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KIYATEC Assay Hits the Mark in Study to Predict Patient Response to First Line Ovarian Cancer Drugs

On August 1, 2019 KIYATEC, Inc. reported that results from its prospective, multi-center pilot study, to investigate their assay’s predictive accuracy and correlation to outcome among newly diagnosed ovarian cancer patients, have been published in Scientific Reports. Study findings represent both a preliminary clinical validation for the company’s ovarian cancer assay and a significant developmental milestone for the assay’s technology platform, known as Ex Vivo 3D Cell Culture (EV3D) (Press release, KIYATEC, AUG 1, 2019, View Source [SID1234538040]).

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"For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes," said Matthew Gevaert, CEO of KIYATEC. "Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care."

In the study, primary tissue from 92 newly diagnosed ovarian cancer patients were prospectively collected and tested for response to National Comprehensive Cancer Network (NCCN)-recommended frontline chemotherapy drugs at KIYATEC’s central laboratory. Assay results were successfully generated for 83 (90%) patient samples. All 92 patients received standard of care chemotherapy (80% adjuvant, 20% neoadjuvant) independent of the KIYATEC drug response prediction test result.

A total of 44 patients (of the 83 patients tested) met minimum follow-up time of 6 months post-chemotherapy for inclusion in this publication. The KIYATEC assay successfully predicted responders (i.e. platinum sensitive) and non-responders (i.e. platinum resistant) with an accuracy of 89% (39/44, p<0.0001).

Investigators also assessed assay accuracy and correlation to outcome among the 35 of 44 (80%) patients who received adjuvant chemotherapy. In this cohort, the KIYATEC assay correctly predicted responders and non-responders with 89% accuracy (31/35, p=0.0004). From date of surgical debulk, progression free survival (PFS) among test subjects predicted to respond to the first line chemotherapy they received was over 20 months v. 9 months for patients predicted not to respond (p=0.01).

"At present, clinicians have no way of knowing, prior to treatment, which of our newly diagnosed or relapsed ovarian cancer patients will respond or not to approved drug therapies," said Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC), and an author of the study. "To predict a complex future result with very high accuracy is a meaningful achievement, especially given that sometimes these outcomes take months to define. Similar test performance in larger, follow-on studies would establish this as a go-to tool in cancer drug selection that should help improve patient outcomes in ovarian cancer."

Based on these promising findings, KIYATEC has opened a prospective, pivotal clinical study, 3D-PREDICT (NCT03561207), in 500 patients to further validate EV3D-enabled clinical assays for newly diagnosed and recurrent ovarian cancer (8-drug panel) and glioblastoma (12-drug panel). The study is currently open to enrollment.

Novavax to Host Conference Call to Discuss Second Quarter Financial Results on August 7, 2019

On August 1, 2019 Novavax, Inc. (NASDAQ: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported it will report its second quarter 2019 financial and operating results following the close of U.S. financial markets on Wednesday, August 7, 2019 (Press release, Novavax, AUG 1, 2019, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-second-quarter-financial-2 [SID1234538039]).

Conference call details are as follows:

Date: August 7, 2019
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 3193866
Webcast: www.novavax.com, "Investors"/ "Events"
Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, August 7, 2019 until
7:30 p.m. ET May 9, 2019
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 3193866
Webcast: www.novavax.com, "Investors"/ "Events", until November 7, 2019

Adamis Pharmaceuticals Announces Pricing of Public Offering of Common Stock and Warrants

On August 1, 2019 Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including respiratory disease, allergy and opioid overdose, reported the pricing of its previously announced underwritten public offering of 12,000,000 shares of its common stock and warrants to purchase up to 12,000,000 shares of its common stock (Press release, Adamis Pharmaceuticals, AUG 1, 2019, View Source [SID1234538038]). Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined public offering price of $1.00, resulting in gross proceeds of approximately $12,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company and excluding the proceeds from the exercise of any warrants. All shares of common stock and warrants to purchase common stock to be sold in the public offering are being sold by Adamis. The warrants will be exercisable commencing on the date of issuance, will expire five years from the date of issuance, and have an exercise price of $1.15 per share, subject to certain adjustments. The shares of common stock and warrants will be purchased together but will be issued separately and will be immediately separable upon issuance.

The offering is expected to close on August 5, 2019, subject to the satisfaction of customary closing conditions. The company has also granted the underwriters a 30-day option to purchase up to 1,800,000 additional shares of its common stock and/or warrants to purchase up to 1,800,000 additional shares of its common stock.

Raymond James & Associates, Inc. is acting as the sole book-running manager for the offering. Maxim Group LLC is acting as lead manager for the offering.

The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the repayment, refinancing, redemption or repurchase of existing or future indebtedness or capital stock and working capital.

The securities described above are being offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at [email protected].

Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.

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

OPKO Health to Report Second Quarter 2019 Financial Results on August 7, 2019

On August 1, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three months ended June 30, 2019, as well as provide guidance on expected revenues and operating expenses for the third quarter 2019, after the close of the U.S. financial markets on Wednesday, August 7, 2019 (Press release, Opko Health, AUG 1, 2019, View Source [SID1234538037]).

OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, August 7, 2019.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, August 7, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 7984069
WEBCAST: OPKO 2Q19 Results Conference Call
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 7984069. The replay can be accessed for a period of time on OPKO’s website at OPKO 2Q19 Results Conference Call.

About OPKO Health, Inc.
OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation’s third largest clinical laboratory

I-Mab Biopharma And TRACON Pharmaceuticals Announce Dosing Of The First Patient In The U.S. Phase 1 Clinical Trial Of The CD73 Antibody TJD5 In Patients With Advanced Solid Tumors

On August 1, 2019 I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focusing on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, and TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, jointly reported that TRACON has dosed the first patient in a U.S. Phase 1 first-in-human clinical trial of I-Mab’s proprietary CD73 antibody TJD5, also known as TJ004309, in patients with advanced solid tumors (NCT identifier number: NCT03835949) (Press release, Tracon Pharmaceuticals, AUG 1, 2019, View Source [SID1234538036]). TJD5 will be dosed in the Phase 1 trial both as a single agent and in combination with TECENTRIQ (atezolizumab), a PD-L1 antibody marketed by Roche. I-Mab entered into a research collaboration with Roche in April 2019 where Roche agreed to supply TECENTRIQ to I-Mab for use in clinical study in combination with TJD5.

The multicenter, open-label, dose escalation Phase 1 study will evaluate safety and tolerability of TJD5, and determine a recommended dose for further clinical studies of its efficacy and safety as a single agent and in combination with standard dose TECENTRIQ in patients with advanced or metastatic cancer who are refractory to or intolerant of all available therapy.

TJD5, a novel, differentiated humanized antibody against CD73, is from I-Mab’s proprietary discovery pipeline being co-developed through a corporate collaboration between TRACON and I-Mab signed in November 2018. The two companies have a second broader strategic partnership to develop up to five bispecific antibodies from I-Mab’s immuno-oncology portfolio.

"TJD5 builds on earlier successes of I-Mab’s proprietary innovative pipeline and is the third internally discovered drug candidate to enter clinical studies in the U.S. This clinical milestone is the result of our well-executed ‘Fast-to-PoC (proof of concept) Global Approach’ to advancing our proprietary innovative drug candidates towards clinical validation in the United States, and a testament to the productive strategic partnership with TRACON," said Joan Shen, M.D., Ph.D., Head of R&D of I-Mab. "Treatment resistance to PD-1/PD-L1 is one of the major challenges across cancer types. We hope the combination of TJD5 and TECENTRIQ will provide a novel treatment option to address the unmet medical needs."

"Submitting the IND and dosing the initial cancer patient with TJD5 following the signing of our first partnership agreement with I-Mab is an important milestone, as we have both expanded our pipeline in immuno-oncology and further demonstrated TRACON’s product development capabilities designed to reduce the cost and time of clinical development for our partners," commented Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We will continue to work with I-Mab to optimize the clinical development of TJD5, an antibody with global best-in-class potential."

About TJD5 (TJ004309)

TJD5 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJD5 is in a Phase 1 clinical trial in the US to assess the tolerability and preliminary efficacy as a single agent and in combination with TECENTRIQ, a PD-L1 antibody marketed by Roche, in patients with advanced solid tumors. The antibody is also expected to be studied in clinical trials in China sponsored by I-Mab.