On July 20, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug Administration that LuViva has passed safety and electromagnetic compliance requirements necessary to be used in clinical trials (Press release, Guided Therapeutics, JUL 20, 2021, View Source [SID1234584994]). The clinical trials are expected to begin this quarter and SMI estimates that Chinese FDA approval and initial sales in China will occur in the second half of 2022. SMI reports that it has signed sub-distributor contracts for three provinces in expectation of Chinese FDA approval next year.

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"Passing compliance testing certified by the Chinese State Food and Drug Administration is a major milestone for us," said Gene Cartwright, CEO of Guided Therapeutics. "We expect progress in China to accelerate based on this milestone, which allows the start of the clinical study in China."

According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women in the world, and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year, and 30,000 deaths occur annually due to cervical cancer in China.

On July 20, 2021 Flatiron Health real-world data (RWD) reported the U.S. Food and Drug Administration (FDA)’s recent approval of a new dosing regimen for ERBITUX (Eli Lilly and Company’s cetuximab) that can have a direct positive impact on the lives of patients with metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN) (Press release, Flatiron Health, JUL 20, 2021, View Source [SID1234584993]).

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The FDA approved a supplemental biologics license application (sBLA) for ERBITUX which provides a new, biweekly dosing regimen for the medicine’s indicated use in patients with K-Ras wild-type, EGFR-expressing metastatic CRC or SCCHN, when used as a single agent or in combination with chemotherapy.

This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.

"Time is a precious commodity for patients with advanced cancer – every moment that is not spent traveling to and from or in the clinic are moments spent living life," said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron Health. "We are proud that Flatiron RWD brings the evidence we gather from patients’ real-life experiences to bear directly on improvements to their care."

"This dosing change approval allows physicians to provide our patients with the same efficacious treatments in less frequent clinic visits," says Lee Schwartzberg, MD, Chief Medical Officer at OneOncology, a longtime Flatiron community oncology partner. "It is encouraging to see the innovative use of real-world data and regulatory pathways that made this label change a reality."

The approval decision marked a foundational proofpoint for the successful use of RWD to fill evidence gaps in the post-approval setting for regulatory decision-making. Efficacy results from overall survival analyses using Flatiron RWD in patients with metastatic CRC, who received either the weekly or biweekly ERBITUX dosing regimens, supported the results of the population pharmacokinetic modeling analyses in the sBLA. The application was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published literature in patients with CRC and SCCHN.

"We are proud that our long-standing partnership with Flatiron Health is helping to advance the adoption of real-world evidence to support regulatory decision-making," said Christian Nguyen, Pharm.D., vice president of global patient outcomes and real-world evidence, Lilly Oncology. "Being able to fill key evidence gaps through the rigorous analysis of high-quality real-world data will help us all to more quickly bring potential new treatment options for approved medicines to patients."

On July 20, 2021 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, reported that a consortium between the Erasmus MC and ISA has been awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104 to treat hepatitis B in chronically infected patients, in collaboration with Erasmus MC in The Netherlands (Press release, ISA Pharmaceuticals, JUL 20, 2021, View Source [SID1234584992]).

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The clinical study, to be conducted in close collaboration with the Gastroenterology & Hepatology department of the Erasmus MC, is entitled the ‘HEB-PEP study’. The project starts in August 2021 and the clinical phase is expected to begin in 2022. It will provide an insight into which dose of ISA104 is safe, tolerable and potentially effective in chronic HBV patients.

ISA104 is an immunotherapy based on ISA’s Synthetic Long Peptide (SLP) technology designed to direct a strong and specific immune response against the hepatitis B virus (HBV), with the aim to cure chronically infected patients. It will be ISA’s next program to go into clinical development, with its lead program ISA101b in late-stage clinical trials for human papillomavirus type 16 (HPV16) induced cancers.

ISA Pharmaceuticals has previously demonstrated that SLP immunotherapy for HPV16 can eradicate HPV16-induced pre-cancerous lesions1,2,3. ISA, in collaboration with Erasmus MC, has developed a set of antigenic long peptides to create an SLP vaccine, ISA104, aimed to boost the patient’s immune response to clear cHBV.

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: "We are excited to announce this TKI project which will enable us to bring a next product to the clinic from ISA’s pipeline. It is a new highlight of our long-standing collaboration with Erasmus MC. This project will test the safety and immune-stimulatory capacity of ISA104, by taking an important next step to potentially curing patients with chronic Hepatitis B, a tremendous global health burden."

Chronic HBV infection affects an estimated 257 million patients worldwide and 20–30% of adults who are chronically infected will develop cirrhosis and/or liver cancer4. Currently, no effective curative treatments exist. Therapeutic vaccines harbour great potential to cure chronic HBV aiming to achieve viral control and clearance. SLP immunotherapies act through induction of potent and durable anti-viral adaptive immune responses.

On July 20, 2021 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, reported that a consortium between the Erasmus MC and ISA has been awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104 to treat hepatitis B in chronically infected patients, in collaboration with Erasmus MC in The Netherlands (Press release, ISA Pharmaceuticals, JUL 20, 2021, View Source [SID1234584992]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The clinical study, to be conducted in close collaboration with the Gastroenterology & Hepatology department of the Erasmus MC, is entitled the ‘HEB-PEP study’. The project starts in August 2021 and the clinical phase is expected to begin in 2022. It will provide an insight into which dose of ISA104 is safe, tolerable and potentially effective in chronic HBV patients.

ISA104 is an immunotherapy based on ISA’s Synthetic Long Peptide (SLP) technology designed to direct a strong and specific immune response against the hepatitis B virus (HBV), with the aim to cure chronically infected patients. It will be ISA’s next program to go into clinical development, with its lead program ISA101b in late-stage clinical trials for human papillomavirus type 16 (HPV16) induced cancers.

ISA Pharmaceuticals has previously demonstrated that SLP immunotherapy for HPV16 can eradicate HPV16-induced pre-cancerous lesions1,2,3. ISA, in collaboration with Erasmus MC, has developed a set of antigenic long peptides to create an SLP vaccine, ISA104, aimed to boost the patient’s immune response to clear cHBV.

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: "We are excited to announce this TKI project which will enable us to bring a next product to the clinic from ISA’s pipeline. It is a new highlight of our long-standing collaboration with Erasmus MC. This project will test the safety and immune-stimulatory capacity of ISA104, by taking an important next step to potentially curing patients with chronic Hepatitis B, a tremendous global health burden."

Chronic HBV infection affects an estimated 257 million patients worldwide and 20–30% of adults who are chronically infected will develop cirrhosis and/or liver cancer4. Currently, no effective curative treatments exist. Therapeutic vaccines harbour great potential to cure chronic HBV aiming to achieve viral control and clearance. SLP immunotherapies act through induction of potent and durable anti-viral adaptive immune responses.

On July 20, 2021 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, and Insilico Medicine, an industry leader in end-to-end artificial intelligence for target discovery, small molecule chemistry, and clinical development, reported to reach strategic partnership in advancing development of novel therapie (Press release, GenFleet Therapeutics, JUL 20, 2021, View Source [SID1234584991]).

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The agreement outlines a constructive framework where GenFleet will synergize its own R&D systems with Insilico’s end-to-end AI-powered drug discovery platform, with a view to jointly addressing significant unmet medical needs and tackling novel & difficult targets in cancer therapeutics.

In collaboration with Insilico’s AI-powered identification methods, GenFleet will enhance the exploration of the dynamic structure-activity relationship between target proteins and drug molecules through virtual structure research to develop highly selective inhibitors and deliver targeted therapies overcoming drug resistance.

Featuring a competitive pipeline with novel mechanisms, GenFleet has established its comprehensive R&D functions spanning from early discovery to global multi-regional clinical trials. In pursuing targets & indications without proof of concept global-wise, GenFleet has applied latest computational sciences to drug development including DNA-encoded Library screening, computer-aided drug design, digital clinical trial solutions, etc.

Insilico Medicine is a global leader AI-powered drug discovery company. Since 2014, Insilico Medicine developed the AI-powered drug discovery platform consisting of PandaOmics AI-powered novel target discovery engine, Chemistry42 deep generative reinforcement learning system allowing for de-novo design of novel molecules with the desired properties that do not exist in the known chemical space, and InClinico, which predicts clinical trial outcome. As a pioneer and leader in the industry, Insilico Medicine has built a strong drug discovery and development team, a broad distributed discovery partner network, and initiated multiple internal therapeutic programs.

"GenFleet’s portfolio strategy is heavily based on solid technical capabilities, and since its inception, GenFleet has been leveraging such top-notch capabilities world-wide. Through the integration of conventional biotech approaches with emerging technologies such as AI and computational biology, we expect that our R&D capability and efficacy will get a tremendous boost through optimization of target screening, molecular design, real world clinical research, among others. We are very excited to form a collaboration with such leading companies as Insilico, and we look forward to some ‘game-changers’ out of it," said Qiang Lu, Ph.D., Co-founder and Chairman of Board of GenFleet Therapeutics.

"Through cooperation, GenFleet will reinforce its R&D systems with the AI-powered platform and we are projected to substantially improve the success rate of designing original preclinical candidate compounds in shortened cycle time. GenFleet will continuously employ new tools and techniques to enrich its cutting-edge pipeline and develop life-saving medicines for patients around the globe," said Jiong Lan, Ph.D., Co-founder and Chief Executive Officer of GenFleet Therapeutics.

"At Insilico we only partner with the companies that have the commitment to innovate using the latest advances in next-generation AI. We are very excited to collaborate with GenFleet, one of the most innovative biotechnology companies in China now working on unleashing the power of world-class artificial intelligence systems to discover and develop cutting-edge therapeutics for the benefits of the patients worldwide," said Alex Zhavoronkov, PhD, founder and CEO, Insilico Medicine.

"Embracing cooperation and innovation, Insilico is honored to form partnership with GenFleet who shares with us the commitment to innovative drug development. By analyzing and screening huge volumes of data, Insilico’s AI-powered platform boasts unique generation model management and reinforcement learning techniques. We believe our collaboration will provide GenFleet with powerful assistance in its development of transformative therapies," said Feng Ren, Ph.D., Chief Scientific Officer of Insilico Medicine.