On August 1, 2023 OSE Immunotherapeutics reported that the Company has received €200,000 grant innovation funding from the French Government and Region Pays de la Loire as part of the "France 2030 investment plan" operated by Bpifrance (Press release, OSE Immunotherapeutics, AUG 1, 2023, View Source [SID1234646942]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:
"We thank the French government, the "Region Pays de la Loire" and Bpifrance to help OSE in developing next future generation immunotherapies based on the unique advantages that RNA Therapeutics could offer as a novel first-in-class modality. Exciting progress is being made to explore and define new frontiers of science in RNA-based medicines paving the way for RNA therapeutic-based immunotherapies targeting diseases that cannot be treated with other conventional drug groups. OSE is building a first-in-kind research platform at the intersection of Antibody Engineering, Data Science, Artificial Intelligence (AI) regularly used by the OSE Team and adding now novel RNA Therapeutics and RNA Delivery methods recently patented by OSE to continue to develop next-generation immunotherapy medicines modulating immune cell responses in the field of immuno-inflammation and immuno-oncology. I thank warmly the OSE R&D team moving fast in this new emerging RNA era generating exciting opportunities for future transformative medicines".

On August 1, 2023 Renaissance Pharma Ltd., ("Renaissance" or "the Company"), a rapidly emerging company focused on the development of life changing therapies in paediatric rare disease reported the signing of an exclusive license agreement with St. Jude Children’s Research Hospital ("St. Jude") for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma (Press release, Pharma, AUG 1, 2023, View Source [SID1234642049]).

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Neuroblastoma represents 8-10% of all childhood cancers 1, is the second most common cancer in children and is the most common cancer in children under one year of age2. 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3. Each year more than 500 HRNB patients are diagnosed in Europe and 300 in the US. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 monoclonal antibody (mAb) treatment.

Hu14.18 is an anti GD2 humanised mAb. A novel Phase II trial incorporating Hu14.18 into induction therapy and additionally, within post-consolidation therapy, demonstrated outstanding patient outcomes with OS of 86.0% and EFS of 73.7%4. Within the patient population, where the antibody was used in all patients prior to consolidation and maintenance, 66.7% achieved a Partial Response or better after the first two chemo-immunotherapy induction cycles, and 96.8% achieved a Partial Response or better at the end of induction. Data from the successful Phase II study was published in the Journal of Clinical Oncology in December 2021 and will soon reach maturity in regard to its 5-year OS readouts5.

Renaissance Pharma, launched today, is led by Executive Chairman, Lee Morley; Chief Executive Officer, Simon Ball; Chief Medical Officer, Dr Jonathan Morgan; and Chief Technical Officer, Debra Nevin. The Company’s founding team members are highly experienced with extremely relevant and proven track records across orphan disease states, antibody technologies, oncology and paediatric therapeutic areas.

Under the terms of the licensing agreement, Renaissance Pharma has secured exclusive development, manufacturing and commercialisation rights to US, Canada, Europe, China, Japan and Turkey.

Renaissance will now pursue interaction with the FDA, EMA and other Regulatory Agencies internationally to configure the optimal path for Hu14.18’s submission.

Lee Morley, Executive Chairman of Renaissance Pharma, said: "We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients. The Phase II data as published in the Journal of Oncology is breathtaking and I am certain that the neuroblastoma community will be as excited as we are when considering the potential significance of this breakthrough treatment. Our responsibility is now to continue the journey that St. Jude so professionally began. Our intent is simple, to get Hu14.18 into the hands of treating physicians as swiftly as possible so the potential benefits Hu14.18 offers can be passed on to the patients that so desperately need them. This responsibility begins immediately."

Simon Ball, CEO of Renaissance Pharma, said: "It is rare to have the opportunity to make such a significant improvement in a treatment paradigm; with Hu14.18, we have just that opportunity. Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible. The collaboration with St. Jude marks the intention of Renaissance and we must now play our part in making the product available."

"It is exciting and deeply meaningful to see how our clinical efforts to develop Hu14.18 may now have the potential to positively impact patients with high-risk neuroblastoma around the world," said Sara M. Federico, MD, St. Jude Department of Oncology.

On August 1, 2023 Blue Water Biotech, Inc. ("Blue Water" or the "Company") (Nasdaq: BWV), reported it has entered into a definitive agreement for the exercise of certain existing warrants to purchase 2,486,214 shares of its common stock at a reduced exercise price of $1.09 per share, in exchange for new warrants as described below (Press release, Onconetix, AUG 1, 2023, View Source [SID1234641114]). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $2.7 million, before deducting placement agent fees and other offering expenses payable by the Company. The transaction is expected to close on or about August 2, 2023, subject to satisfaction of customary closing conditions.

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H.C. Wainwright is acting as the exclusive placement agent for this transaction.

The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes, including executing on launch activities for Blue Water’s commercial portfolio announced in a letter to shareholders issued earlier this month.

The shares of common stock issuable upon exercise of the existing warrants are registered pursuant to an existing registration statement on a Post-Effective Amendment No. 1 to Form S-1 on Form S-3 (File No. 333-267142), declared effective by the Securities and Exchange Commission (the "SEC") on May 4, 2023.

In consideration for the immediate exercise of the existing warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The shares of common stock issuable upon exercise of the new warrants is subject to stockholder approval. The Company agreed to convene a stockholders’ meeting on or before 90 days following the closing date of the transaction to obtain such approval. The new warrants will be exercisable for up to an aggregate of 4,972,428 shares of common stock, at an exercise price of $1.09 per share and have a term of exercise equal to five years from the date of stockholder approval.

The new warrants offered in the private placement have not been registered under the 1933 Act, or applicable under state securities laws. Accordingly, the new warrants and shares of common stock issuable upon the exercise of the new warrants 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. As part of the offering, the Company has agreed to file a resale registration statement on Form S-3 with the SEC as soon as practicable to register the resale of the shares of common stock issuable upon the exercise of the new warrants issued in the private placement, and to have such resale registration statement declared effective within 90 days following the date of the agreement.

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

On August 1, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the execution of an Assignment Agreement (the "Agreement") with Mundipharma International Corporation Limited ("MICL"), Mundipharma Medical Company ("MMCo"), and Acrotech Biopharma Inc. ("Acrotech") for the commercialization of FOLOTYN (Pralatrexate) in the People’s Republic of China ("China") (Press release, CASI Pharmaceuticals, AUG 1, 2023, View Source [SID1234640200]).

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FOLOTYN (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). This product was approved by both the US Food and Drug Administration ("FDA") and China’s National Medical Products Administration (NMPA) for PTCL. Under the terms of the Agreement, CASI will assume MICL’s rights and obligations with respect to the commercialization of FOLOTYN in China.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are very pleased to add FOLOTYN, another unique and approved drug product to our commercial portfolio. The licensing of FOLOTYN is consistent with the company’s strategy to grow our hematological malignancy therapeutic area franchise. We will leverage CASI’s existing sales and commercial team’s established capabilities and infrastructure to launch and commercialize FOLOTYN."

"CASI has proven and strong capability to commercialize proprietary medications and are extremely pleased to broaden our existing relationship with them. We look forward to this exciting launch and bringing this novel medicine to PTCL patients in China," said Dr. Ashish Anvekar, President of Acrotech Biopharma.

On August 1, 2023 Pierre Fabre reported 2023 Annual Report (Presentation, Pierre Fabre, AUG 1, 2023, View Source [SID1234639494]).

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