On February 8, 2022– Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, reported that it will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, at 2:20 p.m. Eastern Time (Press release, Veracyte, FEB 8, 2022, View Source [SID1234607842]).

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A live audio webcast of the company’s presentation will be available on Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On February 8, 2022 Qurient Co. Ltd. (KRX: 115180), a clinical stage biotech company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for Q901, a small molecule oncology drug candidate targeting cyclin dependent kinase 7 (CDK7) (Press release, Qurient Therapeutics, FEB 8, 2022, View Source [SID1234607858]).

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The company plans to enroll up to 70 patients with advanced solid tumors in a Phase 1/2 clinical study taking place in the United States. The goal of the study will be to determine the maximum tolerated dose, dose-limiting toxicities, and the recommended Phase 2 dose of Q901.

"IND clearance for Q901 is an important step forward in developing this novel drug candidate that may provide a new alternative treatment to patients with relapsed or refractory malignancies," says Kiyean Nam, Ph.D., CEO of Qurient. "We look forward to initiating the clinical study for Q901 and presenting additional nonclinical efficacy data of Q901 in various cancer models at an upcoming scientific meeting."

Q901 is a highly selective CDK7 inhibitor that has been shown in in vitro studies to only inhibit CDK7 in the human kinome. CDK7 is a master regulator of cell cycle checkpoints and an essential component of transcription machinery. Additional data from preclinical studies has demonstrated that selective inhibition of CDK7 specifically kills cancer cells with aberrant cell division cycle or transcriptional regulation. Nonclinical pharmacology studies of Q901 have demonstrated that the selective inhibition of CDK7 exerts tumor growth inhibition in a number of murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers.

Qurient licensed the CDK7 inhibitor program at lead stage from Lead Discovery Center (LDC) and the Max-Planck Society and further optimized the program, completed the IND-enabling studies, and submitted the IND application.

"We are thrilled about the second CDK-selective inhibitor from the LDC pipeline to reach cancer patients. The nomination of Q901 for clinical development emphasizes the translational competence of LDC and represents an extremely important milestone," adds Bert Klebl, CEO and CSO of the LDC. "Starting out with an early-stage and BMBF grant funded academic collaboration with two academic partners, and strongly supported by additional financing from the Max-Planck Foundation, LDC has launched this journey to identify and generate mono-specific CDK7 inhibitors. After an initial animal proof-of-concept, the CDK7 assets were licensed to our strategic collaboration partner, Qurient. We respectfully appreciate our ongoing partnership with Qurient, who are now moving the second joint program, after Q702, forward to clinical trials. While licensing these projects and jointly starting the spin-off, QLi5, we have since built a sustainable and strong partnership with Qurient, with more to come, focusing on the translation of innovative biology and drug discovery programs from LDC’s academic network."

"Qurient has proven to be the ideal partner for this project, and we are more than happy about the results of this strategic partnership," says Jörn Erselius, Managing Director at Max-Planck Innovation GmbH.

The CDK7 inhibitor project and other projects have been supported in part by private sponsors and charities, especially Max-Planck-Foundation, which supports many Max Planck research projects and researchers, including the most recent Nobel Laureates at Max Planck.

On February 8, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the closing of its initial public offering of 9,487,500 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,237,500 additional shares of its common stock, at a public offering price of $15.00 per share (Press release, Arcellx, FEB 8, 2022, View Source [SID1234607896]). The aggregate gross proceeds from the offering were $142.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx. All of the shares of common stock were offered by Arcellx. Arcellx’s common stock began trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol "ACLX."

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BofA Securities, SVB Leerink, Barclays and William Blair acted as joint book-running managers for the offering.

A registration statement relating to the offering has been filed with the Securities and Exchange Commission and became effective on February 3, 2022. The offering was made only by means of a prospectus, copies of which may be obtained from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected] or by telephone at (888) 603-5847; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687, or by email at [email protected]. Copies of the final prospectus related to the offering are available at www.sec.gov.

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 sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 8, 2022 Catalyst Clinical Research, a leading provider of clinical research services, and Ledger Run, a leading innovator in clinical operations technology, reported that it will partner to create streamlined clinical trial business processes to enhance and accelerate global studies (Press release, Catalyst Clinical Research, FEB 8, 2022, View Source [SID1234607815]).

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Ledger Run will expand its partnership with Catalyst Oncology, Catalyst Clinical Research’s full-service, niche oncology CRO solution. Catalyst Oncology has implemented a proprietary Ledger Run platform known as ClinRunTM to improve site budget and payment capabilities. The expanded partnership will allow Catalyst to take advantage of the fully integrated capabilities of ClinRun by adding contracting and forecasting solutions.

"Ledger Run is a great strategic partner for Catalyst because the company provides a unique combination of innovative technology solutions and professional services," said Nick Dyer, CEO at Catalyst. "Their ClinRun integrated platform and first-class support have helped us overcome the operational challenges of complex oncology studies and deliver real value to our customers and investigative sites."

Focusing on next-generation cancer therapies, Catalyst Oncology provides skilled management of immuno-oncology and targeted therapies as well as expert oversight of complex studies to deliver customized clinical research solutions exclusively for the biotech market. Ledger Run’s ClinRun platform helps with budgeting, contracting, making payments, and forecasting. The software suite also automates manual tasks, reduces errors, and speeds cycle times while promoting engagement with investigator sites.

"Catalyst is doing remarkable work in oncology," said Gary Lubin, Chief Executive Officer at Ledger Run. "They are managing very complicated trials, often with challenging protocol designs.

"We are thrilled that Catalyst has selected us to help manage their critical clinical business operations and embraced our responsibility as a trusted business partner," Lubin added. "We are confident that our smart technologies and services will create value for their customers."

On February 8, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report fourth quarter and full-year 2021 financial results and provide a corporate update on February 15, 2022 (Press release, Corcept Therapeutics, FEB 8, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-fourth-quarter-and-full-year-2021 [SID1234607843]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

Click to Join Meeting

Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1861918.

A replay will be available through February 22, 2022, at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 1861918. You may also access a replay on the Investors / Past Events tab of www.corcept.com