On February 23, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported the signing of a license agreement with Luminary Therapeutics for the use of TcBuster for the manufacturing of gene-modified cell therapies (Press release, Bio-Techne, FEB 23, 2021, View Source [SID1234575503]). TcBuster is Bio-Techne’s proprietary non-viral transposon-based gene delivery system used to advance cell therapy manufacturing.

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Under the terms of this agreement, Bio-Techne grants Luminary Therapeutics a non-exclusive license for TcBuster. Luminary Therapeutics will use TcBuster in their LMY-920 program, a BAFF-CAR-T product. Luminary Therapeutics plans to file an IND with the FDA later this calendar year.

"This agreement with Luminary Therapeutics brings Bio-Techne’s cutting-edge TcBuster system one step closer to delivering gene-modified cell therapies," said Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "With this license agreement, Bio-Techne will increase its presence as a key player in the cell and gene therapy market."

"The use of TcBuster during the manufacturing process provides significant benefits over the current viral approaches allowing for delivery of larger cargo with safe integration profiles," said John Hurley, Luminary Therapeutics’ COO. "We are excited to utilize GMP grade TcBuster reagents to provide our patients with a cutting-edge next generation CAR-T therapy."

On February 23, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its fourth quarter and year end 2020 financial results after market close on Tuesday, March 2, 2021 (Press release, Rigel, FEB 23, 2021, View Source [SID1234575428]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

On February 23, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (Press release, Oncolytics Biotech, FEB 23, 2021, View Source [SID1234575453]).

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Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:

"These very exciting data demonstrate pelareorep’s ability to overcome major shortcomings of CAR T cells," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep’s ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep’s business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors."

The electronic poster titled "Combination Therapy with Oncolytic Viruses and CAR T Cells," was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics’ website (LINK).

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On February 23, 2021 Cleveland BioLabs, Inc. (NASDAQ:CBLI), reported that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the issuance and sale of 2,000,000 shares of its common stock at a purchase price of $7.00 per share in a registered direct offering (Press release, Cleveland BioLabs, FEB 23, 2021, View Source [SID1234575469]). The closing of the offering is expected to occur on or about February 23, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $14 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

The shares described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On February 23, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will collaborate with Protean BioDiagnostics Inc. to research the ability of Biocept’s Target Selector molecular assay to determine EGFR status in non-small cell lung cancer (NSCLC) patients (Press release, Biocept, FEB 23, 2021, View Source [SID1234575485]). The research will be conducted in an independent pathology laboratory setting.

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Protean BioDiagnostics also expects to validate the analytical performance of a laboratory developed test (LDT) based on Biocept’s EGFR assay test kit in accordance with the requirements of the College of American Pathologists (CAP) validation process.

Biocept’s novel molecular assay kit, available for research-use-only and with CE-IVD mark, enables molecular laboratories around the world to utilize its Target Selector platform to analyze both formalin-fixed paraffin-embedded (FFPE) tissue samples and circulating tumor DNA (ctDNA) from biological fluids. Target Selector leverages patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, requiring less tumor sample and resulting in higher assay sensitivity than most commercial assays. Biocept’s molecular assays have been validated for the detection of frequent oncogenic mutations EGFR, KRAS and BRAF, which are among the most frequently evaluated biomarkers for lung cancer and melanoma.

"We are pleased to collaborate with Biocept to demonstrate the potential of its assay in determining EGFR status," said Anthony M. Magliocco, MD, President and CEO of Protean BioDiagnostics. "Obtaining adequate tissue sample for genomic profiling continues to be a challenge in first-line therapy selection for patients with NSCLC. Target Selector EGFR assays require 50% less tumor input sample than most commercial assays, making it a potentially powerful tool in helping qualify more patients for targeted tyrosine kinase inhibitor, or TKI, therapy. This potential advantage is coupled with previous studies demonstrating Target Selector assays’ best-in-class low-end limit of detection of mutations in both FFPE and liquid biopsy samples."

"Protean BioDiagnostics is the ideal partner for this collaboration, as we share a joint commitment to advancing the best possible care for patients with cancer," said Michael Nall, Biocept President and CEO. "Protean has extensive experience working with some of the world’s leading biotechnology companies. Together, our goal is to demonstrate how Target Selector assays can help physicians create more personalized, responsive treatment plans for their patients."

About Target Selector Molecular Assay Kits
Target Selector molecular assay kits are marketed for research-use-only (RUO) in the U.S. and CE-IVD in the European Union and other CE Mark geographies, offering industry-leading sensitivity for the detection of mutations/variants of interest in both FFPE and ctDNA. Target Selector assays with Switch-Blocker technology can also provide results with smaller DNA inputs (minimum 4.6 ng) than most tissue-based assays, allowing laboratories to get results even with small amounts of tissue. These capabilities should allow laboratories to eliminate macro-dissection of tumor blocks, potentially resulting in major workflow improvements and cost savings.

Target Selector assays can be used in combination with a variety of low-cost analytical platforms including qPCR, Sanger sequencing, microarrays, and mass-spectrometry, in addition to next generation sequencing. Target Selector kits (RUO and CE-IVD) offer high content per assay, which can reduce costs by selectively amplifying multiple mutations/variants in hot-spot regions of interest in a single reaction. All Target Selector assays are quantitative.

Target Selector molecular assay kits (RUO and CE-IVD) are currently available for EGFR and BRAF mutations. Additional test kits for other oncogene mutations are planned for launch in the future. For more information on Biocept’s Target Selector molecular assay kits, contact Biocept Customer Service at (888) 332-7729 or [email protected].