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

On December 15, 2022 Enlaza Therapeutics, the first covalent biologic platform company, reported its official launch with the closing of $61 million in seed financing (Press release, Enlaza Therapeutics, DEC 15, 2022, https://enlazatx.com/press_release/enlaza-therapeutics-launches-with-61-million-financing-to-advance-the-first-covalent-biologic-therapeutic-platform/ [SID1234625340]). The financing was led by Avalon Ventures and joined by Lightspeed Venture Partners, Frazier Life Sciences, and Samsara BioCapital. The financing will be used to further advance Enlaza’s proprietary War-LockTM platform and build a pipeline of covalent biologics with an initial focus on developing novel, differentiated cancer therapeutics with targeted efficacy and low toxicity.

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"We’ve combined recent breakthroughs that allow introduction of proprietary unnatural amino acids to protein drugs, which enables specific covalent binding to their target proteins," said Sergio Duron, Ph.D., CEO of Enlaza Therapeutics. "Our covalent biologic platform is white-space technology, and we are pioneering an entirely new class of biologic therapeutics with the potential for significantly improved efficacy and safety to address numerous indications and disease areas."

"Enlaza has built a highly differentiated therapeutic platform which, for the first time, will enable covalent biologics," said Jay Lichter, Ph.D., Managing Partner of Avalon Ventures. "The platform provides the opportunity to develop drugs against multiple target classes, offering opportunities across all therapeutic areas."

The War-Lock platform creates highly specific therapeutic warheads that lock onto targets of interest, producing broadly applicable therapeutic candidates with excellent drug-like properties. For example, protein drugs derived from the platform can be modified to incorporate various payloads, creating antibody-drug conjugates (ADCs) or radioligand therapies (RLTs) with specific target tissue delivery, without the need for half-life extension engineering. Enlaza has generated preclinical data for its oncology drug candidates showing fast tumor penetration coupled with high systemic clearance, high tumor retention, and low off-target toxicity.

"The breadth of Enlaza’s platform will be transformative across multiple modalities," said Shelley Chu, M.D., Ph.D., Partner at Lightspeed Venture Partners.

Marcos Milla, Ph.D., Venture Partner at Samsara BioCapital said, "The Enlaza platform opens the possibility to enhance the therapeutic index of biologic drugs in a way that is not accessible with platforms relying on conventional recombinant technologies. It also offers an opportunity to address hard to target cell surface molecules in a highly specific fashion."

"We are impressed with the in vitro and in vivo data the team has generated and believe that Enlaza can build an industry leading pipeline of important new protein drugs employing its incomparable technological advantage," said Jamie Topper, M.D., Ph.D., Managing Partner of Frazier Life Sciences.

In addition to Dr. Duron, Enlaza’s leadership team includes Sanford (Sandy) Madigan, Ph.D., President and Chief Business Officer, Analeah Heidt, Ph.D., Chief Scientific Officer, and Lei Wang Ph.D., Scientific Advisor and Professor at the University of California, San Francisco (UCSF). The company’s Board of Directors is comprised of Jay Lichter, Ph.D. Avalon Ventures; Jamie Topper, M.D., Ph.D., Frazier Life Sciences, Shelley Chu, M.D., Ph.D., Lightspeed Venture Partners, Marcos Milla, Ph.D., Samsara BioCapital, and Sergio Duron, Ph.D., CEO, Enlaza Therapeutics.

Enlaza’s War-Lock platform is based on technologies exclusively licensed from UCSF, negotiated through UCSF’s Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the University, and The Scripps Research Institute.

On December 15, 2022 AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported that the U.S. Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to proceed with a global Phase 2 study of safusidenib for the treatment of patients with IDH1 mutant glioma (Press release, AnHeart Therapeutics, DEC 15, 2022, View Source [SID1234625339]). Glioma is a type of cancer that develops in the glial cells of the brain.

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"Receiving IND clearance from US FDA to advance safusidenib into a global Phase 2 trial in glioma represents an important milestone, as we continue to advance our clinical pipeline of precision oncology therapeutics," said Bing Yan, M.D., Co-Founder and Global Chief Medical Officer, AnHeart Therapeutics. "We are excited about the prospects of our mIDH1 inhibitor and how it can address the unmet medical need for patients with glioma, one of the most common type of primary brain tumors."

"Current standard of care treatment for IDH mutant glioma is far from satisfying, and no targeted therapy or immuno-therapy has been approved to treat lower grade glioma patients with IDH1 mutations. We look forward to working with AnHeart Therapeutics to further develop safusidenib in the clinical setting for IDH1 mutant glioma patients who desperately need therapies with a better efficacy and safety profile," said David A. Reardon, M.D., Dana-Farber Cancer Institute and Harvard Medical School.

Safusidenib is a potent, small molecule mIDH1 inhibitor. Mutations in IDH1 are frequently found in various tumor types such as glioma, cholangiocarcinoma, and chondrosarcoma. Safusidenib has also shown high blood brain barrier penetration from prior studies.

A Phase 1 clinical trial of safusidenib in glioma patients demonstrated a promising efficacy and safety profile in 12 non-enhancing and 35 enhancing glioma patients. The objective response rate (ORR) was 33% and 17% in non-enhancing and enhancing patients, respectively.

The Phase 2, multicenter, open label, clinical study will evaluate the efficacy and safety of safusidenib in patients with WHO Grade II or Grade III glioma.

About Glioma

Glioma is a type of cancer that develops in the glial cells of the brain. Gliomas are classified into Grades I, II, III or IV. Mutations in IDH1 are present in the majority of adult Grade II and Grade III gliomas (together categorized as lower grade glioma). IDH1 mutations are observed in about 75% of lower-grade gliomas, where no approved targeted therapy is available. Approximately 30,000 patients are newly diagnosed with mIDH1+ lower-grade glioma in the US, Europe and China annually.