On May 5, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended March 31, 2022 (Press release, Corvus Pharmaceuticals, MAY 5, 2022, View Source [SID1234613657]).

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"We are advancing our three clinical product candidates according to a clear strategy focused on the interaction of tumors with the immune system," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our product candidates have demonstrated enhanced immune responses to a wide range of solid and hematologic cancers and are designed to act alone or in combinations. We are a leader in the modulation of CD73 and adenosine to affect tumor immunity, with mid-to-late stage clinical trials for mupadolimab and ciforadenant on track for initiation later this year. In addition, we have demonstrated encouraging potential of our ITK inhibitor on T cell differentiation, raising important new potential applications in cancer and autoimmune diseases."

2022 Key Areas of Focus
Corvus is advancing three clinical programs in 2022, including plans for a Phase 2 study for mupadolimab in front-line non-small cell lung cancer (NSCLC), a Phase 1b/2 study for ciforadenant in front-line renal cell cancer (RCC), and the ongoing Phase 1/1b study for CPI-818 in T-cell lymphoma.

The Company will host an R&D Symposium on Tuesday, May 10, 2022 to provide an update on these clinical programs. The event will take place in New York City from 9:00 – 11:30 am Eastern Time. A webcast of the event will be available on the Corvus website at www.corvuspharma.com.

Mupadolimab (anti-CD73)

The Company continues to enroll its two Phase 1b/2 clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in each expansion cohort and treated with the combination of mupadolimab and pembrolizumab.
The Company plans to initiate a randomized Phase 2 clinical trial evaluating mupadolimab as a front-line therapy for the treatment of patients with advanced NSCLC later this year. The randomized, blinded clinical trial will compare standard chemotherapy plus pembrolizumab (anti-PDL-1) with or without mupadolimab. The Company intends to enroll approximately 150 patients with any tumor PDL-1 expression in the clinical trial, potentially addressing a large patient population. The primary endpoint for the study will be progression free survival and secondary endpoints will evaluate objective response rate and overall survival.
Ciforadenant (adenosine 2a receptor antagonist)

The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial, which is anticipated to be initiated in the third quarter 2022, will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting. The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
CPI-818 (selective ITK inhibitor)

Corvus and its partner in China, Angel Pharmaceuticals, are enrolling patients with relapsed T cell lymphomas in Phase 1/1b trial evaluating single agent therapy with CPI-818. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China. Monitoring of immune modulation of normal T cells as well as safety and anti-tumor activity are being assessed in the clinical trial, with data expected later this year. Based on interim results observed in patients with peripheral T cell lymphoma (PTCL) in these Phase 1/1b clinical trials, the Company believes such results could provide the foundation for a potential global phase 2 clinical trial in advanced PTCL.
Financial Results
As of March 31, 2022, Corvus had cash, cash equivalents and marketable securities totaling $62.9 million. This compared to cash, cash equivalents and marketable securities of $69.5 million as of December 31, 2021.

Research and development expenses for the three months ended March 31, 2022 totaled $5.1 million compared to $8.2 million for the same period in 2021. The decrease of $3.1 million was primarily due to lower outside clinical trial and personnel costs.

The net loss for the three months ended March 31, 2022 was $8.3 million compared to a net loss of $11.6 million for the same period in 2021. Total stock compensation expense for the three months ended March 31, 2022 was $0.7 million compared to $1.2 million for the same period in 2021 and the non-cash loss from our equity method investment in Angel Pharmaceuticals was $1.0 million for the three months ended March 31, 2022 compared to $0.1 million in the same period in 2021.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. The Company’s second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.

About Mupadolimab
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, 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 and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.

About CPI-818
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to 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 Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and leukemias and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational 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.

On May 5, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the first quarter ended March 31, 2022 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 5, 2022, View Source [SID1234613673]).

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"In the first quarter of 2022, we achieved multiple clinical milestones and expanded our strategic partnerships with industry leaders," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Most recently at AACR (Free AACR Whitepaper), we shared promising clinical data on ZN-c3 – our potentially best-in-class Wee1 inhibitor – from two ongoing trials, in addition to preclinical data on its potential in settings including AML, PARP-resistant ovarian cancer, and in combination with ZN-d5, our BCL-2 inhibitor. The urgency for novel, tolerable treatments that address cancer patients’ unmet needs remains high, and we have prioritized the development of ZN-c3 and ZN-d5, as we are confident in their ability to fill treatment gaps for a range of solid and liquid tumors. Furthermore, we are thrilled to partner with Pfizer and Caris Life Sciences and are grateful for their support as we work toward delivering differentiated oncology candidates to patients in need."

Program Highlights:

In April 2022, Zentalis presented five abstracts at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and held a webcast event with Key Opinion Leader, Kathleen Moore, M.D., to further discuss the clinical and preclinical data. Additional details on the data presented at the AACR (Free AACR Whitepaper) conference are available here.
In March 2022, Zentalis announced the first patient was dosed in the potentially registrational Phase 1/2 study of ZN-d5, the Company’s BCL-2 inhibitor, in patients with relapsed or refractory light chain (AL) amyloidosis. The trial is a global, single arm, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of ZN-d5.
In March 2022, Zentalis announced a strategic collaboration with Caris Life Sciences, the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare. Utilizing its molecular profiling platforms, Caris will help identify and characterize patients for Zentalis’ clinical studies, initially for clinical trials investigating ZN-c3.
Corporate Highlights:

In April 2022, the Company sold 953,834 of its common shares at a price of $26.21 per share to Pfizer for gross proceeds of approximately $25.0 million. Zentalis and Pfizer plan to jointly advance the clinical development of ZN-c3. In addition, Zentalis intends to use the net proceeds to fund ongoing and planned clinical trials, including studies of ZN-c3 and ZN-d5 and for working capital and general corporate purposes.
Adam Schayowitz, Ph.D., MBA, Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer, has joined Zentalis’ Scientific Advisory Board. Dr. Schayowitz will work closely with Zentalis’ senior management team to provide input on the Company’s clinical strategy.
In March 2022, Zentalis announced it contributed $1 million to the Stand Up to Cancer (SU2C) Catalyst program to support research that investigates certain small molecule inhibitors for the treatment of various cancer types.
First Quarter 2022 Financial Results

Cash and Marketable Securities Position: As of March 31, 2022, Zentalis had cash, cash equivalents and marketable securities of $289.4 million. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2022, together with approximately $24.7 million of net proceeds from the April 2022 Pfizer equity investment, prioritization of the clinical development of ZN-c3 and ZN-d5, and budget reallocation, will be sufficient to fund its operating expenses and capital expenditures requirements into the first quarter of 2024.
Research and Development Expenses: Research and development expenses for the three months ended March 31, 2022 were $46.1 million, compared to $38.4 million for the three months ended March 31, 2021. The increase was primarily due to increases in external research and development expenses related to Zentalis’ clinical product candidates as the Company advanced its clinical pipeline and personnel costs.
General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2022 were $11.8 million, compared to $12.0 million during the three months ended March 31, 2021. The decrease in expenses was primarily attributable to allocable expenses and stock based compensation.

On May 15, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) (Press release, Elpiscience, MAY 5, 2022, View Source [SID1234613705]). ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization.

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In the study, ES104 demonstrated:

42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation
Anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients
Well-tolerated and preliminary safety profile consistent with prior studies
The Phase 2 study in patients with BTC is currently being conducted at four leading medical centers in Korea and Compass Therapeutics plans to open additional sites in the United States. In China, Elpiscience is currently enrolling patients in a ES104 Phase 1/2 study for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC). ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are encouraged by the impressive interim Phase 2 data in BTC patients from our partner," said Steve Chin, Chief Medical Officer of Elpiscience. "ES104 in combination with paclitaxel showed a high ORR including responses in all four BTC subtypes and good overall tolerability consistent with prior studies. We believe in the clinical strategy to simultaneously target VEGF and DLL4 and look forward to our study findings in advanced CRC patients."

For more information on the Phase 1/2 clinical study in patients with unresectable locally advanced or metastatic CRC, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed ES104 greater China rights from Compass Therapeutics in January 2021 and is conducting Phase 1/2 study in China for treatment in patients with unresectable locally advanced or metastatic colorectal cancer.

On May 5, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2022 (Press release, Nektar Therapeutics, MAY 5, 2022, View Source [SID1234613720]).

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Cash and investments in marketable securities at March 31, 2022 were approximately $704.4 million as compared to $798.8 million at December 31, 2021, which is expected to support operations into 2025.

"The new strategic plan that we recently announced refocuses our company around specific investment into our most important pipeline programs – NKTR-358, NKTR-255, and core preclinical candidates," said Howard W. Robin, President and CEO of Nektar. "In addition, we have now implemented a cost restructuring plan which extends our cash runway through the first half of 2025. We believe our pipeline in auto-immune disease and oncology provides a path to bringing important therapeutics to patients and creating value for our shareholders."

Summary of Financial Results
Revenue in the first quarter of 2022 was $24.8 million as compared to $23.6 million in the first quarter of 2021.

Total operating costs and expenses in the first quarter of 2022 were $141.4 million as compared to $133.0 million in the first quarter of 2021. Operating costs and expenses increased primarily as a result of an increase in R&D expense.

R&D expense in the first quarter of 2022 was $107.3 million as compared to $95.6 million for the first quarter of 2021. R&D expense increased primarily due to increases in expense for bempegaldesleukin, NKTR-255 and NKTR-358.

G&A expense was $27.3 million in the first quarter of 2022 and $31.7 million in the first quarter of 2021.

Net loss for the first quarter of 2022 was $90.4 million or $0.49 basic and diluted loss per share as compared to a net loss of $123.0 million or $0.68 basic and diluted loss per share in the first quarter of 2021.

On April 25, 2022, Nektar announced new strategic and cost restructuring plans (View Source) and conducted a call with analysts and investors to present those plans. On that call, the company provided annual financial guidance for 2022, and because of that, the company stated it would not hold its regular quarterly conference call conducted in conjunction with release of Q1 2022 financial results.

On May 5, 2022 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric clinical trial enrollment for oncology, and Amber Specialty Pharmacy, a pioneer and leader in the specialty pharmacy industry with true best-in-class programs and locations strategically placed across the United States, reported its partnership to provide advanced data-driven technology solutions for patient recruitment services to the oncology research ecosystem, and thereby offer better access for cancer patients to leading-edge clinical trials (Press release, Massive Bio, MAY 5, 2022, View Source [SID1234613747]). Through this partnership, Amber Specialty Pharmacy will seamlessly connect patients in need for clinical trials with Massive Bio’s matching and concierge enrollment services and support cancer patients and providers throughout the country; the combined capabilities include Amber’s 26 million payer lives, over 50 US Limited Distribution Networks and Massive Bio’s 60,000 unique cancer patients, 12 countries global presence – making this the first and largest partnership of its kind.

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"Amber Specialty Pharmacy is dedicated to meeting the clinical, emotional, and financial needs of cancer patients and their caregivers. Our Oncology Center of Excellence (COE) was designed to provide cancer patients with an enhanced level of care during their treatment journey." said Kristin Williams, president of Amber Specialty Pharmacy. "When faced with a cancer diagnosis, time is of the essence. It is critical that advanced cancer patients have real-time access resources readily available to them, including clinical trial options and a pathway to enrollment across lines of therapy. Massive Bio’s AI technology platform and expertise in cancer clinical trials are fully aligned with these goals, resulting in improved health outcomes and reduced costs for the industry," Williams added.

Amber Specialty Pharmacy’s patient-centered model of care and oncology COE team provides patients and their caregivers individualized care with ongoing education and support to ensure patients have what they need to feel supported throughout their treatment journey. They also utilize a proprietary artificial intelligence (AI) model to identify patients at risk for lower adherence early in treatment, which allows real time interventions, offering guidance and support to patients, leading to positive treatment outcomes. The model is also built to remove barriers to coverage and building bridges toward seamless collaboration between providers and pharmacy.

"Amber Specialty Pharmacy’s best-in-class service model has earned the trust of the nation’s largest stakeholders in healthcare, as well as many pharmaceutical commercial partners in the oncology space", said Selin Kurnaz, Massive Bio’s CEO and Co-Founder. "Massive Bio’s patient centered and AI-augmented approach to trial recruitment levering our command center and SYNERGY-AI engine, combined with Amber’s advanced analytics and capabilities using a technology platform with real-time patient insights, enables all the oncology research stakeholders to optimize patient enrollment and activation at an exponential scale nationwide. We are the only company to use an AI-integrated app and mobile technology to find your eligibility for clinical trials, as well as the best sites closest to you, and it is a natural extension to integrate and partner with Amber’s outstanding Oncology COE model and platform."

Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, and also the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its Massive Bio’s AI-based technology, website and apps across iOS and Android platforms, expanding their presence as a global company with country-level success in 12 markets.

"With over 13,000 active cancer clinical trials active in the US at any given time, the oncology trial ecosystem and its providers look to industry leaders and digital health solutions for better ways to activate real-time data insights and succeed in this complex research environment, which is ever-focused in oral oncolytic and individualized precision medicine approaches", mentioned Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "We are excited to leverage our personalized concierge patient-centric models and Amber’s data-driven approach to generate patient insights in real time, which will augment and optimize our already successful AI-enabled trial recruitment and enrollment movement, improve patient retention, and expand access to precision cancer care and cost-saving strategies at a larger and technology-enabled scale", added Loaiza-Bonilla.

This partnership envisions to anticipate and satisfy the needs of pharma and CRO partners, research sites, clinical teams, and eligible patients in real time, using digital tools to accelerate cancer research, providing additional patient-centered services in oncology, and catalyzing the expansion of specialty pharmacy and Massive Bio’s capabilities as a new patient-centered AI-enabled standard model in oncology research.