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Genotype-Based FSH Choice Boosts IVF Outcomes
Genotype-Based FSH Choice Boosts IVF Outcomes

Medscape

time14-05-2025

  • Health
  • Medscape

Genotype-Based FSH Choice Boosts IVF Outcomes

Follicle-stimulating hormone receptor (FSHR) N680S–genotyped women treated with either recombinant FSH or urinary FSH had higher pregnancy rates of 51% vs 40% in non-genotyped control individuals. This personalized approach also improved cumulative live birth rates to 40% vs 29% in non-genotyped control individuals. METHODOLOGY: A total of 475 women undergoing in vitro fertilization (IVF) were randomized to receive either recombinant FSH or urinary FSH for ovarian stimulation, with their FSHR N680S variant analyzed afterward. Researchers compared outcomes between 221 optimally treated women (based on FSHR genotype) and 991 non-genotyped control individuals, with adjustment for age, body mass index, and fertilization method. Clinical data were supported by laboratory experiments where COS-1 cells were transfected with homozygous FSHR variants and stimulated with either urinary FSH or recombinant FSH to evaluate receptor activity. Primary outcomes were cumulative pregnancy rates and clinical live birth rates for all treatments related to the first ovarian stimulation cycle. TAKEAWAY: Women who underwent genotype-guided FSH selection showed significantly higher pregnancy rates (51% vs 40%; odds ratio [OR], 1.40; 95% CI, 1.12-1.75; P = .003) and live birth rates (40% vs 29%; OR, 1.55; 95% CI, 1.23-1.96; P < .001) than non-genotyped control individuals. = .003) and live birth rates (40% vs 29%; OR, 1.55; 95% CI, 1.23-1.96; < .001) than non-genotyped control individuals. Urinary FSH proved optimal for S-allele carriers, while recombinant FSH showed better results for asparagine homozygous carriers, with 33% more oocytes retrieved in NN-genotype women treated with recombinant FSH. In vitro experiments revealed the S variant displayed higher extracellular cyclic adenosine monophosphate when stimulated with urinary FSH vs recombinant FSH (10 IU: 176 vs 39 pmol/mg; P = .002; 90 IU: 227 vs 58 pmol/mg; P = .007). IN PRACTICE: 'In the context of applying precision medicine to OS [ovarian stimulation] prior to IVF, the most important finding was an 11% higher CLBR [cumulative life birth rate] in the first OS cycle in women who had been treated with the type of FSH that best matched their FSHR N680S genotype as compared to non-genotyped controls,' the authors of the study wrote. SOURCE: The study was led by Ida Hjelmér, Department of Translational Medicine, Lund University, Malmö, Sweden. It was published online in Frontiers in Endocrinology . LIMITATIONS: The study was not sufficiently powered to evaluate the effect of the precision medicine concept on miscarriage or ovarian hyperstimulation syndrome risk. Results cannot be extrapolated to women with polycystic ovary syndrome, endometriosis, or other excluded conditions. The study comprised only women undergoing their first ovarian stimulation cycle, limiting its applicability to those requiring multiple treatments. DISCLOSURES: The study was funded by EU Interreg NYPS 20201846 and an ALF government grant. Aleksander Giwercman reported receiving an unrestricted grant from Ferring Pharmaceuticals to the ReproUnion research network and a lecture fee from Merck Serono. Additional disclosures are noted in the original article.

A simple oral swab test before IVF likely to boost success rate
A simple oral swab test before IVF likely to boost success rate

Hans India

time13-05-2025

  • Health
  • Hans India

A simple oral swab test before IVF likely to boost success rate

Swedish researchers have developed a simple oral swab test, which can help boost the success rate of the in vitro fertilization (IVF) procedure. IVF treatment involves stimulating the woman's ovaries to mature many eggs, which are then retrieved and fertilised with sperm in the laboratory before being returned to the uterus. There are two different types of hormone treatments to choose from for egg maturation: biological or synthetic. Besides the risk of serious side effects, the therapies sometimes require women to go into intensive care -- and many attempts at IVF fail. Selecting which therapy is best for the woman has become a major challenge. While mapping genes is costly and takes time, the new simple oral swab test within an hour shows which hormone therapy is most suitable. 'Our hope is that this will reduce the risk of suffering for women, increase the number of successful treatments, and cut costs for taxpayers. Our goal is for the test to be available by the start of 2026,' said Yvonne Lundberg Giwercman, professor at Lund University. A total of 1,466 women undergoing IVF treatment in Sweden were included in the study, and 475 were randomised to two different hormone treatments while the rest were controls. Using gene sequencing, the team mapped the action of the gene follicle-stimulating hormone (FSH), which is known to play an important role in egg maturation. The study identified that women with a particular variant of the FSH receptor (FSHR) gene that mediates the action of the hormone responded best to the biological hormone treatment, while others benefited from receiving the synthetic type of hormone. To decode the genetic profile, the team turned to the oral swab test, which proved to be significantly efficient. Within an hour, it produced results that can be seen with the naked eye as a pink or yellow colour. By knowing the woman's genetic profile in advance, we can increase the number of successful pregnancies, said Giwercman, in the study published in the journal Frontiers in Endocrinology.

Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting
Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting

Yahoo

time12-05-2025

  • Business
  • Yahoo

Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting

SAN JOSE, May 12, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that Dr. Pamela D. Garzone, Chief Development Officer of Anixa, will present a poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on May 30 – June 3, 2025, in Chicago, Illinois. Lead author on the poster is Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa's ovarian cancer CAR-T immunotherapy. Presentation Details: Title: Phase 1 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) Session: Developmental Therapeutics—Immunotherapy Session Type: Poster Session Date & Time: June 2, 2025, 1:30 PM – 4:30 PM CT Abstract ID: TPS2682 About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit or follow Anixa on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking StatementsStatements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. Contact:Mike CatelaniPresident, COO & CFOmcatelani@ View original content to download multimedia: SOURCE Anixa Biosciences, Inc. Sign in to access your portfolio

Anixa Biosciences and Moffitt Cancer Center Complete Dosing in Third Cohort in Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences and Moffitt Cancer Center Complete Dosing in Third Cohort in Ovarian Cancer CAR-T Clinical Trial

Associated Press

time26-02-2025

  • Business
  • Associated Press

Anixa Biosciences and Moffitt Cancer Center Complete Dosing in Third Cohort in Ovarian Cancer CAR-T Clinical Trial

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ('Anixa' or the 'Company') (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced has it has dosed its final patient in the third cohort of its ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center ('Moffitt'). The fourth cohort is expected to commence after a 30-day verification that there continue to be no adverse effects experienced by the third cohort. The third cohort in the trial received a dose of one million CAR-positive cells per kilogram of patient weight, which represents a tenfold increase compared to the first cohort. This escalation is an important step in evaluating the safety and efficacy of CAR-T therapy for ovarian cancer patients. The fourth cohort will increase the dosage by another factor of three. Anixa's FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial ( NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy. Dr. Amit Kumar, Chairman and CEO of Anixa, stated, 'With the completion of the third cohort, we are gaining important insights into the potential of CAR-T therapy for ovarian cancer. Increasing the dose is a key step in evaluating the therapy's effectiveness while ensuring patient safety. Additionally, the recent approval of our protocol amendment allows eligible patients to receive a second dose if they may benefit from it. This amendment also expands enrollment criteria to include rare ovarian cancer subtypes, making the therapy accessible to more patients. Now, all eligible participants can receive a second dose without requiring separate IND approvals, helping us better assess the full potential of this treatment. As we move forward with the fourth cohort, we remain committed to advancing our CAR-T program with the goal of improving treatment options for ovarian cancer patients.' About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against 'retired' proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit or follow Anixa on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words 'believes,' 'expects,' 'intends,' 'plans,' 'anticipates,' 'likely,' 'will' and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in 'Item 1A - Risk Factors' and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. Mike Catelani 408-708-9808

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