On April 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform, reported the enrollment of Patient 10 in its GTB-3550 TriKE first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, APR 8, 2021, View Source [SID1234577763]). Patient 10 will be dosed at 100mcg/kg/day.

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!

Highlights from the first nine patients treated with GTB-3550 TriKE include:

Up to 63.7% Reduction in Bone Marrow Blast Levels
Restores Patient’s Endogenous NK Cell Function, Proliferation and Immune Surveillance
No Progenitor-derived or Autologous/Allogenic Cell Therapy Required
No Cytokine Release Syndrome Observed
3 out of the Last 5 Patients Treated (25mcg/kg/day to 100mcg/kg/day) Respond
"We are pleased with the continued clinical performance of our lead TriKE product candidate, and in reaching this important patient enrollment milestone," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The data from the first nine patients treated with GTB-3550 indicates significant bone marrow blast level reductions in AML and MDS patients without the need for expensive progenitor-derived or autologous/allogenic cell therapies."

About High-Risk Myelodysplastic Syndromes
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia
Acute myeloid leukemia is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial
Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

On April 8, 2021 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported that Company management will present at the 20th Annual Needham Virtual Healthcare Conference taking place April 12-15, 2021 (Press release, Viracta Therapeutics, APR 8, 2021, View Source [SID1234577762]). The Company will also participate in one-on-one investor meetings at the conference.

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!

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.

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!

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.

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.

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!

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.

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.

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!

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