On June 17, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported a change to its presentation time at the upcoming JMP Securities Hematology and Oncology Forum. Updated details are as follows (Press release, Syros Pharmaceuticals, JUN 17, 2020, View Source [SID1234561193]):

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

JMP Securities Hematology and Oncology Forum
Date: Thursday, June 18
Presentation Time: 3:20 p.m. ET

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.

On June 17, 2020 Ipsen (Euronext: IPN; ADR: IPSEY) reported the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for the investigational use of liposomal irinotecan (ONIVYDE) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) together, known as NALIRIFOX for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Ipsen, JUN 17, 2020, View Source [SID1234561162]). The FDA’s Fast Track program facilitates the development and expedites the review of drugs that treat serious conditions and have the potential to address an unmet medical need.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The final analysis from the multicenter, open-label Phase 1/2 study will be presented as a late-breaking oral presentation at the first time ever virtual ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer on July 1, 2020 and will include data on primary and secondary endpoints. Ipsen has also initiated patient enrollment in the international Phase 3 NAPOLI-3 clinical study investigating the safety and efficacy of NALIRIFOX versus gemcitabine + nab-paclitaxel in the first-line setting (NCT04083235).

ONIVYDE is approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

"Since the initial approval of ONIVYDE in metastatic pancreatic cancer, we have continued to dedicate our research efforts to better understand the needs of pancreatic cancer patients. Through ongoing clinical investigations and exploratory real-world analyses, we have sought to determine whether patients who receive active treatment early have an improvement in survival," said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. "As we continue to enroll additional patients in the ongoing Phase 3 NAPOLI-3 clinical study, we look forward to working closely with the FDA to potentially bring ONIVYDE to more pancreatic cancer patients earlier in the disease."

Pancreatic cancer is a rare and deadly disease that accounts for about 3% of all cancer and 7% of all cancer deaths.1 Of the 57,600 people with pancreatic cancer in the United States, more than half are diagnosed with metastatic disease, which has an overall 5-year survival rate of three percent (3%).1

Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant study criteria are met and enables a company to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis.

On June 17, 2020 Phost’in Therapeutics (Montpellier France), a biopharmaceutical company focused on the discovery and development of N-glycosylation inhibitors, reported the appointments of Dr.Alain Herrera, MD,PhD as Chief Medical Officer and Pr. Bernard Pau, PhD, as Chief Operating Officer (Press release, Phost’in, JUN 17, 2020, View Source [SID1234561178]). Pr. Bernard Pau will also serve as Chairman of the Board.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Phost’in Therapeutics has previously announced in April 2020 that it has successfully secured a €10.3 million Series A round, from an international syndicate of Life Science and Innovation Investor led by Remiges Ventures to advance the clinical development of Phost’in’s main program, PhOx430, and to enhance capacity of its discovery platform.

Dr. Alain Herrera, MD, PhD has headed for ten years the Oncology business at Sanofi (1998-2008) where he was successively Vice President responsible for Global Oncology Business Strategy and Development and Head of Global Oncology Franchise and contributed to the worldwide registration of oxaliplatin (ELOXATIN) and rasburicase(FASTURTEC/ELITEK) as well as the Gastric and Head & Neck indications for docetaxel (TAXOTERE). Since 2008, he has worked with several companies in Europe, US and Asia being primarily involved in clinical development strategy, pipeline evaluation,product launch and positioning, partnerships. He is also an independent member of several Supervisory Boards/Boards of Directors including Nanobiotix, IDDI, GR-Transfert, AVEC Foundation. His previous responsibilities within Pharmaceutical industry include the roles of Chairman of Chiron Therapeutics Europe, Director of Chiron B.V, Corporate Vice President and Member of Management Council of Chiron Corporation and Managing Director at Pierre Fabre Oncology Laboratories. Besides these duties, Dr. Herrera hasalso been since 1991 Hematologist Consultant at Antoine Beclere Hospital. He has published and lectured extensively as an invited speaker at national and international meetings on cancers, and has authored a lot of original manuscripts in addition to contributing to numerous review articles and book chapters. He is an active member of ASCO (American Society of Clinical Oncology) and ESMO (Free ESMO Whitepaper) (European Society of Medical Oncology).

Dr.Alain HERRERA, who has been counseling Phost’in Therapeutics for the past 3 years to anticipate the clinical development of its main program PhOx430, a First-In-Class N-glycosylation inhibitor for the treatment of aggressive solid tumors, will be the company’s first CMO.

"I’m very excited about the promise of Phost’in Therapeutics pipeline, targeting aberrant Nglycosylation mecanisms"said Dr. Herrera. "As CMO, I really look forward to bringing PhOx430 into clinical trials for the full benefit ofpatients suffering of rare and aggressive tumors."

Pr. Bernard Pau,former student of the Institut Pasteur and Honorary Professor of immunology and biotechnology at the Universitybof Montpellier, has pioneered in France the industry transfer of innovation by bridging the gap between academic research and industry. His 30 years fruitful experience as a scientific manager and entrepreneur has been covering the fields of drug discovery, diagnostic tests and biotechnology.Afte r starting in industry, in Sanofi were he was Head of the Immunodiagnostics Department, he has built a brilliant career as a researcher and academic, constantly advocating for his "tripod": training,innovative research and economic partnerships. Thus, he directed a mixed research unit associating the CNRS, the university and the Bio-Rad group, participated in the creation of several pharmaceutical innovative companies(Innodia, Biodol Therapeutics, Kinnov Therapeutics, iMAb, …),and was appointed by French government as director of the CNRS Life science Department from 2002 to 2004. Pr.Bernard Pau co-authored more than150 international papers and patents.

"I am incredibly honored to have the opportunity to serve as COO of Phost’in Therapeutics" Bernard Pau stated. "Phost’in Therapeutics is committed to challenging the treatment of life threatening diseases, by using its innovative platform ofresources in Glyco-Immuno-Oncology, and I hope to be a valued resource the company can rely on."

Pr.Pau will also serve as Chairman of the Board.With the addition of Pr. Pau, Phost’in’s Board of Directors consists of five members, including Karine Chorro and Dr. Luvovic Clarion, co-founders and respectively CEO and CSO, Hitoshi Ono of Remiges Ventures, and Richard J. Meadows who both joined in April 2020, following the Series A completion. One of the 201 top ten Life Science Investors in North America according to Forbes Magazine, Richard Meadows was Co-Founder of and Managing Partner at CTI Life Sciences Fund and Partner at the Biotechnology Group of CDP Capital Technology Ventures.

On June 17, 2020 Median Technologies (Paris:ALMDT) (ALMDT), The Imaging Phenomics Company, reported the results of a preliminary retrospective study on the evaluation of the risk of recurrence for patients with primary liver cancer (HCC – hepatocellular carcinoma) based on a non-invasive biomarker (Press release, MEDIAN Technologies, JUN 17, 2020, View Source [SID1234561194]). The iBiopsy imaging biomarker discovery platform, which integrates advanced technologies in artificial intelligence has produced these results on one of the three indications on which it is positioned. Bearing in mind, the various clinical development plans for iBiopsy were communicated on April 20, and relate to (1) the evaluation of severity of hepatic fibrosis in non-alcoholic fatty liver disease (NASH – Non Alcoholic Steatohepatitis), (2) the identification of responders/non-responders to certain immunotherapies in oncology, and finally (3) the detection, characterization and prognosis of primary liver cancer (HCC).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The level of hepatic fibrosis1 is of great prognostic value and helps inform therapeutic intervention with regard to liver disease. The diagnosis of fibrosis is classically based on the anatomo-pathological examination of a fragment of liver collected by a hepatic puncture, a painful invasive act, presenting risks for the patient and which turns out to be expensive.

There was a two-fold objective for the preliminary retrospective study: first, to accurately quantify liver fibrosis on CT images, and second, to correlate the score of fibrosis with the risk of recurrence in post-operative patients with HCC.

Therefore, a learning algorithm was used on the pre-operative CT scans of 94 patients that were separated in two sets (training and validation) in order to model the relationship between image features of liver, spleen and hepatic fibrosis characterized by histological METAVIR scoring system (F0-F4). The performance of iBiopsy testing characterized by the area under the curve (AUROC) is 0.91 with a specificity of 1 for the diagnosis of severe fibrosis (F3-F4). Using this quantification methodology, iBiopsy non-invasive fibrosis biomarker permits the stratification of pre-operative patients at high-risk of tumor recurrence (HR = 4.1 (CI: [1.2,13.9], p-value<0.01). Such knowledge can positively impact the therapeutic approach in patients to undergo hepatic resection.

Based solely on the threshold values ​​of advanced fibrosis, the iBiopsy fibrosis test would avoid biopsy in 100% of cases, unlike other imaging techniques such as ultrasonic elastography and elasto-MR which have lower specificity and sensitivity values. These very encouraging first results need to be confirmed in larger independent patient cohorts. This will be one of the objectives of the Liver iBiopsy study, conducted in collaboration with the AP-HP, as part of the AP-HP Median partnership announced on March 2.

"These initial results are exciting and show the relevance of our approach. With the integration of the AI technologies, cloud computing and our data science expertise, we are positioning iBiopsy as a platform for the discovery of imaging biomarkers, on which we will deploy our entire non-invasive biomarkers portfolio, " said Fredrik Bragg, CEO and co-founder of Median.

"In this first study, the success of the quantification of HCC-related fibrosis via routine scanner imaging opens the prospective to the evaluation of the severity of fibrosis on NASH patients using the same modality. Our objective is to exploit the information content of the images widely used in clinical routine and clinical trials. iBiopsy allows for the comprehensive analysis of features of images on whole organ, which permits a true evaluation of the entire tumoral landscape and increases the amount of information that we can extract from images, and thus the performance of the biomarkers we calculate," he added.

About iBiopsy: Based on the most advanced AI technologies and with expertise in data science, Median’s iBiopsy proprietary imaging platform allows for the extraction of non-invasive imaging biomarkers, which are the disease "signatures". These biomarkers, obtained from standard medical imaging modalities are used both in the field of clinical development and clinical routine in which medical needs regarding disease detection, treatment options and follow-up of patients are still unmet and have yet to foster the promise of predictive and precision medicine.
Median’s iBiopsy development program is supported by the European Investment Bank (EIB) through a financial loan of €35 million under the Juncker Plan, the European Fund for Strategic Investments, which aims to support research and innovation projects developed by companies with high growth potential.

On June 17, 2020 ISA Pharmaceuticals B.V., a private clinical-stage immunotherapy company, reported plans to initiate a potentially pivotal clinical trial for the combination of ISA101b and Libtayo (cemiplimab) in oropharyngeal cancer, a type of head-and-neck cancer, under its strategic immuno-oncology collaboration with Regeneron (Press release, ISA Pharmaceuticals, JUN 17, 2020, View Source [SID1234561163]). In addition, Regeneron will increase its equity stake in ISA Pharmaceuticals.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The new oropharyngeal cancer trial is the third trial planned under the clinical collaboration between ISA Pharmaceuticals and Regeneron. ISA101b, an immunotherapy targeting human papillomavirus type 16 (HPV16), is currently in a Phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck cancer in combination with Libtayo, a PD-1 inhibitor that is being jointly developed by Regeneron and Sanofi. A second Phase 2 trial investigating the same combination in cervical cancer is also planned. More than 60 percent of head-and-neck cancers and approximately 55 percent of cervical cancers are HPV16 induced.

Under the revised agreement, the clinical collaboration offers a potential shortened path to first approval in the HPV16-positive oncology indications being studied in the next few years. The agreement also streamlines ISA Pharmaceuticals’ access to license fees, milestone payments and royalties. Together with the recently secured 20 million Euro loan from the European Investment Bank, development of ISA101b is now fully funded through the data readout of ongoing and planned pivotal trials which will support regulatory filings.

"This agreement will accelerate the development and commercialization of our lead asset, ISA101b, to treat two important cancers with high unmet medical needs." commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals. "We are extremely pleased to be working with Regeneron and for their continued support of both ISA Pharmaceuticals and our clinical studies in both indications."

"Thanks to this updated clinical collaboration, we are able to rapidly diversify our research into a broader array of HPV16-induced cancers," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. "ISA101b offers a validated mechanism of action, and we look forward to working with ISA Pharmaceuticals to determine the synergistic potential of combining this novel immunotherapy with Libtayo to better address these difficult-to-treat cancers."