Bicycle Therapeutics to Present at the Canaccord Genuity 39th Annual Growth Conference

On August 1, 2019 Bicycle Therapeutics plc, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will present at the Canaccord Genuity 39th Annual Growth Conference on Wednesday, August 7, 2019 at 1:30 p.m. EDT in Boston, MA (Press release, Bicycle Therapeutics, AUG 1, 2019, View Source [SID1234538042]).

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A live webcast of the presentation can be accessed in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.

Modra Pharmaceuticals Announces First Patients Treated in Phase IIb Metastatic Prostate Cancer Trial

On August 1, 2019 Modra Pharmaceuticals B.V. ("Modra") reported the start of patient treatment in its Phase IIb clinical study evaluating the efficacy and tolerability of its lead candidate, ModraDoc006/r, in metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Modra Pharmaceuticals, AUG 1, 2019, View Source [SID1234538041]). ModraDoc006/r is a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In evaluation to-date, ModraDoc006/r has shown potential to reduce important toxicities, such as neutropenia and neuropathy, with the possibility of enhancing the efficacy of treatment, in addition to providing the benefits of oral ‘at-home’ administration. The trial will be conducted at approximately 40 clinical centers in the United States and Europe, with initial data readout expected during the first half of 2021. The compound is also being tested in a Phase II clinical study in breast cancer, which began earlier this year.

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"Prostate cancer is one of the most commonly diagnosed malignancies in men in the Western world, with docetaxel typically administered as the first line of chemotherapy treatment in the metastatic setting. Improving outcomes for these patients by reducing key toxicities and enhancing efficacy associated with the use of chemotherapy would meet a significant need. Our objective is therefore to demonstrate clinical benefit over current standard of care while also making a positive impact on patients’ lives," commented Colin Freund, CEO of Modra.

"Based on our existing pre-clinical and clinical data, we believe ModraDoc006/r has the potential to favorably impact treatment outcomes and raise the quality of life for prostate cancer patients," explained Dr. Edwin de Wit, Chief Development Officer of Modra. "This comparative Phase IIb trial will enable us to evaluate the benefits of oral ModraDoc006/r versus standard of care intravenous docetaxel."

The Phase IIb study, randomized 1:1 Modra006/r versus intravenous docetaxel, will evaluate 100 mCRPC patients eligible for first line systemic chemotherapy. The primary endpoint is objective response rate as assessed by response evaluation criteria in solid tumors (RECIST 1.1). The secondary endpoints include efficacy, safety and health-related quality of life assessments.

"Intravenously administered chemotherapy is widely used, but nevertheless always involves a significant time investment for patients in regard to travel to and from the clinic and receiving the treatment itself, as well as the considerable burden of dealing with its side effects. To that end, ModraDoc006/r has the potential to become an exciting new oral option for prostate cancer which retains or improves on the therapeutic characteristics of docetaxel and easily incorporates chemotherapy within the lives of cancer patients," added Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Oncology at Karmanos Cancer Institute, Detroit.

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane chemotherapy based on docetaxel, an intravenously administered therapy that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard IV docetaxel.

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]).

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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.

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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.