On July 23, 2020 APAC Biotech, an Indian biotechnology company involved in extensive research on personalized immunotherapy using dendritic cells for over a decade, reported that it was finally granted Indian patent (340947), entitled "COMPOSITION AND METHOD FOR PRODUCING ACTIVATED DENDRITIC CELLS" (Press release, APAC Biotech, JUL 23, 2020, View Source [SID1234562313]).

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The company has previously conducted trials and received the approval by the Drug Controller General Of India in 2017 for its product APCEDEN (personalized dendritic cell-based immunotherapy). Being completely autologous in nature, it has been successfully infused to patients with an excellent safety profile and efficacy.

APAC Biotech’s present invention provides a composition comprising of a population of activated dendritic cells tutored in the lab to produce immunogens useful in the treatment of cancer. The invention also provides a method for producing a population of activated dendritic cells specific to a patient’s whole tumor protein. Most significantly, the procedures used to manufacture dendritic cells replicate the natural environment of the human host very closely. APAC Biotech’s technology, therefore, guarantees the highest quality of customized dendritic cells produced for clinical use and marketed at the lowest cost, as compared to any other biotech company globally.

APAC BIOTECH, in their continuous research for making cutting-edge technology feasible for all patients, has more patents lined up which will be eventually filed to other countries as well.

APAC BIOTECH’s new product is named LTR-MEMVAXRALEUCEL, which is a unique, advanced and never-been-used-before technology (licensed) based on homogenous loading of whole tumor amplified mRNA and whole tumor protein, specifically designed for Glioblastoma and Pancreatic Ductal Adenocarcinoma for which clinical trial is awaited, and APAC BIOTECH is in talks with various eminent hospitals and principal investigators to initiate the trial in India very soon.

"We are proud to acknowledge that APCEDEN is a completely Make in India product. With the Indian FDA approval and Indian patent, we hope to raise investments to expand our operations PAN India and help the cause of cancer treatment. We are also looking at global partners to expand our operations on a technology transfer basis," commented Mr. Arun Mehra, CEO.

On July 23, 2020 Novartis Presented the Corporate Presentaion (Presentation, Novartis, JUL 23, 2020, View Source [SID1234562312]).

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On July 23, 2020 Quadriga BioSciences, a leader in the field of transporter technology for cancer therapeutics, reported that the first patient has been dosed in a Phase 1 study of QBS10072S in patients with advanced malignancies. QBS10072S is a novel, first-in-class, bifunctional amino acid analogue that targets LAT1 (L-type amino acid transporter 1) expressing cancers for active transport into tumor cells to disrupt DNA replication (Press release, Quadriga BioSciences, JUL 23, 2020, View Source [SID1234562311]). It is well-recognized that LAT1 is highly expressed on many aggressive forms of cancer and has been shown to be an independent prognostic factor of poor patient outcome. QBS10072S is designed to be transported into high LAT1 expressing tumor cells and spare normal tissues, which typically do not express LAT1.

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"Today’s announcement marks the initiation of the first-in-class LAT1 targeted cancer clinical program for the company," said Gordon Ringold, Ph.D., chief executive officer of Quadriga BioSciences. "Initiation of this study is a major milestone for Quadriga and our partner, NBQ, a joint venture of Quadriga in China, that has partnered with us on the development of QBS10072S. We believe this program has the potential to significantly help patients with brain metastases and those with late-stage astrocytoma, also known as glioblastoma multiforme (GBM)."

Preclinical studies have demonstrated that QBS10072S significantly suppresses tumor growth and improves survival in a triple negative breast cancer (TNBC) spontaneous brain metastasis model and in orthotopic GBM models. Additionally, whole body autoradiography studies with radiolabeled QBS10072S showed significant drug accumulation in the brain tumors of mice when the drug was administered intravenously.

"One of the biggest hurdles to developing effective treatments for brain cancer is that most drugs cannot cross the blood-brain-barrier (BBB), and it is encouraging to see the preclinical data of QBS10072S was able to be transported across the BBB, accumulate preferentially in the brain tumor, resulting in reduced tumor growth and improved survival in animal models," said Professor W. K. Alfred Yung, M.D., Professor of Neuro-Oncology at MD Anderson and executive committee member of the Moon Shots Program. "I look forward to the development of QBS10072S in patients with brain metastases and glioblastoma multiforme."

"We are very pleased to be in partnership with Quadriga BioSciences to advance this novel and important treatment into clinical development for central nervous system (CNS) cancers, for which very limited treatment options are available for patients," said Frank Yan, Ph.D., chief executive officer of NBQ and partner at 3E Bioventures Capital. "This research furthers the field of cancer metabolism and advances potential treatment options for patients whose cancers harbor genetic abnormalities."

About the Study

The Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of QBS10072S in patients with various metastatic malignancies. The primary objectives of the study are to determine the maximum tolerated dose, pharmacokinetics, and preliminary anti-tumor activity of QBS10072S. Disease-specific expansion cohorts with brain metastases and astrocytoma will be enrolled at the maximally tolerated or biologically relevant dose. Please refer to www.clinicaltrials.gov for additional clinical trial details.

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.