On July 30, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported the approval of the third of four stages of the Phase I/II study (AB18001) with the compound AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) (Press release, AB Science, JUL 30, 2025, View Source [SID1234654633]).

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The third stage has been approved in France, Germany, Spain and Greece. The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for different treatment stages of AB8939.

-Stage 1: Determination of the MTD after 3 consecutive days of treatment with AB8939 alone.
-Stage 2: Determination of the MTD after 14 consecutive days of treatment with AB8939 alone.
-Step 3: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax.
-Stage 4: Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.

The first two stages of Phase 1 were completed with 28 and 13 patients enrolled, respectively, and determined the MTD of AB8939 after 3 consecutive days of treatment (21.3 mg/m2 ) and after 14 consecutive days of treatment (21.3 mg/m2 ).

The third stage now consists of evaluating the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, "The approval of this third stage is a key milestone for the Phase I/II study with AB8939 in AML. The combination of AB8939 and venetoclax has the potential to change the standard of care in the treatment of relapsed/refractory AML".

▪Rationale for the AB8939 + venetoclax combination

The combination of AB8939 + venetoclax has several potential benefits:

1 – Both molecules have low hematologic toxicity. This combination could therefore be less toxic than azacitidine + venetoclax as first-line treatment for AML.

2 – These two molecules act on different and complementary targets in cancer cells, which could have an additive or even synergistic effect in terms of efficacy.

-AB8939 has two modes of action:

oMicrotubule destabilization: Microtubules are cellular structures essential for cell division (mitosis). By destabilizing them, AB8939 prevents cancer cells from dividing properly, leading to their death. The advantage is that this type of chemotherapy is independent of the TP53 mutation that creates the most resistance to standard chemotherapies.

oInhibition of ALDH (aldehyde dehydrogenase): ALDH is an enzyme found in cancer stem cells, a subtype of cells in AML that are particularly resistant to treatment and responsible for relapses, as they can survive conventional chemotherapy. By inhibiting ALDH, AB8939 specifically targets these stem cells, reducing resistance to treatment and limiting the risk ofrelapse.

-Mechanism of action of venetoclax: Inhibition of BCL2

oBCL2 is a protein that prevents apoptosis (programmed cell death) in cancer cells.

oBCL2 is another factor in AML resistance, as it allows cancer cells to survive despite treatment.

oBy blocking BCL2, venetoclax promotes apoptosis, making cancer cells more vulnerable.

-There is an additive, even synergistic, potential for the combination By simultaneously targeting these mechanisms, the combination could reduce the chances of cancer cells escaping treatment (resistance). This potential synergistic effect arises from the fact that inhibiting ALDH and BCL2 could weaken the resistance mechanisms of cancer stem cells, while destabilizing microtubules prevents cell proliferation. Together, these actions are more powerful than if each molecule were used alone.

3 – Finally, AML is difficult to treat due to its heterogeneity and resistance mechanisms. AB8939 is effective in vitro and in vivo in animals and generates responses in human patients with the poorest prognostic factors when treated with standard of care chemotherapies, namely TP53 mutation, MECOM and complex karyotype.

▪Non-clinical pharmacology data Animal studies have demonstrated the following properties of AB8939 that are relevant for the treatment of AML: -AB8939 is active ex vivo against AML cancer cells from chemotherapy-naive or chemotherapy-refractory/relapsed patients, particularly those with TP53 mutations or complex karyotypes.

-AB8939 eradicates blasts in the blood and bone marrow in PDX models resistant to 5-AraC (cytarabine), particularly those with MECOM rearrangements. -AB8939 increases survival and has an additive effect in combination with the standard treatments azacitidine and venetoclax. -ALDH expression is a characteristic of cancer stem cells (CSCs), and AB8939 is an ALDH1/2 inhibitor. Therefore, AB8939 is a targeted therapy for leukemic cancer stem cells.

-AB8939 eradicates leukemia cancer stem cells in a human PDX model of AML.

▪Potential market for AB8939 in AML

Treatments for AML represent an estimated market potential of more than €2 billion per year.

AB8939 was entirely discovered by AB Science, which retains full ownership of the intellectual property rights, reflecting AB Science’s priority to develop innovative drugs aimed at improving patients’ lives.

The composition of AB8939, including its use in the treatment of AML, is covered until 2026 by a patent granted in all geographical areas where AB8939 could be marketed, including Europe (patent EP 3253749), the United States (US 10,570,122), Canada (CA 2975644), China (CN 107531685), South Korea (KR 10-2544132), Japan (JP 6713000), Hong Kong (HK 1243700), Israel (IL 253779), Australia (AU 2016214283), Russia (RU 2758259), Brazil (BR 112017016883-9), Mexico (MX 377742), India (IN 480996) and South Africa (ZA 2017/05537). An extension of this protection for 5 years is possible in certain countries.

A second patent application for medical use has been filed to protect the use of AB8939 in the treatment of AML with certain chromosomal abnormalities. If this application is accepted, protection for AB8939 will be extended until 2044 for these subpopulations of AML patients. In addition to patent protection, AB8939 is also eligible for regulatory data protection in numerous countries, preventing generic competition for a period of up to 8 years from product registration.

AB8939 has also received orphan drug designation for AML from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

On July 30, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology (Press release, Anixa Biosciences, JUL 30, 2025, https://ir.anixa.com/news/detail/1089/anixa-biosciences-receives-notice-of-allowance-from-canadian-intellectual-property-office-for-patent-covering-breast-cancer-vaccine-technology [SID1234654634]). This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company’s novel immunogenic approach to breast cancer prevention and treatment in Canada.

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With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer remains the most commonly diagnosed cancer in women globally and a leading cause of cancer-related death. In Canada, breast cancer accounts for approximately 25% of all new cancer cases in women and 13% of female cancer deaths annually. Despite widespread awareness and screening efforts, there is currently no approved vaccine for the prevention of breast cancer—highlighting a significant and unaddressed need in public health.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

On July 30, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that it has been granted New Zealand Patent No. 785587 titled "WHOLE-CELL CANCER VACCINES AND METHODS FOR SELECTION THEREOF" (Press release, BriaCell Therapeutics, JUL 30, 2025, View Source [SID1234655036]). The patent covers methods of selecting its whole-cell cancer immunotherapy technology for subjects with cancer based on HLA allele profile matching, providing exclusivity through February 27, 2037, and supporting BriaCell’s precision medicine approach aimed at personalizing immunotherapy for improved patient outcomes.

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"We are thrilled that the New Zealand Patent Office recognized the innovative nature of BriaCell’s novel whole cell immunotherapy and its potential therapeutic applications for cancer patients," said Dr. William V. Williams, President and CEO of BriaCell.

The newly granted patent is part of BriaCell’s broader strategy to establish a strong international patent portfolio enabling the global development and commercialization of its immunotherapy platform across multiple cancer indications.

On July 30, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer (Press release, Can-Fite BioPharma, JUL 30, 2025, View Source [SID1234654651]).

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The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.

"This milestone reflects the strong interest among both investigators and patients in exploring Namodenoson as a potential treatment for one of the deadliest and most aggressive cancers," stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. "We are encouraged by the pace of enrollment and remain committed to advancing Namodenoson as a much-needed therapeutic option for patients with pancreatic cancer."

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

On July 30, 2025 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, reported that it has signed a non-binding term sheet with Evotec SE (Press release, Sandoz, JUL 30, 2025, View Source [SID1234654611]). This paves the way for Sandoz to potentially acquire 100% of the issued and outstanding equity interests of Just–Evotec Biologics EU SAS for an amount of around USD 300 million, which owns the J.POD biologics development and manufacturing facility in Toulouse, France.

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Richard Saynor, CEO of Sandoz, said: "We aim to capitalize on the projected USD 300 billion biosimilar market opportunity over the next decade. The intended acquisition is fully in line with our strategy to reinforce in-house biosimilar capabilities, while creating additional strategic flexibility. Following successful completion, the Toulouse site would be used to develop and manufacture Sandoz biosimilars. JEB´s fully automated and high throughput technology platform will help us move faster, scale smarter, and maintain high quality while keeping costs under control."

Sandoz and Evotec SE will now work to negotiate details of the contracts and carry out the relevant works-council consultation processes, as well as the mandatory employee bid process in France. Closing the proposed transaction will be subject to finalizing the contracts and obtaining all necessary approvals. Further details of the terms cannot be shared at this stage and will only be disclosed after successful signing of the contracts.

Just-Evotec Biologics has been a key strategic partner for Sandoz since 2023. The proposed acquisition would complement previously announced investments in Sandoz biosimilar manufacturing and development sites. The planned investment would be in line with existing Sandoz capital-expenditure commitments related to Sandoz operations in Europe.

Upon completion of the proposed transaction, JEB employees would transfer with the acquired entity and would become part of the Sandoz Group. JEB brings an advanced and integrated continuous manufacturing platform with automation that enables manufacturing to run continuously end-to-end.