Reven Holdings Announces the Launch of Its Translational Oncology Program: Targeting Tumor Microenvironment to Improve Treatment Outcomes in Cancer

On April 23, 2021 Reven Holdings, Inc. ("Reven") reported that it has launched its translational oncology program as a new drug discovery and development initiative that is aimed at changing the therapeutic landscape for difficult-to-treat forms of cancer (Press release, Reven Holdings, APR 23, 2021, View Source [SID1234578416]). The overarching goal of this program is to treat cancer patients more effectively by altering the immediate surroundings of their tumor tissue, also known as the tumor microenvironment (TME). That is because TME is a key contributor to disease progression and metastasis. Several cells in the TME prevent patient’s immune system elements from mounting a strong immune response against cancer cells. Reven Pharmaceuticals is committed to developing new strategies aimed at overcoming the immunosuppressive TME. Specifically, Reven will employ its lead compound RJX for targeting the TGF-beta signaling in cancer patients. Transforming growth factor (TGF)-beta can limit the T-cell infiltration to the TME and inhibits T-cells as well as NK-cells with leads to a markedly diminished anti-tumor immune response within the TME. In addition to the TGF pathway, The SYK-PI3K-AKT signaling pathway is also critical for the survival of cancer cells. Reven Pharmaceuticals will explore new generation inhibitors of this biochemical signaling pathway as a new class of anti-cancer drugs.

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Another oncology platform being explored by Reven Pharmaceuticals targets the so-called "Lactate Shuttle" in the TME. Cancer cells specifically use lactate to mediate several environment changes that support tumor growth and stimulate more lactate production. Targeting the "lactate shuttle" by facilitating lactate clearance may eliminate the contribution of lactate to the immunosuppressive TME in cancer patients. It is noteworthy that ingredients of Reven’s anti-inflammatory, investigational drug product RJX have been shown to facilitate lactate clearance.

Dr. Fatih Uckun, the Chief Medical Officer of Reven Pharmaceuticals reviews the proof of concept and clinical impact potential of such innovative strategies aimed at the TME in cancer patients with multiple myeloma in a recent article that was published in the prestigious peer-reviewed high-impact biomedical journal Cancers. The article was published on April 22, 2021:

Uckun, F.M. Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma. Cancers 2021, 13, 2018. View Source

"Scientific data from multiple studies suggest a tremendous therapeutic potential for the RJX platform and provide the foundation for our optimism regarding the commercialization potential of RJX," said Brian Denomme, Co-founder, President and Chief Operating Officer. "This new article emphasizes our commitment to advancing our pipeline for cancer patients through our translational oncology program," stated Michael Volk, Chief Strategy Officer of Reven. CEO Peter Lange added: "Our goal is to leverage the most recent R&D discoveries about health benefits of TME targeting strategies in our efforts aimed at building a rich product pipeline that includes rationally designed anti-cancer agents that are optimized for specific target indications".

About Rejuveinix (RJX)

RJX is an intravenous (IV) formulation of physiologically compatible compounds that is being developed for more effective treatment of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105). It is currently being evaluated as a COVID-19 drug candidate in high risk COVID-19 patients (ClinicalTrials.gov Identifier: NCT NCT04708340; View Source).

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar. He has served as a member of several editorial boards and National Institutes of Health grant review/special emphasis panels.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation, as well as postdoctoral research training in immunology and microbiology at the University of Minnesota. Dr. Uckun has more than thirty years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters, and is an inventor on numerous patents.

For eleven years, Dr. Uckun worked as a Professor of Bone Marrow Transplantation, Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota, where he became the first recipient of the Endowed Hughes Chair in Biotherapy. At the Keck School of Medicine of the University of Southern California, he was a Professor and Head of Translational Research in Leukemia and Lymphoma of the CCBD and a Principal Investigator of the Stem Cell-Regenerative Medicine Initiative for six years. From 2012 to 2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the National Cancer Institute Alliance for Nanotechnology in Cancer.

Dr. Uckun has held executive positions in multiple biotechnology companies and has extensive regulatory experience. Prior to joining Reven as its Chief Medical Officer and Chief Scientific Officer, Dr. Uckun served as Vice President of Scientific Solutions at Worldwide Clinical Trials, Chief Medical Officer of Oncotelic and Mateon Therapeutics, Head of Immuno-Oncology at Ares Pharmaceuticals, and as Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health. Previously, he was Vice President of Research and Clinical Development at Nantkwest, and Chief Scientific Officer of both Jupiter Research Institute and Paradigm Pharmaceuticals. Dr. Uckun is a former Vice Chair of the New Agents Committee as well as a Member of the Leukemia Steering Committee of the Children’s Cancer Study Group, an NCI-funded cooperative clinical trials consortium that coordinated pediatric and adolescent/young adult leukemia trials at 120 institutions in the U.S., Canada, Australia and Europe.

Dr. Uckun has deep knowledge and experience in the treatment of infectious diseases and their complications as well. In particular, he has extensive experience in viral, fungal, and bacterial infections of immunocompromised hosts, septic shock, ARDS, systemic capillary leak syndrome and cytokine release syndrome (CRS). He served as the Principal Investigator of a virus neutralizer project funded by the Defense Advanced Research Projects Agency (DARPA) as part of its unconventional countermeasures program. Dr. Uckun directed several federally funded virology/innate immunity projects and published numerous peer-reviewed papers on RNA viruses and anti-viral agents.

Knight Therapeutics to Acquire Regional Rights to Exelon®

On April 23, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight") a pan-America (ex-USA) specialty pharmaceutical company, reported that it has entered into a definitive agreement under which Knight will acquire the exclusive rights to manufacture, market and sell Exelon (rivastigmine Patch, Capsules and Solution) in Canada and Latin America (the "Territory"), as well as an exclusive license to use the intellectual property and the Exelon trademark, from Novartis within the Territory (Press release, Knight Therapeutics, APR 23, 2021, View Source;id=202438&p=2193050&I=1206939-c7Z3G6f3m8 [SID1234578415]).

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Exelon (rivastigmine) is a prescription product that was first approved in 1997 and is currently registered and sold in approximately 90 countries. Exelon is indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease.

At closing, Knight will pay USD $168 million in cash and an additional milestone payment of up to USD $12 million upon the achievement of certain conditions. Exelon had annual revenues for 2020 of approximately 47 Million US dollars for Canada and Latin America.

"We are excited to add Exelon to our portfolio of specialty CNS products and continue to support this well established and important therapy option in an area of such high unmet need as Alzheimer’s", said Samira Sakhia, President and Chief Operating Officer of Knight.

"The acquisition of Exelon leverages Knight’s pan-American (ex-US) platform and further validates our Rest-of-world strategy", said Amal Khouri, Chief Business Officer of Knight. "Exelon will be the first product that we will be selling across our entire territory".

The closing of this transaction is subject to anti-trust clearance in Brazil. In conjunction with closing, Knight will enter into a transition service agreement until transfer of marketing authorization, on a country by country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country by country basis.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss the Exelon acquisition today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Friday, April 23, 2021
Time: 8:30 a.m. ET
Telephone: Toll Free 888-506-0062 or International 973-528-0011
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at https://www.gud-knight.com

Protara Therapeutics Provides Regulatory Update for TARA-002 for the Treatment of Lymphatic Malformations

On April 23, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported a path forward related to TARA-002 for the treatment of Lymphatic Malformations (LMs), which are rare malformations of the lymphatic vasculature for which there is no U.S. Food and Drug Administration (FDA)-approved treatment (Press release, Protara Therapeutics, APR 23, 2021, View Source [SID1234578413]). Based on feedback from the FDA, the Company intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and subsequently initiate a clinical study in pediatric LM patients pending alignment with FDA on study design.

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"With the benefit of the recent FDA feedback, we will work with the agency to align on a clinical study in pediatric LM patients, which, we believe, combined with the existing dataset for OK-432 (the originator compound for TARA-002), which demonstrated treatment effect and support for strong safety profile in over 500 LM patients, should provide a robust data package for this rare disease," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We have already begun preparation to initiate a clinical study in LMs and we look forward to continued collaboration with FDA to achieve our goal of delivering the first approved medication for LMs to these patients and their physicians."

TARA-002 is derived from the same cell bank as OK-432, a broad immunopotentiator approved in Japan and Taiwan for the treatment of LMs, where it is currently the standard of care. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and the originator compound OK-432, which has been studied in more than 500 patients in one of the largest Phase 2 trials ever conducted in LMs. TARA-002 has been granted Rare Pediatric Disease designation by the FDA for the treatment of LMs.

About Lymphatic Malformations

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of 3 years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

Molecular Partners Files Registration Statement for Proposed Initial Public Offering in the United States

On April 23, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing common shares, in the United States (the "Offering") (Press release, Molecular Partners, APR 23, 2021, View Source(SIX%3A%20MOLN,SEC%E2%80%9D)%20relating%20to%20a%20proposed [SID1234578412]). All securities to be sold in the Offering will be offered by the Company. The number of common shares to be represented by each ADS, the number of ADSs to be offered and the price range for the ADSs in the proposed Offering have not yet been determined. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "MOLN." The Company’s common shares are listed on the SIX Swiss Exchange ("SIX") pursuant to its International Reporting Standard under the ticker symbol "MOLN."

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JP Morgan, SVB Leerink and Cowen & Co. are acting as joint lead bookrunners for the Offering. RBC Capital Markets is also acting as bookrunner and Kempen & Co is acting as lead manager for the Offering.

The securities referred to in this announcement are to be offered only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at PostSaleManualRequests@broadridge.com or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105.

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The common shares underlying the ADSs are expected to be listed on the SIX. In connection with this listing, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 ("FinSA") and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 ("FinSO").

Cytokinetics to Announce First Quarter Results on May 6, 2021

On April 22, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report first quarter results on May 6, 2021 at 4:00 PM Eastern Time (Press release, Cytokinetics, APR 22, 2021, View Source,4%3A00%20PM%20Eastern%20Time. [SID1234578409]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 6097958.

An archived replay of the webcast will be available via Cytokinetics’ website until May 20, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 6097958 from May 6, 2021 at 7:30 PM Eastern Time until May 20, 2021.