On August 30, 2021 InnoCare Pharma (HKEX: 09969), a commercial-stage biopharmaceutical company, reported the Investigational New Drug (IND) clearance of its second-generation pan-TRK inhibitor ICP-723 by the US Food and Drug Administration (FDA) for starting phase I clinical trial in the United States (Press release, InnoCare Pharma, AUG 30, 2021, View Source [SID1234587018]).

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Preclinical studies have shown that ICP-723 has a good safety profile and high activity against a variety of solid tumors, and the potential to provide a broad-spectrum anti-cancer therapy for patients with solid tumors with NTRK gene fusion. The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumors, and evaluate the anti-tumor efficacy of ICP-723 on NTRK fusion-positive cancers.

ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, etc., and for patients resistant to the first generation of TRK inhibitors.

Currently in China, ICP-723 is in the Phase I dose escalation (1mg, 2mg, 3mg and 4mg), ICP-723 showed efficacy in two patients with qualified neurotrophic tyrosine receptor kinase (NTRK) fusion. The NTRK fusion positive patient in 3 mg cohort reached stable disease (>20% tumor reduction) and the patient in 4 mg cohort achieved partial response at the first tumor assessment at the end of cycle 1, or day 28.

"I feel excited that ICP-723 becomes our third innovative drug entering the clinical stage in the United States," said Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, "As a novel small molecule second generation pan-TRK inhibitor, ICP-723 has potent activity and high selectivity in preclinical experiments, which is expected to overcome the resistance to the first-generation TRK inhibitor to better benefit patients. "

On August 30, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company, reported the appointment of current Chief Operating Officer, Jennifer Chow, as Chief Executive Officer and Managing Director (Press release, Chimeric Therapeutics, AUG 30, 2021, View Source [SID1234587227]).

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Ms Chow has been Chief Operating Officer of Chimeric since November 2020. Prior to joining Chimeric, Ms Chow was Head of Global Marketing, Analytics and Commercial Operations at leading global CAR T company Kite Pharmaceuticals (acquired by Gilead Sciences in 2017 for US$12 billion). Ms Chow was responsible for assessing and prioritizing research and external assets for development, ensuring optimal clinical development of the Kite pipeline for global commercialisation.

Ms Chow has more than 20 years of commercial strategy and marketing experience focused on cellular therapy, hematology and oncology. She was previously Global Cell Therapy Commercial Lead at Celgene Corporation and was responsible for designing and developing the global CAR T commercial strategy and operating model. Ms Chow was also formerly at Roche, Nycomed/Takeda and Schering Canada.

"We are delighted to announce the appointment of Jennifer as MD & CEO. During her time with Chimeric thus far as COO, Jennifer has demonstrated outstanding dedication and leadership while importantly proving to be exceedingly knowledgeable in the field of cell therapy," said Paul Hopper, Executive Chairman, Chimeric Therapeutics.

"The team we’ve been able to assemble at Chimeric brings deep scientific & commercial cell therapy expertise to the business and gives us great confidence moving forward under Jenn’s leadership."

For the purpose of ASX Listing Rule 3.16.4, a summary of the material terms of Ms Chow’s employment agreement is set out in appendix 1.

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.

On August 30, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation (ODD) for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas (Press release, Lantern Pharma, AUG 30, 2021, View Source [SID1234591495]). This news follows the recent announcement of the FDA granting LP-184 ODD for the treatment of pancreatic cancer.

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LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including glioblastoma and pancreatic cancer.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses driven by RADR, Lantern’s proprietary machine learning-based artificial intelligence platform, have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy. According to market analysts at GlobalData, the global GBM market is expected to reach $1.8 billion USD in therapy sales and is growing at a CAGR of 12.8%.

"GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern Pharma. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."

"We recently reported positive preclinical data that demonstrated LP-184 inhibits tumor growth by greater than 106% and improved survival in animal models of GBM," continued Mr. Sharma. "This new data that we reported, in collaboration with the Kennedy Krieger Institute and Johns Hopkins, on the efficacy of LP-184 in GBM cell lines, in-vivo animal models, and in patient-derived neurospheres, validated in-silico predictions generated by our RADR A.I. platform. We believe LP-184’s ability to cross the blood-brain barrier, together with its anti-tumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184’s potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors."

"With our extended and expanded agreement with the Kennedy Krieger Institute and Johns Hopkins, we look forward to further advancing the potential of LP-184 as a new, potent treatment option for GBM, especially in areas of unmet clinical need, including MGMT-unmethylated, temozolomide (TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all of which are often associated with poor prognosis and outcome for patients."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

On August 30, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, reported that the company is scheduled to present at the following September investor conferences (Press release, Agios Pharmaceuticals, AUG 30, 2021, View Source [SID1234586987]):

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Citi’s 16th Annual Biopharma Virtual Conference
Panel: Sickle Cell, Beta-Thal, ITP & PKD – Measuring Industry Progress in Benign Hematology
Friday, September 10 at 12:30 p.m. ET
2021 Cantor Virtual Global Healthcare Conference
Monday, September 27 at 8:00 a.m. ET
Live webcasts of the presentations can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. Replays of the webcasts will be archived on the Agios website for at least two weeks following each presentation.

On August 30, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its partner Gloria Biosciences (GloriaBio) has received approval from China’s National Medical Products Administration (NMPA) for zimberelimab (GLS-010), an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin’s lymphoma (cHL) (Press release, Ligand, AUG 30, 2021, View Source [SID1234587002]). GloriaBio has development and commercialization rights in China with respect to zimberelimab through a sublicense agreement with Ligand’s licensee Wuxi Biologics Ireland Limited.

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Zimberelimab is a fully human monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in the downregulation of the immune system by preventing the activation of T cells. Other anti-PD-1 antibodies have been approved by the U.S. FDA in multiple cancer types. In addition to cHL, GloriaBio is investigating zimberelimab in advanced solid tumors and in March 2021 was granted Breakthrough Therapy Designation for the treatment of patients with recurrent or metastatic cervical cancer in China. Zimberelimab is being developed by Arcus Bioscience in North America, Europe, Japan and certain other territories through a 2017 license agreement.

"We are delighted to see GloriaBio’s progress with zimberelimab including receipt of NMPA approval. When we acquired the OmniAb technology in 2016, there were no OmniAb-derived antibodies in the clinic. GloriaBio’s approval just five years after our acquisition and just four years after they entered the clinic is truly impressive," said John Higgins, CEO Ligand Pharmaceuticals. "Approval of this OmniAb-derived antibody represents the first of many regulatory events we expect over the coming years from what we believe is the industry’s best-in-class antibody discovery engine. Indeed, this is our biggest year ever for regulatory approvals for our partnered products."

About Zimberelimab

Zimberelimab is a fully human monoclonal antibody that binds to PD-1, restoring the antitumor activity of T cells. GloriaBio contracted with Ligand’s partner WuXi Biologics to discover and develop GLS-010 using Ligand’s transgenic rat platform, OmniRat. WuXi and GloriaBio subsequently out-licensed zimberelimab rights to Arcus, excluding China and certain other territories. Arcus, in collaboration with Gilead Sciences, is conducting multiple Phase 1 and Phase 2 trials to evaluate the safety and tolerability of zimberelimab in subjects with prostate, colorectal, non-small cell lung (NSCLC), pancreatic, triple-negative breast and renal cell cancers. A Phase 3 trial was initiated in 2021 to evaluate zimberelimab monotherapy or in combination with Arcus’ anti-TIGIT antibody (AB154) in patients with PD-L1-positive locally advanced or metastatic NSCLC.

In a Phase 2 study in Chinese patients with relapsed and refractory cHL zimberelimab showed impressive preliminary efficacy and a manageable safety profile, with an overall response rate of 90.6%, a 6-month progression-free survival rate of 88.2% and treatment-related adverse events (TRAEs) of mostly grade 1-2; most immune-related adverse events were grade 1-2 and did not limit treatment.1 In a Phase 2 study in Chinese patients with recurrent or metastatic cervical cancer zimberelimab also showed TRAEs of mostly grade 1-2.2 Zimberelimab also demonstrated encouraging therapeutic activity and manageable safety profile in Chinese patients with relapsed or refractory cHL and recurrent or metastatic cervical cancer, and could be a new safe and effective treatment option. GloriaBio has received approval in China for zimberelimab for the treatment of recurrent or refractory cHL. Under the terms of Ligand’s agreement with WuXi, Ligand is entitled to royalties on future product sales.

About OmniAb

The OmniAb antibody discovery platform provides Ligand’s biopharmaceutical partners access to the world’s most advanced antibody repertoires and screening technologies to enable unparalleled discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse, each capable of generating high-quality, fully human antibodies that have been naturally optimized through in vivo affinity maturation. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and are optimally leveraged through AI-enhanced antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. The OmniAb suite of technologies and differentiating AI and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry.