On March 8, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its Chief Executive Officer, Zachary Hornby, will present at the Oppenheimer 32nd Annual Healthcare Conference, which will take place virtually (Press release, Boundless Bio, MAR 8, 2022, View Source [SID1234609694]). Presentation details are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Date: Tuesday, March 15, 2022
Time: 2:00 PM – 2:30 PM ET

On March 8, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for Guardant360 TissueNext under the existing local coverage determination (LCD) (MolDX: Next-Generation Sequencing for Solid Tumors) (Press release, Guardant Health, MAR 8, 2022, View Source [SID1234609693]). Guardant360 TissueNext is the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The policy covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service. "We are pleased that Medicare has taken this important step to make complete genomic profiling more widely available for patients with advanced cancers," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for patients with advanced stage cancer. In December 2019, Palmetto GBA expanded LCD of the Guardant360 assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumor cancers.

On March 8, 2022 Mytide Therapeutics, a company transforming peptide manufacturing with predictive analytics and machine learning, reported that it has raised $7 million in Series A financing (Press release, Mytide Therapeutics, MAR 8, 2022, View Source [SID1234609692]). The round was led by Alloy Therapeutics, a biotechnology ecosystem company, and was joined by Uncommon Denominator and the Mytide founding team. As part of the financing, Alloy Therapeutics CEO Errik Anderson will join Mytide’s Board of Directors. This financing will allow Mytide to scale its AI-enabled Gen2 platform to support cost-effective, scalable, and decentralized manufacturing for a wide-variety of peptide and peptide conjugate applications for therapeutic discovery and personal peptide vaccines (PPV).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Together, we are excited to empower developers of peptide and combination therapeutics and enable rapid innovation in this promising modality, for the ultimate benefit of patients."

Mytide’s Gen2 platform produces both natural and non-natural peptides 30-times faster than traditional manufacturing practices by eliminating bottlenecks throughout the entire process of synthesis, analysis, purification, and lyophilization. Through rigorous in-process data collection, Mytide’s continuously learning AI-guided engine enables higher purity, production reliability, and speed, by controlling a proprietary set of chemical processes, analytical tools, and robotics. These tools enable access to a novel peptide space including difficult-to-manufacture non-canonical amino acids, constrained peptides, and short-proteins that are inaccessible or uneconomical to produce and screen using traditional peptide manufacturing processes.

Mytide’s robust data capture and processing techniques represents one of the largest and fastest growing peptide manufacturing data repositories in the world. Through unparalleled manufacturing speed and precision, Mytide’s technology has addressed the high-throughput screening and library generation needs of computational biology modeling to support in vivo and in vitro studies, as well as clinical trial studies.

"At Mytide, we aim to overcome the time-consuming and labor-intensive organic chemistry processes limiting peptide and other biopolymer production. Our goal is to speed drug developers’ ability to translate therapeutic innovations into clinical impact," said Mytide co-founder Dale Thomas. "Our platform takes a holistic view of the entire manufacturing process and couples it with a fully closed-loop computational biology platform, unlocking therapeutic development at unprecedented speeds and precision. The investment from Alloy Therapeutics brings our quick-turn manufacturing technology into a broad drug discovery ecosystem to further accelerate the development of new peptide therapeutics."

Peptides are a high growth drug discovery modality of interest within the pharma industry, with multiple PPVs in Phase III clinical trials. To validate its technology, Mytide has actively partnered its continuous manufacturing platform with pharmaceutical companies requiring scalable and time-sensitive manufacturing for both research and clinical programs. Mytide’s Gen2 platform is designed to easily be integrated into cGMP manufacturing environments to allow for scalable and decentralized clinical trial manufacturing of a partner’s lead peptide-based therapeutic candidates. Mytide continues to advance upon the progress in molecular access and analysis being made by the likes of Integrated DNA Technologies (IDT), Illumina, and Thermo Fisher Scientific.

"Mytide represents an exciting opportunity to bring down barriers in drug development further, by providing Alloy’s ecosystem of industry partners with access to high-quality, AI-enabled peptide manufacturing," said Errik Anderson, Alloy Therapeutics CEO and founder. "Together, we are excited to empower developers of peptide and combination therapeutics and enable rapid innovation in this promising modality, for the ultimate benefit of patients."

On March 8, 2022 Australian clinical-stage drug development company Noxopharm (ASX:NOX) reported its Phase 1 CEP-2 sarcoma trial is underway with a first patient enrolled and dosed at City of Hope in Los Angeles, California (Press release, Noxopharm, MAR 8, 2022, View Source [SID1234609691]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted to have dosed the first patient in the CEP-2 trial," said City of Hope CEP-2 Principal Investigator Mark Agulnik, M.D. "The study investigates the use of Veyonda in combination with the chemotherapy drug doxorubicin for first-line treatment of approximately 30 patients with soft tissue sarcoma, which is an aggressive cancer in urgent need of new treatment options."

City of Hope, a world-renowned cancer center in the U.S., is the first site to commence treatment, but recruitment is ongoing and Noxopharm plans to open future major U.S. trial sites.

"Partnering with the prestigious City of Hope for this CEP-2 study, along with the MD Anderson Cancer Center and Beverly Hills Cancer Center for our radiation therapy trial [DARRT] program, represents the strength of our programs and the talent and experience of our team at Noxopharm," said Noxopharm CEO and Managing Director Gisela Mautner, M.D.-Ph.D., MPH. "We look forward to adding additional prestigious study sites in the near future as we all work toward new treatment options."

The first safety results for the CEP-2 study will be available after patient cohort 1 has completed the first cycle of combination therapy. The CEP-2 study is building on the CEP-1 study, which was a Phase 1a/1b trial that was published in April 2021 in the peer-reviewed journal Current Therapeutic Research, and showed the success of Veyonda in boosting the efficacy and safety of chemotherapy in late-stage cancer patients.

On March 8, 2022 Ixaka Ltd, an integrated cell and gene therapy company, reported that Advanced Therapy Medicinal Product (ATMP) classification has been granted by the European Medicines Agency (EMA) for its Chemically Encapsulated Lentiviral vector for Targeted In Vivo CAR T-cell therapy (CELTIC-19) targeted nanoparticle (TNP) product (Press release, Ixaka, MAR 8, 2022, View Source [SID1234609690]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ATMP status was granted to CELTIC-19 due to its potential as a gene therapy medicinal product that targets specific cells and expression of the gene of interest directly within the patient’s body. Such an approach makes it possible to eliminate all the ex vivo stages of genetic modification, that are required for the production of currently marketed cell therapy products.

CELTIC-19 is Ixaka’s lead TNP program for CD19 haematological malignancies. It consists of a polymer nanoparticle encapsulating a bald lentiviral vector encoding for a T-cell specific promoter and the chimeric antigen receptor (CAR). The nanoparticle is coated with a CD3 binding molecule allowing in vivo targeting and transduction of the T-cells. The construct can then be infused systemically into the bloodstream to target and genetically modify T-cells within the body. This approach allows the generation of CAR T-cells which are potentially more efficacious, safer, and considerably less expensive to produce than established CAR T-cell therapies, which have been shown to be effective and have been approved for use in CD19-malignancies.

CELTIC-19’s numerous advantages over established ex vivo CAR T-cells therapies, include but are not limited to its high specificity and transduction efficiency, retreatment possibility, no cytokine requirement and persistent expression.

Gilbert Wagener, Senior Vice President, Chief Medical Officer at Ixaka commented:

"TNP-based in vivo CAR T-cell therapies such as Ixaka’s represent a significant advance over recently approved ex vivo CAR T-cell therapies, and hold the promise of delivering more effective, universal, and safer treatment option for patients. It is great to see this potential recognized by the Europeans Medicine Agency."

Joe Dupere, CEO at Ixaka commented:

"Our nanoparticle-based in vivo gene delivery technology is ideally positioned to deliver on the promise of in vivo CAR-T therapies to transform cancer treatment without the need for costly dedicated manufacturing sites for T-cell modification. The designation of CELTIC-19 as an Advanced Therapy Medicinal Product further signifies its potential as a ground-breaking new treatment option and is an important step on our continued journey."