On July 3, 2024 Delta-fly pharma reported the enrollment of patients in the Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive that was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Feb. 2024, has started as of today in Japan (Press release, Delta-Fly Pharma, JUL 3, 2024, View Source [SID1234644673]).

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This Phase III clinical trial will be conducted at 30 sites with NSCLC experts in Japan and the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint will be confirmed.

As DFP-14323 selectively binds to the aminopeptidase N, which is widely expressed on various cells, as lung cancer and inflammatory cells, it is expected to be effective in the treatment of patients with refractory cancer and when the superiority of the add-on effect can be confirmed in this study, it is expected to provide a novel cancer immunotherapy that is independent of EGFR mutation types, uncommon or common mutation.

We will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, we will promote out-licensing activities to Asian pharmaceutical companies.

Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO: 4598) and contact with us.

On July 3, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first-in-class and best-in-class therapies for hematological malignancies, reported that on July 2, 2024, in relation to the Exclusive Option Agreement with Takeda for the third-generation BCR-ABL inhibitor olverembatinib (HQP1351), Ascentage Pharma has received the US$100 million option payment called for by the Exclusive Option Agreement (Press release, Ascentage Pharma, JUL 3, 2024, View Source [SID1234644672]).

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On June 14, 2024, Ascentage Pharma and Takeda entered into an Exclusive Option Agreement that granted Takeda an exclusive option to enter into an exclusive license agreement for olverembatinib. The Exclusive Option Agreement calls for Ascentage Pharma to receive an option payment of US$100 million and provides for Ascentage Pharma to be eligible for an option exercise fee and additional potential milestone payments of up to approximately US$1.2 billion and double-digit royalties on annual sales.

On July 3, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported that the Company has been issued a patent by the Chinese Patent Office protecting its T cell receptor (TCR) targeting NY-ESO-1 (New York esophageal squamous cell carcinoma 1) and LAGE 1a (L Antigen Family Member-1a), both being well-recognized and validated cancer-testis antigens, expressed in multiple tumor types (Press release, MediGene, JUL 3, 2024, View Source [SID1234644670]).

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"We are delighted to receive the patent grant of our NY-ESO-1 / LAGE1a-targeted TCR in China. This TCR, together with the PD1-41BB costimulatory switch protein, serves as the main component of our lead TCR-T program MDG1015, for the treatment of gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma, for which we remain on track for a US IND submission in the 3rd quarter of this year," said Selwyn Ho, CEO at Medigene AG. " Importantly, this adds to similar patents that were also granted in the United States, Europe, Japan, South Korea, Taiwan and Australia and further expands the opportunity to use our optimal affinity 3S (sensitive, specific and safe) TCRs internationally, across multiple therapeutic modalities, including TCR-T therapies, TCR-guided T cell engagers and TCR natural killer cell therapies."

Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains over 20 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies.

On July 3, 2024 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported the closing of its rights offering and the final results thereof (Press release, Pulse Biosciences, JUL 3, 2024, View Source [SID1234644666]).

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The Company received basic subscriptions and over-subscriptions in excess of $83 million, equal to approximately 138% of the $60 million gross proceeds limit in the rights offering, and subscriptions from over 800 accounts, including those of the Company’s Executive Chairman, Robert Duggan. Available Units were allocated proportionately among those rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under its basic subscription rights, in accordance with the procedures described in the prospectus, as amended to date, relating to the rights offering. The remaining oversubscription amounts will be returned by Broadridge Corporate Issuer Solutions, LLC (the "Subscription Agent") to the investors.

The rights offering resulted in the sale of six million units (the "Units"), at a price of $10.00 per Unit. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and two warrants, each being a warrant to purchase one-half of one share of common stock. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. A total of 5,999,999 shares of common stock and warrants to acquire up to an additional approximately six million shares of common stock were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $60 million. If exercised, additional gross proceeds of up to $66 million may be received through the exercise of warrants issued in the rights offering. Each warrant will be exercisable for $11.00 per whole share, which equals 110% of the subscription price for the Units. Warrants are exercisable immediately and will expire on the fifth anniversary of the closing of the rights offering. Half of the warrants issued in the rights offering are redeemable by the Company if the Company’s stock trading price exceeds $16.50 for twenty consecutive trading days and the other half of the warrants issued in the rights offering are redeemable by the Company if its stock trading price exceeds $22.00 for twenty consecutive trading days.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Shares, warrants and any excess subscription payments are expected to be distributed by the Subscription Agent on or about July 5, 2024.

After giving effect to the issuance of 5,999,999 shares of common stock in the rights offering (but excluding up to approximately six million shares of common stock underlying the warrants issued in the rights offering), the Company has 61,228,332 shares of common stock issued and outstanding.

The Company plans to use proceeds from the offering principally to support further product and clinical development, future regulatory submissions and commercial readiness of its three leading CellFX nsPFA products, Percutaneous Electrode, Cardiac Clamp, and 360° Cardiac Catheter. Each device is designed to deliver significant clinical advantages compared to the current standards of care and have a potential profound positive impact on healthcare for both patients, providers and other stakeholders.

The rights offering was made pursuant to the Company’s registration statement on Form S-3, as modified by the post-effective amendment filed with the Securities and Exchange Commission ("SEC") on May 28, 2024, which was deemed effective by the SEC on May 31, 2024, including the prospectus contained therein, as further modified by the prospectus filed pursuant to Rule 424(b)(2) of the Securities Act of 1933, which contains the detailed terms of the rights offering and was filed with the SEC on June 4, 2024.

On July 3, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results (Press release, Immutep, JUL 3, 2024, View Source [SID1234644662]).

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ESMO Virtual Plenaries are monthly presentations of the latest, original scientific data, including "Phase II trials which demonstrate remarkable therapeutic benefit, scientific insight or progress in an area of unmet need". The oral presentation will announce the substantially improved overall response rate, as advised 27 June 2024, and additional data in patients with first line head and neck squamous cell carcinoma who have negative PD-L1 (Cohort B).

Details for the ESMO (Free ESMO Whitepaper) Plenary presentation

Title: Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma: Primary Results from Cohort B (CPS <1) of the TACTI-003 Study
Presenter: Dr. Robert Metcalf, The Christie NHS Foundation Trust, Manchester, U.K.
Format: Oral Presentation
Date/Time: 18:30-19:30 Central European Time (CEST), July 11, 2024
Webcast Details

Immutep will host a webcast to discuss the clinical data. A replay of the webcast will be available under the Events section of Immutep’s website after the event.

Date/Time: Friday, July 12, at 9am AEST (7pm ET July 11)
Register: Link to register for webcast
Questions: Investors are invited to submit questions in advance via [email protected]
About the TACTI-003 Trial

The TACTI-003 (KEYNOTE-PNC-34) trial is an ongoing Phase IIb study evaluating eftilagimod alfa (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours.

The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).

About Eftilagimod Alfa (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-g and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).