On April 18, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the regulatory approval of Lymphoaim ("Lymphoseek" in the rest of the world; Tc99m tilmanocept) by the Central Drugs Standard Control Organisation, India (Press release, Navidea Biopharmaceuticals, APR 18, 2022, View Source [SID1234612402]).

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Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Sayre Therapeutics will lead Lymphoaim commercialization efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specializes in innovative treatment and medical device commercialization in South Asia.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted that Lymphoaim has received regulatory approval in India and will be available to patients in need." Dr. Rosol continued, "This will also bring a new revenue stream to the Company to help us advance other pipeline products."

Mr. Shukrit Sudhir Chimote, Chief Executive Officer for Sayre, said, "Lymphoaim, a radioactive diagnostic agent, would benefit surgeons in guiding sentinel lymph node biopsies. This product fits well with Sayre’s mission of providing novel treatment solutions, and will certainly help boost our presence in the surgical oncology segment."

On April 18, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the first patient has commenced treatment in its Phase 1 KN-4802 (NCT05242822) clinical trial evaluating its lead Fibroblast Growth Factor Receptor (FGFR) product candidate, KIN-3248 (Press release, Kinnate Biopharma, APR 18, 2022, View Source [SID1234612401]). KIN-3248 is a next-generation pan-FGFR inhibitor being developed for the treatment of intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC), as well as other solid tumors.

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"With the dosing of the first patient in our Phase 1 trial of KIN-3248, we are excited to further advance the development of this next-generation therapy which we believe is unique among FGFR inhibitors and has the potential to offer a new targeted therapy option for cancer patients with FGFR-altered tumors," said Richard Williams, MBBS, PhD, Chief Medical Officer of Kinnate. "We are grateful for the contribution of all the participants in this multi-center trial and for the support of our clinical collaborators at each trial site."

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor that has been developed to address both primary FGFR2 and FGFR3 oncogenic alterations and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as ICC and UC. In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other selected adult solid tumors.

"Successfully treating ICC and UC patients with FGFR2 and/or FGFR3 gene alteration-driven cancers remains a significant unmet need in cancer care. KIN-3248 brings a unique approach to potentially address the shortcomings of existing therapies in specific patient populations with primary FGFR2 and/or FGFR3 oncogenic alterations, including those patients with gatekeeper, molecular brake, and activation loop mutations," said Benjamin Garmezy, MD, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at Tennessee Oncology. "We are proud to be the first site to treat a patient with KIN-3248 and look forward to working with Kinnate to continue enrollment in this important Phase 1 trial."

On April 18, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its executive leaders will be providing an overview of the Company’s gene therapies for cancer and diabetes to investors and industry professionals at the following investor and industry conferences in April 2022 (Press release, Genprex, APR 18, 2022, View Source [SID1234612400]).

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Event: NobleCon 18

Conference Dates: April 19-21, 2022

Presentation Date: Wednesday, April 20

Presentation Time: 11:30 a.m. ET

Location: Hard Rock Guitar Hotel, Hollywood, FL – Seminole Ballroom B

Presenter: Ryan Confer, Chief Financial Officer

A high-definition, video webcast of the presentation will be available the following day on the Company’s website at www.genprex.com and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek www.channelchek.com the investor portal created by Noble. The webcast will be archived on the company’s website, the NobleCon website and on Channelchek.com for a period of time following the event.

Event: Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mediterranean (Virtual)

Conference Dates: April 20-22, 2022

Virtual Presentation Date: Available on-demand within the virtual platform for all delegates to view starting April 20, 2022

Presenter: Mark Berger, Chief Medical Officer

This meeting will feature in-person and pre-recorded virtual presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

On April 18, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, reported the appointment of Dr. Nily Osman as Chief Medical Officer effective April 18, 2022 (Press release, Ensysce Biosciences, APR 18, 2022, View Source [SID1234612399]). Dr. Osman will succeed Dr. William Schmidt as he transitions to Senior VP of Clinical Development and continues his role on the Company’s clinical advisory board.

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Dr. Osman, a highly versatile board-certified neurologist, migraine and pain specialist, has over ten years of experience in both R&D and medical affairs within the pharmaceutical, CRO and medical device industries. Dr. Osman was previously the Senior Medical Director at Scholar Rock where she led their program for spinal muscular atrophy and was a practicing neurologist and academic researcher at the University of Toronto. She recently returned from Poland where she spent several weeks leveraging her medical expertise providing care to Ukrainian refugees. Dr. Osman completed her residency at University of Ottawa in adult neurology and a fellowship in headache pain medicine at the University of Toronto. She received her M.D. degree from Jagellonian Medical College in Poland, and her B.S. from the University of Guelph, Canada.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "It is my pleasure to welcome Nily to the Ensysce team as we progress and expand our clinical trials in the development of our abuse and overdose-protected pain products. She brings significant expertise and a proven track record in pain and pain management. Her experience in neurology, as well as within the pharmaceutical industry, makes her an extremely valuable addition to Ensysce at such an important time in the Company’s history."

Dr. Lynn Kirkpatrick concluded, "I am also extremely grateful for Dr. Schmidt’s contributions to our clinical programs. He has been instrumental in our path towards commercialization, and I look forward to our continued working relationship in his role as Senior VP of Clinical Development."

Dr. Osman added, "I am delighted to have the opportunity to work with Lynn and join the very talented team at Ensysce and be part of the Company’s mission to launch the next generation opioid products. As the Company progresses on its clinical trials, I look forward to leveraging my direct industry experience as I believe this is truly an exciting time to join the Company with several key milestones approaching."

On April 18, 2022 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 has closed its previously announced underwritten follow-on offering of 5,625,563 shares of its common stock at a price to the public of $22.22 per share (Press release, Crinetics Pharmaceuticals, APR 18, 2022, View Source [SID1234612398]). The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $125.0 million. The offering included new investors, Braidwell and Suvretta Capital Management’s Averill strategy, as well as participation from existing stockholders.

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

SVB Leerink, Evercore ISI and Cantor acted as joint bookrunning managers for the offering. JMP Securities, a Citizens Company, and H.C. Wainwright & Co. acted as co-lead managers and JonesTrading acted as co-manager for the offering.

The securities described above were offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Securities 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., 4th Floor, New York, New York 10022 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus are also 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.