On October 9, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported that it has filed two new provisional patent applications with the United States Patent and Trademark Office (USPTO). The first application includes claims protecting Akari’s novel immuno-oncology payload, PH1 (a novel Thailanstatin analog), and its spliceosome modulatory mechanism of action, which is expected to provide a therapeutic benefit by activating the host immune system in the fight against cancer. The second patent filing includes claims for a combination therapy of PH1 pipeline ADCs with other immuno-oncology drugs that alleviate checkpoint inhibition and have demonstrated synergy with immune checkpoint inhibitors (ICIs) in preclinical models. These new patent applications are part of a growing patent portfolio strategy designed to further extend Akari’s proprietary position with respect to the Company’s novel PH1 payload. These filings also build upon Akari’s recent provisional patent filing in late September covering the use of Akari’s ADC platform to target cancer by modulating alternative splicing drivers within cancer cells.

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Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, "The filing of these two patent applications furthers our strategy to establish a framework for building a new class of immuno-oncology ADC therapies and build on the tremendous success of checkpoint inhibitors. We believe the data within our patent applications enable the potential of our PH1 payload to build novel first-in-class immune-oncology ADCs and continue to demonstrate Akari’s advances in our understanding of spliceosome modulation as a strategy to attack cancer. In particular, these two patent applications include data that highlight the unique immuno-oncology action that the PH1 payload can potentially unlock to drive differentiated clinical outcomes and remissions for cancer patients in the future."

"We look forward to sharing more details at the upcoming presentation at the Society for Immunotherapy Cancer (SITC) (Free SITC Whitepaper) Congress as an oral presentation on November 9th to highlight the progress of our exciting research on Akari’s spliceosome modulating payload PH1. These specific provisional patent applications are designed to protect our disclosures at the SITC (Free SITC Whitepaper) conference and increase the scope of our intellectual property estate, which we anticipate will enable long term value creation for Akari and potential partners we elect to work with on our ADC portfolio," concluded Mr. Gaslightwala.

To build on the Company’s current patent estate around the PH1 spliceosome modulating payload, these patent filings include data that highlights the immuno-oncology properties of Akari’s proprietary ADCs as a single agent, as well as a synergistic gain-of-function effects from the synergy created when Akari’s proprietary ADCs are combined with certain checkpoint inhibitors, as compared to either single agent-ADC or immune checkpoint inhibitor therapy.

Checkpoint inhibitors have seen historic success across several cancer types but have only benefited roughly 20-30% of patients as measured by response rates in approved cancer types. Akari’s data underscore the potential for creating a new ADC paradigm for targeting cancer via spliceosome modulation and unlocking the potential of a combination checkpoint inhibitor-PH1 ADC regimen in new and exciting ways.

The Company continues to expand its current ADC pipeline to encompass multiple targets, such as AKTX-101 (Trop2 ADC with PH1 payload), as well as future programs (AKTX-102, undisclosed target with PH1 payload).

(Press release, Akari Therapeutics, OCT 9, 2025, View Source [SID1234656890])

On October 9, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported that ONO-4578, an EP4 antagonist, in combination with Opdivo, an anti–PD-1 antibody and chemotherapy which is one of the standard treatments in this setting met the primary endpoint in the Phase 2 clinical trial (ONO-4578-08 study) in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) (Press release, Ono, OCT 9, 2025, View Source [SID1234656550]).

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In the trial, ONO-4578 in combination with Opdivo and chemotherapy demonstrated a statistically significant prolongation of progression-free survival (PFS) compared with placebo in combination with Opdivo and chemotherapy. In addition, no new safety concerns were identified in the trial. Ono will publish the results at an upcoming academic meeting.

About ONO-4578-08 study

ONO-4578-08 study is a multicenter, randomized Phase 2 clinical trial, conducted in Japan, South Korea and Taiwan in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. ONO-4578 in combination with Opdivo and chemotherapy (S-1 + oxaliplatin or capecitabine + oxaliplatin) was compared with placebo in combination with Opdivo and chemotherapy. In this trial, patients received 40 mg of ONO-4578 once daily and 360 mg of Opdivo every 3 weeks in combination with chemotherapy until disease progression or unacceptable toxicity was observed. The primary endpoint of this trial is PFS.

About Gastric cancer

It is estimated that approximately 126,000 new cases with gastric cancer are diagnosed per year in Japan1) (approximately 968,000 cases worldwide2)) and approximately 43,000 deaths per year in Japan1) (approximately 660,000 deaths worldwide2)) resulting from gastric cancer, which is the third most common type of cancer following colorectal cancer and lung cancer in Japan. Combination therapies with anti–PD-1 antibody and chemotherapy have been approved for the first-line treatment of HER2-negative unresectable advanced or recurrent gastric cancer as the standard treatment. However, unresectable gastric cancer remains incurable, and a new treatment option is needed for patients with gastric cancer.

About ONO-4578

ONO-4578 is a selective, oral antagonist of EP4, which is one of the prostaglandin E2 (PGE2) receptors, developed by Ono. PGE2, which is produced by cancer cells, suppresses the action of cancer immunity through EP4 receptors expressed on various immune cells3)~5). ONO-4578 is expected to exert antitumor effect by suppressing EP4-mediated effects of PGE2 and by restoring cancer immunity6). In the phase 1 clinical trial in patients with unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) after the third- or later-line treatment, a combination therapy with ONO-4578 and Opdivo showed antitumor effect and a manageable safety profile7). Currently, Ono is conducting several clinical trials of ONO-4578, including a global phase 2 clinical trial in patients with colorectal cancer.

On October 9, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 – 21, 2025 at the Hotel Del Coronado in San Diego, California (Press release, CytoDyn, OCT 9, 2025, View Source [SID1234656533]).

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Presentation Date: Tuesday, October 21, 2025

Time: 9 a.m. PDT

Register to view presentation: Webcast Link

Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact [email protected].

On October 9, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Austria (Press release, Greenwich LifeSciences, OCT 9, 2025, View Source [SID1234656534]).

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The Company’s application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 6,070 new cases of breast cancer were diagnosed in Austria in 2022, which is the most common cancer diagnosed in women, representing approximately 28% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Austria with 1,789 deaths in 2022.

CEO Snehal Patel commented, "We are collaborating with principal investigators at the Ordensklinikum Linz in Upper Austria. The site approached the Company after patients asked about participating in FLAMINGO-01. We recently visited the site in Linz, where we started training activities. We hope to activate the site this year and plan to further develop the geographic strategy for Austria, where we are considering additional sites in Vienna and Salzburg."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 9, 2025 Leap Therapeutics (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has closed its previously announced private placement led by Winklevoss Capital raising $58,888,888 in cash to initiate a digital asset treasury strategy. At the closing of the transaction, Leap issued (i) 15,212,311 shares of common stock (the "Shares"), (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase up to an aggregate of 80,768,504 shares of common stock, and (ii) warrants to purchase an additional 71,985,605 shares of common stock at an exercise price of $0.5335 per share (the "Warrants" and together with the Shares and the Pre-Funded Warrants, the "Units") (Press release, Leap Therapeutics, OCT 9, 2025, View Source [SID1234656536]).

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Winklevoss Capital will provide both capital and strategic support to help Leap structure and execute its digital asset treasury strategy. Leveraging the expertise of Winklevoss Capital, Leap aims to build long-term shareholder value through participation in digital assets. A portion of the capital will be used to continue development of Leap’s therapeutic programs, including FL-501 and sirexatamab, which has recently completed a randomized controlled Phase 2 trial in patients with colorectal cancer that is being presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on October 19 in Berlin, Germany.

Pursuant to a lead investor agreement, Leap has increased the size of its Board of Directors to 12 members, and Winklevoss Capital will have the right to nominate two individuals to Leap’s Board of Directors, one of whom shall also be the chairperson of the Board.

Leap expects to release additional updates regarding its treasury activities in the near-term.

Parcrest acted as the placement agent in connection with the financing.

Morgan, Lewis & Bockius LLP acted as legal advisor to Leap, and Cooley LLP acted as legal advisor to Winklevoss Capital.

The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from the registration requirement of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder, and applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirement of the Securities Act and such applicable state securities laws. Concurrently with the execution of the securities purchase agreements, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale by the purchasers participating in the offering of the Shares and the shares of common stock underlying the Pre-Funded Warrants and the Warrants. Any offering of the Company’s common stock under the resale registration statement will only be made by means of a prospectus.

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

The private placement was conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).