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Children’s Hospital Los Angeles Receives $25 Million for Pediatric Cancer, Vision and Rehabilitation Programs

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.

Corvus Pharmaceuticals Presents Updated Clinical Data from its Phase 1/1b Clinical Trial of CPI-818 at the 12th Annual T-Cell Lymphoma Forum

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]).

"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.

University of Pennsylvania Scientists Receive ACGT Grant to Accelerate CAR T-Cell Clinical Trial for Prostate Cancer

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]).

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.

Entry into a Material Definitive Agreement

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]).

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.

Kezar Announces Pricing of $49.4 Million Public Offering of Common Stock and Pre-Funded Warrants

On January 31, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmune disease and cancer, reported the pricing of an underwritten public offering of 16,115,385 shares of its common stock, and to certain investors in lieu thereof, pre-funded warrants to purchase 2,884,615 shares of its common stock at an exercise price of $0.001 per share (Press release, Kezar Life Sciences, JAN 31, 2020, View Source [SID1234553781]). The public offering price of each share of common stock is $2.60 and the public offering price of each pre-funded warrant is $2.599. In addition, Kezar has granted the underwriters a 30-day option to purchase additional shares of common stock of up to 15% of the aggregate number of shares of common stock plus the shares of common stock underlying the pre-funded warrants being offered in the offering. The offering is expected to close on February 4, 2020, subject to customary closing conditions.

Cowen, Wells Fargo Securities and William Blair are acting as joint book-running managers for the offering.

Kezar expects to receive gross proceeds of $49.4 million from the offering, before deducting underwriting discounts and offering expenses. Kezar intends to use the net proceeds from the offering primarily to fund the research and development of its product candidates, acquire or license products or technologies that are complementary to its own, although Kezar has no current plans, commitments or agreements with respect to any acquisitions or licenses as of the date hereof, and for working capital and general corporate purposes.

The securities described above are being offered by Kezar pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission ("SEC") dated July 3, 2019. A preliminary prospectus supplement relating to the offering is, and a final prospectus supplement related to the offering will be, filed with the SEC and available on the SEC’s website at View Source Copies of the preliminary and final prospectus supplements relating to the offering may be obtained, when available, by contacting Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; Wells Fargo Securities, LLC Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897 or by email at [email protected]; or William Blair & Company, L.L.C. Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.