On July 3, 2024 (the "Effective Date"), Eagle Pharmaceuticals, Inc. (the "Company") and Curia Global, Inc., f/k/a Albany Molecular Research, Inc. ("AMRI") and Curia New Mexico, LLC (together with AMRI, "Curia") reported to have entered into a Settlement Agreement and Release ("Settlement Agreement") relating to the settlement of all their claims and counterclaims in Curia Global, Inc. v. Eagle Pharmaceuticals, Inc., AAA Case No. 01-23-0000-2937, American Arbitration Association (the "AAA Arbitration"), and Curia Global, Inc. v. Eagle Pharmaceuticals, Inc., Index No. 651064/2023, Supreme Court of the State of New York, County of New York (the "NY Court Action") and other claims and disputes relating to these proceedings.

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As previously disclosed, the AAA Arbitration relates to disputes arising from the parties’ Vasopressin Commercial Supply Agreement, dated April 15, 2018 ("Vasopressin CSA"), and the NY Court Action relates to disputes arising from the parties’ PEMFEXY Master Development and Supply Agreement, dated March 26, 2021 (the "PEMFEXY MSA"). The Company and Curia have agreed to a mutual release of all claims arising from or concerning the Vasopressin CSA (other than any future indemnity claims that may be asserted related to defects or product liability), or the allegations, claims or counterclaims in the AAA Arbitration or the NY Court Action, in addition to payment, covenants, representations and other terms, the material terms of which are summarized below. The parties’ releases are subject to the payment of the full settlement amount and the passage of a specified time period thereafter with no Events of Default (as described below). The Settlement Agreement provides that the settlement is not an admission of liability or wrongdoing by either party. The PEMFEXY MSA remains in effect.

Pursuant to the Settlement Agreement, the Company agreed to pay Curia $26.5 million in accordance with the following payment schedule: $10.0 million within one business day of the Effective Date (paid on July 5, 2024); $10.0 million on or before February 17, 2025; and $6.5 million on or before July 7, 2025. In addition, Curia has filed a Stipulation of Discontinuance with Prejudice in the NY Court Action pursuant to the Settlement Agreement and the parties have agreed to take all other necessary steps to cause the prompt dismissal with prejudice of all claims in the NY Court Action, including the withdrawal of the appeal in the NY Court Action.The parties have jointly submitted a request to the arbitrators in the AAA Arbitration to issue a final award on consent recording the settlement.

Pursuant to the Settlement Agreement, an Event of Default occurs upon a failure by the Company to pay when due any of the settlement payments described above, and specified bankruptcy and insolvency events with respect to the Company.

The foregoing description of the material terms of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, which the Company intends to file with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

On July 3, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer, will participate in a fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 6:45 a.m. PDT / 9:45 a.m. EDT (Press release, Atara Biotherapeutics, JUL 3, 2024, View Source [SID1234644660]).

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A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

On July 3, 2024 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it has entered into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 1,425,000 shares of common stock in a registered direct offering and warrants to purchase up to 1,425,000 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.39 per share (Press release, CNS Pharmaceuticals, JUL 3, 2024, View Source [SID1234644661]). The warrants issued pursuant to the concurrent private placement will have an exercise price of $1.26 per share, will be exercisable immediately following the date of issuance and will expire 5 years from the initial exercise date.

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The closing of the Offering is expected to occur on or about July 5, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $1.98 million before deducting financial advisory fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The common stock will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-279285) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on May 17, 2024. The warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source

The private placement of the ordinary warrants and the underlying shares will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent 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 requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On July 3, 2024 ImmuneOnco Biopharma reported that Timdarpacept (IMM01) combined with Tislelizumab for refractory cHL Phase III clinical trial successfully completed the first patient enrollment on July 1, 2024 (Press release, ImmuneOnco Biopharma, JUL 3, 2024, View Source [SID1234655701]).

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IMM01 is the first SIRP-α-FC fusion protein to enter the clinical stage in China and is developed to use in combination with other drugs to treat a variety of blood and solid tumors. The results of two Phase II clinical trials of IMM01 were released in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 annual meeting. One is the new updated data of Phase II trial for IMM01 combined with Tislelizumab in cHL patients who have failed prior PD-(L)1 antibody therapy, after 6.87 months of follow-up, ORR reached 66.7%, CR 24.2%, DCR 93.9%, median PFS and median DOR were not reached. In addition, IMM01 combined with Tislelizumab was well tolerated. Another is the phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). After 12.8 months follow-up, ORR reached 64.7%, including 29.4% CR), 15.7% mCR with hematologic improvement (HI): 5.9% HI and 13.7% mCR alone. 12-month PFS reached 54.4%. The updated data show that MM01 combined with AZA were well tolerated and effective in patients with treatment-naive higher-risk MDS.

Founder and chairman of ImmuneOnco Dr. Tian, Wenzhi said: "We are very pleased to see the completion of the first patient enrollment in our Phase III registration clinical trial of Timdarpacept (IMM01) combined with Tislelizumab for cHL refractory to PD-(L)1 monoclonal antibody. This therapy tries to meet ’unmet clinical need’ since there is very limit treatment options for those young-age onset patients. Timdarpacept activates macrophages to turn "cold tumors" into "hot tumors", and macrophages will present more tumor antigens to T lymphocytes to induce tumor-specific T cell responses, thereby restoring and expanding the sensitivity and therapeutic response to Tislelizumab This is well supported by our clinical data. In contrast, PD-1 antibody combined with another T cell-associated immune checkpoint antibody is difficult to achieve such clinical manifestations. We firmly believe that the development of Timdarpacept in combination with Tislelizumab for refractory cHL will have great market competitiveness. We will quickly advance the phase III registered clinical trial and strive to bring benefits to cHL cancer patients as soon as possible."

Chief Medical Officer/Senior Vice President of ImmuneOnco, Dr. Lu, Qiying, said: "the project of IMM01, the company’s key product, combined with Tislelizumab successfully completed the enrollment of the first patient in phase III clinical trial for the cHL patients refractory to PD1/PD-L1 therapy. this is another important milestone indicating that the clinical development of IMM01 has fully entered the registered clinical trial stage. This is globally first registration of trial large molecule drug against CD47 for cHL. From approval of CDE on May 16 to First Patient in on July 1, our team took one and half month to get the work done , indicating that the team had strong execution ability and worked efficiently. We are confident that we can quickly promote the clinical development of IMM01 products to bring new treatment options for cancer patients to solve the unmet clinical needs."

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).