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 22, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that positive feedback has been received from the US Food and Drug Administration ("FDA") regarding the planned TACTI-004 Phase III trial of eftilagimod alfa ("efti") in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression (Press release, Immutep, JUL 22, 2024, View Source [SID1234644994]).

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The FDA feedback from this Type C meeting, along with feedback previously received from the Paul-Ehrlich-Institut ("PEI") and the Spanish Agency for Medicines and Health Products ("AEMPS"), concludes the preparatory regulatory interactions for the design of this registrational trial. This marks a significant step forward to develop an effective treatment for non-squamous and squamous 1L NSCLC patients who have high, low, or no PD-L1 expression and are eligible for anti-PD-1 therapy.

The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials.

"We are pleased with the FDA’s feedback as this allows us to successfully conclude our regulatory preparation for the TACTI-004 registrational trial. This represents a key milestone in our late-stage development process for efti centred on potentially driving a new standard of care globally in the treatment of non-small cell lung cancer. We hope to achieve this through efti in combination with KEYTRUDA, which has led to strong efficacy data with a favourable safety profile in 1L NSCLC patients regardless of PD-L1 expression," stated Christian Mueller, Immutep’s SVP, Regulatory and Strategy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

TACTI-004 (Two ACTive Immunotherapies-004) Registrational Phase III Trial Design
TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical trial to evaluate Immutep’s efti in combination with KEYTRUDA and standard chemotherapy compared to the standard-of-care, KEYTRUDA in combination with chemotherapy and placebo in first-line metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. In this pivotal PD-L1 all comer trial, the dual primary endpoints will be progression-free and overall survival with a prespecified futility boundary and a pre-planned interim analysis. The trial will be conducted globally and enrol approximately 750 NSCLC patients (including both squamous and non-squamous subtypes).

About Eftilagimod Alfa (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On July 22, 2024 NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT) reported that they have signed a Master Services Agreement (MSA), which will facilitate the production of actinium-225 (Ac-225), a critical medical isotope used to kill cancer cells while minimizing the impact to healthy tissues (Press release, NorthStar Medical Radiostopes, JUL 22, 2024, View Source [SID1234645010]).

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Medical isotopes are essential for a wide range of diagnostic and therapeutic procedures, including cancer treatments and advanced imaging techniques. Pursuant to the multi-year MSA, the companies will work together to process and purify radium-226 that will be irradiated to produce Ac-225. The scope of the agreement also includes potential target design projects and exploration of opportunities to provide backup supply to each other’s customers.

Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, "We are pleased to enter into this agreement with NorthStar. This collaboration is a significant step forward in our mission to support healthcare providers and patients by providing high-quality medical isotopes. Together, we are accelerating our radium-226 target design and fabrication efforts and establishing another irradiation relationship that will enable us to expand our production of Ac-225."

BWXT Medical will collaborate closely with NorthStar, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, to streamline production processes, enhance safety protocols and innovate new methods of isotope generation. This collaboration will leverage the strengths of both organizations, combining cutting-edge technology with extensive industry knowledge.

"At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialization of effective new radiodiagnostics and radiotherapies that can potentially be applied to devastating cancers and rare, complex conditions," said Dr. Frank Scholz, NorthStar’s president and chief executive officer. "This agreement could be instrumental to the radiopharmaceutical industry and patient health. We are excited to collaborate with BWXT on actinium production and believe our complementary technical capabilities will play a critical role in bringing novel therapies to patients who so urgently need them."

BWXT Medical recently announced that it has submitted a Drug Master File (DMF) for Actinium-225 API to U.S. Food and Drug Administration (FDA). DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.

An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later stage clinical studies and, ultimately, new drug applications.