Samyang Biopharm USA, Inc. and Spanish National Research Council (CSIC) Announce Strategic Collaboration to Study SYB-010; A First-in-Class, Immune Stimulatory Monoclonal Antibody

On August 30, 2021 Samyang Biopharm USA, Inc. (View Source) a subsidiary of Samyang Holdings Corp. (View Source), reported that the company has entered into a research collaboration with the Spanish National Research Council (CSIC), a state agency for scientific research and technological development (Press release, Samyang Biopharmaceuticals, AUG 30, 2021, View Source [SID1234587009]). The two organizations will work together to study the effect of NKG2D-ligand-containing vesicles and Samyang’s proprietary monoclonal antibody, SYB-010, on NKG2D receptor expression and NK cell function. Financial terms of the agreement were not released.

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"CSIC is the ideal partner for our early-stage discovery program with their proven scientific capability and successful track record in analyzing the immunomodulatory impact of antibodies. We look forward to future involvement within this collaboration" said Sean McKenna, Ph.D., Vice President of Research, Samyang Biopharm USA. "Partnering with CISC on SYB-010 will allow Samyang to advance our promising drug candidate."

SYB-010 is a monoclonal antibody targeting the human NKG2D-ligands, MCA/B, which has shown a clear immumodulatory effect in pre-clinical models. Treatment with this antibody markedly reduces tumor growth; while showing potential to also reduce the number of metastases and increasing overall animal survival. In 2019, Samyang acquired global rights for the development, manufacturing and commercialization of SYB-010 (formerly CuraB-10) from CanCure, LLC. More information on that collaboration can be found here. Samyang continues to develop this antibody both internally and through collaborations to enable future clinical programs.

"By combining our expertise in pre-clinical research that analyzes the immunomodulatory effect of drug candidates, we hope to confirm the potential of SYB-010 as a transformative cancer agent," said Drs. Valés-Gómez and Reyburn, Group Leaders at Spanish National Research Council. "We believe that this project is an important step in helping improve our overall understanding of the biology regulating this receptor and its ligands; and will allow us to foster further discovery and development efforts for Samyang."

"We believe that SYB-010 has great clinical potential and are pleased to be collaborating with CSIC whose breadth of experience in pre-clinical research will allow Samyang to advance this compound forward into the clinic," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "Through this collaboration, we will benefit from our partner’s strong science expertise and enabling technologies to further influence and enhance our lead program and have the opportunity to evaluate the full potential of SYB-010 at this critical juncture."

Castle Biosciences Recognized as a Top 100 Healthcare Technology Company of 2021

On August 30, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that it has been included in The Healthcare Technology Report’s Top 100 Healthcare Technology Companies of 2021 list (Press release, Castle Biosciences, AUG 30, 2021, View Source [SID1234587008]).

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The companies selected for this year’s list include a variety of organizations, from well-known names to newer, rapidly growing companies, in the fields of healthcare software, biotechnology, medical devices and consumer health technology. Awardees were nominated and selected based on a thorough evaluation process. Among the key criteria considered were product or service quality, customer adoption, management team caliber, organizational effectiveness and company growth, among other factors.

"Congratulations to Castle Biosciences for being recognized as one of the Top Healthcare Technology companies in our 2021 list," said the editorial team of The Healthcare Technology Report. "Organizations such as Castle are making great strides to both modernize and advance healthcare. We look forward to continued advancements from Castle in the field of skin cancer testing."

"We are honored to be recognized as a Top 100 Healthcare Technology Company," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are committed to transforming the management of skin cancer and other dermatologic conditions through our innovative genomic tests. Since our formation in 2008, we have been focused on improving patient care and outcomes through the application of emerging artificial intelligence techniques in molecular diagnostics. As we continue to grow our suite of tests for diseases with unmet clinical need, accolades like these reinforce our focus and reflect our position as a leader in dermatologic testing."

The full list can be viewed at https://thehealthcaretechnologyreport.com/.

About The Top 100 Healthcare Technology Companies of 2021

This year’s awardees comprise a broad range of companies from well-known names to relatively newer but rapidly growing enterprises. The diverse range of sophisticated products and services offered through these companies — from digital pharmacies to holistic patient care and AI-powered robotics to digital healthcare payments — have not only led to the modernization of the healthcare sector but also to a brighter future where healthcare is democratized for all. Advancements in healthcare, whether through data and communications, research and clinical trials, or consumer offerings, have also helped to create an environment where more promising care alternatives are possible. The pioneering companies selected for this year’s list have one thing in common: they are revolutionizing the way we live, and the way we navigate one of the most important factors for all of us: our health.

About The Healthcare Technology Report

The Healthcare Technology Report provides market research and insights, business news, investment activity updates and important corporate developments related to the healthcare technology sector. Based in New York City, the firm is run by a seasoned team of editors, writers and media professionals highly knowledgeable on healthcare technology and the various companies, executives and investors that make up the sector.

TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

On August 30, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, AUG 30, 2021, View Source [SID1234587007]). Details of the data presentations are included below.

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"We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL." Mr Weiss continued, "We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination."

IwCLL 2021 PRESENTATION INFORMATION

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

Abstract Number: 1083667
Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Abstract Number: 1083987
Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

Abstract Number: 1083634
Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Currently, the conference agenda, including abstract titles, is available via the iwCLL website at View Source Full text abstracts will be publicly available on September 13, 2021.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

Rocket Pharmaceuticals Announces $26.4 Million Private Placement

On August 30, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported a securities purchase agreement with a fund affiliated with RTW Investments, LP, the Company’s largest shareholder, for the purchase of an aggregate of 812,516 shares of common stock, par value $0.01 per share, at a purchase price of $32.48 per share, the closing price on August 27, 2021, for aggregate gross proceeds of approximately $26.4 million to the Company before offering expenses (Press release, Rocket Pharmaceuticals, AUG 30, 2021, View Source [SID1234587006]). The private placement is expected to close on or about August 31, 2021, subject to the satisfaction of customary closing conditions. Rocket expects to use the net proceeds from the private placement to continue to advance and expand its pipeline of product candidates, for research and development expenses and for working capital.

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The securities to be sold in the private placement have not been 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. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the common shares issued in the private placement upon the purchasers’ request.

This press release shall not constitute 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. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Quest Diagnostics to Speak at the Morgan Stanley 19th Annual Global Healthcare Conference

On August 30, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Morgan Stanley 19th Annual Global Healthcare Conference (Press release, Quest Diagnostics, AUG 30, 2021, View Source [SID1234587005]). Steve Rusckowski, Chairman, CEO and President and Jim Davis, Executive Vice President, General Diagnostics will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, as well as the company’s current perspective on the impact of the COVID-19 pandemic. The presentation is scheduled for Thursday, September 9, 2021, at 9:30 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until October 9, 2021.