1stOncology™: Cancer Intelligence Service – Page 10447 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

NovalGen receives CTA approval to start a Phase 1/2 first in human study to evaluate the safety, pharmacokinetics and efficacy of NVG-111 in Chronic Lymphocytic Leukemia & Mantle Cell Lymphoma

On April 7, 2021 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported that its Clinical Trial Application ("CTA") has been accepted by the UK Medicines and Healthcare products Regulatory Agency ("MHRA"), and that University College London Hospital ("UCLH") has been activated as NovalGen’s first UK clinical site (Press release, UCLB, APR 7, 2021, View Source [SID1234577693]). The Company is now ready to conduct a Phase 1/2 first in human study evaluating the safety and efficacy of its lead product, NVG-111. The study will include patients with both Chronic Lymphocytic Leukemia ("CLL") & Mantle Cell Lymphoma ("MCL"), and the Company expects to dose the first patient in Q2 2021. NVG-111 is a first-in-class bispecific antibody T-cell engager which simultaneously binds CD3 on T-cells and Receptor Tyrosine Kinase Like Orphan Receptor 1 ("ROR1") on tumour cells.

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!

"Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for NovalGen only 2 years following the company’s formation" said Professor Amit Nathwani, CEO of NovalGen. "We are developing bispecific therapies that can safely harness the immune system to treat both hematological malignancies and solid tumours, and we are excited to imminently bring our first antibody forward to patients with CLL and MCL in this study."

NVG-111 redirects endogenous T-cells to sites of tumours and, upon engagement with the ROR1 antigen on cancer cells, promotes the formation of immunological synapses, selectively killing the tumour independently of major histocompatibility complex, costimulatory molecules and antigen presentation. It is designed to be highly effective in the killing of cancer cells without affecting healthy immune cells or tissues and may potentially target cancer-initiating stem cells, a subpopulation of cancer cells that are resistant to standard cancer therapies. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumours. The initial clinical focus with NVG-111 is in previously treated CLL and MCL patients to establish the drug’s safety and efficacy profile, followed by clinical expansion to target other ROR1-expressing cancers. The Company’s proprietary ROR1 and CD3-targeting bispecific molecule has been engineered for optimal tumour targeting and T-cell activation, respectively, for the efficient killing of cancer cells without excessive release of cytokines.

Achilles Therapeutics Announces Closing of $175.5 million Initial Public Offering

On April 7, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported the closing of its previously announced initial public offering in the United States of 9,750,000 American Depositary Shares ("ADSs") representing 9,750,000 ordinary shares, at an initial public offering price of $18.00 per ADS (Press release, UCLB, APR 7, 2021, View Source [SID1234577692]). The gross proceeds to Achilles from the offering were approximately $175.5 million. All ADSs sold in the offering were offered by Achilles.

J.P. Morgan, BofA Securities and Piper Sandler acted as joint book-running managers for the offering. Chardan, Oppenheimer & Co, and Kempen & Co acted as co-managers.

A registration statement relating to these securities became effective on March 30, 2021. The securities referred to in this announcement were offered only by means of a prospectus. Copies of the preliminary prospectus relating to and describing the terms of the proposed IPO can be obtained from the following sources:

J.P. Morgan Securities LLC, Attention Equity Syndicate Desk, 383 Madison Avenue, New York, New York 10179, or via email: [email protected];
BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, or via email: [email protected]; or
Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or via email: [email protected].

Seagen to Host Conference Call and Webcast Discussion of First Quarter 2021 Financial Results on April 29, 2021

On April 7, 2021 Seagen Inc. (Nasdaq: SGEN) reported that it will report its first quarter 2021 financial results on Thursday, April 29, 2021 after the close of U.S. financial markets (Press release, Seagen, APR 7, 2021, View Source [SID1234577691]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a business update. Access to the event can be obtained as follows:

Thursday, April 29, 2021
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international); conference ID 10153242
Webcast with slides available at www.seagen.com in the Investors section. A webcast replay will be archived on the Company’s website.

Regulus Therapeutics to Present at the 20th Annual Needham Virtual Healthcare Conference

On April 7, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the 20th Annual Needham Healtchare Conference on Thursday, April 15th at 1:30 P.M. ET (Press release, Regulus, APR 7, 2021, View Source [SID1234577690]).

A live webcast of the presentation will be available on the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 30 days following the presentation date.

Quest Diagnostics To Release First Quarter 2021 Financial Results On April 22

On April 7, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2021 financial results on Thursday, April 22, 2021, before the market opens (Press release, Quest Diagnostics, APR 7, 2021, View Source [SID1234577689]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0490 for domestic callers or 203-369-3053 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 22, 2021 until midnight Eastern Time on May 6, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.