On December 18, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that the U.S. Food and Drug Administration (FDA) has approved ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer (Press release, Myovant Sciences, DEC 18, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-fda-approval-orgovyxtm-relugolix [SID1234573116]). ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.

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"I am enormously pleased by the approval of ORGOVYX and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy," said Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. "For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections, the current standard of care, as evaluated in the Phase 3 HERO study. The COVID-19 pandemic has heightened the importance of oral treatments as men with prostate cancer continue to experience difficulties and risks traveling to receive injections."

"Prostate cancer is a very personal journey, but a universal truth is that those of us living with this disease want better treatments and options. That is why the approval of ORGOVYX is such an exciting milestone that brings a long-awaited oral treatment option to men with advanced prostate cancer," said Thomas Farrington, president and founder of the Prostate Health Education Network. "It is so important for men to speak with their doctor and explore what treatment is right for them as they focus on their overall health."

"With the approval of ORGOVYX, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day," said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. "We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer, with the goal of establishing ORGOVYX as the new standard of care. We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of ORGOVYX through its Priority Review pathway."

In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). ORGOVYX lowered prostate-specific antigen (PSA), on average, by 65% at Day 15 and by 83% at Day 29. In a substudy, 55% of men treated with ORGOVYX achieved normal testosterone levels (> 280 ng/dL) or returned to baseline within 90 days of treatment discontinuation. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, with simultaneous publication in the New England Journal of Medicine.

Myovant is committed to ensuring that men in the U.S. who are prescribed ORGOVYX can obtain access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant is launching the ORGOVYX Patient Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two months of therapy, and patient assistance for qualifying uninsured patients. For more information, please contact 833-ORGOVYX (833-674-6899), 8 a.m.–8 p.m. Eastern Time, Monday–Friday.

Conference Call and Webcast
Myovant will hold a conference call on December 21, 2020 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA approval of ORGOVYX for men with advanced prostate cancer. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. A replay of the webcast will be archived on Myovant’s investor relations website.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 190,000 men are estimated to be newly diagnosed in 2020.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 300,000 men are treated with androgen deprivation therapy each year.

About ORGOVYX (relugolix)

ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication

ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information

Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.

On December 18, 2020 A second discovery out of Cancer Therapeutics CRC reported that it has entered into clinical trials (Press release, Cancer Therapeutics CRC, DEC 18, 2020, View Source;utm_medium=rss&utm_campaign=second-cancer-therapeutics-crc-discovery-enters-clinical-trials [SID1234573114]). If successful the discovery could be used to treat breast, prostate and lung cancers.

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The discovery centres around the KAT6A protein, which is commonly implicated in cancer types with solid tumours. Associate Professor Tim Thomas brought this protein to the attention of Cancer Therapeutics CRC researchers who then developed potential therapies that have subsequently been licensed to Pfizer through the CRC’s commercial partner, CTxONE.

"The KAT6A project was brought into Cancer Therapeutics as a novel target idea, and through collaboration between our experienced drug development researchers and the original investigators, we were able to develop potential therapies that were subsequently licensed to Pfizer. It is exciting to see this project enter clinical trials and take one step closer to becoming a treatment," said Brendon Monahan, Chief Scientific Officer at Cancer Therapeutics CRC.

This is the second of Cancer Therapeutics CRC’s discoveries to enter the clinic in 2 months. This highlights the value of collaborative research models such as Cancer Therapeutics CRC to the medical research ecosystem.

"The collaboration has resulted in such a successful team of high calibre researchers who have repeatedly shown they produce world class results. In addition to improving cancer treatment outcomes, this will potentially bring returns greater than $400 Million that can be used to grow Australia’s drug discovery capabilities creating jobs and opportunities" said Lisa Dube, CEO of Cancer Therapeutics CRC.

On December 18, 2020 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China (Press release, Antengene, DEC 18, 2020, View Source [SID1234573103]).

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The trial is a Phase 3 randomized, controlled, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to three prior lines of therapy. A total of 150 patients will be randomized in a 2:1 ratio to receive SVd or Vd treatment.

ATG-010 is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and the first and only drug approved by the Food and Drug Administration (FDA) for use in both relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. In December 2020, National Comprehensive Cancer Network (NCCN) added three different ATG-010 combination regimens to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for previously treated multiple myeloma, including SVd, SDd and SPd. In China, Antengene is conducting a Phase 2 registrational clinical trial of ATG-010 for rrMM (MARCH).

"The NMPA approval of BENCH trial demonstrates our ability to efficiently execute, and marks a great start of Antegene’s first Phase 3 registrational trial to validate SVd regimen’s efficacy and safety (as evidenced in the global BOSTON trial) in Chinese population." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "Since becoming a public company, our clear focus has been on advancing the clinical development of ATG-010. We will initiate immediately our Phase 3 trial of ATG-010 for rrMM patients in China and believe the unique and novel MoA of ATG-010 will provide physicians new treatment options for more oncology indications."

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO) is a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved ATG-010 in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved ATG-010 as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 is so far the first and only oral SINE compound approved by the FDA. ATG-010 is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm Therapeutics, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral ATG-010 versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed planned interim futility analysis and that Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two Phase 2 registrational clinical trials of ATG-010 in China for relapsed refractory multiple myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

On December 18, 2020 Abbott (NYSE: ABT) reported that it will present virtually at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 12, 2021 (Press release, Abbott, DEC 18, 2020, View Source [SID1234573102]). Robert B. Ford, president and chief executive officer, will present at 9 a.m. Central time.

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A live webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

On December 18, 2020 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a leader in science-based approaches to enhancing the quality and nutritional value of crops and food ingredients, reported that it has entered into definitive agreements with several institutional and other accredited investors for the purchase of 2,618,658 shares of its common stock, at a purchase price per share of $3.055, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Arcadia Biosciences, DEC 18, 2020, View Source [SID1234573100]). Additionally, Arcadia has also agreed to issue to the investors unregistered warrants to purchase up to 2,618,658 shares of common stock. The closing of the offering is expected to occur on or about December 22, 2020, subject to the satisfaction of customary closing conditions.

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The warrants to purchase up to 2,618,658 shares of common stock have an exercise price of $3.00 per share, will be immediately exercisable, and will expire five and one-half years from the issue date.

The gross proceeds to Arcadia, before deducting placement agent fees and other offering expenses, are expected to be approximately $8.0 million. The potential gross proceeds from the exercise of the warrants, if fully exercised on a cash basis, will be approximately $7.86 million. No assurance can be given that any of the warrants will be exercised. Arcadia intends to use the net proceeds from the offering to fund GoodWheat customer acquisition costs Including digital marketing programs, brand and retail channel development and general corporate costs.

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

The shares of common stock described above (but not the warrants or the shares of common stock issuable upon exercise of the warrants) are being offered pursuant to a "shelf" registration statement (File 333-224893) filed with the Securities and Exchange Commission (SEC) and declared effective on June 8, 2018. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone: (646) 975-6996.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or 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.