On August 22, 2024 The U.S. Food and Drug Administration (FDA) reported that it will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) on September 26, 2024, to discuss a class-wide risk-benefit assessment of PD-L1 expression level cutoffs for immune checkpoint inhibitors in gastric and esophageal cancers. Cumulative data have shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in these patient populations. As part of this meeting, Bristol Myers Squibb will meet with the Committee to discuss approved U.S. indications for Opdivo (nivolumab)-based combinations in advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC), and unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Bristol-Myers Squibb, AUG 22, 2024, View Source [SID1234646054]).

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"With proven survival benefits, Opdivo-based regimens have changed the outlook for patients with GC, GEJC, EAC and ESCC regardless of PD-L1 status," said Ian M. Waxman, M.D., vice president, senior global program lead, late development, oncology, Bristol Myers Squibb. "We look forward to the opportunity to discuss the importance of Opdivo-based regimens as treatment options for appropriate gastric and esophageal cancer patients more in depth with the Committee."

Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy was granted full approval by the FDA for the treatment of adult patients with advanced or metastatic GC, GEJC, and EAC in 2021. This approval was supported by results of the Phase 3 CheckMate -649 trial. In CheckMate -649, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared with chemotherapy in all randomized patients regardless of PD-L1 status. CheckMate -649 is the largest Phase 3 trial of an immunotherapy in advanced or metastatic GC, GEJC, and EAC.

Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy and Opdivo in combination with Yervoy (ipilimumab) were granted full FDA approval in 2022 for the first-line treatment of adult patients with unresectable advanced or metastatic ESCC. This approval was supported by results of CheckMate -648, the largest Phase 3 trial of an immunotherapy in first line ESCC, which showed that the two Opdivo-based regimens demonstrated a statistically significant and clinically meaningful OS benefit compared to chemotherapy alone in all randomized patients who were enrolled regardless of PD-L1 status.

Opdivo and Opdivo-based combinations are important treatment options for multiple types of cancers with FDA approvals across 11 cancer types. In addition to GC, GEJC, EAC, and ESCC, Opdivo and Opdivo-based combinations are also approved in melanoma, renal cell carcinoma, urothelial carcinoma, classic Hodgkin lymphoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, hepatocellular carcinoma and squamous cell carcinoma of the head & neck.

On August 22, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following conferences (Press release, BioCryst Pharmaceuticals, AUG 22, 2024, View Source [SID1234646053]):

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2024 Wells Fargo Healthcare Conference in Boston on Thursday, September 5, 2024, at 1:30 p.m. ET.
H.C. Wainwright 26th Annual Global Investment Conference in New York on Monday, September 9, 2024, at 9:00 a.m. ET.
2024 Cantor Global Healthcare Conference in New York on Thursday, September 19, 2024, at 12:45 p.m. ET.

Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On August 22, 2024 Aveta Biomics, a pioneering oncology company developing first-in-class oral immuno-oncology drugs, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to APG-157, its next-generation immuno-oncology drug, for the neoadjuvant treatment of Head and Neck Cancer (HNC) (Press release, Aveta Biomics, AUG 22, 2024, View Source [SID1234646052]). This designation underscores the potential of APG- 157 to address a significant unmet medical need in treating a highly challenging form of cancer.

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The FDA’s Fast Track Designation is intended to facilitate the development and to expedite the review of drugs aimed at treating serious conditions with unmet medical needs. This designation allows for more frequent interactions with the FDA, eligibility for rolling submissions for a marketing application, and potential Accelerated Approval, ultimately aiming to bring promising new treatments to patients more rapidly.

"There is an urgent need for new treatments for head and neck cancer patients, many of whom face poor survival odds and considerable morbidities following current standard-of-care treatments, including surgery, radiotherapy, and chemotherapy/targeted treatments. The rare grant of Fast Track Designation for neoadjuvant treatment in Head and Neck Cancer underscores the FDA’s recognition of the potential role of APG-157 in providing meaningful treatment benefits to these patients," said Parag Mehta, PhD, Chief Executive Officer of Aveta Biomics.

Head and Neck Cancer affects approximately 900,000 people globally, with an overall five-year mortality rate of around 50%, a figure that has remained largely unchanged for decades. The molecular complexity of these tumors presents significant challenges for existing treatments, including targeted therapies. APG-157 is a first-in-class drug that acts through a dual mechanism: inducing selective apoptosis of cancer cells while also reprogramming the immune environment.

"This Fast Track Designation, based on our comprehensive Phase 1 and Phase 2 data, accelerates our ability to bring our promising first-line therapy to all newly diagnosed, locally advanced Head and Neck Cancer patients in a frontline setting," added Karim Malek, MD, MTh, MBA, Chief Medical Officer of Aveta Biomics.

On August 22, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CFO Raphi Levy will present a corporate overview and update at the H.C. Wainwright 26th Annual Global Investment Conference on September 10th, 2024 and in the Sidoti Virtual Investor Conference on September 18-19th, 2024 and will participate in the Redburn Atlantic and Rothschild & Co 2024 Radiopharma Conference on September 26th, 2024 and the Lytham Partners Fall 2024 Investor Conference on October 1st, 2024 (Press release, Alpha Tau Medical, AUG 22, 2024, View Source [SID1234646050]).

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Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: September 10, 2024
Time: 12:00 – 12:30PM EST
Location: New York, NY

Event: Sidoti Small-Cap Virtual Investor Conference
Date: September 19, 2024
Time: 11:30AM – 12:00PM EST
Location: Virtual

Event: Redburn Atlantic and Rothschild & Co 2024 Radiopharma Conference
Date: September 26, 2024
Time: 8:30AM – 2:30PM EST
Location: New York, NY

Event: Lytham Partners Fall 2024 Investor Conference
Date: October 1, 2024
Time: 8:00AM – 7:00PM EST
Location: Virtual

Mr. Levy will be available for 1×1 investor meetings at all conferences. Please reach out to your H.C. Wainwright, Sidoti, Rothschild & Co, or Lytham Partners representatives to schedule.

On August 22, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy (Press release, Clarity Pharmaceuticals, AUG 22, 2024, View Source [SID1234646029]).

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The FDA’s Fast Track Designation is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a potentially faster review process once Clarity submits its product approval application. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic."

Clarity’s ongoing clinical program with 64Cu-SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease. The completed Phase I PROPELLER study demonstrated favourable safety and efficacy results in patients with prostate cancer prior to radical prostatectomy. Driven by the compelling findings from the PROPELLER study, Clarity commenced a registrational Phase III trial in this patient population, CLARIFY, where recruitment is ongoing. In parallel, the Phase I/II trial, COBRA, 64Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer lesions in patients with BCR. Based on the results from the COBRA study, Clarity commenced planning of a second registrational Phase III imaging trial. The Fast Track Designation is supported by the initial clinical evidence suggesting that 64Cu-SAR-bisPSMA may offer improved lesion detection compared to existing prostate cancer diagnostics.

"We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumour uptake and retention and exhibited a capability of detecting much smaller lesions. The longer half-life of the isotope also translates into a longer shelf-life than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution, while also supporting flexible patient scheduling. These features are not available with gallium-68 and fluorine-18 based diagnostics. Clarity is committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management.

"This designation highlights the potential of 64Cu-SAR-bisPSMA to provide a novel diagnostic option for patients with prostate cancer and address the limitations of the current-generation diagnostic radiopharmaceuticals," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the U.S. FDA. A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.