On October 20, 2022 SYnAbs reported a research collaboration program to discover novel therapeutic antibodies against challenging G Protein Coupled Receptor (GPCR) targets (Press release, Domain Therapeutics, SEP 20, 2022, View Source [SID1234622452]).

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For Domain Therapeutics, this collaboration aims at diversifying its proprietary portfolio of immunotherapies with biologics to deliver therapeutic solutions against tumors triggering GPCR-mediated immunosuppression. Under the terms of the agreement, Domain Therapeutics retains exclusive worldwide rights to validate, optimize, develop and commercialize any therapeutic antibodies discovered in the course of the collaboration.

For SYnAbs, the goal is to further optimize its technologies capable of generating highly specific antibodies targeting epitopes that are difficult to express in their native and functionally active conformation.

SYnAbs approach consists in immunizing species with peptides and its proprietary syngeneic cell lines, all mixed with its in-house adjuvant in order to neutralize the immunotolerance usually developed against highly homologous transmembrane targets and benefit from a natural in-vivo maturation.

SYnAbs is also the developer of the rat-LOU species, a species known to be a high responder against haptens and which has the unique ability to naturally generate autoantibodies. This animal is already the source of several therapeutic antibodies such as Siplizumab (licensed to MedImmune, Phase III), LO-CD2b (Preclinical Tox), LO-TACT- 1, anti-CD25 (Phase I/II) and more recently SYnC3aR, a blocking mAb to hC3aR anaphylatoxin receptor.

Under the terms of the agreement, SYnAbs will utilize its know-how and proprietary technologies combined with Domain Therapeutics deep expertise in GPCRs and immuno-oncology to identify novel high-potential drug candidates. Domain will be responsible for the preclinical and clinical development of the jointly discovered antibodies and for a potential partnership with a third party company according to Domain Therapeutics strategy.

On September 20, 2022 Alpine Immune Sciences, Inc. (the "Company") and Cowen and Company, LLC ("Cowen") reported that mutually terminated the Sales Agreement (the "Sales Agreement") between the parties dated July 2, 2021 (Filing, 8-K, Alpine Immune Sciences, SEP 20, 2022, View Source [SID1234621331]). The Sales Agreement provided that the Company may sell shares of its common stock, from time to time, for up to $75,000,000 in aggregate sales proceeds, through an "at the market" equity offering program under which Cowen acted as sales agent. No shares of the Company’s common stock were sold under the Sales Agreement that has been terminated.

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The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on July 2, 2021.

On September 20, 2022 Verismo Therapeutics, a clinical-stage biotechnology company and a Penn-spinout behind the novel KIR-CAR platform technology, reported that is has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1 clinical trial of SynKIR-110 (Press release, Verismo Therapeutics, SEP 20, 2022, View Source [SID1234619712]).

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The Phase 1 trial, STAR-101 (SynKIR T cell Advanced Research), will assess safety, tolerability, and preliminary efficacy of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma. This first-in-human trial seeks to address several areas of high unmet medical need. For each indication, the five-year survival rates are 49.7% for ovarian cancer, 30% for cholangiocarcinoma and 10% for mesothelioma. Patients suffering from these diseases urgently need a successful treatment option.

STAR-101 will mark the first-in-human study for SynKIR T cells, a next generation approach to cell therapy targeting solid tumors powered by the KIR-CAR platform. Its unique, multi-chain KIR-CAR construct reduces T cell exhaustion through the natural on-and-off switch that allows the cells to rest when not bound to the tumor, as well as enhanced surface stability to improve the performance of the cells in the harsh microenvironment of solid tumors.

"Pre-clinical data have shown enhanced efficacy in murine models with no additional safety concerns. The FDA’s clearance of our SynKIR-110 IND represents a new chapter for Verismo as we initiate the first-ever clinical trial for KIR-CAR T cells. It also validates the years of innovative research and hard work by industry pioneers at Penn and the Verismo team," said Dr. Bryan Kim, CEO of Verismo.

"SynKIR-110 is the first product to use the novel KIR-CAR platform. Our technology incorporates a natural on/off switch that allows KIR-CAR T cells to rest when not exposed to tumor antigens, as well as providing an enhanced cell-surface stability of the KIR-CAR," said Dr. Laura Johnson, CSO of Verismo. "These enhancements will allow KIR-CAR T cells to better cope with the harsh tumor microenvironment of solid tumors and, potentially, lead to better outcomes for our patients."

Verismo plans to begin enrolling patients in the first quarter of 2023 at the initial clinical site, the Hospital of the University of Pennsylvania.

On September 20, 2022 Shuttle Pharmaceuticals Holdings, Inc. ( Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT) while reducing its side effects, reported that it entered into an agreement with TCG GreenChem, Inc. to manufacture Ropidoxuridine, the Company’s lead clinical sensitizer drug candidate, for use in formulating the drug product for testing in clinical trials of Ropidoxuridine and RT of cancers (Press release, Shuttle Pharmaceuticals, SEP 20, 2022, View Source [SID1234619711]).

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"Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need and the current limitations of using ‘off-label’ drugs with potential new sensitizer agents," said Dr. Anatoly Dritschilo, Chief Executive Officer of Shuttle Pharmaceuticals. "Ropidoxuridine, our lead clinical sensitizer drug candidate, sensitizes rapidly growing cancer cells and selective histone deacetylase (HDAC) inhibitors, to sensitize cancer cells and stimulate the immune system. Our novel technologies will be tested in combination with radiation therapies, such as conventional X-ray and proton radiation therapies, and in combination with immune therapies."

"Today’s agreement with TCG GreenChem allows us to advance our clinical research, including our proposed Phase II clinical trials, to establish the data necessary for the FDA to determine efficacy in treating brain tumors, sarcomas and pancreatic cancers, diseases that offer potential for orphan designations. For instance, the FDA has already granted approval of our application for orphan-drug designation for Ropidoxuridine for the treatment of glioblastoma. We look forward to working with TCG GreenChem to advance our clinical work to improve outcomes for these cancer patients," Dr. Dritschilo concluded.

In conjunction with manufacturing Ropidoxuridine, TCG GreenChem will perform process research, development and optimization work for Shuttle Pharma related to Ropidoxuridine and create working standards of starting materials and intermediates to support the qualitative/quantitative analysis of the drug reaction progress, determination of impurities, total mass balance and assay yields of the reactions. Shuttle Pharma will own all intellectual property and improvements developed through the Manufacturing Agreement.

TCG GreenChem, Inc. was founded by former large pharma pharmaceutical executives with a track record in the development of hundreds of New Chemical Entities into the clinic and commercialization of several well-known pharmaceutical products for Boehringer Ingelheim Pharmaceuticals, Inc., Sepracor, Inc., and Merck & Co, Inc. Dr. Chris Senanayake, the CEO and CSO of TCG GreenChem, CSO of TCG Lifesciences Pvt Ltd., and who serves on the board of directors of Shuttle Pharma, is a pioneering scientist and business executive who recently received two 2022 Business Worldwide Magazine CEO Awards, including "Best CEO in the Pharmaceutical Industry – North America" and the "Growth Strategy CEO of the Year – USA." In addition, he has been recognized as one among the "Top 20 Dynamic CEOs of 2022" in The CEO Publication Magazine. Also, Dr. Joseph D. Armstrong, III, co-founder and COO of TCG GreenChem, and one of the recipients of the Presidential Green Challenge Award, as determined by the EPA, is on Shuttle Pharma’s Scientific Advisory Board. In this capacity, Dr. Armstrong provides insight on green technologies to manufacture and formulate clinical supplies of Ropidoxuridine, to accelerate this molecule rapidly through the drug development pathway to commercialization.

Various sources have estimated that more than 800,000 patients in the US are treated with radiation therapy for their cancers. According to the American Cancer Society about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes. The number of patients being treated with RT is expected to grow by more than 22% over the next five years. Based on a rough estimate of a course of radiation sensitizing brand drug therapy (off label at this time) of $12,000 per patient—the market size would be in excess of $4.0 billion.

On September 20, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that it will present the latest developments on delivery of novel RNAi therapies for cancer, and its GalAhead platform and programs, at the 2nd Annual Oligonucleotide Therapeutics and Delivery Conference (Press release, Sirnaomics, SEP 20, 2022, View Source [SID1234619710]). The conference will take place on September 21 and 22, 2022 with workshops on September 20, 2022 at Copthorne Tara Hotel, London, UK.

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Presentation Details

Presentation Title: Delivery of Novel siRNA Constructs for Treating Cancer
Presenter: Dr. David Evans, Chief Scientific Officer, Sirnaomics
Time/Date: 15:20 GMT on Wednesday, September 21, 2022
Presentation Topics:
Creating novel siRNA constructs for cancer treatment
Introduction to Sirnaomics’ polypeptide nanoparticle delivery system (PNP-IT)
Introduction to STP705, Sirnaomics’ lead oncology siRNA therapeutic targeting TGF-β1/COX-2
Discussion of novel siRNA therapeutics targeting other oncology indications

Presentation Title: GalAhead Therapeutic Platform and Programs
Presenter: Dr. Jack Wei, Senior Director, Sirnaomics
Time/Date: 16:30 GMT on Thursday, September 22, 2022
Presentation Topics:
Introduction to GalAhead, Sirnaomics’ GalNAc-RNAi therapeutic platform
Miniaturized RNAi (mxRNA) as a key technological component of the platform
Validation of technology in vivo and in vitro
Progress report on GalAhead-based programs