On February 3, 2020 Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, President: Atsuhiro Wakumoto, hereafter, "Nippon Kayaku") and Bayer Yakuhin, Ltd. (Headquarters: Osaka, President: Heike Prinz, hereafter, "Bayer Yakuhin") reported that it signed an agreement on the co-promotion in Japan with regard to Nubeqa (generic name: darolutamide), for which Bayer received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with non-metastatic castrationresistant prostate cancer (nmCRPC) (Press release, Nippon Kayaku, FEB 3, 2020, View Source [SID1234553749]).

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Based on this agreement, the medical representatives (MRs) of the two companies will collaborate to provide medical information on Nubeqa. The product will be marketed by Bayer and co-promoted with Nippon Kayaku.

Bayer will expand its prostate cancer portfolio with Nubeqa in addition to Xofigo Injection (generic name: radium-223 dichloride), which was launched in June 2016 as a treatment for CRPC with bone metastases. With the co-promotion agreement with Nippon Kayaku, a leading company in the area of prostate cancer, Bayer will provide appropriate information on Nubeqa to a broad range of healthcare professionals.

Nippon Kayaku has provided products for the treatment of urologic tumors and its respective information since the launch of BleoTM in 1969. Through this joint effort with Bayer Yakuhin to provide healthcare professionals with information on the proper use of Nubeqa, Nippon Kayaku would like to expand treatment options for patients and further contribute to the improvement of healthcare.

Bayer and Nippon Kayaku will promote proper use of Nubeqa and provide information on this product, aiming at further contributing to the treatment of patients with prostate cancer. Nippon Kayaku and Bayer sign agreement for the co-promotion of Nubeqa-2/4-

About Nubeqa
Nubeqa is an androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at View Source

Nubeqa, which is jointly developed by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, has been approved in the U.S., Brazil and Japan under the brand name Nubeqa. Filings in the European Union and other regions are underway or planned.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.1 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.1 Prostate cancer is the fifth leading cause of death from cancer in men.1 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.2 It mainly affects men over the age of 50, and the risk increases with age.3

Treatment options range from surgery to radiation treatment to therapy using hormonereceptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.4 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.5

CRPC is an advanced form of the disease where the cancer keeps progressing despite androgen deprivation therapy (ADT) treatment, even when the amount of testosterone is reduced to very low levels in the body.6,7 In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death.6-3/4-

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On February 2, 2020 Children’s Hospital Los Angeles (CHLA) reported that the Margie and Robert E. Petersen Foundation has contributed $25 million to establish an endowment supporting three of the hospital’s signature programs: the Cancer and Blood Disease Institute (CBDI), the Vision Center and Inpatient Rehabilitation Services (Press release, Children’s Hospital Los Angeles, FEB 2, 2020, View Source [SID1234553750]).

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"This endowment expands the Petersen’s legacy of generosity by providing CHLA with a resource that will forever advance our mission to create hope and build healthier futures for children," says President and CEO Paul S. Viviano. "I am so grateful for this gift that will support a wide range of initiatives including research projects, technology upgrades, clinical care, key physician recruitment, capital projects, unreimbursed care and more."

The Margie and Robert E. Petersen Foundation, led by President GiGi Carleton, supports children’s health and well-being throughout Southern California, fulfilling the Petersen’s desire to care for the community by helping all children reach their full potential. Margie Petersen was a former CHLA Trustee, and both she and her husband Robert Petersen, founder and chairman of Petersen Publishing Co., were longtime supporters of the hospital. The Foundation has supported several CHLA programs and projects over the years, including an $8.5 million gift to open a state-of-the-art inpatient rehabilitation space in 2015, named the Margie and Robert E. Petersen Foundation Rehabilitation Center and honoring their sons Bobby and Richie Petersen.

"Through their transformative philanthropy and leadership, the Petersens dedicated their lives to helping children overcome obstacles of all kinds," says Alexandra Carter, CHLA Senior Vice President and Chief Development Officer. "They would be proud to know that this gift will help save children from debilitating illnesses by helping one of the nation’s top children’s hospitals provide families and patients the multidisciplinary, family-centered care they need."

In recognition of this transformative gift, CHLA will be naming the main driveway at its 4650 Sunset Boulevard campus the Margie and Robert E. Petersen Entry Plaza, in honor of Mr. Petersen’s role as founding publisher of Hot Rod and Motor Trend magazines and founder of the Petersen Automotive Museum.

On February 1, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies with biomarker patient enrichment selection, reported that updated results from its Phase 1/1b clinical trial of CPI-818, the Company’s ITK-inhibitor, which were presented in an oral presentation at the 12th Annual T-Cell Lymphoma Forum in La Jolla, California, taking place January 30 to February 1, 2020 (Press release, Corvus Pharmaceuticals, FEB 1, 2020, View Source [SID1234553771]).

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"Our Phase 1/1b clinical trial of CPI-818, our selective covalent ITK inhibitor designed to address T-cell lymphomas, is enrolling well and continues to provide promising clinical data for patients with advanced, refractory forms of this cancer," said Mehrdad Mobasher, M.D., chief medical officer of Corvus. "To-date, the data demonstrates that the biology and pharmacology of ITK inhibition with CPI-818 has been as expected and the trial is proceeding according to plan. We are pleased to provide this update at the T-Cell Lymphoma Forum, a meeting dedicated to this difficult to treat family of cancers. We are now ready to advance the trial to higher drug doses where we will evaluate its activity in specific disease cohorts."

The CPI-818 Phase 1/1b study is currently enrolling patients with several types of advanced, refractory T-cell lymphomas, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), cutaneous T-cell lymphoma (CTCL) and other T-cell lymphomas. The study employs an adaptive, expansion cohort design to select the dose and evaluate the safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy of CPI-818. The initial phase of the trial is evaluating escalating doses in successive cohorts of patients in order to determine the optimum dose. A second phase will evaluate safety and tumor response to this optimum dose of CPI-818 in disease-specific patient cohorts that may be expanded based on early signs of efficacy. The study is enrolling patients at major medical centers in the United States, Australia and South Korea.

CPI-818 Phase 1/1b Clinical Trial Results at 12th Annual T-Cell Lymphoma Forum
The preclinical and early clinical data from the Phase 1/1b clinical trial of CPI-818 were presented by Dr. Mobasher in an oral presentation session at the T-Cell Lymphoma Forum. The data builds on preclinical and early clinical data from the first seven patients in the study presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 61st Annual Meeting, which took place in December 2019. The key updates from Dr. Mobasher’s presentation, which is titled "CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor. Pre-clinical Characterization and Interim Results of a Phase I/Ib Dose-Escalation Trial in Patients with Relapsed/Refractory T-Cell Lymphoma," included:

16 patients have been enrolled in the first four dose cohorts in the initial phase of the trial, receiving a 100 mg, 200 mg, 400 mg or 600 mg oral dose of CPI-818 two times per day, with no dose limiting toxicities and no grade 3 or 4 treatment related adverse events observed.
The median patient follow-up period is now three months, with 11 patients remaining on therapy. One patient with CTCL treated with the 200 mg dose of CPI-818 achieved a reduction in lymphadenopathy and improvement of PET scan imaging; another patient with CTCL receiving the 400 mg dose has exhibited improvement in cutaneous disease. These patients continue on therapy.
The results from the pharmacokinetic and occupancy studies for the first 12 patients have been in-line with expectations, with increasing target occupancy with higher doses based on available data from the 100 mg, 200 mg, and 400 mg doses. The maximum target occupancy has not yet been achieved in the first three dose cohorts, but the Company continues to anticipate that maximum target occupancy will be achieved in the 600 mg cohort, which was recently initiated.

On January 31, 2020 A scientific team is developing a new CAR T-cell gene therapy treatment for advanced metastatic prostate cancer at the Abramson Cancer Center of the University of Pennsylvania (Philadelphia, Pennsylvania) with a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT) (Press release, University of Pennsylvania, JAN 31, 2020, View Source [SID1234554029]).

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The ACGT grant was awarded to Joseph Fraietta, PhD, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, MD, director of the Prostate and Kidney Cancer Program, associate professor of medicine, and nationally renowned expert in the field of prostate and kidney cancer. The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy, a therapy that has been successful in treating blood cancers. Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.

"The grant from ACGT will help us advance our clinical work in a very novel way," said Dr. Fraietta. "If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer."

"The ACGT Scientific Advisory Council is impressed with the potential of this research team and their successful innovations in the use of T-cell therapy," noted Kevin Honeycutt, CEO and president of ACGT. "Because Drs. Fraietta and Haas are building on direct results already achieved with patients, there may be less transition time required to get a promising new treatment into the clinic for prostate cancer patients. Plus, we believe this research could provide a tumor-attack roadmap to help fight other cancers, including lung, pancreatic, ovarian and brain."

In the ACGT-funded study, Drs. Fraietta and Haas are going from the bedside back to the benchtop to employ new insight into how to better enable T-cells to battle cancer cells in solid tumors. Drs. Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality. This research builds on durable results being achieved by Dr. Haas in related prostate cancer clinical trials. In these trials, different doses of CAR T-cell gene therapies are being used to treat metastatic patients for whom traditional hormonal therapies, chemotherapies, radiation and surgery have failed.

"For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy," said Honeycutt. "Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise."

ACGT has been instrumental in funding some of the decade’s most transformative research, including breakthroughs in the use of CAR T-cell gene therapy for leukemia by the University of Pennsylvania’s Carl H. June, MD. "Dr. June received his first ACGT grant in 2004 and a second in 2008, back when gene therapy was considered a risky proposition," says Honeycutt. "Fast forward to today and the field has changed dramatically with major pharmaceutical companies and research institutions vying for the next big discovery using gene therapy or immunotherapy."

To learn more about Alliance for Cancer Gene Therapy (ACGT), visit acgtfoundation.org, call 203-358-5055, or join the ACGT community on Facebook, Twitter, Instagram and YouTube. To learn more about University of Pennsylvania’s Abramson Cancer Center, visit pennmedicine.org/cancer.

On January 31, 2020, Sierra Oncology, Inc. (the "Company") reported that it has entered into a security purchase agreement (the "SPA") with Gilead Sciences, Inc. ("Gilead"), pursuant to which the Company agreed to (i) issue to Gilead 725,283 shares (the "Shares") of the Company’s common stock (the "Common Stock") and (ii) issue a warrant (the "Warrant") to purchase up to 725,283 shares of Common Stock (the "Warrant Shares"), with an exercise price equal to $13.20 per share, in consideration of the Company’s and Gilead’s agreement to amend that certain Asset Purchase Agreement dated August 20, 2018, as set forth in the Amendment to the Asset Purchase Agreement dated October 28, 2019 (Filing, 8-K, Sierra Oncology, JAN 31, 2020, View Source [SID1234553919]).

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The Warrant contains customary provisions allowing for adjustment to the exercise price and number of Warrant Shares issuable including in the event of any stock split, reverse stock split, stock dividend, other dividend or distribution of assets, recapitalization or similar transaction as described in the Warrant. In addition, subject to limited exceptions, Gilead will not have the right to exercise its Warrant to the extent that, after giving effect to such exercise, it, together with any affiliates, would beneficially own in excess of 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise, which percentage may be increased or decreased, from time to time, at Gilead’s election upon 61 days’ notice to the Company. The Warrant is exercisable from any time after the date of issuance, which was January 31, 2020, until its expiration on January 31, 2025.

The Shares, the Warrant, and Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "1933 Act") and were issued in a private placement pursuant to Section 4(a)(2) of the 1933 Act.

Pursuant to the SPA, upon the request of Gilead, the Company will register the resale of the Shares and Warrant Shares.

As previously stated in a Current Report on Form 8-K filed with the Securities and Exchange Commission on November 13, 2019, a copy of the Amendment to the Asset Purchase Agreement will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

The foregoing summaries of the SPA and the Warrant do not purport to be complete and are subject to and qualified in their entirety by the terms of the SPA and the Warrant, copies of which are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and are incorporated by reference herein.