On October 29, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the third quarter ended September 30, 2020 (Press release, Corvus Pharmaceuticals, OCT 29, 2020, View Source [SID1234569361]).
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"We have several important milestones for our cancer and COVID-19 programs in the coming months," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "For our lead program, ciforadenant combined with atezolizumab in renal cell cancer (RCC), we are on track to meet with FDA in December to finalize the design of a Phase 3, biomarker driven clinical trial focused on RCC patients that are positive for the Adenosine Gene Signature. The data on the signature, which has been confirmed independently, suggests that positive patients may be most likely to benefit from treatment with ciforadenant. We are also encouraged that our ITK inhibitor, CPI-818, has shown activity in patients with advanced peripheral T cell lymphoma, and we look forward to sharing updated data at the ASH (Free ASH Whitepaper) meeting in December."
"For CPI-006, we continued to enroll patients in our Phase 1 cancer study and in our recently launched Phase 1 study in patients with COVID-19. The initial results in COVID-19 patients have been encouraging and aligned with our expectations based on CPI-006’s unique mechanism of B cell activation and subsequent antibody and memory B cell production. This includes the generation of a polyclonal immune response to the SARS-CoV-2 virus induced by relatively low doses of CPI-006, which may offer advantages over passive administration of monoclonal antibodies. We will present the latest data on the COVID-19 program at the SITC (Free SITC Whitepaper) meeting in November, and based on the positive results to-date, plan to initiate a larger registrational study before the end of the year."
"On the corporate development front, in October we co-founded Angel Pharmaceuticals, a biopharmaceutical company based in China. Angel expands our pipeline into the large and growing Chinese healthcare market and provides the potential to accelerate our product development on a global basis. In addition, Corvus will initially retain a 49.7% ownership position in the company."
Recent Achievements
CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity
Initiated an open-label, Phase 1 study of CPI-006 in COVID-19 patients with mild to moderate symptoms that require hospitalization and reported initial data that supports its potential as a novel immunotherapy approach for these patients. This includes the inducement of sustained high titers of SARS-CoV-2 specific antibodies and increased levels of memory B cells, with a dose-response effect seen in the first two cohorts with prolonged high titers of antibodies observed out to 56 days.
Published results from initial cohorts of COVID-19 study and data characterizing the novel immunotherapy approach with CPI-006 online at medRxiv.org. The preclinical data in the manuscript demonstrate that administration of CPI-006 resulted in B cell activation, antibody secretion and induction of memory B and T cells. The clinical data in the manuscript is consistent with laboratory studies and reflected high titers of IgG and IgM anti-SARS-CoV-2 antibodies.
Completed planned enrollment in each of the study’s four cohorts (0.3, 1.0, 3.0 and 5.0 mg/kg), with additional enrollments ongoing in order to expand certain cohorts. Additional data from the study, including results from all four cohorts, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November.
Completed enrollment in three dose escalation arms of the CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination with ciforadenant and combination with pembrolizumab and we continue to enroll the triplet combination dose escalation arm with ciforadenant and pembrolizumab.
CPI-818: A small molecule ITK inhibitor
Continued follow-up on patients enrolled in the CPI-818 Phase 1/1b clinical trial, with a focus on the seven patients with peripheral T-cell lymphoma (PTCL). To-date, there have been two responses in this group – one patient who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation that achieved a complete response and completed one year of treatment; and one patient who failed multiple prior therapies that achieved a partial response.
Co-Founding of Angel Pharmaceuticals in China
Announced the co-founding of Angel Pharmaceuticals in China to create clinical study synergies and accelerate development timelines for the Company’s pipeline (ciforadenant, CPI-006 and CPI-818) while retaining 49.7% ownership of Angel.
Anticipated Future Events
The Company will present Phase 1 study results with CPI-006 in COVID-19 patients at the SITC (Free SITC Whitepaper) annual meeting, which is being held virtually on November 9-14, 2020.
The SITC (Free SITC Whitepaper) poster presentation will be available on November 9 at 8:00 am ET on the SITC (Free SITC Whitepaper) meeting website.
Title:
Immunotherapy with B cell activating antibody CPI-006 in patients (pts) with mild to moderate COVID-19 stimulates anti-SARS-CoV-2 antibody response, memory B cells and memory T effector cells
Poster #: 325
Lead Author: Gerard J. Criner, MD, Temple University Hospital
Category: In-Progress Clinical Trials
Based on interim data from the Phase 1 study, and assuming the remainder of the data in the study supports it, begin a pivotal, randomized, double blind study of CPI-006 in hospitalized COVID-19 patients in December 2020, with results expected to be available around mid-2021.
On track to meet with the U.S. Food and Drug Administration (FDA) in December 2020 to obtain feedback on the Company’s proposed pivotal trial for ciforadenant in patients with refractory renal cell carcinoma. The proposed pivotal trial will utilize the Company’s Adenosine Gene Signature biomarker to select patients who may be most likely to benefit from treatment with ciforadenant plus atezolizumab.
Present updated clinical data from the CPI-818 Phase 1/1b clinical trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020.
Financial Results
At September 30, 2020, Corvus had cash, cash equivalents and marketable securities totaling $51.4 million, as compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019.
Research and development expenses for the three months ended September 30, 2020 totaled $6.6 million compared to $9.0 million for the same period in 2019. The decrease of $2.4 million was primarily due to a $0.8 million decrease in CPI-818 drug manufacturing costs, a $0.8 million decrease in outside research service costs and a $0.5 million decrease in personnel costs.
General and administrative expenses for the three months ended September 30, 2020 totaled $3.2 million dollars compared to $2.5 million for the same period in 2019. The increase of $0.7 million primarily consisted of an increase in professional service costs.
The net loss for the three months ended September 30, 2020 was $9.8 million, compared to a net loss of $11.0 million for the same period in 2019. Total stock compensation expense for the three months ended September 30, 2020 was $1.3 million compared to $1.7 million for the same period in 2019.