ImmVira Announces Preclinical and Clinical Data to Be Presented at the 2021 ASCO and AACR Annual Meeting

On April 8, 2021 ImmVira reported that the company will be presenting its first innovative product, MVR-T3011, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4-8 2021 (Press release, Immvira, APR 8, 2021, View Source [SID1234577761]). Results from the first Phase 1 study of MVR-T3011 as an intratumoral injection in patients with advanced solid tumors in the United States and Australia will be presented.

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In addition, the company will be presenting its latest preclinical research progress on the company’s MVR-T3011 administered as an intravenous infusion at the 112th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on April 10-15 and May 17-21, 2021.

Shanghai Genechem Co., Ltd. (Genechem) Announces appointment of Dr. Eric Rowinsky and Dr. Manuel Hidalgo to Scientific Advisory board, and abstract presentation at AACR 2021 on Claudin 6 Ab and K-Ras TCR-T

On April 8, 2021 Shanghai Genechem Co., Ltd. (Genechem), a discovery company dedicated to novel target discovery and development of novel therapeutics, reported the appointment of Dr. Eric Rowinsky, President and Executive Chairman of the Board of Rgenix, Inc., and Dr. Manuel Hidalgo, Chief of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, to its Scientific Advisory Board (Press release, Shanghai GeneChem, APR 8, 2021, View Source [SID1234577760]). Drs. Rowinsky and Hidalgo will bring their strong expertise in translational and clinical development to support Genechem’s mission to bring its innovative pipeline to global markets through novel target discovery, early development in China, and global partnership.

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Genechem also announces that it will present two abstracts at AACR (Free AACR Whitepaper) 2021, on an antibody against Claudin 6, and a TCR-T therapy against K-Ras mutations. (View Source!/9325/presentation/2600, View Source!/9325/presentation/1949)

"We are excited to welcome Drs. Rowinsky and Hidalgo, global leaders in biopharma industry and translational/clinical development, to our SAB, as we position Genechem to collaborate with cancer centers and biopharmaceutical companies globally to advance development of its innovative pipeline developed on our Good Research Practice (GRP) platform, leveraging CHAMP antibody discovery platform and Cell Therapy Discovery platform", commented Yueqiong Cao, Founder and CEO of Genechem.

"Genechem has built an innovative preclinical pipeline over the last five years, building on almost 20 years of partnership with research Oncologists in China, and I look forward to contributing my expertise to their mission of bringing innovative medicine to patients and partners globally. I am also impressed by their vision and global caliber management team, which I will enjoy working with", Dr. Rowinsky remarked.

Dr. Rowinsky is currently serving on the Board of Directors for Biogen and as President and Executive Chairman of RGenix, Inc. Dr. Rowinsky has also been the Chief Scientific Officer of Clearpath Development Co., which rapidly advances development stage therapeutic assets to pre-defined human proof-of-concept milestones. Dr. Rowinsky was the Head of Research and Development and Chief Medical Officer of Stemline Therapeutics, Inc., a biotechnology company focusing on the discovery and development of therapeutics targeting cancer stem cells. Dr. Rowinsky has also been an Adjunct Professor of Medicine at New York University and has been an independent consultant from 2010-2019. Prior to that, he was the Chief Executive Officer of Primrose Therapeutics, Inc., a start-up biotechnology company focusing on the development of therapeutics for polycystic kidney disease. From 2005 to December 2009 he served as the Chief Medical Officer and Executive Vice President of ImClone Systems Incorporated, a life sciences company. From 1996 to 2004 Dr. Rowinsky held several positions at the Cancer Therapy & Research Center’s Institute for Drug Development, including Director of the Institute and Director of Clinical Research. During that time, he held the SBC Endowed Chair for Early Drug Development and was Clinical Professor of Medicine at the University of Texas Health Science Center at San Antonio. From 1988 to 1996 Dr. Rowinsky was an associate professor of oncology at the Johns Hopkins School of Medicine and on the staff of the Johns Hopkins Hospital. Dr. Rowinsky is also a member of the Boards of Directors of Fortress Biotech Inc., Purple Biotech Ltd. and Verastem, Inc., all of which are biopharmaceutical companies.

"As a clinical oncologist involved in drug discovery and clinical trials, I’m excited to bring my expertise to Genechem and help advance its antibody and cell therapy platforms. I am pleased to support Genechem’s global efforts in advancing scientific understanding of cancer and addressing clinical unmet needs, in particular in solid tumors," said Dr. Hidalgo, who receives an honorarium for participation on Genechem’s SAB.

Manuel Hidalgo, M.D., Ph.D.is currently the Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center. He is also the Hugh E. Luckey Distinguished Professor of Medicine and a senior member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. Dr. Hidalgo received his MD degree from the University of Navarra in Pamplona, Spain in 1992 and a Ph.D. degree from University Autonoma of Madrid in 1997. He trained in medicine and medical oncology at Hospital ¨12 de Octubre¨ in Madrid and at the University of Texas Health Science Center in San Antonio. He also completed a fellowship program in anticancer drug development at the Institute of Drug Development in San Antonio, TX. Prior to this position he served as an Assistant Professor of Medicine at the Division of Hematology and Oncology at the University of Texas Health Science Center in San Antonio. In 2001, Dr. Hidalgo relocated to Johns Hopkins University to be Director of the Gastrointestinal Oncology Program at the Kimmel Comprehensive Cancer Center at Johns Hopkins and Associate Professor of Oncology. In 2009 he became Director of the Clinical Research Program at the Spanish National Cancer Center and Vice director of Translational Research in 2011. In 2015 he became the Chief of the Division of Hematology and Oncology and Director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center in Boston. He was also the Theodore W. and Evenly G. Berenson Professor of Medicine at Harvard Medical School. His main focus of research has been new drug development in pancreatic cancer. His group popularized the use of Avatar mouse models for cancer research and recently contributed to the development and approval of nab-paclitaxel for pancreatic cancer treatment. His current work focuses on strategies for personalized medicine and immunotherapy in pancreatic cancer.

Ryvu Announces Partial Clinical Hold of Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

On April 8, 2021 Ryvu Therapeutics (WSE:RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States (Press release, Ryvu Therapeutics, APR 8, 2021, View Source [SID1234577759]). Patients who are currently taking RVU120 may continue treatment in the study. No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.

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Ryvu received the clinical hold letter from the FDA on April 8th and plans to work diligently with the agency to address the comments and request, in order to resolve the partial clinical hold.

The partial clinical hold was initiated following Ryvu’s recent report to the FDA of a Serious Adverse Event involving a patient death that may possibly be related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis. The other patient in the same study cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.

"Patient safety is Ryvu’s priority," said Pawel Przewiezlikowski, CEO of Ryvu. "Based on the totality of the data we have for RVU120, we believe that it continues to be a promising treatment option for cancer patients, and we will continue to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. We remain on track to present detailed interim safety and efficacy data at upcoming scientific conferences."

Ryvu will host a conference call to discuss today’s announcement for addressing investor’s questions, on Friday, April 9th 2021, at 8:00am CET. The conference will be open for everyone to participate: View Source

Personalis Presents Data at AACR Annual Meeting 2021 Showcasing the Personalis ImmunoID NeXT Platform®

On April 8, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021 (Press release, Personalis, APR 8, 2021, View Source [SID1234577754]).

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These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following are details and links to the scientific posters that will be presented at the online meeting.

Poster Number, Session Category and Session Title

Title & Presenter

Date

Location

399

Clinical Research (Excluding Trials)

Biomarkers Predictive of Therapeutic Benefit

Pan-cancer survey of HLA loss of heterozygosity using a robustly validated NGS-based machine learning algorithm

Presenter: Rachel Marty Pyke, PhD

April 10, 2021

Online

555

Clinical Research (Excluding Trials)

Liquid Biopsies: Circulating DNA

Longitudinal exome-scale liquid biopsy monitoring of evolving therapeutic resistance mechanisms in head and neck squamous cell carcinoma patients receiving anti-PD-1 therapy

Presenter: Charles Abbott, PhD

April 10, 2021

Online

1898

Immunology
Tumor

Antigenicity/Processing and Presentation

Accurate modeling of antigen processing and MHC peptide presentation using large-scale immunopeptidomes and a novel machine learning framework

Presenter: Rachel Marty Pyke, PhD

April 10, 2021

Online

2227

Molecular and Cellular Biology / Genetics

Genomic Profiling of Tumors

Pan-cancer shedding patterns of tumor circulating cell free DNA

Presenter: Fábio Navarro, PhD

April 10, 2021

Online

2241

Molecular and Cellular Biology / Genetics

Genomic Profiling of Tumors

Profiling tumor-infiltrating immune cells using an augmented transcriptome

Presenter: Eric Levy, PhD

April 10

Celcuity Reports Preliminary Data from Phase 1b Trial of Gedatolisib plus Ibrance® and Endocrine Therapy for Patients with ER+/HER2- Metastatic Breast Cancer and Provides Corporate Update

On April 8, 2021 Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase 1b clinical trial evaluating gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients (Press release, Celcuity, APR 8, 2021, View Source;Metastatic-Breast-Cancer-and-Provides-Corporate-Update [SID1234577753]). As of the January 11, 2021 data cut-off date, 53 of the 88 evaluable patients (60%) had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash.

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"We are very encouraged by this preliminary data for gedatolisib from our ongoing Phase 1b trial in patients with breast cancer," said Brian Sullivan, CEO and Co-Founder of Celcuity. "The robust response rate and the observed tolerability profile are particularly compelling given the need for a therapeutic regimen that can address endocrine therapy resistance. We look forward to sharing additional data from the study at a future medical conference in 2021. Developing a therapeutic such as gedatolisib allows us to more fully leverage our CELsignia cellular analysis platform."

Preliminary Phase 1b Data for Gedatolisib:

The preliminary Phase 1b data set for the 103 patients enrolled utilized a January 11, 2021 data cut-off. Patients were enrolled in one of four expansion arms (A, B, C, D), according to their prior treatment history for metastatic breast cancer. All patients received gedatolisib in combination with standard doses of palbociclib and endocrine therapy (either letrozole or fulvestrant). In Arms A, B, and C, patients received an intravenous dose of 180 mg of gedatolisib once weekly. In Arm D, patients received an intravenous dose of 180 mg gedatolisib on a four-week cycle of three weeks-on, one week-off. The primary endpoint was objective response as determined using Response Evaluation Criteria in Solid Tumors v1.0, or RECIST v1.0.

The preliminary efficacy and safety analysis showed:

53 of the 88 evaluable patients (60%) had an objective response.
66 of the 88 evaluable patients (75%) had a clinical benefit, defined as either a confirmed objective response or stable disease for at least 24 weeks.
Gedatolisib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs associated with gedatolisib were stomatitis and rash. Gedatolisib was discontinued in 10% of patients.
22 patients were continuing to receive gedatolisib in combination with the other study drugs, 17 of whom have been on study treatment for more than two years.
In light of these encouraging results, Celcuity is planning to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022.

Corporate Update

Management team expanded in key areas

With the in-licensing of gedatolisib, Celcuity has broadened and deepened its management team with experienced pharmaceutical development and regulatory affairs experts.

Arthur DeCillis, M.D., Chief Medical Officer

Dr. DeCillis was the Chief Medical Officer for Eleven Biotherapeutics (now known as Sesen Bio Inc.) and VP Clinical Research for Exelixis. Prior to that, he served in senior drug development roles at Novartis and Bristol-Myers Squibb. Arthur has been involved in the development of several commercialized oncology drugs, including SPRYCEL (dasatinib), AFINITOR (everolimus), FARYDAK (panobinostat), and CABOMETYX (cabozantinib).

John R. MacDonald, Ph.D., DABT, Senior Vice President of R&D

Dr. MacDonald led the preclinical and clinical R&D efforts at MGI Pharma, an oncology-focused pharmaceutical company until its sales to Eisai Co. He has over 30 years of experience in all aspects of pharmaceutical drug development and licensing. Prior to MGI, he worked for Warner-Lambert (now Pfizer).

Sheri Smith, Head of Clinical Operations (Acting)

Ms. Smith was the former Senior Director of Clinical Operations at MGI Pharma, where she was responsible for all clinical operations. For the past 17 years, she has served as President of Courante Oncology, a specialty clinical research services company serving pharmaceutical and medical device companies.

Bernhard Lampert, Ph.D., Head of CMC

Dr. Lampert has extensive drug development experience in the pharmaceutical and biotech industries, including ten years in large, fully integrated pharmaceutical companies, including Gilead and GSK. He received his Ph.D. in Medicinal Chemistry from the University of Georgia in 1989.

Marie DeGayner Kuker, Head of Regulatory

Ms. Kuker has more than 35 years of experience in the pharmaceutical industry, most recently as head of global regulatory affairs for 3M Pharmaceuticals and Drug Delivery Systems before founding her consultancy in 2007. Marie is an appointed Fellow of the Regulatory Affairs Professionals Society.

Celcuity announces $25 million debt financing agreement with Innovatus Capital Partners, LLC

Celcuity has entered into a debt financing agreement with Innovatus Capital Partners, LLC (Innovatus) to provide Celcuity with up to $25 million in term loans with the first $15 million tranche funded at closing. Celcuity will be able to draw on two additional tranches of $5 million each upon the achievement of certain clinical trial and financing milestones. Celcuity is entitled to make interest only payments for 36 months or up to 48 months if certain conditions are met. The loans will mature on the fifth anniversary of the initial funding date. Innovatus has the right to convert up to 20% of the outstanding principal amount into shares of Celcuity common stock until the third anniversary of the loan agreement. The loan agreement includes customary warrant coverage and is secured by all of Celcuity’s assets. Armentum Partners LLC acted as sole advisor to Celcuity on this transaction.

Webcast Presentation and Conference Call Information

The Celcuity management team will host a webcast/conference call today, April 8, 2021, at 5:00 p.m. ET to discuss the gedatolisib license agreement and provide a corporate update. To participate in the call, dial 1-877-407-8035. A live webcast presentation can be accessed using this weblink: View Source or via Celcuity’s website at View Source A replay of the webcast will be available on the Celcuity website for a limited time following the event.

About the Phase 1b Gedatolisib Clinical Trial

The B2151009 trial is a multicenter, open-label, on-going Phase 1b study in patients with ER+/HER2- metastatic breast cancer. Four dose expansion arms enrolled 103 patients to determine if the triplet combination of gedatolisib plus palbociclib and letrozole or gedatolisib plus palbociclib and fulvestrant produced a superior objective response (OR), compared to historical control data of the doublet combination (palbociclib plus endocrine therapy). More information about the trial is available at NCT02684032.

About Gedatolisib

Gedatolisib is a potent, reversible dual inhibitor that selectively targets PI3K and mTOR. Gedatolisib was originally developed by Wyeth and clinical development was continued by Pfizer after it acquired Wyeth. Celcuity licensed exclusive global rights to gedatolisib from Pfizer in April 2021. An on-going Phase 1b trial evaluating patients with ER+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled 138 patients. Patient enrollment for the four expansion arms of the trial is complete. Based on the favorable preliminary results reported to date from the Phase 1b trial, we intend to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022.