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Modra Pharmaceuticals Presents Preliminary Data from Phase IIb Trial of ModraDoc006/r in Metastatic Prostate Cancer at 2021 ASCO GU Annual Meeting

On February 12, 2021 Modra Pharmaceuticals ("Modra") reported preliminary data from its ongoing Phase IIb trial for lead candidate, ModraDoc006/r, a proprietary oral therapeutic based on the widely-used intravenous (IV) taxane chemotherapy, docetaxel, in metastatic Castration-Resistant Prostate Cancer (mCRPC) patients (Press release, Modra Pharmaceuticals, FEB 12, 2021, View Source [SID1234575041]). The randomized study is evaluating the tolerability and efficacy of ModraDoc006/r versus IV docetaxel in 100 mCRPC patients eligible for first line systemic chemotherapy. Initial encouraging safety, tolerability and efficacy data were presented on February 11 during a poster highlights session at the 2021 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), held virtually from February 11 – February 13, 2021.

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Separately, Modra announced that patient recruitment for the trial is now complete.

The study is an open label, randomized 1:1 trial of ModraDoc006/r administered twice daily, once per week, versus the standard of care IV docetaxel administered on a 21-day cycle. At the data cut-off of November 30, 2020, 98 patients were enrolled worldwide; 49 patients each have been randomized to IV docetaxel and to ModraDoc006/r, with 58 patients currently on treatment. Initial observations suggest a favorable safety and tolerability profile for ModraDoc006/r compared to IV docetaxel at its standard dose of 75mg/m2. ModraDoc006/r at a 20-20mg dose1 exhibited mild gastro-intestinal toxicities, with no signs of hematological toxicity or neuropathy, which represent the typically expected dose-limiting toxicities for IV docetaxel. Based on oral administration, ModraDoc006/r also eliminated traditional taxane induced infusion-related reactions and was administered without corticosteroid premedication. Over 50% of patients are still receiving treatment, but preliminary efficacy data of ModraDoc006/r are encouraging, including decreases in Prostate-Specific Antigen (PSA) levels; these data continue to evolve as follow-up continues. Now fully enrolled, the trial will proceed with investigating its primary endpoint, radiographic progression free survival (rPFS), as well as secondary endpoints including efficacy, safety and health-related quality of life assessments.

"The initial data suggest a remarkably favorable toxicity profile, without signs of cytopenia or neuropathy, in patients treated with ModraDoc006/r at the weekly dose of 20 mg twice in a day. The risk of infection and anemia are critical hurdles in the use of IV docetaxel in mCRPC and limit its usage despite its established position as standard of care in this patient population. This speaks to the importance of providing an alternative therapeutic such as ModraDoc006/r to address the unmet need still present in standard treatment of this disease and to improve outcomes in mCRPC," said Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Internal Medicine, Division of Hematology/ Oncology at the University of Michigan.

"Our trial continues to demonstrate the potential of ModraDoc006/r as a better tolerated, convenient oral therapeutic option for patients with metastatic CRPC. The tablet formulation has the potential to extend this treatment option to an increasing number of mCRPC patients, including otherwise underserved patient populations such as the elderly, those with significant comorbidities and those who cannot tolerate IV docetaxel. The critical need for an easily administered oral treatment that eliminates the need to go to a hospital or clinic for an infusion, thereby also reducing exposure time, has been made more apparent by the COVID-19 pandemic. We look forward to further investigating ModraDoc006/r and supporting its development for the benefit of mCRPC patients," commented Colin Freund, CEO of Modra.

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 not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce 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, as compared to standard IV docetaxel.

OncXerna Therapeutics to Participate at the Upcoming Investor Conferences

On February 12, 2021 OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-based biomarker platform to potentially predict patient responses to its first-in-class targeted oncology therapies, reported that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will participate at the upcoming virtual investor conferences (Press release, OncXerna Therapeutics, FEB 12, 2021, View Source [SID1234575039]):

Conference: LifeSci Partners Precision Oncology Day
Date: February 17, 2021

Conference: Cowen 41st Annual Health Care Conference
Date: March 1, 2021

Conference: Oppenheimer 31st Annual Healthcare Conference
Date: March 17, 2021

New Study from Leading University of Utah Radiation Oncologist Validates Ability of Myriad Genetics’ Prolaris® test to Guide Treatment for Prostate Cancer

On February 12, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported additional data further validating the prognostic power of its Prolaris test and its ability to help accurately predict which men with more aggressive prostate cancer will benefit from intensification of therapy and which patients may safely avoid such treatments (Press release, Myriad Genetics, FEB 12, 2021, View Source [SID1234575038]). This second validation study was presented during an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium (ASCO-GU) by Jonathan Tward M.D., Ph.D, associate professor in the Department of Radiation Oncology at the University of Utah.

According to estimates by the American Cancer Society, 248,530 new cases of prostate cancer are expected to be diagnosed this year in the U.S. While early screening tests have helped reduce the mortality rate, they can often result in overdiagnosis and overtreatment of a disease that is clinically insignificant. The Prolaris test can more accurately predict the aggressiveness of the cancer allowing for more precise treatment and avoidance of more intense therapies with a patient’s parallel morbidities.

"There are many viable treatment paths for men with prostate cancer," said Dr. Tward. "This new data helps distinguish the most appropriate personalized treatment path for each patient based on how their specific tumor is behaving. For some men, this means being able to avoid overtreating patients with therapies including hormone treatment that can momentously impact their quality of life, while still appropriately treating their prostate cancer."

The new data comes from a second study following previous data, recently published in Clinical Genitourinary Cancer in January 2021, that incorporated men treated surgically or with radiation therapy. This new study combined a Prolaris molecular risk score threshold with a clinical model for predicting a patient’s benefit from androgen deprivation therapy. Prolaris determined that about one of every two men with unfavorable intermediate-risk and one of every five men with high-risk prostate cancer are below the proposed threshold associated with aggressive disease and can therefore safely be treated with less intense therapy while maintaining the benefits of treatment. Additional key findings revealed that the Prolaris test was an accurate predictor of progression to metastatic disease.

"Myriad Genetics was the first company to offer a test that directly measures the molecular biology of an individual patient’s prostate cancer," said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics. "This study by Dr. Tward and his team is another strong validation of the prognostic power of the Prolaris test and our ongoing commitment to providing healthcare professionals with the tools needed to determine the most effective treatments and monitoring strategies for each patient."

In March 2020, the National Comprehensive Cancer Network updated its professional guidelines to include biomarker testing for unfavorable intermediate and high-risk patients with prostate cancer. With the updated guidelines, Prolaris was one of only two prognostic tests to be considered for those expanded indications. Approximately 60% of men with prostate cancer currently have insurance or Medicare access to Prolaris, and Myriad continues to work toward expanding access so that every man who is facing difficult treatment decisions will be able to utilize the full benefits of the test.

Sierra Oncology Announces Presentation at LifeSci Partners Precision Oncology Day

On February 12, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported that President and Chief Executive Officer Stephen Dilly, MBBS, PhD, will present an overview of the company at the LifeSci Partners Precision Oncology Day taking place Wednesday, February 17, 2021 (Press release, Sierra Oncology, FEB 12, 2021, View Source [SID1234575037]).

A replay of the presentation will be available following the conference on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

Phio Pharmaceuticals Announces $7.7 Million Registered Direct Offering of Common Stock Priced At-the-Market

On February 12, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale of 2,246,784 shares of the Company’s common stock, at a purchase price of $3.42 per share, in a registered direct offering priced at-the-market under Nasdaq rules for gross proceeds of approximately $7.7 million (Press release, Phio Pharmaceuticals, FEB 12, 2021, View Source [SID1234575036]). The closing of the offering is expected to occur on or about February 17, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Phio currently intends to use the net proceeds from the offering for general working capital needs, including the development of its immuno-oncology programs, other research and development activities and for general corporate purposes.

The shares of common stock are being offered by Phio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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 state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.