On March 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Corvus Pharmaceuticals, MAR 10, 2022, View Source [SID1234609881]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to advance three clinical programs for novel product candidates targeting CD73, the adenosine 2A receptor, and ITK, which are involved in immune response to cancers and other diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have established sound scientific foundations for our product candidates, which give us confidence as we initiate mid-stage clinical trials in front-line treatment of lung cancer and renal cell cancer. In addition, our partnership with Angel Pharmaceuticals has expanded the clinical development of CPI-818 for T cell lymphomas into China and is accelerating global development of this product candidate."

Mupadolimab (anti-CD73)

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 non-small cell lung cancer (NSCLC). The randomized, blinded 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.
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 initial results are anticipated to be presented in the second half of 2022.
In November 2021, the Company presented results from its Phase 1/1b clinical trial that, along with pre-clinical data, provided further evidence regarding mupadolimab’s mechanism of action and its potential anti-tumor activity in cancer patients. The data showed that mupadolimab doses of 12mg/kg or greater, resulted in complete occupancy of the CD73 target and B cell activation. In the assessment of anti-tumor activity in sixteen evaluable patients receiving the 12mg/kg or greater doses of mupadolimab, tumor regression (not meeting the threshold for partial response by RECIST) was seen in five patients who had progressive disease as the best response to most recent prior therapy, which included anti-PD(L)1. We believe these interim findings support mupadolimab’s potential to cause tumor regression in patients with tumors refractory to anti-PD(L)1.
CPI-818 (selective ITK inhibitor)

The Company’s partner in China, Angel Pharmaceuticals, initiated patient enrollment in a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China.
The Company continues to enroll patients in its Phase 1/1b clinical trial, which was expanded to include patients with certain types of T cell leukemias in addition to T cell lymphomas.
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.
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 renal cell cancer (RCC) in combination with ipilimumab (anti-PD-1) and nivolumab (anti-CTLA-4). The clinical trial 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.
The Company continues to advance its understanding of the Adenosine Gene Signature biomarker, which has been confirmed by other groups as a means to identify an unfavorable group of renal cell cancer patients. Tumor biopsies from the Phase 2 clinical trial will be evaluated for expression of the Adenosine Gene Signature.
Financial Results
As of December 31, 2021, Corvus had cash, cash equivalents and marketable securities totaling $69.5 million compared to $44.3 million as of December 31, 2020. Corvus expects full year 2022 net cash used in operating activities to be between $34 million and $36 million.

Research and development expenses for the three months and full year ended December 31, 2021 totaled $4.8 million and $29.1 million, respectively, compared to $7.2 million and $31.8 million for the same periods in 2020. In the fourth quarter of 2021, the decrease of $2.4 million was primarily due to a decrease in clinical trial and personnel costs.

Net loss for the three months and full year ended December 31, 2021 was $9.2 million and $43.2 million, respectively, compared to net income of $27.3 million and a net loss of $6.0 million for the same periods in 2020. Results for the year ended December 31, 2020 included a $37.5 million gain from the deconsolidation of Angel Pharmaceuticals. Total stock compensation expense for the three months and year ended December 31, 2021 was $0.7 million and $4.2 million, respectively, compared to $1.2 million and $5.7 million for the same periods in 2020.

Conference Call and Webcast
Corvus will host a conference call and webcast today, March 10, 2022, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2021 financial results. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13727689. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On March 10, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported the company will participate and be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 10, 2022, View Source [SID1234609880]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Roth Capital Partners 34th Annual Conference
Date: March 15, 2022
Time: 10:00 am PT / 1:00 pm ET
Format: Fireside chat and available for 1×1 investor meetings

Oppenheimer 32nd Annual Healthcare Conference
Date: March 16, 2022
Time: 3:20 pm ET
Format: Virtual presentation and available for 1×1 investor meetings
Webcast: To register, click on the link HERE
A replay of the Oppenheimer presentation will be available on the Investor page of the company website.

On March 10, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and reported fourth quarter and full year 2021 financial results (Press release, Oncternal Therapeutics, MAR 10, 2022, View Source [SID1234609879]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This past year was a decisive one for Oncternal, as we reached consensus with the FDA on our Phase 3 clinical trial ZILO-301 of zilovertamab in patients with MCL, advanced our ROR1-targeting CAR-T cell therapy candidate ONCT-808 towards IND submission, and initiated IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are focusing our resources on hematological malignancies and prostate cancer, areas of high unmet patient need where we believe our potentially first-in-class or best-in-class product candidates can make the greatest difference. We believe our strong balance sheet will enable us to advance these programs into mid-2023, as we navigate a historically challenging macro environment."

Recent Highlights

In January 2022, we announced that we reached consensus with the FDA on the design and major details of the Phase 3 Study ZILO-301 to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In December 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of zilovertamab in combination with ibrutinib for patients with MCL and chronic lymphocytic leukemia (CLL) [NCT03088878] at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Virtual Annual Meeting.
Objective response rate (ORR) of 81% (21 of 26 evaluable patients) observed for patients with MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical ORR of 66% for ibrutinib monotherapy
Complete response (CR) rate of 35% for MCL patients treated with zilovertamab plus ibrutinib (9 of 26 evaluable patients), which compares favorably to the historical ORR of 20% for ibrutinib monotherapy, and with CRs remaining durable for up to 32 months
Median progression-free survival (PFS) of 35.9 months for MCL patients with median follow-up of 14.4 months, which compares favorably to the historical ibrutinib monotherapy median PFS of 12.8 months
Landmark PFS of 100% at 36 months for CLL patients who had previously received one or two prior lines of therapy, which compares favorably to historical ibrutinib monotherapy PFS of ~ 75%
Median PFS had not been reached for CLL patients with one or two prior lines of therapy, and median PFS was 36.1 months for patients receiving > 2 prior lines of therapy, with a median follow-up of 29.0 months
The combination of zilovertamab and ibrutinib continued to be well tolerated, with a safety profile consistent with or improved compared with historical data for ibrutinib monotherapy
In November 2021, we announced joining the Karolinska Institutet’s NextGenNK Competence Center to support our next generation ROR1-targeted cell therapy initiatives, and the establishment of a Cell Therapy Scientific Advisory Board, comprised of industry and academic leaders in the cell therapy field.
In October 2021, we presented encouraging preclinical data with ONCT-534, the lead candidate in our preclinical dual-action androgen receptor inhibitor (DAARI) program, during a virtual poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual International Conference on Molecular Targets showing anti-tumor activity in preclinical studies relevant to important tumor resistance mechanisms, including those involving expression of the androgen receptor splice variant (AR-V7).
In November 2021, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial evaluating ONCT-216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma [CT02657005] at the Connective Tissue Oncology Society 2021 Virtual Annual Meeting. Two patients continue to demonstrate durable complete responses, including one patient with a durable CR for 24 months on treatment, and no evidence of disease off treatment after several months.
Expected Upcoming Milestones

Zilovertamab (ROR1 antibody) program
Initiation of global registrational Phase 3 Study ZILO-301 in the second quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study in the second quarter of 2022
Have a Phase 1b investigator sponsored trial of zilovertamab plus docetaxel initiated for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
ONCT-216 (ETS inhibitor) program
Updated interim clinical data for patients with Ewing sarcoma treated in the dose intensified expansion cohort in the fourth quarter of 2022
Fourth Quarter and Full Year 2021 Financial Results
Our grant revenue was $0.6 million for the fourth quarter ended December 31, 2021. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH). For the full year 2021, grant revenue was $4.3 million.

Our total operating expenses for the fourth quarter ended December 31, 2021 were $8.6 million, including $1.7 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $2.6 million. Net loss for the fourth quarter was $8.1 million, or a loss of $0.16 per share, basic and diluted. For the full year 2021, total operating expenses were $35.7 million, including $5.9 million in non-cash stock-based compensation expense, and our net loss was $31.3 million, or a loss of $0.64 per share, basic and diluted.

As of December 31, 2021, we had approximately 49.4 million shares of common stock outstanding. $90.8 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations into mid-2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.

On March 10, 2022 xCures reported their collaboration with Tyra Biosciences for a real-world biomarker study involving patients with FGFR-mutant bladder cancer receiving Balversa (erdafitinib) as their standard of care medical therapy (Press release, xCures, MAR 10, 2022, View Source [SID1234609878]). The study is supported by Tyra Biosciences, Inc., a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. This study will investigate a patient’s tumor DNA through their blood and urine samples to provide information on their treatment and what options might be available if their disease worsens.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bladder cancer is the sixth most common cancer in the United States and is associated with genetic mutations in the patient’s bladder or urothelium (the lining of the lower urinary tract). Approximately one in five patients with recurrent and refractory bladder cancer has alterations in fibroblast growth factor (FGFR) genes. These are typically detected with a tumor biopsy, a procedure that may be invasive and anxiety provoking.

US FDA has recently approved Balversa to treat adult patients with locally advanced or metastatic urothelial carcinoma with certain FGFR2 or FGFR3 gene mutations. Overall, about one third of patients treated with Balversa have a confirmed tumor response. However, acquired resistance can be a consequence of treatment and is a devastating reality for patients initially responding to targeted cancer therapies. As new treatments have become more selective, there is a strong demand to address this significant limitation.

In this study, samples collected from bladder cancer patients receiving standard of care Balversa will be tested using a non-invasive diagnostic method that uses the blood and urine samples, instead of tissue, to detect gene alterations that may occur at the time of tumor progression. These less intrusive samples may allow for the assessment of how treatment with Balversa affects clinical response, disease progression, and/or genetic alterations detected in cell free tumor DNA.

"xCures is excited to partner with Tyra Biosciences to deliver on the promise of precision oncology and translational medicine for bladder cancer," said Mika Newton, CEO of xCures. "This study is a great example of how patients and their doctors have the opportunity to both better understand their options and contribute to research in real time."

"We’re excited to support xCures on this biomarker study, which utilizes a non-invasive approach to identify FGFR mutations in patients with bladder cancer," said Todd Harris, CEO of Tyra Biosciences. "This study could yield valuable insights into FGFR-mutant biology and overall tumor progression in bladder cancer, and we hope to leverage these findings as we advance our TYRA-300 program toward the clinic."

The study is being conducted under a decentralized model, leveraging xCures’ direct-to-patient precision oncology platform to reach patients anywhere in the United States. Patients interested in participating in the study can get more information at:

View Source and View Source

On March 10, 2022 Amgen (NASDAQ:AMGN) reported that it will virtually present at the 32nd Annual Oppenheimer Healthcare Conference at 11:20 a.m. ET on Wednesday, March 16, 2022 (Press release, Amgen, MAR 10, 2022, View Source [SID1234609877]). Rob Lenz, M.D., Ph.D., senior vice president of Global Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference . The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.