On January 20, 2022 -Pluristyx, Inc., an advanced therapy tools and services biotechnology company, panCELLa, a privately held biotechnology company, and Implant Therapeutics, a developer of genetically engineered stem cells, reported that they have entered into a manufacturing and distribution strategic alliance that offers cell therapy companies streamlined access to the next generation of safe, universal, cost-effective, "off-the-shelf" induced pluripotent stem cells (iPSCs) (Press release, Pluristyx, 20 20, 2022, View Source [SID1234605668]). The agreement will enable commercial access to iPSCs containing panCELLa’s FailSafe and Implant’s hypoimmunogenic technology derived from fully consented and regulatory appropriate donors. Both research and clinical grade panCELLa-owned iPSC lines will be manufactured and distributed by Pluristyx, who will also make custom iPSC lines incorporating panCELLa and Implant technology to meet unique customer needs.

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"We evaluated many manufacturing partners and concluded that Pluristyx’s proprietary platform and mRNA reprogramming technologies provided the ideal complement to our platform technologies. We think this combination of complementary skills will enable wide dissemination of our technology."

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Dr. Mahendra Rao, Chief Executive Officer of Implant, commented, "We evaluated many manufacturing partners and concluded that Pluristyx’s proprietary platform and mRNA reprogramming technologies provided the ideal complement to our platform technologies. We think this combination of complementary skills will enable wide dissemination of our technology."

"Pluristyx is excited to be working with panCELLa and Implant to commercialize their unique gene-edited platforms and iPSC lines. The combination of Pluristyx’s iPSC manufacturing and reprogramming technologies with panCELLa and Implant’s Stealth and FailSafe platforms will provide immediate access to a unique and ideal raw material for making the next generation of cell therapies," said Dr. Benjamin Fryer, Chief Executive Officer of Pluristyx.

On January 20, 2022 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported a therapeutic co-development partnership with Fannin Innovation Studio (Press release, Champions Oncology, JAN 20, 2022, View Source [SID1234605618]). The partnership will combine novel therapeutic targets identified within Champions’ Lumin platform with Fannin’s Therapeutic Raptamer platform to develop next generation Raptamer Drug Conjugates (RDC’s). RDCs engage tumor-specific therapeutic targets at a cell’s surface to deliver potent toxic payloads to the tumor, without affecting normal cells. The planned partnership will initiate with a single program focused on a previously unexplored target present in tumor indications such as non-small cell lung cancer (NSCLC), head and neck cancer, and other solid tumors. The partnership will also leverage the unique experimental platforms available at Champions to ensure rapid and efficient development towards clinical evaluation. Under the terms of this agreement, Champions and Fannin will share equal ownership of the developed therapeutic and establish a joint venture after specific development milestones are met.

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Ronnie Morris, MD, President and CEO of Champions Oncology, said "We’re excited to announce another partnership in drug discovery and development. Our experimental and digital research platforms continue to expand our understanding of tumor cell biology. With our AI-driven analytics, and deeply characterized dataset, we can completely reconstruct a tumor at the molecular level and identify differences between a tumor cell and normal cell. Over the past year, we have identified a considerable number of therapeutic targets that were previously overlooked using conventional methods, and we continue to scale our efforts to reveal others. The specific target being leveraged in this partnership has a profile that makes it uniquely interesting for an RDC-based therapeutic. Fannin’s Raptamer Platform is a compelling approach to therapeutic discovery, and we believe this partnership is the right approach for this target. We are eager to see this program develop with our combined expertise."

Atul Varadhachary, MD, PhD, Managing Partner of Fannin Innovation Studio, noted that "Our validated Raptamer platform provides a unique opportunity to rapidly develop selective, high-affinity ligands for targeted payload delivery to a variety of tissues, including tumors. The Raptamer platform provides complementary capabilities to Champions’ multiomic computational platform, and we are excited about our joint venture with Champions as well as the initial neo-antigenic target for our partnership."

On January 20, 2022 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported its lead candidate VT1021 will advance into a Phase 2-3 registrational study through the company’s collaboration with the Global Coalition for Adaptive Research (GCAR) (Press release, Vigeo Therapeutics, JAN 20, 2022, View Source [SID1234605637]). VT1021 will be part of GCAR’s GBM AGILE Phase 2-3 adaptive platform trial for patients with glioblastoma.

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VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype.

GBM AGILE is a patient-centered adaptive platform trial to support registration that tests multiple therapies for patients with newly diagnosed and recurrent glioblastoma (rGBM) – the deadliest form of brain cancer.

VT1021 was selected for inclusion in the global AGILE Phase 2-3 trial based on the unique and relevant mechanism of action and the existing strong preliminary clinical data from the completed open-label, multicenter Phase 1/2 study (NCT03364400), evaluating the safety and preliminary anti-tumor efficacy of single-agent VT1021 in subjects enrolled in both dose escalation and dose expansion cohorts.

In the rGBM expansion cohort, VT1021 demonstrated significant single agent activity. Among 22 evaluable GBM subjects, 3 had complete response (CR), 1 had partial response (PR), and 7 had stable disease (SD). The overall disease control rate (DCR) was 50%. In the responder group, the average time on study was over 300 days with 2 subjects on study for over 480 days at the conclusion of the study. These two subjects continued to receive VT1021 through an extension study and have both have gone over 525 days receiving VT1021.

"We are excited that GCAR selected VT1021 for its Phase 2-3 study for patients with glioblastoma," said Vigeo COO Dr. Jing Watnick. "In the expansion study, VT1021 demonstrated noteworthy single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47, and we believe it could be an important new treatment option for patients. We look forward to providing an update when the trial commences."

Vigeo also plans to initiate efficacy studies in additional solid tumor indications, including pancreatic cancer, with its lead candidate, VT1021 during the first half of 2022.

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

On January 20, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that it will host a webcast highlighting its ADC platform and solid tumor pipeline on Tuesday, February 8, from 9:00 to 11:00 a.m. ET (Press release, ADC Therapeutics, 20 20, 2022, View Source [SID1234605670]).

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Chris Martin, PhD, Chief Executive Officer, Patrick van Berkel, PhD, Senior Vice President of Research & Development, and Joseph Camardo, MD, Chief Medical Officer, will provide insight into the company’s proprietary ADC platform technology and a deep dive into the company’s promising pipeline of programs for the treatment of various solid tumors.

A live webcast will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

On January 20, 2022 Mabwell (Shanghai) Bioscience reported a $547 million IPO on Shanghai’s STAR Board (Press release, Mabwell Biotech, JAN 20, 2022, View Source [SID1234605619]). Established in 2017, Mabwell is a clinical-stage antibody developer with 15 assets in its pipeline: three are in BLA stage, three in pivotal trials and six in Phase I/II trials. The company’s lead candidates are biosimilars. It develops therapies for indications in auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases. The company has a wholly-owned US subsidiary, Mabwell Therapeutics, in San Diego. Mabwell’s shares have fallen 22% below their IPO price.

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