing programmability, offering a new class of medicines with transformative potential," said Avak Kahvejian, Ph.D., Co-Founder and CEO of Abiologics and General Partner at Flagship Pioneering. "Creating protein biologics with artificial building blocks rather than naturally occurring amino acids allows Synteins to go unrecognized by the immune system, offering significant advantages compared to today’s biologics such as less frequent dosing, oral delivery and the ability to reach parts of the body that were previously impossible to access and treat. With Synteins, Abiologics is poised to bring boundary-breaking medicines to patients across a range of diseases."

In addition to Afeyan and Kahvejian, Abiologics’ founding team includes Mike Hamill, Ph.D., Chief Innovation Officer of Abiologics and Senior Principal at Flagship Pioneering, Kala Subramanian, Ph.D., Founding President of Abiologics and Operating Partner at Flagship Pioneering, Jaclyn Dunphy, Ph.D., Senior Director of Strategy and Research Operations at Abiologics, and Alicia Kaestli, Ph.D., Senior Associate at Flagship Pioneering. Bradley Pentelute, Ph.D., Professor of Chemistry at MIT, is an Academic Co-Founder of Abiologics.