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ISA Pharmaceuticals, in partnership with Erasmus MC, is awarded TKI grant and expands clinical pipeline

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.

GenFleet Therapeutics and Insilico Medicine Announce Strategic Partnership

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]).

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.

Jazz Pharmaceuticals to Report 2021 Second Quarter Financial Results on August 3, 2021

On July 20, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 second quarter financial results on Tuesday, August 3, 2021 after the close of the financial markets (Press release, Jazz Pharmaceuticals, JUL 20, 2021, View Source [SID1234584990]). Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss second quarter 2021 financial results and provide a business and financial update.

Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

Agilent PD-L1 IHC 22C3 pharmDx Expands CE-IVD mark in Non-small Cell Lung Cancer (NSCLC)

On July 20, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union (Press release, Agilent, JUL 20, 2021, View Source [SID1234584988]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

"This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Lung cancer is the leading cause of cancer death overall and the 2nd most commonly diagnosed cancer in Europe.1 NSCLC makes up approximately 85% of all lung cancer cases.2 In Europe, the average five-year survival rate for lung cancer is less than 20%.3

"This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.4 Sanofi and Regeneron developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 (Study 1624) clinical trial.4

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.4

Immunicom’s Data at ASCO Expand on the Antitumor Activity of its Novel Non-Pharmaceutical Immunotherapy in Late-Stage Breast Cancer Patients

On July 20, 2021 Immunicom, Inc., a clinical stage biotech, reported that shared preliminary data from its metastatic triple-negative breast cancer (mTNBC) clinical trial with its novel breakthrough Immunopheresis therapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 (Press release, Immunicom, JUL 20, 2021, View Source [SID1234584987]). Immunicom’s subtractive immunotherapies are designed to remove immune inhibitors and enhance patients natural immune response without compromising quality-of-life as is typically seen after treatment with chemo-/immuno-oncology agents. ASCO (Free ASCO Whitepaper)’s Annual Meeting is one of the world’s premier scientific gatherings of cancer specialists and researchers.

Immunicom is investigating its FDA-designated breakthrough Immunopheresis therapy, which is a filtration-based subtractive treatment designed to capture sTNF-R proteins that are shed by cancer cells and inhibit a patient’s natural anti-tumor immune activity. Immunicom presented data for the second cohort of mTNBC patients treated with Immunopheresis in combination with weekly chemotherapy procedures (paclitaxel [60 mg/m2] plus carboplatin [AUC2] combination), which were found to be generally safe and provided early, promising signs of antitumor activity.

Immunicom previously presented data for the initial cohort of patients treated with Immunopheresis alone at AACR (Free AACR Whitepaper)’s Annual Meeting 2021, revealing an 80% decrease of the inhibitory sTNF-R proteins and observation of sustained quality-of-life while on therapy with minimal side effects (details here).

"The ASCO (Free ASCO Whitepaper) data expand on our breakthrough Immunopheresis therapy, specifically in combination with low-dose chemotherapy to demonstrate potential for synergistic and enhanced activity of sTNFR pulldown in late-stage patients who have failed multiple prior lines of therapy," said Dr. Robert Segal, Immunicom Chief Medical Officer. "The goal of halting disease progression and the potential of going into disease remission with this approach, where side-effects are minimal, has significant implications for the health and well-being of these patients with terminal disease. To be able to continue with normal daily activities, is in stark contrast to what these patients might normally experience if they choose to undergo a last-ditch treatment effort with yet another round of standard chemotherapy."

Immunicom’s abstract, "Extracorporeal pulldown of soluble TNFRs to unleash the activity of endogenous TNFα in chemorefractory triple-negative breast cancer patients – first-in-human experience" was published in ASCO (Free ASCO Whitepaper)’s June 2021 Journal of Clinical Oncology. The study’s principal investigator and lead author is Piotr Wysocki, MD, PhD, Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow, and President of the Polish Society of Clinical Oncology.