On May 10, 2024 Bristol Myers Squibb (NYSE: BMY) reported the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, MAY 10, 2024, View Source;73L-Trial/default.aspx [SID1234643076]). CheckMate -73L evaluated Opdivo (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy (ipilimumab) versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. The observed adverse events of Opdivo with CCRT followed by Opdivo plus Yervoy were generally consistent with the known profiles of each component in the regimen.

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"Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting," said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb. "There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this setting. We want to thank the patients, families and investigators for their contributions to this important research."

The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community.

Opdivo and Opdivo-based combinations have shown positive outcomes and are approved treatment options for eligible patients with resectable or metastatic NSCLC.

About CheckMate -73L

CheckMate -73L is a Phase 3 randomized, open label trial evaluating Opdivo in combination with concurrent chemoradiotherapy (CCRT), followed by Opdivo plus Yervoy, or Opdivo (monotherapy), compared to CCRT alone followed by durvalumab, in patients with previously untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery. A total of 925 patients were randomized to receive specified doses on specified days of either Opdivo in combination with CCRT followed by Opdivo plus Yervoy (Arm A), Opdivo in combination with CCRT followed by Opdivo monotherapy (Arm B), or CCRT followed by durvalumab (Arm C). The primary endpoint of the trial is progression-free survival (PFS) by RECIST 1.1 per blinded independent central review (BICR) for Arm A vs. Arm C. Secondary endpoints include overall survival (OS) across the study arms, PFS by RECIST 1.1 per BICR across the study arms, as well as objective response rate (ORR), time to response (TTR) and duration of response (DOR) per RECIST 1.1 per BICR, and additional safety and efficacy endpoints.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

On May 10, 2024 WestGene, a biotech company dedicated to mRNA technology, reported a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043 (Press release, WestGene Biopharma, MAY 10, 2024, View Source [SID1234643094]). This landmark achievement marks the world’s first approval of an EB virus-related mRNA therapeutic cancer vaccine.

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Founded by renowned Dr. Yuquan Wei, Academician of the Chinese Academy of Sciences, and Dr. Xiangrong Song, WestGene has become a driving force in mRNA technology research and innovative drug development. With a relentless pursuit of scientific excellence, WestGene’s latest milestone underscores its commitment to advancing the frontiers of biomedicine.

The FDA approval of WGc-043 represents a significant advance in cancer treatment, offering new hope to patients with advanced EB virus-related cancers. EB virus is highly correlated with more than ten malignancies, including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, cervical cancer, and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus. These are potential indications for WGc-043.

WGc-043 shows promising efficacy, low toxicity, broad applicability, efficient scalability, and cost effectiveness. WGc-043 has already completed investigator-initiated trials (IIT) in NPC and NKTL, demonstrating superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines. Once successfully launched, WGc-043 will provide a new treatment option for patients with advanced EB virus-positive solid tumors and hematologic malignancies.

As WestGene moves forward, its strategic focus on global collaboration underscores its vision for commercial expansion and market penetration. With a diverse pipeline of over 20 mRNA-based therapeutic products targeting a spectrum of diseases, WestGene is poised to reshape the biopharmaceutical landscape. WestGene has made significant breakthroughs in the three key technologies of mRNA drug development: mRNA sequence design, delivery vectors, and manufacturing. And the patent for ionizable lipids has been granted in countries and regions such as China, the United States and Europe.

The FDA approval of WGc-043 marks a turning point in the fight against cancers and underscores WestGene’s commitment to mRNA technology. As WestGene continues to push the boundaries of scientific discovery, its pioneering spirit promises to open new frontiers in cancer therapy and beyond.

On May 10, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2024, and recent corporate updates (Press release, Checkpoint Therapeutics, MAY 10, 2024, View Source [SID1234643077]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have worked closely with our third-party contract manufacturing organization ("CMO") for cosibelimab to resolve their inspection deficiencies noted in the complete response letter ("CRL") we received from the U.S. Food and Drug Administration ("FDA") last December. Recently, our CMO submitted to FDA their response to the inspection deficiencies, which we believe could allow for the resubmission of our biologics license application ("BLA"). We plan to meet with the FDA shortly, at which time we will seek to reach alignment for a potential mid-year BLA resubmission."

Recent Corporate Updates:

Checkpoint submitted a BLA to the FDA in January 2023 seeking approval of 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, and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party 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. Checkpoint intends to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year.
In January 2024, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $14.0 million.
In March 2024, Checkpoint announced the appointment of life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors.
Financial Results:

Cash Position: As of March 31, 2024, Checkpoint’s cash and cash equivalents totaled $11.2 million, compared to $4.9 million at December 31, 2023, an increase of $6.3 million.
R&D Expenses: Research and development expenses for the first quarter of 2024 were $8.5 million, compared to $15.8 million for the first quarter of 2023, a decrease of $7.3 million. Research and development expenses for the first quarter of 2024 included $0.5 million of non-cash stock expenses, compared to $0.4 million for the first quarter of 2023.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $2.5 million, compared to $2.3 million for the first quarter of 2023, an increase of $0.2 million. General and administrative expenses for the first quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2023.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2024 was $10.9 million, or $0.33 per share, compared to a net loss of $10.5 million, or $0.89 per share, in the first quarter of 2023. Net loss for the first quarter of 2024 and 2023 both included $1.1 million of non-cash stock expenses.

On May 10, 2024 SN Bioscience Co. Ltd. (CEO Park Young-hwan) reported that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a new drug for polymer nanoparticle anticancer under clinical trial (Press release, SN BioScience, MAY 10, 2024, View Source [SID1234643095]). SNB-101 was designated as an orphan drug for small cell lung cancer and pancreatic cancer in July of last year and February of this year, respectively. By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials.

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Despite a long period of research and development, SCLC still remains a field with high medical unmet needs. Currently, the first-line standard treatment is a combination therapy of cisplatin and etoposide, a classic cytotoxic anticancer drug, and ‘clinical trials’ are included as second-line treatments in the NCCN guidelines.

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Fast Track designation facilitates the interactions with the FDA and allows a rolling review for the submission package so it can be reviewed in each section, rather than waiting until every section of the NDA is completed. Additionally, it may be possible to apply for accelerated approval after the completion of phase 2 clinical trials and priority review immediately after the completion of phase 3 clinical trials when qualified.

SNB-101 is the world’s first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. The nano micelle technology, a core platform technology of SN Bioscience, has been applied. Preclinical and phase 1 clinical results showed that it significantly reduced digestive system adverse events (nausea, vomiting, diarrhea, etc.) compared to existing anticancer drugs, and especially showed excellent efficacy in patients related to lung cancer through lung targeting. The phase 1 clinical trial has been completed, IND for phase 2 has been approved in Korea, and global clinical trials are scheduled to begin after IND approval for phase 2 in the US and Europe in the second half of this year. Following small cell lung cancer and pancreatic cancer, attempts are being made to expand its indications to other solid cancers such as colon cancer, gastric cancer, and biliary tract cancer, and will be verified through phase 2 clinical trials.

On May 10, 2024 Oncolys BioPharma reported non-consolidated Financial Results for the Three Months Ended March 31, 2024 (Press release, Oncolys BioPharma, MAY 10, 2024, View Source [SID1234644739]).

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