On July 23, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported four projects selected to receive funding for clinical and pre-clinical evaluation of futibatinib (TAS-120) (Press release, NCCN, JUL 23, 2020, View Source [SID1234562310]). Futibatinib is an oral, irreversible, selective fibroblast growth factor receptor (FGFR) 1–4 Inhibitor. In a phase 1 dose-escalation trial, futibatinib demonstrated tolerability, pharmacodynamic activity, and preliminary antitumor activity in heavily pretreated patients with advanced solid tumors1. NCCN will provide study oversight while Taiho Oncology is providing drug and funding.

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The following projects were selected following formal scientific evaluation by a panel of NCCN experts:

Phase Ib trial of Olaparib in Combination with Futibatinib in All Solid Tumors with BRCA1/2 Alterations
Jordi Rodon Ahnert, MD, PhD, The University of Texas MD Anderson Cancer Center
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
Siqing Fu, MD, PhD, The University of Texas MD Anderson Cancer Center
Phase 2 Study of FRFR4 Inhibitor Futibatinib in Combination with Anti-PD1 Antibody Pembrolizumab in Patients with Advanced or Metastatic Hepatocellular Carcinoma with FGF19 Expression after Firstline Therapy
Nguyen Hoai Tran, MD, Mayo Clinic Cancer Center
Developing Futibatinib for Use on Novel FGFR Genomic Alterations and in Therapy Combination
Sameek Roychowdhury, MD, PhD, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
"This is a really exciting time for such research," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "There have been some recent discoveries on how FGFR aberrations can impact tumor progression and survival in patients with different cancers, with endometrial cancer being one example. The selected studies offer unique and critical opportunities to learn more about which patients will receive the most benefit from FGFR inhibitors and which approaches are likely to lead to the best outcomes."

"Our support for the National Comprehensive Cancer Network on this important research represents another significant step for Taiho Oncology, as we continue to broaden our collaboration with key investigators in the development of futibatinib," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We thank NCCN for their selection of futibatinib for further research and look forward to the generation of data from these studies as we explore the full potential of futibatinib in patients with a variety of solid tumors."

Proposals were peer reviewed by a Scientific Review Committee, which consisted of distinguished oncologists from NCCN Member Institutions. The funded concepts were selected based on several criteria, including scientific merit, existing data, feasibility, and the types of studies needed to further evaluate futibatinib.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. For more information, visit NCCN.org/orp.

On July 23, 2020 Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma"; 3692.HK), a leading biopharmaceutical company in China, reported a strategic collaboration and licensing agreement for almonertinib with EQRx, a biopharmaceutical company committed to making innovative medicines at dramatically lower prices for the benefit of people and society (Press release, Jiangsu Hansoh Pharmaceutical, JUL 23, 2020, View Source [SID1234562309]). Under the terms of the agreement, EQRx will be responsible for the development and commercialization of almonertinib in the United States, Europe, Japan and all other global markets outside of Greater China, and Hansoh Pharma will continue its development and commercialization of almonertinib in Greater China. EQRx and Hansoh will seek to jointly conduct global studies to further expand the potential of almonertinib as a monotherapy and in combination therapy settings. Hansoh will receive approximately $100 million in upfront payment and development and regulatory milestones, with additional undisclosed commercial milestones as well as royalty payments.

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"With a world-class clinical and regulatory team, EQRx is an outstanding partner for Hansoh Pharma to advance the development of almonertinib outside of Greater China," said Aifeng Lyu, Ph.D., President of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., a subsidiary of Hansoh Pharma. "We look forward to working closely with EQRx for the benefit of lung cancer patients around the world."

"We are excited to add almonertinib to our ever expanding pipeline of innovative medicines," said Alexis Borisy, chairman, founder and chief executive officer of EQRx. "This agreement adds a high quality, clinically significant therapy for treating lung cancer, while bringing EQRx a step closer to making critically important medicines affordable for people who need them."

In March 2020, almonertinib received marketing authorization from the NMPA in China for second-line treatment in patients with EGFR T790M mutation-positive NSCLC. Almonertinib provides a highly efficacious treatment option with favorable safety profile for advanced NSCLC patients.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths among both men and women globally, including in China. In 2018, there were approximately 867,500 new diagnoses of lung cancer in China, of which 737,400, or approximately 85%, were recorded as NSCLC in 2018, with a five-year survival rate of only 19.3%. About 40% of these are EGFR mutation-positive and approximately 50% of patients treated with first- or second-generation EGFR TKI therapy will acquire resistance related to the T790M mutation. [1]

About Almonertinib

Almonertinib 110mg once-daily tablet is a medicine indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an NMPA-approved test, who have progressed on or after prior EGFR TKI therapy. Almonertinib has demonstrated high, nanomolar inhibitory activity against common EGFR mutations, as well as drug-resistant T790M mutations.

On July 23, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 6, 2020, following the release of its second quarter 2020 financial results (Press release, Puma Biotechnology, JUL 23, 2020, View Source [SID1234562307]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On July 23, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its second quarter 2020 financial results after the market closes on Thursday, August 6, 2020 (Press release, Personalis, JUL 23, 2020, View Source [SID1234562306]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 4682918. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On July 23, 2020 Noxopharm, a clinical-stage Australian oncology drug development company listed on the ASX (ASX:NOX), reported that has claimed a breakthrough in the search for restoring immune function within "cold" microtumors, converting them to so-called "hot" tumors (Press release, Noxopharm, JUL 23, 2020, View Source [SID1234562305]).

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The breakthrough stems from new preclinical data from two independent research groups. The data confirms that idronoxil, the active ingredient in the company’s immuno-oncology drug candidate, and sphingosine-1-phosphate inhibitor, Veyonda, activate cancer-fighting immune cells and then enable their entry into microtumors.

Cold tumors lack cancer-fighting T cells, regarded as a fundamental hurdle in enabling immuno-oncology drugs known as immune checkpoint inhibitors (ICIs) to work in more patients and in more cancer types. ICIs have been hailed as the future of cancer therapy, but they require the presence of active T cells in order to work, meaning that they are poorly effective in cold tumors. The majority of human tumors appear to be cold, making the development of a drug or technique that repopulates tumors with immunocompetent T cells a major priority of global pharmaceutical companies.

This new research was conducted by The Institute of Biochemistry, Faculty of Medicine of the Goethe-University, Frankfurt, and the Department of Clinical Oncology and the Centre for Cancer Research at Hong Kong University. Other preclinical and clinical data held by Noxopharm, together with the new research data, leads Noxopharm to believe it is close to claiming the first drug capable of converting tumors from cold to hot across multiple cancer types in a well-tolerated way.

Dr. Graham Kelly, Noxopharm CEO, said, "This is exciting news because it suggests that Veyonda could hold the answer to arguably the biggest challenge currently facing the oncology world, that of restoring the cancer-fighting ability of the body’s immune system in order to achieve higher response rates to immuno-oncology drugs."

Noxopharm now is in a position to discuss with industry partners the opportunity to use Veyonda to enable ICI drugs to work in patients whose cancers fail to respond to the ICI drug alone.