Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2020 Financial Results
“We have several important milestones for our cancer and COVID-19 programs in the coming months,” said
“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 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
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) 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.
- Announced the co-founding of
Angel Pharmaceuticalsin Chinato 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 annual meeting, which is being held virtually on
November 9-14, 2020.
- The SITC poster presentation will be available on
November 9at 8:00 am ETon the SITC meeting website.
||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|
|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 2020to 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) annual meeting in December 2020.
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
The net loss for the three months ended
About Corvus Pharmaceuticals
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.
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 CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment.
CPI-006 is a potent humanized monoclonal antibody that reacts with a specific site on CD73. It has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies in development for treatment of cancer, such antibodies have been reported to react with a different region of CD73 and are designed to block production of adenosine, which is not involved in the immunomodulatory processes seen with CPI-006. CPI-006 is currently being evaluated in an ongoing Phase 1 study in patients with COVID-19 and has demonstrated enhanced antibody responses to the SARS-CoV-2 virus.
CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. The Company is conducting a Phase 1 dose escalation trial in patients with refractory T-cell lymphomas.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company’s ability and the ability of
Chief Financial Officer
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||$||6,619||$||8,996||$||24,639||$||29,055|
|General and administrative||3,226||2,517||9,242||8,359|
|Total operating expenses||9,845||11,513||33,881||37,414|
|Loss from operations||(9,845||)||(11,513||)||(33,881||)||(37,414||)|
|Interest income and other expense, net||49||509||539||1,789|
|Net loss per share, basic and diluted||$||(0.33||)||$||(0.37||)||$||(1.13||)||$||(1.21||)|
|Shares used to compute net loss per share, basic and diluted||29,500,318||29,389,003||29,419,431||29,331,290|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||51,361||$||77,982|
|Operating lease right-of-use asset||1,825||2,327|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||10,975||$||9,347|
|Operating lease liability||2,537||3,188|
|Total liabilities and stockholders' equity||$||55,862||$||83,646|
Source: Corvus Pharmaceuticals, Inc.