On August 22, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported that the U.S. Food and Drug Administration (FDA) has reviewed its Investigational New Drug (IND) submission, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Celcuity, AUG 22, 2023, View Source [SID1234634615]). Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024.

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"We are excited to initiate the clinical development of gedatolisib in prostate cancer," said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. "Gedatolisib’s highly differentiated mechanism of action makes it uniquely suited to address the complex PI3K/mTOR activity involved in this disease."

In the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib.

The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D.

"Treatment options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor are limited, and there is an urgent need for new drugs to treat this patient population," said Karim Fizazi, MD, PhD, Professor of Medicine at Institute Gustave Roussy and GETUG President. Professor K. Fizazi, who is one of the primary principal investigators for this study, further stated: "Since PI3K/mTOR and androgen receptor signaling are commonly aberrantly activated in mCRPC, combining gedatolisib with the approved androgen receptor inhibitor darolutamide represents a potentially promising treatment option for these patients."

Registration Information for the Virtual Science Day

Celcuity will host a Virtual Science Day for analysts and investors on Thursday, September 21, 2023, from 10:00 a.m. – 12:00 p.m. ET, featuring presentations by key opinion leaders and Celcuity’s leadership. During this meeting, Celcuity will provide an in-depth scientific overview of gedatolisib, the importance of comprehensive, rather than selective, inhibition of the PI3K/mTOR pathway, and review its clinical development strategy, including a discussion about its Phase 1b/2 study in mCRPC.

A live chat-based Q&A session will follow the formal presentations. To register for the event, please click here. A replay of the webcast will be available on the "Events & Presentations" section of Celcuity’s website for a limited time following the event.

About Gedatolisib

Gedatolisib is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Inhibiting all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the absence of mTOR inhibition.

On August 22, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection, based upon results from the CheckMate -76K trial (Press release, Bristol-Myers Squibb, AUG 22, 2023, View Source [SID1234634614]).

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This approval builds upon the 2018 EC approval based on results from the CheckMate -238 trial. Opdivo is now indicated for use in the European Union as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Opdivo is now the only PD-1 inhibitor that – between two approvals – is indicated as an adjuvant treatment within stages IIB, IIC, III, as well as stageIV resected melanoma.

"Patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery. This can be a very impactful event for patients," said Peter Mohr, MD, Chief Physician and Head, Skin Cancer Center, Buxtehude, Department of Dermatology, Elbe-Kliniken, Germany. "This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring."

The EC’s decision is based on results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI: 0.30-0.59; p<0.0001). The safety profile of Opdivo was consistent with previously reported studies.

CheckMate -76K is part of Bristol Myers Squibb’s development program which explores the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.

"With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. "This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer. We thank all the patients, researchers, and physicians who were involved along the way to help make this additional option for patients possible."

The EC approval covers all European Union member states, as well as Iceland, Liechtenstein, and Norway. Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, Wales).

CheckMate –76K Efficacy and Safety Results

Results from the CheckMate –76K study evaluating adjuvant Opdivo versus placebo in patients with completely resected stage IIB or IIC melanoma include:

Efficacy: Adjuvant Opdivo, with a minimum follow-up of 7.8 months, reduced the risk of recurrence or death by 58% versus placebo (HR 0.42; 95% CI: 0.30-0.59; p<0.0001). Twelve-month recurrence-free survival (RFS) rates for Opdivo were 89% (95% CI: 86-92) versus 79% (CI: 74-84) for placebo. The RFS benefit was observed across predefined subgroups in the trial, including T category and disease stage.
Safety: In the pooled dataset of nivolumab as monotherapy across tumor types (n = 4646) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (44%), musculoskeletal pain (28%), diarrhea (26%), rash (24%), cough (22%), nausea (22%), pruritus (19%), decreased appetite (17%), arthralgia (17%), constipation (16%), dyspnoea (16%), abdominal pain (15%), upper respiratory tract infection (15%), pyrexia (13%), headache (13%), anemia (13%) and vomiting (12%). The majority of adverse reactions were mild to moderate (Grade 1 or 2).
About CheckMate -76K

CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB or IIC melanoma.

The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.

On August 22, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP) (Press release, Biodesix, AUG 22, 2023, View Source [SID1234634612]). The data will be presented by principal investigator of the ORACLE study, Michael Pritchett, DO, MPH, on Thursday, Aug. 24, 2023 in a live poster presentation in Chicago, IL.

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The Nodify XL2 test is designed to identify likely benign lung nodules that can be monitored with computed tomography (CT) scans instead of costly invasive procedures. The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.

The analysis to be presented at AABIP investigated the effect of improved identification of benign lung nodules on the remaining patients who received a diagnostic biopsy. Prior to implementation of the Nodify XL2 test, 49% of patients receiving a biopsy had a lung cancer diagnosis compared to 74% when the test was used in clinical decision making, representing a 51% relative increase in the cancer diagnosis rate.

"Finding a suspicious lung nodule can create fear and anxiety for patients, whether it is found through lung cancer screening or an incidental finding from imaging for general medical purposes," said Dr. Pritchett. "It is very encouraging that the Nodify XL2 test is helping physicians avoid unnecessary invasive procedures on benign lung nodules and prioritize patients with a higher risk of lung cancer. These results offer peace of mind to both patients and providers as they navigate the diagnostic plan."

On August 21, 2023 Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech") reported that it has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its Class 1 innovative therapeutic biological product SG1827 for injection (Press release, Sumgen Biotech, AUG 21, 2023, View Source;a=nav&id=351 [SID1234656272]). The indication is for the treatment of advanced malignant solid tumors.

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One of the main mechanisms of action for SG1827 is to provide co-stimulatory signals for T cell activation. This plays a crucial role in promoting the recognition of and attack to tumors by immune cells, and it helps improve the clinical efficacy of immunotherapies such as anti-PD-1/PD-L1 antibody treatment. Early research has shown that SG1827, both as a monotherapy and in combination with other immune checkpoint antibodies, exhibits significant anti-tumor activity. Furthermore, no obvious cytokine release reactions have been observed, indicating good safety profiles.

Dr. Ming Lv, founder of Sumgen Biotech, stated: "SG1827 is one of Sumgen Biotech’s most important pipeline layouts in the ‘post-PD-1 era,’ and is the company’s ninth project to enter the clinical phase. SG1827 has a clear pharmacological mechanism, definite efficacy, and good safety. In the early stages of R&D, targeted molecular design was used to significantly optimize its PK characteristics and improve the developability. This not only puts SG1827 in a leading position in the global R&D competition for the same target but also gives it the potential to become a "Best in Class" drug. We will actively advance the clinical development of SG1827, striving to benefit more cancer patients as soon as possible."

On August 21, 2023 GenScript reported 2023 interim results (Presentation, GenScript, AUG 21, 2023, https://www.genscript.com/gsfiles/IPO/2023%20Interim%20Results%20Final.pdf?101034653 [SID1234644731]).

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