Follicle Stimulating Hormone Follow-On Biologic(Anhui Anke Biotechnology)

Proov’s range of tests offers a comprehensive fertility baseline assessment with its four products: Reserve: Follicle Stimulating Hormone, Predict: Luteinizing Hormone, Confirm: PdG and Check: Human Chorionic Gonadotropin. According to the company, these treatments enable women to measure their major fertility hormones; providing insight into the hormonal factors underlying ovarian reserve, peak fertility, ovulation, implantation and confirmation of pregnancy. Amy Beckley, founder of Proov, said: “Many products are positioned as the answer to fertility issues when they only provide half the picture of what may be going with their reproductive system.” “Proov begins to fill that critical gap in knowledge for people trying to conceive. We are thrilled to have a partner like 2San who have the same values of empowering people to lead better lives, providing them with products that are accessible, affordable and high-quality.” Beckley, having suffered seven miscarriages and choosing to undergo multiple rounds of IVF, created Proov primarily to help women take their fertility journeys into their own hands. 2San operates internationally with a team of clinical experts and distribution specialists. Proov is the first of several products 2San will distribute in the fertility space. Valerie Palmieri, member of the 2San scientific advisory committee, added: “We are continuously scouring the globe to bring novel solutions and digital technologies to market that transform lives and empower people everywhere to own their health.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); “Proov’s innovative fertility at-home tests provide a way for people to take their fertility journey into their own hands. We are excited to be the exclusive partner in distributing these products to stores nationwide.” This summer, 2San will also distribute a novel male fertility test that measures the key indicators of male fertility, of which there are no competing products on the market. The product, SwimCount, will expand the male fertility market and also give men the 'ability to take control of their fertility.'

SAN JOSE, Calif. – Although CAR-T therapies have only been approved for the treatment of B-cell blood cancers, tiny ITUS believes it is on track to develop a CAR-T treatment for solid tumors. On Nov. 14, the California company struck a deal with Pennsylvania-based The Wistar Institute for a Chimeric Antigen Receptor T-Cell (CAR-T) technology aimed initially at treating ovarian cancer and eventually additional solid tumors. Amit Kumar, chief executive officer of ITUS, told BioSpace in an exclusive interview that he believes the licensed technology has a “unique approach” to targeting ovarian cancer. Instead of using an antibody fragment, like the B-cell targeting CAR-Ts, the engineered T-cells being developed by ITUS will use the Follicle Stimulating Hormone (FSH) to target ovarian cells that express the FSH-Receptor. Kumar said the CAR-T treatment will most likely will used to treat refractory ovarian cancer patients for which there are few options. “This approach is different from what others are trying,” Kumar said. “The Follicle Stimulating Hormone is exclusive to the ovaries. It’s not found on the other cells in the body. Attacking this unique receptor on the ovarian cancer cell will be a powerful approach.” So far the animal studies performed by ITUS are showing promise, Kumar said. Next year the company intends to complete data studies and Investigative New Drug Application so they can take the program into the clinic and begin work on humans. That will hopefully lead to confirmation of ITUS’s theories about FSH, Kumar said. It will also likely lead to other solid tumor targets, particularly in prostate and pancreatic cancers. The expectation is if the ITUS approach works on solid tumors the value to cancer patients will be immense because there are more solid tumors than blood cancers. Case in point, Kumar said, the ovarian cancer market dwarfs the B-cell cancer market. The American Cancer Society estimates for 2017 that about 22,440 women will receive a new diagnosis of ovarian cancer and about 14,080 women will die from ovarian cancer. On average, the five-year relative survival for all types of ovarian cancer is about 45 percent. If it’s found early and treated, relative survival rates increase to about 92 percent. ITUS formed a subsidiary, Certainty Therapeutics, to develop and commercialize the CAR-T technology. Days after ITUS licensed the CAR-T technology, the company and its new subsidiary entered into a research and development agreement with Moffitt Cancer Center to advance the program and help drive it into the clinic. Kumar said the agreement is in line with ITUS’s goal of remaining a lean company. He said the company’s plan is to work with partners at every level. The deal with Moffitt gives ITUS access to Moffitt’s laboratories and a “group of stellar world-class physicians and researchers who can do the work,” Kumar said. This strategy will allow the company to work with multiple research institutes and advance the ITUS technologies to a stage where they can be partnered with corporate allies. In addition to the CAR-T program, ITUS is also moving forward with its Cchek cancer detection platform, a program invented by Kumar. The program is a liquid biopsy that will measure immune cells that indicate cancer development. Kumar said they believe this technology will work on every type of tumor. Instead of measuring cancer, the Cchek platform will measure the body’s immune response to cancer. The Cchek platform should be able to determine if a traditional biopsy is required. Kumar said 95 percent of biopsies are negative, which means that many patients have gone through minor traumas from some of the tests for a negative result. “There’s all sorts of issues with a biopsy. Our goal is to develop a test that’s confirmatory. Before that needle gets stuck in your lung (for a lung cancer biopsy), we want a simple blood-based test. From that test they can tell if a biopsy is necessary,” Kumar said. “If we can eliminate 25 to 50 percent of biopsies, it’s a home run.” ITUS is initially developing its Cchek technology with a focus on prostate and breast cancers. Kumar estimated that the company is about 18 to 24 months away from taking it to the U.S. Food and Drug Administration for approval and possible commercialization. During this time period, Kumar hopes ITUS can find corporate partners to help commercialize the test. Kumar, the former head of CombiMatrix Corporation, became CEO of ITUS in July. He took over after it had shifted its focus to almost exclusively developing cancer therapies. Over the next few months, the company will primarily focus on its two programs while Kumar begins to meet with investors and media to talk about the company. “We’re still under the radar right now, and we feel that we’ll be coming out pretty soon,” Kumar said.