On April 13, 2023 Adcendo ApS ("Adcendo"), a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with a high unmet medical need, reported that it will be presenting novel data evaluated in co-operation with the Laboratory of Experimental Oncology at KU Leuven/Leuven Cancer Institute on the expression of the novel ADC target uPARAP in Soft Tissue Sarcoma (STS) and Bone Sarcoma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in Orlando, Florida on the 14-19 April, 2023 (Press release, ADCendo, APR 13, 2023, View Source [SID1234630057]).

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Details of the conference and presented poster are as follow:

Presentation title: 1457 / 27 The urokinase plasminogen activator receptor-associated protein (uPARAP) is an attractive target for the development of antibody-drug conjugates (ADCs) for treatment of mesenchymal malignancies

Session: Experimental and Molecular Therapeutics, Chemistry

Session Title: Antibody Drug Conjugates

Authors: Pernille Barkholt (1), Agnieszka Wozniak (2), Chao-Chi Wang (2), Che-Jui Lee (2), Lore De Cock (2, 3), Lars Henning Engelholm (1), Carmel Lynch (1), Dominik Mumberg (1), and Patrick Schöffski (2, 3)

Date & Time: 17 April at 09:00am – 12.30pm CDT

Abstracts will be published on 04 April, and can be accessed at View Source

uPARAP is a novel ADC target overexpressed by mesenchymal cancer cells including soft tissue and bone sarcomas and may play an important role in shaping the tumor microenvironment.

The presentation entitled "The urokinase plasminogen activator receptor-associated protein (uPARAP) is an attractive target for the development of antibody-drug conjugates (ADCs) for treatment of mesenchymal malignancies" demonstrates that uPARAP is strongly over-expressed by cancer cells in multiple soft-tissue & bone sarcoma subtypes, with limited expression in healthy tissues.

Based on its differentiated expression profile, uPARAP is an attractive novel target for development of uPARAP-targeting ADCs in a broad range of sarcoma subtypes. Additionally, uPARAP receptor levels may serve as a potential biomarker for patient enrichment in clinical studies of such uPARAP-targeting ADCs.

Dominik Mumberg, Chief Scientific Officer of Adcendo, said: "We are excited to share data on the expression of uPARAP in soft tissue and bone sarcoma. In addition to its differentiated expression profile in multiple sarcoma subtypes uPARAP is a constitutively recycling endocytic receptor with unique internalization properties, making it a highly attractive ADC target."

Patrick Schöffski, Head of the Department of General Medical Oncology at the University Hospitals and the Laboratory of Experimental Oncology at the Catholic University in Leuven, commented: "Due to its significant morphological and biological heterogeneity, treatment progress and therapeutic options in soft tissue and bone sarcoma have so far been quite limited. We are extremely encouraged by the data highlighted in this study, which provides further evidence on the potential utility of uPARAP as a novel target for drug development across multiple sarcoma subtypes. We are looking forward to continuing to explore the molecular epidemiology of uPARAP in various types of sarcoma and to investigate uPARAP-directed ADCs in patient-derived xenograft models of sarcoma.

On April 13, 2023 The Wisconsin Alumni Research Foundation (WARF), which has a mission of supporting research at the University of Wisconsin-Madison, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported a partnership to leverage Ginkgo’s proprietary high-throughput combinatorial CAR discovery and screening platform with the aim of discovering next generation GD2 CAR T-cell therapies with improved persistence, proliferation, fitness, and other functional properties to improve efficacy for the treatment of solid tumors (Press release, Ginkgo Bioworks, APR 13, 2023, View Source [SID1234630056]).

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Through this partnership, Ginkgo will collaborate with the University of Wisconsin-Madison researchers Professor Krishanu Saha, Ph.D., as principal investigator (PI) and Dr. Christian Capitini, M.D. as co-PI. Professor Saha’s lab focuses on developing the next-generation cell engineering techniques to advance human therapeutics, and Dr. Capitini is a pediatric oncologist who has extensive clinical experience with CAR T-cell therapies, including serving as a site PI for the clinical trial that led to the first FDA approval of a CAR T-cell therapy. The two have collaborated on the development of a GD2 CAR T-cell therapeutic candidate for the treatment of neuroblastoma, a type of cancer generally affecting young children, using a non-viral, site-specific integration method developed by Professor Saha and published in the Journal for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): Production and characterization of virus-free, CRISPR-CAR T cells capable of inducing solid tumor regression.

Under this collaboration, Ginkgo will use its pooled CAR screening platform to design and characterize novel intracellular signaling domains that prevent the exhaustion of T-cells in the GD2 solid tumor context. Any novel designs will be validated in high throughput in vitro screens and in in vivo murine models. In addition, Ginkgo and WARF plan to collaborate on the development of a pooled in vivo screening platform to advance novel CAR discovery further.

"Ginkgo’s high throughput screening method has proven successful in enabling massively parallel testing of CAR designs, and has already led to the discovery of new intracellular domains (ICD) combinations," said Krishanu Saha, a professor at the University of Wisconsin-Madison. "By partnering with Ginkgo, we aim to unlock the potential to transform patient outcomes and reimagine the future of solid tumor cancer treatment."

CAR T-cell therapies show tremendous promise for the treatment of cancer. However, their use has thus far largely been limited to targeting blood cancers because they have failed to show consistent efficacy in treating solid tumors, which represent approximately 90% of adult human cancers. Part of the challenge when applying CAR T-cell therapies to solid tumors is T-cell exhaustion, a state of dysfunction arising from excessive antigen stimulation in the immunosuppressive environment of a solid tumor.

WARF and Ginkgo hope to work towards solving this challenge by utilizing Ginkgo’s high-throughput combinatorial CAR discovery platform. As a platform technology company, Ginkgo can leverage its full stack of mammalian cell engineering expertise and capabilities to enable the high throughput screening of CAR T-cells to help discover and optimize future next-generation therapeutic candidates for its partners.

"WARF is delighted to see this important collaboration," says Erik Iverson, WARF CEO. "We know these alliances between our university researchers and leading biotech industry partners have the potential to result in benefits that positively impact human health."

"This collaboration represents a fantastic opportunity to demonstrate the potential value of pooled CAR screening approaches directly in the context of devastating diseases like early childhood cancers," said Narendra Maheshri, Head of Mammalian Engineering at Ginkgo. "It’s especially exciting to work with pioneers like Professors Saha and Capitini, who have pushed R&D boundaries in the laboratory and whose approach is thoroughly grounded in the translation of their findings for clinical impact."

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.