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Novel targeted drug shows promise in advanced kidney cancer

On February 13, 2020 Dana-Farber Cancer Institute reported Scientists report promising activity of a novel drug that targets a key molecular driver of clear cell renal cell carcinoma (ccRCC) in patients with metastatic disease (Press release, Dana-Farber Cancer Institute, FEB 13, 2020, View Source [SID1234554290]).

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Researchers from Dana-Farber Cancer Institute report a response rate of 24 percent across all risk categories of patients given an oral first-in-class agent that targets hypoxia-inducible factor (HIF) 2-a, which promotes new blood vessel growth that fuels kidney tumors.

Results of treatment with the drug, known as MK-6482, are being presented in an abstract of a phase I/II study at the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium. Based on these findings, a phase III trial has been launched.

"A new drug as a single agent showing an overall response rate of 24 percent across all risk categories – poor, intermediate, and good and in a heavily refractory population – is quite promising," said Toni Choueiri, MD, first author of the abstract. Choueiri is director of the Lank Center for Genitourinary Oncology and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

The drug targets a component of the body’s mechanism for sensing oxygen levels and turning on genes that enable the body to adjust to hypoxia – a shortage of oxygen – by making more red blood cells and forming new blood vessels. Dana-Farber scientist and Choueiri’s mentor and collaborator William G. Kaelin Jr., MD shared the 2019 Nobel Prize in Medicine with two other researchers for unraveling this complex mechanism, which can be hijacked by cancer to help tumors survive and grow.

In the vast majority of patients with clear cell renal carcinoma, a tumor suppressor protein known as Von Hippel-Lindau (VHL) is not functional. As a result, hypoxia inducible factor (HIF) proteins accumulate inside the tumor cell, wrongly signaling there is a shortage of oxygen, and activating the formation of blood vessels, fueling tumor growth. Understanding this abnormal process has paved the way for new cancer drugs – MK-6482 being one of them and is distinct in that it targets HIF-2a directly leading to blocking cancer cell growth, proliferation, and abnormal blood vessel formation.

The study of MK-6482 included 55 patients with advanced clear cell kidney cancer who had an average of 3 prior lines of therapies.

After a median follow-up period of 13 months, the overall response rate was 24 percent. Forty-one patients had stable disease with a disease control rate (complete response plus partial response plus stable disease) of 80 percent. There were partial responses in two of five favorable-risk patients; 10 of 40 intermediate-risk patients; and one of 10 poor-risk patients.

The median duration of response had not been reached: 81 percent of patients had an estimated response of more than six months, and 16 patients continued treatment beyond 12 months. The median progression-free response rate was 11 months.

The authors concluded that MK-6482 "is well-tolerated with a favorable safety profile and demonstrated promising single-agent activity in heavily pre-treated patients" with clear-cell kidney cancer across the various risk groups.

The presentation (Abstract 611) is scheduled for Oral Abstract Session C: Renal Cell Cancer on Saturday, February 15, 2020, at 8:00 a.m. (PT) at the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium in the Moscone West Building, San Francisco, CA.

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Choueiri has pending patents for biomarkers of immune checkpoint blockers. Choueiri’s disclosures include grants, personal fees or nonfinancial support from Agensys, Alexion, Alligent, Analysis Group, AstraZeneca, Bayer, Bristol-Myers Squibb, Calithera, Cerulean, Clinical Care Options, Corvus, Eli Lilly, Esai, Exelixis, Foundation Medicine Inc., Genentech, Roche, F. Hoffman-La Roche, GlaxoSmithKline, Heron Therapeutics, Harborside Press, American Society of Medical Oncology, Ipsen, NCCN, Kidney Cancer Journal, L-path, Merck, Michael J. Hennessy Associates, Research to Practice, Navinata Healthcare, NEJM, Novartis, Peloton, Pfizer, EMD Serono, Platform Q, Prometheus Labs, Sanofi/Aventis, Takeda, Tracon, Pionyr, Tempest, The Lancet Oncology and Up-to-Date.

DiaMedica Therapeutics Announces Closing of $8.5 Million Public Offering of Common Shares

On February 13, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, reported the closing of its previously announced underwritten public offering of an aggregate of 2,125,000 shares of its voting common shares at a public offering price of $4.00 per share (Press release, DiaMedica, FEB 13, 2020, View Source [SID1234554289]).

The gross proceeds of the offering were $8.5 million, before deducting the underwriting discount and other offering expenses.

DiaMedica intends to use the net proceeds from the offering to continue its clinical and product development activities and for other working capital and general corporate purposes.

Craig-Hallum Capital Group LLC acted as the sole managing underwriter for the offering.

The securities described above were offered pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-235775), which was declared effective by the U.S. Securities and Exchange Commission (SEC) on January 9, 2020. A final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Craig-Hallum Capital Group LLC at 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55402, Attention: Equity Capital Markets, by telephone at 612-334-6300, or by email 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 other 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 other jurisdiction.

DelMar Pharmaceuticals Announces Fiscal Second Quarter 2020 Financial Results and Recent Corporate Updates

On February 13, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its financial results for the three and six months ended December 31, 2019 and provided a corporate update (Press release, DelMar Pharmaceuticals, FEB 13, 2020, https://ir.delmarpharma.com/news/detail/925/delmar-pharmaceuticals-announces-fiscal-second-quarter-2020-financial-results-and-recent-corporate-updates [SID1234554288]).

"We are pleased with the pace of progress of both trials, which in some cases have enrolled patients faster than our previous forecasts. We are seeing rapid progress with encouraging survival benefits in both our Phase 2 trials per recent announcements and publications, and look forward to sharing our upcoming update of clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in San Diego April 24 to 29," commented Saiid Zarrabian, DelMar’s President and Chief Executive Officer. "Following a productive quarter, we continue to believe that our cash position will provide the runway to enable us to achieve topline results for two of our three patient groups in our two Phase 2 trials."

RECENT CORPORATE UPDATES

January 2020 – Announced the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma. The article highlights results from the first 22 patients of our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme ("GBM") being conducted at Sun Yat-sen University Cancer Center ("SYSUCC") in China.
November 2019 – Provided positive interim clinical data and held Key Opinion Leader GBM summit at the Society for Neuro-Oncology annual meeting. The updated clinical data in two poster sessions included the following:
The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM being conducted at SYSUCC.
The second poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at M.D. Anderson Cancer Center.
SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED DECEMBER 31, 2019

For the three months ended December 31, 2019, the Company reported a net loss of approximately $1.7 million, or $0.15 per share, compared to a net loss of approximately $1.8 million, or $0.75 per share, for the same period of 2018.

For the six months ended December 31, 2019, the Company reported a net loss of approximately $3.3 million, or $0.35 per share, compared to a net loss of approximately $3.8 million, or $1.63 per share, for the same period of 2018.

Basic and fully diluted loss per share

At December 31, 2019, the Company had cash and cash equivalents of approximately $6.3 million. In August 2019, the Company completed an underwritten public offering for net proceeds of approximately $6.6 million. The cash and cash equivalents at December 31, 2019 are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2020.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: View Source

ABOUT DELMAR PHARMACEUTICALS, INC.

Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

The Company’s current pipeline is based around VAL-083, a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on DelMar’s internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

Further information on DelMar’s clinical trials can be found on clinicaltrials.gov: View Source;term=val-083&cntry1=&state1=&recrs

For additional information, please visit View Source; or contact DelMar Pharmaceuticals Investor Relations: [email protected] / (604) 629-5989.

Corvus Pharmaceuticals Presents Updated Clinical Data from its Phase 1b/2 Clinical Trial of Ciforadenant at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium

On February 13, 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 updated results from its Phase 1b/2 clinical trial of ciforadenant, an adenosine A2A receptor antagonist, in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Corvus Pharmaceuticals, FEB 13, 2020, View Source [SID1234554287]). The data were presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco by Lawrence Fong, M.D., study investigator and leader of the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

"We are pleased to see activity in mCRPC both with ciforadenant monotherapy and in combination with atezolizumab," said Richard Miller M.D., chief executive officer of Corvus. "The results from this study and prior results reported with CPI-006, our anti-CD73 antibody, indicate that prostate cancer is another potential disease that is amenable to therapy with adenosine blockade. Many prostate cancers express CD73 and contain adenosine that is produced by multiple biochemical sources. Our recently published adenosine signature allows us to identify tumors where adenosine is playing an immunosuppressive role and where adenosine blockade may be clinically useful. We plan to pursue the mCRPC indication further and we anticipate additional data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting in late May/June. Overall, these results continue to demonstrate our leading position in the development of agents targeting the adenosine pathway."

Ciforadenant, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. The ciforadenant Phase 1b/2 study is currently enrolling patients with renal cell cancer (RCC) and mCRPC. The mCRPC arm of the study, which began enrolling patients in October 2019, is evaluating ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The study is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy and form the basis for future biomarker driven studies.

Ciforadenant Phase 1b/2 Clinical Trial Results at ASCO (Free ASCO Whitepaper) GU
The clinical data from the Phase 1b/2 trial of ciforadenant were presented by Dr. Fong in a poster presentation titled "Adenosine Receptor Blockade with Ciforadenant ± Atezolizumab in Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)" at the ASCO (Free ASCO Whitepaper) GU 2020 conference. The presentation included data from 35 patients with advanced mCRPC, including 11 that received ciforadenant as a monotherapy (100 mg twice daily) and 24 that received ciforadenant (100 mg twice daily) in combination with atezolizumab (840 mg delivered intravenously every two weeks). These patients had failed a median of three prior therapies and 43% had visceral metastases, which is a negative prognostic factor for patients with mCRPC. The key updates from Dr. Fong’s presentation included:

With median follow up of 3.2+ months, there was one partial response (PR, RECIST); this patient had a prostate-specific antigen (PSA) level drop from 98 to less than 1. Ten additional patients had tumor regression not meeting the criteria for PR. Seven patients have confirmed stable disease exceeding 6 months; one of these patients remains on therapy. Five patients have unconfirmed stable disease and continue on therapy. A total of 9 patients continue on therapy.
Gene expression profiling of tumor biopsies demonstrate a significant correlation of tumor CD73 expression with the adenosine signature (p=0.02). This correlation supports the relevance of adenosine in prostate cancer, its production by CD73 and the expression of adenosine induced immunosuppressive genes. Prior work in renal cell cancer, recently published in Cancer Discovery in January 2020, showed that the adenosine signature is associated with resistance to anti-PD(L)1 therapy, and predicted response to ciforadenant.
Treatment was well tolerated with 1 Grade 3 adverse event of fatigue in monotherapy and 1 Grade 3 adverse event of anemia in the combination arm.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These product candidates are being studied in ongoing Phase 1 and 2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant, and in combination with pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

Adenosine Gene Signature
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor. These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated macrophages, which are thought to mediate resistance to anti-PD(L)1 treatment. In renal cell cancer this biomarker is associated with response to ciforadenant.

Corcept Therapeutics to Announce Audited Financial Results, Provide Corporate Update and Host Conference Call

On February 13, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020 (Press release, Corcept Therapeutics, FEB 13, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-0 [SID1234554286]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

Conference Call Information

To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.