Palm Beach, FL –December 10, 2019 – Much R&D from companies and investors has been pouring into the targeted drug therapies markets, enabling pharma companies and other industry researchers to find better and more effective ways to combat cancer in all its forms. As the prevalence of cancer rises so does the growth rate of R&D and the resulting increase in revenues. One of the sub-markets of targeted drug oncology to continue to rise is the small molecule oncology market, The National Cancer Institute defines small molecule drugs as : “A substance that is able to enter cells easily because it has a low molecular weight. Once inside the cells, it can affect other molecules, such as proteins, and may cause cancer cells to die. This is different from drugs that have a large molecular weight, such as monoclonal antibodies, which are not able to get inside cells very easily. Many targeted therapies are small-molecule drugs or small molecule inhibitors.” Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Clovis Oncology, Inc. (NASDAQ: CLVS), ArQule, Inc. (NASDAQ: ARQL), Aptose Biosciences Inc. (NASDAQ: APTO) (TSX: APS), Fate Therapeutics, Inc. (NASDAQ: FATE).
A recent article from Fact.MR reported that sales of oncology small molecule drugs are forecasted to exceed $66 Billion in 2019, up from $63bn in 2018. It added that the key drivers are: “High prevalence of cancer, coupled with the notable preference for more effective drugs that can easily enter and get absorbed in the cells is primarily boosting sales of oncology small molecule drugs… Increasing awareness about the availability of novel and easily absorbable drugs for cancer treatment is providing an impetus to oncology small molecule drugs sales… Modulating the immune system via a small-molecule approach offers several unique benefits that are complementary to, and potentially synergistic with, biologic modalities. An increasing number of biopharma companies are thus utilizing ‘selective targeting small molecules’ that accurately exploit the vulnerabilities in cancer cells. Such a pragmatic approach towards cancer is likely to create a plethora of opportunities in terms of new product developments in the oncology small molecule drugs market.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Received Positive FDA Pre-IND Guidance for Berubicin – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its positive response to the Company’s previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.
“We were encouraged by the initial feedback provided by the FDA as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time,” stated CEO of CNS, John M. Climaco. “We are continuing the process of preparing a new IND in accordance with the guidance we received from the FDA. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide as we believe in Berubicin’s potential to offer oncologists the only anthracycline effective against brain cancer.” Read this and more news for CNSP at: https://financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that the Italian Medicines Agency (AIFA) has approved rucaparib for reimbursement in Italy. Rucaparib will soon be available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy. Rucaparib is indicated for eligible patients regardless of BRCAstatus, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.
“We very much welcome the arrival of the PARP inhibitor rucaparib, which offers a new treatment option after surgery and two lines of chemotherapy to all eligible women affected by relapsed ovarian cancer,” declared Nicoletta Cerana, National President of Acto Onlus, the number one Italian network of patient associations involved in the fight against ovarian cancer and gynecological tumors. “Ovarian cancer is a highly lethal neoplasm which now, thanks to the PARP inhibitors, can finally be made chronic. Patients know this and are ready to embark upon the difficult journey towards chronicity. As an association, we therefore hope that rucaparib can be prescribed as soon as possible in all Italian regions.”
ArQule, Inc. (NASDAQ: ARQL) recently announced final results from the phase 1 study for ARQ 531, an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK) in patients with relapsed or refractory hematologic malignancies at the American Society of Hematology (ASH) 2019 Annual Meeting & Exposition in Orlando, Florida.
“The final phase 1 data set confirms the potential utility of ARQ 531 for the treatment of these heavily pretreated CLL patients. We were excited to observe such deep and durable responses at a well-tolerated dose in this highly refractory population,” commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. “In addition, the three responses we observed in Richter’s Transformation patients were a welcome outcome and allowed several patients to transition to potentially curative therapies.”
Aptose Biosciences Inc. (NASDAQ: APTO) (TSX: APS) recently announced the presentation of preclinical data for its first-in-class, FLT3/BTK inhibitor CG-806 at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, FL. The University of Texas MD Anderson Cancer Center researchers presented two posters elucidating CG-806’s mechanism of action in targeting chronic lymphcytic leukemia (CLL) cells and its inhibitory effect on ibrutinib-resistant mantle cell lymphoma (MCL) cells.
“More than 50% of patients with CLL and MCL discontinue ibrutinib treatment due to intolerance or the emergence of refractory or resistant disease,” said William G. Rice, Ph.D., Chairman and Chief Executive Officer of Aptose. “Our data indicate that CG-806 not only induces apoptosis in CLL cells, but also targets the microenvironment and rescue pathways that lead to resistance or refractory disease. CG-806 also was shown to be more potent than ibrutinib to induce apoptosis in both CLL and MCL cells. We are pleased that CG-806 is now in the clinic in CLL patients who are resistant, refractory or intolerant to ibrutinib and other agents considered the current standard of care.”
Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced new in vivopreclinical data for FT596, its off-the-shelf, multi-antigen targeting natural killer (NK) cell product candidate derived from a clonal master engineered induced pluripotent stem cell (iPSC) line. The data were featured during the 61st American Society of Hematology (ASH) Meeting and Exposition as part of the organization’s CAR-T and Beyond press program, which spotlighted promising next-generation cancer immunotherapies having the potential to overcome the key limitations of patient-specific chimeric antigen receptor (CAR) T-cell therapy.
“Current patient- and donor-specific CAR T-cell immunotherapies recognize only one antigen and fail to address the significant risk of relapse due to antigen escape. FT596 is ground-breaking in that it is designed to be available off-the-shelf for timely patient access and to promote deeper and more durable responses by targeting multiple tumor-associated antigens,” said Bob Valamehr, Ph.D., Chief Development Officer of Fate Therapeutics. “Additionally, since FT596 is manufactured from a renewable master engineered iPSC line, the complexities of patient-by-patient genetic engineering and production are greatly reduced and, for the first time, we are able to mass produce multi-functional cellular immunotherapies in a uniform and cost-effective manner.”
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