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

On April 8, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the issuance of US$100 million of shares at a price equivalent to US$30.5 per American Depositary Share ("ADS") via a private placement to funds affiliated with Baring Private Equity Asia ("BPEA") (Press release, Hutchison China MediTech, APR 8, 2021, View Source [SID1234577711]).

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Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We expect significant growth of our business this year as we look to accelerate our oncology revenues from ELUNATE, SULANDA and the potential upcoming approval of savolitinib, likely to be a first-in-class selective c-MET inhibitor in China. We are rapidly expanding global development of our ten oncology assets, all of which were discovered in-house at HUTCHMED, and are planning to initiate 8-10 registration and registration-intent studies in 2021. This is the right time to welcome BPEA to our existing shareholder base, a firm with a long history of supporting innovative globally-focused businesses. We look forward to partnering with BPEA in the next stage of our development."

Mr. Jean Eric Salata, Chief Executive Officer and Founding Partner of BPEA, said, "With this strategic investment, BPEA is demonstrating our long-term commitment to HUTCHMED, an emerging biopharma leader in Asia. The healthcare sector in China is a core area of investment focus for BPEA. HUTCHMED is developing and delivering highly differentiated oncology therapies to patients around the world and we look forward to working with the CEO and management team to support the company’s innovation and global growth aspirations".

Founded in 1997, BPEA is one of the largest and most established independent private equity firms in Asia with approximately $23 billion of assets under management. BPEA has a well-established track record investing in the healthcare sector with a diverse portfolio across different verticals, providing strategic capital to and working closely with industry leaders to grow their businesses over the long-term.

HUTCHMED will receive all proceeds from this private placement of the equivalent of 3,278,689 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

HUTCHMED has agreed to issue 16,393,445 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by BPEA. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. BST on April 14, 2021.

Following admission of the Shares to trading on AIM, the issued share capital of HUTCHMED will consist of 744,515,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 744,515,660 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 744,515,660 ordinary shares were converted in their entirety, they would be equivalent to 148,903,132 Nasdaq-traded ADSs (each equating to five ordinary shares).

On April 8, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the issuance of US$100 million of shares at a price equivalent to US$30.5 per American Depositary Share ("ADS") via a private placement to funds affiliated with Baring Private Equity Asia ("BPEA") (Press release, Hutchison China MediTech, APR 8, 2021, View Source [SID1234577727]).

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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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Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We expect significant growth of our business this year as we look to accelerate our oncology revenues from ELUNATE, SULANDA and the potential upcoming approval of savolitinib, likely to be a first-in-class selective c-MET inhibitor in China. We are rapidly expanding global development of our ten oncology assets, all of which were discovered in-house at HUTCHMED, and are planning to initiate 8-10 registration and registration-intent studies in 2021. This is the right time to welcome BPEA to our existing shareholder base, a firm with a long history of supporting innovative globally-focused businesses. We look forward to partnering with BPEA in the next stage of our development."

Mr. Jean Eric Salata, Chief Executive Officer and Founding Partner of BPEA, said, "With this strategic investment, BPEA is demonstrating our long-term commitment to HUTCHMED, an emerging biopharma leader in Asia. The healthcare sector in China is a core area of investment focus for BPEA. HUTCHMED is developing and delivering highly differentiated oncology therapies to patients around the world and we look forward to working with the CEO and management team to support the company’s innovation and global growth aspirations."

Founded in 1997, BPEA is one of the largest and most established independent private equity firms in Asia with approximately $23 billion of assets under management. BPEA has a well-established track record investing in the healthcare sector with a diverse portfolio across different verticals, providing strategic capital to and working closely with industry leaders to grow their businesses over the long-term.

HUTCHMED will receive all proceeds from this private placement of the equivalent of 3,278,689 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation

HUTCHMED has agreed to issue 16,393,445 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by BPEA. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion

Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. BST on April 14, 2021.

Following admission of the Shares to trading on AIM, the issued share capital of HUTCHMED will consist of 744,515,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 744,515,660 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 744,515,660 ordinary shares were converted in their entirety, they would be equivalent to 148,903,132 Nasdaq-traded ADSs (each equating to five ordinary shares).

On April 8, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its first-quarter 2021 financial results will be released on Wednesday, May 5, 2021 (Press release, Horizon Therapeutics, APR 8, 2021, View Source [SID1234577743]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

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.