On July 29, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported a presentation on its ovarian cancer CAR-T therapy clinical trial at the International Gynecologic Cancer Society (IGCS) 2024 Annual Global Meeting being held October 16-18, 2024, in Dublin, Ireland (Press release, Anixa Biosciences, JUL 29, 2024, View Source [SID1234645123]).

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The presentation, titled "Phase I Clinical Trial of Autologous T-cells Genetically Engineered with a Chimeric Receptor to Target the Follicle Stimulating Hormone Receptor (FSHR) in Recurrent Ovarian Cancer (OVCA)," will be presented by the study’s principal investigator, Dr. Robert Wenham, Chair of Gynecologic Oncology at Moffitt Cancer Center, Anixa’s collaboration partner.

About Anixa’s CAR-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T. Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

On July 26, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV) (the "Company"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private placement (the "Private Placement") for gross proceeds to the Company of $2 million (Press release, Rakovina Therapeutics, JUL 27, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-closes-previously-announced-over-subscribed-private-placement [SID1234645110]).

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In connection with the Private Placement, the Company issued 19,950,000 units (each, a "Unit") at a purchase price of $0.10 per Unit. Each Unit is comprised of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange (the "TSXV") is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.

According to Executive Chairman Jeffrey Bacha, the funds will be used to further the company’s Artificial Intelligence (AI) fueled drug candidate research. Bacha said, "We are continuing activities under our AI collaboration to screen billions of drug candidates against DNA-damage response targets. We anticipate having initial output from this effort in the form of recommended molecular structures for validation in our laboratories at the University of British Columbia in early fall, which puts us on track to have initial data from validating in vivo models later this year."

Defects on our natural DNA-damage response mechanism are involved in the formation and growth of approximately three out of every four cancers. First generation DDR-inhibitors, called PARP-inhibitors, currently generate approximately $3 billion in annual sales and have provided significant benefit to patients diagnosed with certain types of breast, ovarian, and prostate cancer. Rakovina Therapeutics’ goal is to advance one or more next-generation DDR drug candidates into human clinical trials in collaboration with pharmaceutical partners.

In connection with the Private Placement, the Company paid a cash finder’s fee to Hampton Securities Limited totaling $1,200 and issued 12,000 finder’s warrants (each, a "Finder’s Warrant"). Each Finder’s Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance, subject to acceleration on the same terms as the Warrants issued in connection with the Private Placement.

The Private Placement is subject to the final acceptance of the TSX-V and all securities issuable in connection with the Private Placement are subject to resale restrictions for a period of four months plus one day from the date of issuance.

On July 26, 2024 Orano reported Half-year results reflect the deteriorated situation in Niger in an otherwise favorable dynamic 2024 financial outlook confirmed (Presentation, Orano, JUL 26, 2024, View Source;orano-2024-half-year-results.pdf?sfvrsn=a29c3931_6 [SID1234647176]).

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On July 26, 2024 Bristol-Myers Squibb reported second quarter 2024 results (Presentation, Bristol-Myers Squibb, JUL 26, 2024, View Source [SID1234646907]).

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On July 26, 2024 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported to have received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Dasynoc, a novel treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL) (Press release, Xspray, JUL 26, 2024, View Source [SID1234645158]). The updated NDA was sent to the FDA on January 31, 2024. In the CRL the FDA requests additional information pertaining to the labeling comprehension and the pre-approval inspection at the third party’s manufacturing site, which was conducted 10 to 19 of June, 2024. Importantly, the FDA does not request additional clinical studies, nor does it question any submitted stability or clinical data.

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To meet the FDA’s requirements, Xspray Pharma will work together with its third-party manufacturer to address the requests relating to the pre-approval inspection. In addition, the FDA has suggested a dialogue in the near term with Xspray to adapt the labeling strategy.

"We are encouraged that the FDA’s feedback confirms the stability and clinical data of Dasynoc. While the additional requests from the FDA were unexpected, we are confident in our ability to address these in a timely manner" said Per Andersson, CEO of Xspray Pharma. "This delay of the anticipated September launch is unfortunate as it impacts patients who do not have a viable treatment option when they are prescribed dasatinib and co-medicate with acid reducing agents. Our team remains dedicated to ensure that Dasynoc reaches patients as soon as possible, offering a valuable new treatment option for CML. Xspray welcomes the opportunity to work with the FDA to expedite the resubmission of the NDA. We will revert within the coming weeks with an updated time plan."

About Dasynoc
Dasynoc is an innovative treatment designed for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL). Dasynoc leverages the proven safety and efficacy of dasatinib along with distinct patient benefits driven by Xspray’s patented HyNap Technology.

Dasynoc offers bioequivalence at doses 30% less, which means patients are dosed lower. Additionally, bioavailability within patients may be more precise and predictable, ensuring patients get the benefit of their intended dose. Finally, it will be possible to prescribe Dasynoc freely with any acid reducing agent (ARA) including Proton Pump Inhibitors (PPIs), H2 antagonist or antacids.

Co-medication of both Tyrosine Kinase Inhibitors (TKIs) and ARAs is common as was recently highlighted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), demonstrating that 54% of CML patients, despite a warning, were prescribed a PPI. This is not without potential consequence, as a separate published study demonstrated 5-year overall survival was reduced by 15% in patients who took both a TKI with PPI.