Elevation Oncology Announces the Promotion of Valerie Malyvanh Jansen, M.D., Ph.D., to Chief Medical Officer

On October 20, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported the appointment of Valerie M. Jansen, M.D., Ph.D., as Chief Medical Officer (Press release, Elevation Oncology, OCT 20, 2021, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-the-promotion-of-valerie-malyvanh-jansen-m-d-ph-d-to-chief-medical-officer [SID1234591584]). Dr. Jansen was promoted from her prior role as Vice President, Clinical Development.

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"Dr. Jansen has made significant contributions to Elevation Oncology’s vision since her arrival at the Company earlier this year and we are thrilled to have her take on this role within the Elevation Oncology executive team," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Valerie has an extensive background in oncology and a deep understanding of precision medicine, and under her leadership, Elevation Oncology is well positioned for success. I am confident in her continued oversight of our current clinical program targeting NRG1 fusions with seribantumab, reporting on the first clinical data from the Phase 2 CRESTONE study in mid 2022, and contributing to the development of new therapies that can make the genomic map of each patient’s tumor actionable."

Dr. Jansen commented: "Seribantumab is the first proof point for Elevation Oncology’s approach for developing precision medicines, by identifying oncogenic drivers through genomic testing and developing therapeutics that are designed to intervene and improve patient outcomes. Through the adaptable and responsive clinical trial model that has been developed with our diagnostic partners for CRESTONE, we can meet the patients where they are in their journey and provide a potential treatment option. I look forward to continuing the successes that Elevation Oncology has achieved thus far, and building a pipeline of therapeutic candidates in support of our ultimate goal to develop therapeutics by targeting the underlying causes of oncogenesis."

Prior to joining Elevation Oncology, Dr. Jansen served as Executive Medical Director at Mersana Therapeutics, a clinical-stage biopharmaceutical company with a focus in oncology, where she led clinical development of antibody-drug conjugate therapies for patients living with cancer. Previously, she was a senior medical advisor at Eli Lilly and Company, where she led global translational science for abemaciclib and served as lead Clinical Research Physician on early and late phase clinical trials.

Prior to joining the pharmaceutical industry, Dr. Jansen started her career in academia as a faculty member at Vanderbilt University, with a translational research program focused on understanding mechanisms of resistance to cancer targeted therapies. She received her M.D. from the University of Chicago Pritzker School of Medicine and her Ph.D. in Molecular Sciences from the University of Tennessee Health Science Center. She completed residency in Internal Medicine and fellowship in Medical Oncology through the ABIM Physician-Scientist Research Pathway at Vanderbilt. Dr. Jansen is board certified in Internal Medicine and Medical Oncology.

Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock

On October 20, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Crinetics Pharmaceuticals, OCT 20, 2021, View Source [SID1234591583]). In addition, Crinetics intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Crinetics. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine, CRN04894, CRN04777 and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink, Evercore ISI and Cantor Fitzgerald are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]; from: Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by telephone at 212-829-7122 or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Clovis Oncology to Announce Third Quarter 2021 Financial Results and Host Webcast Conference Call on November 3

On October 20, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its third quarter 2021 financial results on Wednesday, November 3, 2021, before the open of the US financial markets (Press release, Clovis Oncology, OCT 20, 2021, View Source [SID1234591582]). Clovis’ senior management will host a conference call and live audio webcast at 8:30am ET to discuss the Company’s results in greater detail.

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants 888.440.4615, International participants 646.960.0682, conference ID: 2259685.

BioCryst to Report Third Quarter 2021 Financial Results on November 3

On October 20, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its third quarter 2021 financial results on Wednesday, November 3, 2021 (Press release, BioCryst Pharmaceuticals, OCT 20, 2021, View Source [SID1234591580]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2592545. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2592545.

BeyondSpring Pharmaceuticals Announces New Patient-Derived Cancer Model Data for Plinabulin Monotherapy at the AACR-NCI-EORTC Virtual International Conference to Further Support the Positive Clinical Data Already Reported for the Treatment of Small Cell Lung Cancer

On October 20, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported the presentation of preclinical data in patient-derived cancer models supporting the use of plinabulin in small cell lung cancer (SCLC) at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 7-10, 2021 (Press release, BeyondSpring Pharmaceuticals, OCT 20, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-new-patient-derived-cancer-model-data-for-plinabulin-monotherpy-at-the-aacr-nci-eortc-virtual-international-conference-to-further-support-the-positive-clinical-d [SID1234591579]). Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which induces dendritic cell maturation for durable anti-cancer benefit, and selectively induces certain types of cancer cell apoptosis, both through immune defense protein GEF-H1 release and activation. This study demonstrates plinabulin’s direct single agent anti-cancer tumor effects in patient-derived models of SCLC and additional cancer types, including glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma and triple-negative breast cancer.

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"The positive patient-derived (PDX) preclinical data increases our confidence in pursuing SCLC as an indication for plinabulin, which has shown high response rate data in human studies. This is supplemental to the maturation of dendritic cells in the cancer immune system and the induction of downstream mechanisms in specific cancer cell types," said Dr. Kenneth Lloyd, chief scientific officer of BeyondSpring. "The fact that plinabulin has already been associated with tumor responses in SCLC patients in a Phase 1 study presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting is a good indication that these patient-derived models are predictive. The preclinical data presented here supports our intended strategy for developing an option for cancer patients by combining plinabulin and checkpoint inhibitors in SCLC."

The study was intended to screen cancer cells for susceptibility to plinabulin. For this purpose, PDX models of cancer established from patient tumor biopsies were used in a manner that results in minimal chance for changes in cancer cell genetics, and hence, these models are considered more predictive of clinical response than common cancer models. Eighty PDX three-dimensional culture models were tested. Data showed that the cancer types most sensitive to plinabulin were:

SCLC (mean absolute IC70 = 35 nM; n = 7)
Bladder cancer (mean absolute IC70 = 38 nM; n = 9)
Soft tissue sarcoma (mean absolute IC70 = 57 nM; n = 10)
Dr. Lan Huang, BeyondSpring’s co-founder, CEO and chairwoman concluded, "We have been developing plinabulin in multiple cancer indications, based on the effects of plinabulin on dendritic cells and macrophages. Plinabulin’s anti-cancer effect is supported by the positive Phase 3 DUBLIN-3 non-small cell lung cancer study with evidence of the extension of overall survival. Plinabulin has also shown efficacy in preventing chemotherapy-induced neutropenia, which has received Breakthrough Designation and Priority Review from the U.S. FDA. Plinabulin’s single agent anti-cancer activity in PDX SCLC models and the relevant positive immuno-oncology combo preliminary clinical data in SCLC could potentially expand plinabulin’s cancer indications. We look forward to continuing to expand these anti-cancer indications in the clinic and to validate plinabulin as a ‘pipeline in a drug.’"

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). It is being developed as a "pipeline in a drug" in multiple cancer indications.