On June 24, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported it has reached alignment with the Food and Drug Administration ("FDA") on its biologics license application ("BLA") resubmission strategy for cosibelimab (Press release, Checkpoint Therapeutics, JUN 24, 2024, View Source [SID1234644497]). Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We’re pleased to have reached alignment with the FDA on our BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter ("CRL") received last December. We’re eager to resubmit our BLA and to potentially bring a new and potentially differentiated immunotherapy treatment option to patients with advanced cSCC."

In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization ("CMO") as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.

On June 24, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") reported that the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer ("CRPC") who have progressed on or after standard systemic regimens (Press release, BioNTech, JUN 24, 2024, View Source [SID1234644495]). BNT324/DB-1311 is a next-generation antibody-drug conjugate ("ADC") candidate targeting the transmembrane glycoprotein B7-H3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. The candidate is currently being evaluated in an ongoing Phase 1/2 study (NCT05914116) in patients with advanced solid tumors.

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"The FDA’s decision is a recognition of the potential of our B7-H3-targeting ADC candidate for the treatment of advanced CRPC. While patients with metastatic prostate cancer initially respond to hormone therapy, most patients progress after 18-24 months and develop CRPC, an advanced form of prostate cancer, leading to a poor prognosis for these patients. The 5-year survival rate for patients with metastatic CRPC is only around 36%," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We are committed to further advancing BNT324/DB-1311 with our partner DualityBio and believe that a targeted ADC immunotherapy approach has the potential to improve outcomes for patients at advanced stages of the disease."

"BNT324/DB-1311 is the third asset in our strategic collaboration which has received FDA Fast Track designation, highlighting the potential of the candidate to fill an unmet medical need for novel treatment options for B7-H3 expressing cancers," said Vivian Gu, M.D., Chief Medical Officer at DualityBio. "Preliminary data from our ongoing Phase 1/2 trial has demonstrated antitumor activity and a manageable safety profile of BNT324/DB-1311 in patients with advanced solid tumors. With the designation and support by the FDA, we seek to expedite further development of BNT324/DB-1311."

Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial with BNT324/DB-1311 in patients advanced or metastatic solid tumors. With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the FDA, to support the development and expedite the regulatory review of BNT324/DB-1311.

All three clinical stage ADC candidates in BioNTech’s and DualityBio’s global strategic partnership have received FDA Fast Track designation. The lead candidate in the collaboration, BNT323/DB-1303, a next-ADC candidate targeting the Human Epidermal Growth Factor Receptor 2 ("HER2"), is being evaluated in a Phase 1/2 trial in patients with advanced solid tumors and a global Phase 3 clinical trial in patients with metastatic breast cancer. The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the FDA for the treatment of endometrial cancer in 2023. In January 2024, the companies’ ADC candidate targeting the trophoblast cell-surface antigen 2 ("TROP2"), BNT325/DB-1305, received FDA Fast Track designation for the treatment of patients with platinum-resistant ovarian epithelial cancer.

About BNT324/DB-1311
BNT324/DB-1311 is a next-generation topoisomerase-I-inhibitor-based ADC candidate targeting the immune checkpoint protein B7-H3. The transmembrane glycoprotein B7-H3 plays a critical role in the anti-tumor immune response and the shaping of the tumor microenvironment. It is overexpressed in a range of solid tumors, with limited expression in healthy tissues, and has been associated with disease progression and very poor prognosis.5 Preclinical studies have shown that BNT324/DB-1311 exhibits antitumor activity in various solid tumor models.2 Preliminary data from the ongoing Phase 1/2 trial has demonstrated antitumor activity and a manageable safety profile for BNT324/DB-1311 in patients with advanced solid tumors.1 BNT324/DB-1311 is currently being evaluated in a Phase 1/2 clinical trial (NCT05914116) in patients with advanced or metastatic solid tumors.

On June 24, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its CD19 oncolytic virotherapy drug candidate onCARlytics (CF33-CD19), has dosed the first patient in the intravenous (IV) infusion combination arm of the Phase 1 clinical trial (Press release, Imugene, JUN 24, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0940c6f1-f44a-9947-a02a-a76749b0800a/Imugene_onCARlytics_Doses_First_Patient_in_IV_Combination.pdf [SID1234644492]).

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Known as OASIS, the Phase 1 dose escalation onCARlytics clinical trial is targeting adult patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), which is a cancer immunotherapy.

Imugene Managing Director & CEO Leslie Chong said: "We are pleased to enroll the first IV combination patient and further advance our OASIS trial, which combines our CD19 oncolytic virus with the already approved and marketed CD19 bispecific in patients with advanced solid cancers. While CD19 has been a powerful target for blood cancers, no such targets currently exist for solid cancers. We aspire to change that with onCARlytics, which causes cancers to display CD19 on their cell surface so that an approved CD19 therapeutics can target and kill the cancer. If successful, onCARlytics could open up 90 percent of the market as CD19 products are only approved in blood cancer and provide a new treatment option for patients with solid tumors."

OASIS is currently being conducted at three sites in the U.S. (City of Hope, University of Cincinnati, and MD Anderson Cancer Center), with the potential to open a total of 10 sites to recruit approximately 40-45 patients with advanced solid cancers that have spread. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics, either by IT injection or IV infusion, either alone, or in combination with blinatumomab. In February, the first patient with bile tract cancer was dosed in the IV monotherapy arm of the trial at City of Hope in California. Subject to the rate of patient enrolment, preliminary early combination data are expected in the fourth quarter of 2024.

CD19 has been a powerful target for blood cancers, which make up around 10% of all cancers. Solid cancers like breast, lung, gastric, and colon, etc. do not have a common target on their cell surface and so the goal of onCARlytics is to present a target for CD19 therapies. onCARlytics is a CD19 oncolytic virus that enters solid tumor cells and causes them to display a marker or protein on the surface of the cancer cell called CD19, thus making the cancer cell a target for already approved CD19-targeting drugs, such as blinatumomab, that kill blood cancers with CD19 targets on their cells. If successful, onCARlytics could open up 90% of the cancer market and allow CD19 therapies to become an option to treat patients with solid tumors (valued at ~USD$532B by 2032¹).

The trial is titled: "A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors." See View Source

On June 24, 2024 Singapore-headquartered Juniper Biologics Pte Ltd (Juniper), a leading healthcare and pharmaceuticals company focused on commercialising novel therapies, reported that it has been granted distribution rights for Caris Life Sciences (Caris)’ solid tumour molecular profiling services in the Middle East and Africa (MEA) (Press release, Juniper Biologics, JUN 24, 2024, View Source;utm_medium=rss&utm_campaign=juniper-biologics-expands-distribution-rights-for-caris-life-sciences-molecular-profiling-in-the-middle-east-and-africa [SID1234644491]). Caris is the leading next-generation AI TechBio company and precision medicine pioneer. This expansion follows the initial January 2023 distribution rights partnership with Caris for the same services in Southeast Asia (SEA). Juniper is now poised to offer Caris’ advanced solid tumour molecular profiling services across a broader region, enhancing patient access to personalised treatment options.

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Caris’ best-in-class molecular profiling, combined with proprietary artificial intelligence, provides more precise and individualized cancer treatments. This profiling approach assesses DNA, RNA, and proteins, revealing a molecular blueprint that identifies treatment options specific to each patient’s cancer. Caris has developed the world’s largest and most informative platform for cancer analysis, featuring the most advanced tumour profiling available, including Whole Exome and Whole Transcriptome Sequencing across over 23,000 genes. By analysing biomarkers found in tumours, Caris helps healthcare providers make informed choices for personalised care.

Juniper Biologics is committed to driving positive change in the pharmaceutical industry on a global scale. Aligned with its mission to deliver transformative therapies through bold scientific innovation, Juniper’s collaboration with Caris will enhance access to quality treatments for patient communities in the Middle East and Africa. Juniper continues to pursue impactful partnerships aimed at uplifting communities and individuals, especially in underserved regions where access to advanced therapies is limited.

Raman Singh, Founder and Chief Executive Officer (CEO) of Juniper Biologics, spoke on the successful acquisition: "Caris molecular profiling bridges the gap between tumour biology and cancer treatments, guiding precision medicine through personalised treatment selection for physicians and their patients. Our exclusive partnership with Caris Life Sciences to distribute this service in the Middle East and Africa will significantly empower healthcare professionals to make informed decisions for their patients. This service enables oncologists to recommend highly personalised treatments that specifically target a patient’s cancer, thereby improving and expanding their care options. This targeted approach offers patients, particularly those with rare or aggressive cancers, an improved quality of life."

"Caris is pleased to expand the distribution of our molecular profiling services in the Middle East and Africa through our partnership with Juniper Biologics," said Caris President David Spetzler, MS, PhD, MBA. "This collaboration aligns with Caris’ goal of enabling clinicians worldwide to make the best individualised treatment choices for their patients and ultimately helping to improve patient outcomes."

This partnership marks a significant milestone in expanding access to personalised medicine and advanced cancer treatment technologies in the Middle East and Africa.

On June 21, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study (Press release, Bristol-Myers Squibb, JUN 21, 2024, View Source [SID1234644490]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

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"Subcutaneous nivolumab has the potential to change the way patients living with cancer receive Opdivo treatment and to significantly reduce administration time by utilizing a single injection in three-to-five minutes. By providing patients the same quality of care as IV Opdivo in a fraction of the time, patients can focus on what is important to them rather than spending a longer wait time at the infusion center," said Susan Parker, vice president, global program lead, product design & development, Bristol Myers Squibb. "We are committed to advancing medicines that improve the patient experience and are evaluating innovative formulations across our broad portfolio. We look forward to working with the EMA to advance this application with the goal of introducing the subcutaneous option of Opdivo."

In the Phase 3 CheckMate -67T trial, subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state), the study’s primary endpoints, vs. intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received no more than two prior lines of systemic therapy. Additionally, subcutaneous nivolumab showed noninferiority of the key secondary endpoint of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. The safety profile of subcutaneous nivolumab was consistent with the IV formulation. The pharmacokinetics, efficacy and safety results from CheckMate -67T were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Additional safety analyses and patient reported outcomes were recently presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

About CheckMate -67T
CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic ccRCC who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.