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Spectrum Pharmaceuticals Announces Positive Topline Results in HER2 Exon20 Insertion Mutations from Cohort 2 of the Poziotinib ZENITH20 Trial

On July 27, 2020 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it met the pre-specified primary endpoint in the ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2) (Press release, Spectrum Pharmaceuticals, JUL 27, 2020, View Source [SID1234562400]).

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"The positive results of Cohort 2 are a significant milestone and we are looking forward to meeting with the FDA," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe that poziotinib is a significant advancement for patients with this deadly disease in an area of high unmet medical need."

Cohort 2 of the ZENITH20 clinical trial enrolled a total of 90 patients who received an oral, once daily dose of 16 mg of poziotinib. All the patients had failed at least one line of prior systemic therapy with 60 patients (67%) having failed two or more prior therapies, including chemotherapy and immunotherapy. All responses were read independently and confirmed by a central imaging laboratory using RECIST criteria. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI) 18.9%-38.2%). Based on the pre-specified statistical hypothesis for the primary endpoint, the observed lower bound of 18.9% exceeded the pre-specified lower bound of 17% in this heavily pre-treated population.

The median duration of response was 5.1 months (range 1 to >12.3), with a median follow up of 8.3 months. The disease control rate (DCR) was 70% and the median progression free survival was 5.5 months. The safety profile was in-line with the type of adverse events (AEs) seen with other second-generation EGFR tyrosine kinase inhibitors and similar to Cohort 1. Grade 3 treatment related rash was 30% and diarrhea was 26%. In Cohort 2, no pneumonitis was reported (0/90).

"We are pleased with the results of Cohort 2," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "There are currently no approved therapies for HER2 patients with exon 20 insertion mutations in NSCLC and we are looking forward to reviewing this data with the FDA to determine the path forward."

Cohort 2 was designed to be a registrational study. The company is in the process of requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission. The company plans to present additional study results for Cohort 2 at an upcoming medical meeting.

The ZENITH20 trial is comprised of 7 independent cohorts. Cohorts 1 – 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 – 7 are exploratory. In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. Based on the results of Cohort 1, the company has amended the protocol for ZENITH20 to explore additional twice daily dosing regimens as well as lower single daily dosage amounts. This amendment did not impact Cohorts 2 and 3 as these cohorts were fully enrolled. Results from Cohort 3 are expected in the second half of the year.

Conference Call and Webcast

The company’s management will host a webcast and conference call today, July 27, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the clinical trial results. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 2516797. A live webcast of the call will be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

Avidity Biosciences Appoints Jae Kim, M.D. as Chief Medical Officer

On July 27, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported the appointment of Jae Kim, M.D. as Chief Medical Officer (Press release, Avidity Biosciences, JUL 27, 2020, View Source [SID1234562399]). In his new role, Dr. Kim will be responsible for leading and expanding Avidity’s AOC pipeline and will serve as a key member of its executive management team.

"We are very pleased that Jae is joining Avidity as we continue to build a leading RNA-targeted therapeutics company," said Sarah Boyce, President and CEO of Avidity. "His extensive experience developing monoclonal antibodies and oligonucleotides for a range of serious diseases, including orphan indications, will be invaluable as we progress our AOCs for muscle diseases and other tissue types toward the clinic."

Dr. Kim joins Avidity from Alnylam Pharmaceuticals, Inc., where he served as Clinical Research Head, Chair of the Clinical Trial Review Board, and Vice President of Clinical Development. He oversaw the development of multiple clinical assets across several therapeutic areas and played a key role in the development and approval of Givlaari (givosiran) for acute hepatic porphyria. Prior to Alnylam, he served in roles of increasing responsibility in global development at MyoKardia, Inc. and Amgen. Dr. Kim received his Bachelor of Arts in Neurobiology Magna Cum Laude from Cornell University and his M.D. from Cornell University Medical College. He completed his post-doctoral fellowship in Genetics at Harvard Medical School and his clinical training in cardiovascular disease at the Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Kim is a board-certified cardiologist, was an NIH-funded Principal Investigator, and served on the Faculty of Medicine at Harvard Medical School and the Brigham and Women’s Hospital before joining industry.

"The advent of conjugation methods to expand the therapeutic application of oligonucleotides is an important step forward in the field of RNA-targeted therapeutics," said Dr. Kim. "Avidity’s AOC therapeutics could have broad utility by accessing previously undruggable tissue and cell types, which give us the potential to transform the lives of patients living with serious diseases, who currently have no available treatment options. Avidity has made great progress on its technology and I look forward to joining the team to advance a meaningful portfolio of AOCs through clinical development."

Aurinia Closes US$200 Million Public Offering of Common Shares

On July 27, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the closing of its previously announced underwritten public offering of 13,333,334 common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 27, 2020, View Source [SID1234562398]). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses.

Jefferies and SVB Leerink acted as joint book-running managers for the Offering. Cantor acted as lead manager and Oppenheimer & Co. and H.C. Wainwright & Co. acted as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 2,000,000 additional common shares, for a period of up to 30 days.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the 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.

Oasmia’s partner Elevar Therapeutics and Tanner Pharma Announce Global Named Patient Program to Provide Access to Apealea®

On July 27, 2020 Oasmia Pharmaceutical AB notes that its partner Elevar Therapeutics, Inc. ("Elevar"), a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, and Tanner Pharma Group ("Tanner"), a global provider of integrated specialty access solutions, reported a partnership for a named patient program that will facilitate access to Apealea in areas outside of the United States (U.S.) where Apealea is not commercially available (Press release, Oasmia, JUL 27, 2020, View Source [SID1234562397]). Apealea has been approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

A named patient program, also known as an early or expanded access program, is a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients prior to their commercial availability. Under the terms of the agreement, Tanner will be the exclusive supplier of Apealea to health care providers outside of the U.S. on a named patient basis.

"We are excited to partner with Tanner to ensure patients outside of the U.S. who have no therapeutic alternatives are able to access to Apealea through a named patient program," said Alex Kim, Chief Executive Officer of Elevar Therapeutics
"We are pleased to give hope to patients around the world through our partnership with Elevar for Apealea," said Banks Bourne, Chairman and Founder of Tanner Pharma Group. "The named patient program will help ensure that patients who have no alternative therapeutic options for their disease receive access to Apealea in manner that is reliable, responsible, ethical and in accordance with all local regulatory requirements."

"We are delighted to see that patients and doctors in European countries outside the Nordic region, where Oasmia has already launched Apealea, will now get early access," said Francois Martelet, Chief Executive Officer of Oasmia. "Elevar partnering with Tanner Pharma for a named patient program is a valid means to achieve that access outside of the US. We continue to support Elevar in identification and selection of regional commercialization partners worldwide and will update our progress in due course."

OPKO Health to Report Second Quarter 2020 Financial Results on July 30, 2020

On July 27, 2020 OPKO Health, Inc. (NASDAQ: OPK) reported operating and financial results for the three months ended June 30, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, July 30, 2020 (Press release, Opko Health, JUL 27, 2020, View Source [SID1234562395]). OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on July 30 beginning at 4:45 p.m. Eastern time.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 6946539. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 2Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 2Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6946539.