On December 15, 2022 Jalon Therapeutics reported that it has obtained nearly 2 million euros for its first-in-class drug candidate JRT39 is in advanced preclinical development (Press release, Jalon Therapeutics, DEC 15, 2022, View Source [SID1234628535]).

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After a seed funding of €625,000 raised at the beginning of 2022 from Family offices and Business Angels, Jalon Therapeutics won the Innov’Up PIA call for an amount of €450,000 and issued convertible bonds subscribed by BPI France on November 29, 2022 for an amount of €450,000. In 2021, the company won the "Bourse French Tech" and then the "I-Lab" price, collecting cumulative funding of €440,000 that year.

Created in 2021, Jalon Therapeutics develops a portfolio of oncology products resulting from an innovative therapeutic strategy focused on inhibiting the cellular functions of the AAC-11 protein. To maintain the survival of tumor cells, AAC-11 binds to protein partners. Jalon Therapeutics has developed peptides which, acting as molecular decoys inside the cell, block these interactions. In addition, Jalon Therapeutics peptides bind to AAC-11 partners also present in the membrane of tumor cells, triggering their destruction by membranolysis. These targeted mechanisms potentially address a wide variety of cancers, as indicated by preclinical in-vitro and invivo efficacy studies.

The fully patented approach (Inserm Transfert License agreements) selected by Jalon Therapeutics stems from the pioneering research of Jean-Luc Poyet (Inserm, Hôpital St Louis), an expert in cell-penetrating peptides and in the modulation of proteinprotein interactions. The project is backed by Professors Martine Bagot and Hervé Dombret from Saint Louis Hospital where Jalon Therapeutics has established its own laboratory team. The governance of the company combines several seasoned professionals in the industry all of whom have strong experience in the development and financing of drug candidates in oncology.

"We are proud to have raised these funds, which allow us to pursue our preclinical characterization studies," commented Jérôme Tiollier, Executive Chairman and cofounder of Jalon Therapeutics, and David Loison, CEO. The company now aims to raise the capital needed to finance the regulatory studies prior to future phase I/II clinical trials as well as proof of clinical concept.

On December 15, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is currently working on combining its AccumTM technology with mRNA vaccination as previously reported in press release dated of October 31st, 2022 (Press release, Defence Therapeutics, DEC 15, 2022, View Source [SID1234626258]). This R&D program will not only impact the field of cancer immunotherapy, but it can also be directly applied to the development of new vaccines targeting infectious diseases.

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The mRNA vaccination approach offers tremendous advantages over the use of peptide-or protein-based vaccines. mRNA like any other biomolecule, is extremely sensitive to harsh conditions such as high acidity and enzymatic reactions, which would directly impede their therapeutic potency. In addition, mRNA molecules need to reach the cytoplasm where they can be efficiently translated into full proteins, this is where AccumTM may add stability and potency.

Defence has recently shown that "naked" mRNA can indeed be immunogenic, but the humoral (antibody) response generated against the vaccine is extremely weak. The Defence team is therefore working with a private European company to synthesize mRNA vaccines coupled with AccumTM. The objective is to conduct a head-to-head comparison between AccumTM-linked and "naked" mRNA vaccines in their potential to generate an immune response capable of eradicating and controlling established tumors.

"We expect the AccumTM-mRNA vaccine will be prepared by the end of January 2023, then the in vivo study on animals with pre-established solid tumors will commence. The objective of this study is to demonstrate that AccumTM can significantly enhance the therapeutic potency of a given mRNA vaccine", says Mr. Plouffe, CEO of Defence Therapeutics. "Once completed, Defence will have in its possession its own 100% owned mRNA with AccumTM vaccine for cancer. Defence will also be in a position to license its personalized AccumTM technology to any Pharma company with mRNA vaccines", he adds.

The mRNA therapeutics market size is projected to surpass around USD 128.14 billion by 2030 and growing at a registered CAGR of 13.03% from 2022 to 2030 according to Precedence Research.

On December 15, 2022 xCures, Inc. reported their partnership with RenovoRx, a clinical-stage biopharmaceutical company that focuses on fighting cancer through localized treatment of difficult-to-treat tumors, such as pancreatic adenocarcinoma (Press release, xCures, DEC 15, 2022, View Source [SID1234625455]). Through this collaboration, xCures will help eligible pancreatic cancer patients access a Phase III clinical study entitled, Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC).

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The primary focus of the TIGeR-PaC study is to administer targeted therapy to pancreatic cancer patients safely and without transmission to non-targeted areas. The end goals are to determine whether this targeted method of delivering chemotherapy can extend survival while also improving quality of life.

Although pancreatic cancer treatment has improved, pancreatic cancer patients continue to have poor outcomes – partially due to the tissue surrounding the tumor hampering intravenously delivered chemotherapy drug access to the cancer cells. Unlike intravenous (systemic) chemotherapy, RenovoRx’s technology delivers chemotherapy directly to the pancreas via an artery close to the tumor. RenovoRx designed this technology based on evidence that administering chemotherapy in this way may shrink or stabilize certain types of cancer. In fact, studies have demonstrated that gemcitabine (an FDA-approved chemotherapy) administered directly via the pancreatic arteries may be associated with more than half the patients living over two years.

"As the RenovoRx team looks forward to reporting the first prospective interim analysis for the TIGeR-PaC study, expected in the beginning of 2023, we are pleased to partner with xCures to aid additional pancreatic cancer patients gain access to our study," said Shaun Bagai, CEO of RenovoRx. "Our therapy platform is challenging the standard-of-care treatment (systemic chemotherapy) available to locally advanced pancreatic cancer (LAPC) that is often associated with debilitating side effects for patients."

Mr. Bagai added, "Results of Phase I/II and observational registry studies suggest that the RenovoRx therapy platform may enhance patient survival while countering chemotherapy tolerability issues. The result could be more time for patients with their loved ones and improved quality of life."

"We are thrilled to partner with RenovoRx and help more pancreatic cancer patients gain access to the TIGeR-PaC clinical study," said Mika Newton, CEO of xCures. "We hope our combined efforts will improve recently diagnosed pancreatic cancer patient’s health and quality of life outcomes."

The TIGeR-PaC study is open to adults recently diagnosed with pancreatic adenocarcinoma that has not spread to other body parts and cannot be treated surgically. If you are interested in signing up for the study, click here. Once you do so, a member of the xCures study team will assist you through the screening and enrollment process if you are eligible.

On December 15, 2022, Novavax, Inc. (the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Jefferies LLC and Cowen and Company, LLC, as representatives of the several underwriters named in Schedule I thereto (collectively, the "Underwriters"), relating to the public offering by the Company of 6,500,000 shares of its common stock, par value $0.01 per share ("Common Stock"), at a public offering price of $10.00 per share, less underwriting discounts and commissions, pursuant to the Company’s effective automatic shelf registration statement on Form S-3 (File No. 333-237094) and the related prospectus supplement filed with the Securities and Exchange Commission (the "Common Stock Offering") (Filing, 8-K, Novavax, DEC 15, 2022, View Source [SID1234625409]). In connection with the Common Stock Offering, the Company granted the Underwriters a 30-day option to purchase up to an additional 975,000 shares of Common Stock at the public offering price, less underwriting discounts and commissions, which was exercised in full by the Underwriters on December 16, 2022. The Common Stock Offering is expected to close on December 20, 2022, subject to customary closing conditions.

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The Underwriting Agreement contains customary representations, warranties, covenants and closing conditions. It also provides for customary indemnification by each of the Company and the Underwriters against certain liabilities and customary contribution provisions in respect of those liabilities.

The foregoing description of certain terms of the Underwriting Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and is incorporated by reference herein. A copy of the opinion of Ropes & Gray LLP, relating to the legality of the shares being sold, is filed as Exhibit 5.1 hereto and is incorporated by reference herein.

On December 15, 2022 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Mirati Therapeutics to be a specialty pharmacy partner for KRAZATI (adagrasib), which is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy (Press release, Onco360, DEC 15, 2022, View Source [SID1234625341]). This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification of a clinical benefit in a confirmatory trial.

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"Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients"

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"Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are dedicated to supporting the highly specialized needs of patients battling previously treated, advanced NSCLC with KRAS G12C mutations across the United States."

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 236,740 new cases of lung cancer will be diagnosed in 2022 in the United States with a corresponding 130,180 deaths in 2022. Up to 85% of all lung cancers are histologically NSCLC. When considering all stages and histologic subtypes of lung cancer, five-year overall survival (OS) is only 22.9%. Unfortunately, 56% of lung cancer patients already have metastatic disease upon initial diagnosis. Patients with metastatic lung cancer have a dismal five-year OS of 7%. Approximately 13% of NSCLC patients are found to have KRAS G12C mutations.1,2

KRAZATI is commercialized by Mirati Therapeutics. The FDA approval of KRAZATI is based on results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 (NCT03785249) study evaluating KRAZATI 600 mg twice daily in patients with non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior systemic therapy. The KRYSTAL-1 Phase 2 cohort showed that KRAZATI administration resulted in a 42.9% objective response rate (ORR) in the study population. The most common adverse reactions (≥20%) are diarrhea, nausea, fatigue, vomiting, decreased appetite, dizziness, and QT prolongation