On July 14, 2025 Zenith Epigenetics Ltd. ("Zenith" or the "Company") reported the designation of ZEN-3694 as a Fast Track product by the U.S. Food and Drug Administration ("FDA") (Press release, Zenith Epigenetics, JUL 14, 2025, View Source [SID1234657190]). FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. The Company is also pursuing Orphan Drug and Breakthrough Therapy designations for ZEN-3694 in NUT carcinoma.

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"We are thrilled that the FDA has recognized the strong potential of ZEN-3694 in benefiting patients with NUT carcinoma, an extremely aggressive, deadly cancer, for which there are no effective or approved treatments," said Donald McCaffrey, President & CEO of Zenith Epigenetics. "Fast Track designation will accelerate ZEN-3694’s clinical NUT carcinoma program by expediting its development and review, and allow us to deliver this potentially life-saving drug to patients sooner."

Fast Track Designation

According to the FDA, 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 purpose of the Fast Track program is to speed up the development of important new drugs and get them into the hands of patients earlier than would otherwise be possible.

Benefits of Fast Track designation may include:

More frequent meetings with FDA on drug development planning
More frequent written communication from FDA on clinical trial design and other critical points
Eligibility for Accelerated Approval and Priority Review
NUT Carcinoma

NUT carcinoma is a highly aggressive type of cancer affecting adults and children and typically occurs in the midline area of the body including head, neck, and thoracic areas. While NUT carcinoma is a rare cancer, it is currently underdiagnosed – due to lack of awareness and testing – and the actual incidence is estimated at 10,000 cases per year. However, growing awareness among clinicians, as well as new biomarker testing methods, are improving detection. With rapidly increasing diagnoses, no approved therapies, and a median overall survival of about 6 months, there is a significant unmet need for new therapeutic options in NUT carcinoma.

ZEN-3694

Zenith’s lead clinical candidate, ZEN-3694, is currently being evaluated in two (2) active NUT carcinoma clinical trials in combination with abemaciclib (ClinicalTrials.gov ID: NCT05372640) and cisplatin & etoposide (ClinicalTrials.gov ID: NCT05019716). ZEN-3694 is a potent, selective, orally available BET inhibitor, which is well tolerated for chronic administration and has a favorable safety profile, with more than 550 patients having received the drug. In NUT carcinoma, the NUTM1 gene is fused with a transcriptional regulator – most commonly a BET protein – and drives expression of cancer-causing genes, leading to unchecked growth of tumors. Through disrupting the activity of NUT fusion protein, ZEN-3694 has demonstrated both single-agent and combination efficacy in treating NUT carcinoma. To date, the combination of abemaciclib plus ZEN-3694 has shown superior response rate and duration of response compared to single agent BET inhibitors by inhibiting resistance to therapy.

On July 14, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported the closing of its best-efforts offering of 1,500,000 shares of its common stock (Press release, Cel-Sci, JUL 14, 2025, View Source [SID1234654373]). Each share of common stock was sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5.7 million.

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The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity acted as the sole placement agent for the offering.

The securities were offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 14, 2025 Flatiron Health reported that the novel findings from its research, "Using large language models for scalable extraction of real-world progression events across multiple cancer types," have been presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Artificial Intelligence and Machine Learning, which took place July 10-12, 2025, in Montreal, QC, Canada (Press release, Flatiron Health, JUL 14, 2025, View Source [SID1234654372]).

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The research, led by a multidisciplinary Flatiron team of clinicians, research scientists, and machine learning engineers, demonstrates the power of large language models (LLMs) to accurately and efficiently extract real-world cancer progression events from unstructured electronic health record (EHR) data across 14 cancer types. Study findings concluded that LLMs achieved F1 scores similar to expert human abstractors and produced nearly identical real-world progression-free survival estimates, underscoring the potential of AI to scale high-quality clinical endpoint extraction for oncology research and care. This research utilized on the recently published Validation of Accuracy for LLM/ML-Extracted Information and Data (VALID) Framework to assess the quality of LLM-extracted real-world data, uniquely evaluating both the LLM and an expert human abstractor against a duplicate expert human abstracted reference dataset to directly compare performance.

The LLM that Flatiron scientists optimized for this research was provided by Anthropic—the leading AI safety and research company that builds the Claude family of models.

"AI and machine learning are fundamentally transforming how we generate and use real-world evidence in oncology," said Stephanie Reisinger, Senior Vice President & General Manager, Real-World Evidence at Flatiron Health. "This research exemplifies how Flatiron is harnessing AI and multimodal data to unlock new insights from oncology real-world data—accelerating clinical research, improving patient outcomes, and setting a new standard for evidence generation in cancer care."

"We’re excited to share evidence that large language models can approach, and in some cases, may even exceed expert human performance in extracting critical and clinically nuanced cancer progression endpoints from EHRs," said Aaron B. Cohen, MD, lead author, Head of Research Oncology, Clinical Data at Flatiron Health and practicing oncologist at Bellevue Hospital in New York City. "Scalable, high-quality extraction of such an important and complex endpoint like progression will open new doors for novel research, predictive modeling, and more personalized patient care."

In addition to this work, Flatiron Health will also present "Fairness by design: End-to-end bias evaluation for LLM-generated data," further highlighting the company’s leadership in applying AI and real-world data to advance oncology research. Specifically, this study demonstrates the VALID framework’s ability to evaluate both the quality and fairness of LLM-extracted data, highlighting the importance of ongoing bias assessment.

On July 14, 2025 ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX) reported that it has entered into a definitive agreement (the "Business Combination Agreement") with XenoTherapeutics, Inc. ("Xeno"), a non-profit biotechnology company, under which Xeno will acquire (the "Transaction") all of the issued and outstanding common shares of ESSA (the "Common Shares") (Press release, ESSA, JUL 14, 2025, View Source [SID1234654371]). XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA), the biotechnology royalty aggregator, is acting as the structuring agent and will provide financing to Xeno for this Transaction.

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Under the terms of the Business Combination Agreement, ESSA shareholders will receive a cash payment per Common Share that will be determined based upon ESSA’s cash balance at closing after deducting certain transaction costs, a reserve for liabilities and legal expenses, and a transaction fee (the "Final Cash Amount"). In addition, each ESSA shareholder will also receive one non-transferable contingent value right (each, a "CVR") for each Common Share that entitles the holder to receive a pro rata portion of up to US$2,950,000 (up to US$0.06 per CVR) within 18 months following the close of the Transaction.

To expedite the distribution of cash to ESSA shareholders, ESSA will also apply to the Supreme Court of British Columbia for an order authorizing it to make an initial cash distribution to ESSA shareholders prior to the closing of the Transaction. In total, with the initial cash distribution, if authorized, and the cash payable upon closing of the Transaction, each ESSA shareholder is currently estimated to receive approximately US$1.91 per Common Share, exclusive of any payments received pursuant to the CVR. The date of the applications will be announced by further press release. Inquiries related to such applications can be directed to ESSA’s counsel, Blake, Cassels & Graydon LLP, 1133 Melville Street, Suite 3500, The Stack, Vancouver, BC V6E 4E5 attention: Alexandra Luchenko, or by email to [email protected].

"After conducting a comprehensive review of the opportunities available to ESSA and considering the communications received from our shareholders, the ESSA Board of Directors has unanimously concluded that entering into this agreement with Xeno and XOMA Royalty is in the best interest of the Company and maximizes value for our shareholders as the Company proceeds with its plans to discontinue operations and wind-down its business," said David Parkinson, M.D., President and CEO of ESSA. "This Transaction delivers cash value to shareholders in an expedited timeframe, with less complexity and value risk when compared to a liquidation, and thus delivers more certain value to shareholders."

Transaction Details

The Transaction will be implemented by way of a court-approved plan of arrangement under the Business Corporations Act (British Columbia) and will require approval of at least: (i) 66⅔% of the votes cast by ESSA shareholders; (ii) 66⅔% of the votes cast by ESSA securityholders (including holders of ESSA options and pre-funded warrants), voting together as a single class; and (iii) a majority of the votes cast by ESSA shareholders excluding votes held by certain "interested parties" required to be excluded by Multilateral Instrument 61-101, at a special meeting to be held to consider the Transaction (the "Special Meeting"). In addition to approval by ESSA securityholders, the Transaction is also subject to receipt of court approval, and other customary conditions. The Transaction is expected to close in the second half of 2025.

The Business Combination Agreement provides for customary deal-protection provisions, including a non-solicitation covenant on the part of the Company and a right for Xeno to match any Superior Proposal (each as defined in the Business Combination Agreement). The Business Combination Agreement includes a termination fee of US$2.5 million, payable by the Company under certain circumstances, including in connection with the Company’s entry into an agreement with respect to a Superior Proposal. The directors and senior officers of the Company, owning in aggregate approximately 2.23% of the outstanding shares of Common Shares, have entered into voting and support agreements, pursuant to which they have agreed to vote all of the securities beneficially owned by them in favor of the Transaction.

ESSA Board of Directors and Transaction Committee Recommendations

A transaction committee composed entirely of independent directors of the Company (the "Transaction Committee") unanimously recommended entering into the Business Combination Agreement to the board of directors of ESSA (the "Board"). The Board has evaluated the Business Combination Agreement with the Company’s management, legal and financial advisors and, following the receipt and review of the unanimous recommendation from the Transaction Committee and the opinion of the Transaction Committee’s financial advisors, the Board has unanimously approved the Transaction and determined that the Transaction is in the best interest of the Company. The Board has resolved to recommend that the Company’s securityholders vote in favor of the Transaction, subject to the terms and conditions contained in the Business Combination Agreement.

Advisors

Leerink Partners is serving as the exclusive financial advisor to ESSA and Blake, Cassels & Graydon LLP and Skadden, Arps, Slate, Meagher & Flom LLP are serving as ESSA’s Canadian legal counsel and U.S. legal counsel, respectively.

Stikeman Elliott LLP and Gibson, Dunn & Crutcher LLP are serving as XOMA Royalty’s Canadian legal counsel and U.S. legal counsel, respectively.

On July 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, JUL 14, 2025, View Source [SID1234654370]).

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In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a Complete Response, and three patients have achieved Partial Response (cancer reduction by at least 50%) bringing the best overall response rate to 75% and the CR rate to 55%. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2).

Evaluable
patients

Treatment

N

Overall Response Rate (ORR)

Complete Response (CR)

At Day 60

Best Durability (Time of response)

DLBCL

Lymphodepletion (LD)1 +azer-cel

+Interleukin-2 (IL-2)

12

9/12 (75%)

6/11 (55%)

>450 days on going

For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response.

Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).

Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel.

Leslie Chong, Managing Director and CEO of Imugene, said:

"We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA.

Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel."

Dr John Byon, Chief Medical Officer of Imugene, said:

"DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment.

We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists."

The FDA Fast Track Designation for DLBCL received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria.

Imugene continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.

About primary central nervous system lymphoma (PCNSL)

PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.

About other types of B Cell Lymphoma

Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.