On April 13, 2023 Verismo Therapeutics, a clinical-stage CAR T company, University of Penn spinout, and pioneer of the novel KIR-CAR platform technology, reported the presentation of a poster titled, "A Phase 1 KIR-CAR Clinical Trial for Patients with Cholangiocarcinoma, Mesothelioma, or Ovarian Cancers," at the Annual Cholangiocarcinoma Foundation Conference in Salt Lake City, Utah, April 12-14 (Press release, Verismo Therapeutics, APR 13, 2023, View Source [SID1234630055]). The poster features the novel SynKIR-110 T cell therapy, which is designed to recognize and eliminate mesothelin (MSLN)-overexpressing tumors in patients with advanced cholangiocarcinoma, malignant pleural mesothelioma and ovarian cancers.

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"We are proud to be attending the Annual Cholangiocarcinoma Foundation Conference and presenting our work to the community," said Dr. Laura Johnson, CSO of Verismo Therapeutics. "We are committed to finding new treatments for this devastating disease and we look forward to sharing our progress with the Foundation."

The poster presents the clinical trial design for the first-in-human KIR-CAR Phase I clinical trial STAR-101. The poster discusses:

SynKIR-110 combines MSLN-specific antibody with NK cell signals to redirect patient T cells and eliminate MSLN-overexpressing tumors.
Preclinical research shows prolonged CAR T cell function and superior anti-tumor responses without increased toxicity.
Phase 1 clinical trial to establish feasibility, safety, identify dose, and evaluate clinical responses and biomarkers.
Patients must have standard of care therapy, progressive/inoperable disease, one measurable lesion, good performance status, and MSLN-expressing tumor.
For more information about SynKIR-110, please visit www.verismotherapeutics.com. For additional information regarding the STAR-101 clinical trial please visit ClinicalTrials.gov NCT05568680.

About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform can be combined with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to provide the next-generation multimodal targeted immunotherapy for patients in need.

On April 13, 2023 Totus Medicines, the drug discovery and development company committed to ending the era of untreatable disease, reported the dosing of the first patient in a Phase 1 clinical trial of TOS-358, the company’s first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations (Press release, Totus Medicines, APR 13, 2023, View Source [SID1234630054]).

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The Totus Accel Platform delivers the first biosearch technology that scans, maps, and decodes effective new drugs thousands of times faster than traditional drug discovery processes. As a result, Totus was able to file an Investigative New Drug application with the FDA in a mere 18 months after the TOS-358 program was discovered and developed. Totus uses proprietary molecular tags that track drug binding in individual cells to screen billions of drug molecules across thousands of genes in parallel. By combining this approach with breakthrough machine learning techniques, the company has developed the next generation of cellular analysis. The Totus Accel Platform is more effective, less costly, and thousands of times faster than legacy drug discovery methods, enabling the rapid translation of therapies to patients.

The Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TOS-358 as a single agent in 241 trial participants with select solid tumors. Trial participants will have histologically confirmed diagnosis of colorectal cancer, gastric cancer, non-small cell lung cancer, human epidermal growth factor receptor 2 (HER2) negative breast cancer, squamous cell carcinoma of the head and neck, urothelial cancer, or select gynecologic cancers (ovarian cancer, cervical cancer, or endometrial cancer) with known PIK3CA mutations.

"TOS-358 represents a promising new approach to the treatment of the root cause of nearly 15% of all cancers, and we are excited to be able to advance it into clinical development at such an accelerated rate," said Neil Dhawan, PhD, CEO & co-founder, of Totus Medicines.

This study will be conducted in two parts: a dose finding portion to determine the maximum tolerated dose, and recommended phase 2 dose of TOS-358 administered orally on once a day and twice daily schedules; and a dose expansion portion to evaluate safety and tolerability in tumor-specific cohorts administered TOS-358 at the recommended phase 2 dose and schedule.

For more information on the Phase 1 trial of TOS-358, please visit View Source

On April 13, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in a fireside chat at the 22nd Annual Needham Healthcare Conference being held virtually from April 17th- 20th, 2023 (Press release, CRISPR Therapeutics, APR 13, 2023, View Source [SID1234630052]).

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Fireside Chat
Presenter: Sam Kulkarni, Chief Executive Officer
Date: Wednesday, April 19, 2023
Time: 3:00 p.m. ET

A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On April 13, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. patent application no. 17/192,838 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea) (Press release, Lantern Pharma, APR 13, 2023, View Source [SID1234630051]). The allowed application entitled "Illudin Analogs, Uses Thereof, and Methods for Synthesizing the same" covers the molecule LP-284, including claims covering the new molecular entity itself. A notice of allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee.

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"Our growing intellectual property portfolio strengthens the long-term market position for LP-284 and further validates that novel oncology drug development can be done rapidly and cost-effectively when leveraging data-driven insights," said Panna Sharma, Lantern Pharma’s CEO and President. "LP-284 is an exciting new molecule for non-Hodgkin’s lymphomas and perhaps other hematological malignancies that we developed from initial AI insights from our RADR platform to a first-in-human clinical Phase 1 trial, which we are planning to launch later this year, in around two years and at significantly reduced costs," continued Sharma.

Lantern expects the resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039. Lantern intends to continue to prosecute additional patent applications, including patent applications directed to manufacturing methods and methods of use, to further enhance its existing patent estate protecting LP-284. Lantern anticipates receiving similar patent rights for LP-284 in Europe, Japan, India, China, Australia, Canada, and Korea.

Lantern is currently completing the investigational new drug (IND) enabling studies for LP-284 and anticipates submitting the IND application for LP-284 to the U.S. Food and Drug Administration (FDA) in mid-2023. A first-in-human Phase 1 clinical trial launch is anticipated in 2023 for B-cell non-Hodgkin’s lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other NHL cancer subtypes. Nearly all MCL patients relapse from current MCL standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the U.S. and Europe, MCL and DHL are diagnosed in approximately 9,000 patients each year and have an estimated annual market potential of $1.2 billion.

LP-284 was also recently granted an Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of MCL. The ODD strengthens LP-284’s clinical development path and provides the future potential opportunity for additional market exclusivity and commercial protection. In addition to the ODD granted for LP-284 in MCL, Lantern was previously granted ODDs by the FDA for its drug candidate LP-184 for the treatment of malignant gliomas, pancreatic cancer, and atypical teratoid rhabdoid tumors (ATRT). Lantern has also been granted a Rare Pediatric Disease Designation for LP-184 in ATRT.

On April 13, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported the presentation of six posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023 (Press release, IGM Biosciences, APR 13, 2023, View Source [SID1234630050]).

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"We are proud to show the breadth and depth of our oncology pipeline at this year’s AACR (Free AACR Whitepaper) meeting, as the emerging data from our clinical and pre-clinical efforts on IGM-8444, IGM-7354, IGM-2644, IGM-2537 and imvotamab continue to demonstrate the potential for encouraging anticancer activity coupled with favorable safety profiles," said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. "Looking ahead, we look forward to continued dosing in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients and in our initial clinical study of IGM-7354 in patients with solid tumors. We are also excited to be initiating clinical studies of IGM-2644, our CD38 x CD3 T cell engaging IgM antibody, which we hope will prove to be a safe and more potent form of anti-CD38 therapy for multiple myeloma, including for patients who have previously been treated with daratumumab. We look forward to providing continued updates on these exciting oncology programs."

Presentation details are as follows:

Poster Number: 2933
Title: Novel CD123xCD3 bispecific IgM antibody, IGM-2537, potently induces T-cell mediated cytotoxicity of acute myeloid leukemia cells with minimal cytokine release
Presenter: Gene Li, Ph.D., Senior Scientist, Immuno-oncology, IGM Biosciences
Session Date: Monday, April 17
Session Time: 1:30 – 5:00 PM ET

Poster Number: 2959
Title: Novel CD38xCD3 bispecific IgM T cell engager, IGM-2644, potently kills multiple myeloma cells though complement and T cell dependent mechanisms
Presenter: Keyu Li, Ph.D., Associate Director, IGM Biosciences
Session Date: Monday, April 17
Session Time: 1:30 – 5:00 PM ET

Poster Number: 5660
Title: IGM-7354, an immunocytokine with IL-15 fused to an anti-PD-L1 IgM, induces NK and CD8+ T cell mediated cytotoxicity of PD-L1-positive tumor cells
Presenter: Thierry D. Giffon, Ph.D., Senior Scientist, Immuno-oncology, IGM Biosciences
Session Date: Tuesday, April 18
Session Time: 1:30 – 5:00 PM ET

Poster Number: 4120
Title: Depletion of tissue-resident B cells by a CD20xCD3 IgM bispecific T cell engager in cynomolgus monkeys demonstrates effective tissue penetration and potent target cell killing
Presenter: Miho Oyasu, Ph.D., Associate Director, IGM Biosciences
Session Date: Tuesday, April 18
Session Time: 9:00 AM – 12:30 PM ET

Poster Number: 6123
Title: Characterization of the synergistic tumor cytotoxicity of agonistic DR5 IgM antibody IGM-8444 with chemotherapeutic agents
Presenter: Beatrice T. Wang, Ph.D., Associate Director, IGM Biosciences
Session Date: Wednesday, April 19
Session Time: 9:00 AM – 12:30 PM ET

Poster Number: CT052
Title: A phase 1/2 randomized study of imvotamab monotherapy and in combination with loncastuximab tesirine in relapsed/refractory non-Hodgkin lymphomas
Presenter: Catherine Diefenbach, M.D., Director of Hematology Translational Research, NYU Langone Perlmutter Cancer Center
Session Date: Monday, April 17
Session Time: 9:00 AM – 12:30 PM ET