On May 9, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, reported that the first patient has been dosed in the Phase 2 portion of the AlphaBreak trial evaluating FPI-2265 (225Ac-PSMA I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Fusion Pharmaceuticals, MAY 10, 2024, View Source [SID1234643092]).

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"Actinium-based PSMA targeting RCs have demonstrated compelling safety and clinical activity, which is supported by Fusion’s encouraging data from the Phase 2 TATCIST trial reported recently at the AACR (Free AACR Whitepaper) Annual Meeting. We believe FPI-2265 represents an important potential new treatment option for patients with mCRPC, and with the initiation of the AlphaBreak trial we are pleased to move forward," said Chief Medical Officer Dmitri Bobilev, M.D.

"Despite recent advances in the field, we see many patients with mCRPC still in need of additional treatment options, especially after progressing on lutetium-based radiotherapy. It is encouraging to see the promising clinical activity and good safety profile demonstrated by FPI-2265. The initiation of the AlphaBreak trial brings us a step closer to addressing the gap for patients and providing this needed treatment option," said investigator Luke Nordquist, M.D., FACP, XCancer Chief Executive Officer.

The AlphaBreak trial is a Phase 2/3, randomized, open-label, multicenter study to evaluate the safety and efficacy of FPI-2265 in patients with mCRPC previously treated with 177Lu-PSMA radiotherapy. The Phase 2 dose optimization portion is designed to evaluate whether there are added safety and/or efficacy benefits of two alternative dosing regimens in comparison to the previously studied regimen of 100 kBq/kg every eight weeks. The Phase 2 portion of the AlphaBreak trial is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the U.S. Food and Drug Administration (FDA), the Phase 3 global registration portion of the AlphaBreak trial will enroll approximately 550 patients and is expected to begin in 2025.

About FPI-2265

FPI-2265 is an actinium-225 based PSMA targeting RC, for mCRPC, currently in a Phase 2 trial. Actinium-225 emits alpha particles and holds the promise of being a next-generation radioisotope in cancer treatment. By delivering a greater radiation dose over a shorter distance, alpha particles such as actinium-225 have the potential for more potent cancer cell killing, and targeted delivery, thereby minimizing damage to surrounding healthy tissue.

On May 10, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for its second fiscal quarter ended March 31, 2024 (Press release, Applied DNA Sciences, MAY 10, 2024, View Source [SID1234643075]). The Company’s Form 10-Q can be viewed at View Source The Company will not host a financial webcast or call for this most recent quarterly reporting period. The Company will host an investor update call on June 12, 2024.

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Summary Second Quarter Fiscal 2024 Financial Results:

Total revenues were approximately $930 thousand for the three-month period March 31, 2024, compared to $4.4 million for the second quarter of fiscal 2023. The decrease in revenue of approximately $3.5 million was due to an expected decline in COVID-19 testing services revenue of $3.6 million, driven primarily by the conclusion of a testing contract with the City University of New York (CUNY) in June 2023. This decrease was offset by an increase in product revenue of $96 thousand.
Gross profit for the three-month period ended March 31, 2024, was $296 thousand, compared to $1.8 million for the same period in the prior fiscal year. The gross profit percentage was 32% and 41% for the three-month periods ended March 31, 2024, and 2023, respectively. The decline in gross profit percentage was primarily due to a decline in gross profit percentage for our MDx (Molecular Diagnostics) testing services segment, specifically related to an expected decrease in COVID-19 testing volumes year over year.
Operating expenses decreased to $3.9 million for the three-month period ended March 31, 2024, as compared to $4.5 million for the same period in the prior fiscal year. The decrease in operating expenses is the result of a decrease in selling, general and administrative expenses of approximately $523 thousand and a decrease in research and development expenses of $76 thousand. The decrease in SG&A expenses primarily relates to a decrease in payroll, as well as a decrease in stock-based compensation expense of approximately $88 thousand. These decreases were offset by increases of $217 thousand for the reversal of capitalized offering costs related to the ATM transaction that was terminated during the three-month period ended March 31, 2024, and an increase of approximately $162 thousand in professional fees.
Loss from operations was $3.6 million for the three-month period ended March 31, 2024, compared to $2.7 million for the same period in the prior fiscal year.
Excluding non-cash expenses, Adjusted EBITDA was a negative $3.3 million for the three-month period ended March 31, 2024, compared to a negative $2.1 million for the same period in the prior fiscal year.
Cash and cash equivalents stood at $3.1 million on March 31, 2024, compared with $7.2 million as of September 30, 2023.
Subsequent to the second fiscal quarter ended March 31, 2024, on April 25, 2024, the Company filed a Certificate of Amendment of its Certificate of Incorporation with the Secretary of State of the State of Delaware that effected a one-for-twenty (1:20) reverse stock split of its common stock, par value $.001 per share, effective April 25, 2024. All warrant, option, share, and per share information in this press release gives retroactive effect to a one-for-twenty reverse stock split that was affected on April 25, 2024.

On May 10, 2024, the Company announced that it received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market, informing the Company that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

On May 10, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that the Company executed a collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2 randomized, (one to one), controlled trial evaluating clinical and biological effects of intratumoral INT230-6 followed by the standard of care ("SOC") immuno/chemotherapy vs. SOC immune/chemotherapy alone in early-stage triple-negative breast cancer ("TNBC") in 54 patients in Switzerland and selected countries in Europe (the "INVINCIBLE-4 Study") (Press release, Intensity Therapeutics, MAY 10, 2024, View Source [SID1234643093]). The INVINCIBLE-4 Study is an open-label randomized two-cohort phase 2 clinical trial.

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SAKK shall undertake the trial as the "Legal Sponsor" of the study, with the regulatory agencies in Switzerland and the European Union as described in the study protocol. SAKK will also ensure that all investigators and personnel who participate in the study are informed and trained. Intensity shall fund the study, provide the investigational drug product, and other necessary information to conduct the trial. The primary efficacy endpoint of the INVINCIBLE-4 Study is pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). Additional key research questions include the immune landscape of the tumor microenvironment and peripheral blood, magnetic resonance imaging (MRI) changes predictive for pCR, and adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

"We are excited to be working with SAKK on our INVINCIBLE-4 Study in early-stage triple-negative breast cancer," said Lewis H. Bender, Founder, President and CEO of Intensity Therapeutics, Inc. "TNBC poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality especially in patients with large tumors. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors for event-free survival. Results from our first INVINCBLE-2 study showed that INT230-6 could cause greater than 95% necrosis in large breast cancer tumors following a single dose with the induction of an immune response. By adding up to 2 doses of our unique drug before the standard of care, we hope to increase the rate of patients’ pCR, which is an FDA-approved endpoint for accelerated approval. The pCR data from this study, which we expect in the second half of 2025, should provide the information needed to size our Phase 3 trial in presurgical TNBC."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer

Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and excess human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, mainly because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery.

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.