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).

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"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]).

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"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]).

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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."

On March 8, 2022 Prestige BioPharma Limited (950210: KRX), a Singapore-based biopharmaceutical with operations in USA and South Korea, reported that the preclinical data of their First-in-Class pancreatic cancer treatment, PBP1510 (INN-Ulenistamab), has been shared in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2022 held virtually on March 7-8, 2022 (Press release, Prestige BioPharma, MAR 8, 2022, View Source [SID1234609689]).

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ESMO is one of the leading professional organisations for medical oncology, together with American Association for Cancer Research (AACR) (Free AACR Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

Preclinical data of PBP1510 presented in the poster shows notable regression in tumour volume and weight in subcutaneous as well as orthotopic patient derived cancer xenograft (PDX) mouse models treated with PBP1510 compared to gemcitabine and IgG controls. In the orthotopic PDX model, tumour cells derived from pancreatic cancer patients are surgically implanted into the pancreas of mice. Such models are of high clinical relevance as they aid in establishing organ-specific tumour microenvironment with great accuracy.

In repeated dose toxicity studies, no notable systemic or local toxicity was observed for up to 40 mg/kg of PBP1510. Absence of anti-drug antibodies was noted in all animals receiving PBP1510 indicating low immunogenic potential.

Based on the efficacy and safety demonstrated in the preclinical study, PBP1510 is currently in Phase 1/2a clinical trial in France and Spain.

The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect very few individuals but cause great suffering. This designation provides companies with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU and the U.S. for certain years.

Prestige has strong pipeline portfolio comprising innovative antibody drugs and biosimilars including the frontrunning Herceptin biosimilar HD201 (Tuznue) filed to EMA, Health Canada and MFDS, an Avastin biosimilar HD204 (Vasforda) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe. The company’s second First-in-Class antibody PBP1710 targeting CTHRC1, a ubiquitous protein overexpressed in many types of cancer, is currently in preclinical stage.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We will identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy," and "Prestige will accelerate the development of PBP1510 that has demonstrated solid evidence and potential as the new cure for pancreatic cancer".

On March 8, 2022 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide business updates for the fourth quarter and year ended December 31, 2021, before the US markets open on Monday, March 14, 2022 (Press release, Adaptimmune, MAR 8, 2022, View Source [SID1234609688]). Following the announcement, the Company will host a live teleconference and webcast at 8:30 a.m. EDT (12:30 p.m. GMT) that same day (details below).

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3utRMny.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (1343635).