On May 12, 2022 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported first quarter 2022 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, MAY 12, 2022, View Source [SID1234614368]).

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"We remain focused on the execution of the clinical program for vidutolimod and are delighted with the opportunity to become part of Regeneron, who will help to accelerate the development of vidutolimod as a potential novel treatment for multiple tumor types," said Alan Bash, President and Chief Executive Officer of Checkmate. "This is an exciting opportunity for all stakeholders as we bring this innovative medicine forward and work to make a meaningful difference for patients with difficult to treat cancers."

Recent Business Updates

On April 19, 2022, Regeneron Pharmaceuticals, Inc. and Checkmate Pharmaceuticals, Inc. announced a definitive agreement for the acquisition of Checkmate by Regeneron at an all-cash price of $10.50 per share of Checkmate common stock. The proposed acquisition values Checkmate at a total equity value of approximately $250 million. On May 2, 2022, Scandinavian Acquisition Sub, Inc., a wholly owned subsidiary of Regeneron, commenced a tender offer for all of the outstanding shares of Checkmate common stock. The transaction is expected to close in mid-2022.
First Quarter 2022 Financial Results

Research and development expenses (R&D): R&D expenses for the first quarter of 2022 were $11.6 million, compared to $10.4 million for the same period in the prior year. This increase was primarily driven by higher third-party contract research organization, internal personnel and consulting costs related to our ongoing clinical trials. First quarter 2021 expenses included the impact of a $2.0 million milestone payment to Kuros in March 2021, which became payable upon initiating dosing of the first patient in a Phase 2 clinical trial. There was no corresponding expense in Q1 2022.
General and administration expenses (G&A): G&A expenses for the first quarter of 2022 were $4.2 million, compared to $3.8 million for the same period in the prior year. This increase was primarily attributable to professional fees incurred in Q1 2022 in connection with the proposed acquisition by Regeneron and recruiting costs associated with hiring a chief executive officer in March 2022.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $60.1 million as of March 31, 2022.

On May 12, 2022 TCR² Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, TCR2 Therapeutics, MAY 12, 2022, View Source [SID1234614383]).

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"We are very pleased with the momentum generated in the last quarter as we initiated the next phases on two clinical programs and expect to present in July an expanded dataset on 30 patients treated with gavo-cel," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR² Therapeutics. "The consistent tumor regression observed with gavo-cel in Phase 1 establishes a baseline efficacy and safety profile upon which we can build in Phase 2. With the initiation of the TC-510 Phase 1 clinical trial, which includes the treatment of pancreatic cancer, colorectal cancer and triple negative breast cancer, we have an opportunity to expand the number of indications potentially addressable with our TRuC-T cell therapies. We look forward to a busy second half of execution as we scale these clinical trials as well as build out our preclinical pipeline targeting CD70 with enhancements and allogeneic strategies."

Recent Developments

Gavo-cel:

TCR² initiated the Phase 2 expansion portion of the ongoing Phase 1/2 clinical trial of gavo-cel, its first-in-class TRuC-T cell targeting mesothelin-expressing solid tumors. Enrollment is ongoing and the Company expects to report on progress from the Phase 2 portion of the clinical trial in the second half of 2022.
TCR² announced the Company plans to present the expanded Phase 1 dataset for gavo-cel from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors in July 2022. The presentation will focus on safety, efficacy and translational data and include 30 patients from the Phase 1 dose escalation, with data from additional malignant pleural/peritoneal mesothelioma (MPM) and ovarian patients.
TC-510:

TCR² announced the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for TC-510, a TRuC-T cell targeting mesothelin that co-expresses a PD-1:CD28 chimeric switch receptor. The Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer. The Company expects to report on progress from the Phase 1 portion of the clinical trial in the second half of 2022.
Anticipated Milestones

Gavo-cel:

Present the expanded Phase 1 dataset for gavo-cel in July 2022.
Provide an update from the Phase 2 portion of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
TC-510:

Report initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
Pipeline:

Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
Select a lead candidate for its allogeneic program in 2022.
Manufacturing:

Production of clinical trial material to commence at ElevateBio BaseCamp as capacity is increased in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.
Financial Highlights

Cash Position: TCR² ended the first quarter of 2022 with $232.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $31.1 million for the first quarter of 2022 compared to $23.9 million for the first quarter of 2021. TCR² projects net cash use of $115-125 million for 2022, the lower end of the range previously provided. We expect cash on hand to support operations into 2024.
R&D Expenses: Research and development expenses were $22.9 million for the first quarter of 2022 compared to $15.9 million for the first quarter of 2021. The increase in R&D expenses was primarily due to an increase in headcount, clinical trial expenses associated with patient treatment and manufacturing, and manufacturing facilities expenses.
G&A Expenses: General and administrative expenses were $6.3 million for the first quarter of 2022 compared to $5.7 million for the first quarter of 2021. The increase in general and administrative expenses was due to an increase in personnel costs and other professional fees.
Net Loss: Net loss was $29.1 million for the first quarter of 2022 compared to $21.5 million for the first quarter of 2021.
Upcoming Events

TCR² Therapeutics management is scheduled to participate at the following upcoming conferences.

H.C. Wainwright Global Investment Conference: Garry Menzel, President and Chief Executive Officer of TCR² Therapeutics, will present an update on Company progress on Tuesday, May 24, 2022 at 7:00am ET

On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Executive Officer, is scheduled to participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference on Wednesday, May 18, 2022 at 8:30 am ET at the InterContinental New York Barclay hotel in New York City (Press release, Knight Therapeutics, MAY 12, 2022, View Source(TSX%3A%20GUD)%20(%22,30%20am%20ET%20at%20the [SID1234614403]).

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On May 12, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present new preclinical data highlighting the anti-tumor activity of Wugen’s lead memory natural killer (NK) product candidate WU-NK-101 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress being held June 9-12, 2022, virtually and in-person in Vienna, Austria (Press release, Wugen, MAY 12, 2022, View Source [SID1234614421]).

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The data highlight preclinical activity of WU-NK-101 supporting its clinical development for acute myeloid leukemia (AML). WU-NK-101 displayed activity against AML cell lines both in vitro and in vivo, and improved homing to the bone marrow. Further, the functional characteristics of WU-NK-101 support the potential development of WU-NK-101 for solid tumors, with data showing resistance to an adverse and immunosuppressive tumor microenvironment (TME).

The details of Wugen’s poster presentation at EHA (Free EHA Whitepaper) are as follows:

Title: WU-NK-101, An Allogeneic Memory NK Cell, for the Treatment of Relapse or Refractory (R/R) Acute Myeloid Leukemia (AML)
Session date and time: Friday, June 10, 2022, from 4:30 – 5:45 p.m. CEST
Abstract Number: P1426
Presenting Author: Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer, Wugen
Additional meeting information can be found at www.ehaweb.org/congress.

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On May 12, 2022 Race Oncology Limited ("Race") reported it has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Human ethics approval for this trial has been granted (ASX Announcement: 5 April 2022) (Press release, Race Oncology, MAY 12, 2022, View Source [SID1234614468]).

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Representatives of the Race Oncology clinical team, the contract research organisation Paraxel, and associated clinical teams of the Calvary Mater Hospital are scheduled to meet for site initiation and training on the May 31, 2022. Completion of this site training will enable the first patient to be recruited into the trial.

This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design at trial sites in Australia and Europe (ASX Announcement: November 1, 2021).