The global biopharmaceutical market is driven by many complex factors. These include an increase in the elderly population, surges in the prevalence of chronic diseases such as cancer and diabetes, and an increase in the adoption of biopharmaceuticals around the world. The key to the success of many companies in the sector is the demand, which is driven by the need to avoid both the side-effects associated with some small-molecule therapeutics and invasive surgical treatments. Among the various segments within the biopharmaceutical market, monoclonal antibodies are believed to have the largest market share. This can be attributed to the growing number of studies done with the help of monoclonal antibodies. As a result, the global biopharmaceutical market accounted for USD 186,470 Million in 2017 and is projected to reach USD 526,008 Million by 2025 while registering a CAGR of 13.8% from 2018 to 2025, according to data provided by Allied Market Research. Sunshine Biopharma Inc. (OTC: SBFM), Onconova Therapeutics, Inc. (NASDAQ: ONTX), Ocugen, Inc. (NASDAQ: OCGN), Advaxis, Inc. (NASDAQ: ADXS), Moleculin Biotech, Inc. (NASDAQ: MBRX)
The biopharmaceutical market plays a major role in the cancer treatment industry, which has grown to be one of the largest marketplaces in the world due to the disease’s global prevalence. The Centers for Disease Control and Prevention (CDC) estimated that, between 2010 and 2020, the number of new cancer cases in the U.S. increased by 24% in men and 21% in women. However, by 2020, the CDC also expects that the number of cancer survivors will increase to 18 million compared to 11.7 million in 2007. The Center also highlighted that the number of cancer-related deaths is declining due to early screening as well as better treatment options. Furthermore, the oncology and cancer drug market is expected to grow chiefly due to the surge in cancer research as well as the increase in collaborations between pharmaceutical companies.
Sunshine Biopharma Inc. (OTC: SBFM) announced yesterday breaking news that, “it has ordered a new batch of Adva-27a from its manufacturer in China. The material will be delivered to the laboratories of Sunshine Biopharma’s drug development partner in Montreal (Canada). Sunshine plans to use the material to conduct testing on various types of cancer cells that overproduce Topoisomerase II (TopII). Following these cell culture studies, Sunshine will proceed to perform studies on mice harboring tumors of human origin with TopII amplification. TopII is an essential cell cycle enzyme that is amplified in approximately 4% of all human cancers.
‘All cancer types that have amplification of the Topoisomerase II gene are potential new targets for our Adva-27a,’ said Dr. Steve Slilaty, CEO of Sunshine Biopharma. ‘This is an additional application for our Adva-27a beyond the original multidrug resistance indication,’ he added.
About Sunshine Biopharma: In addition, to working on the development of a treatment for COVID-19, Sunshine Biopharma is engaged in the development of Adva-27a, a unique anticancer compound. Tests conducted to date have demonstrated the effectiveness of Adva-27a at destroying Multidrug Resistant Cancer Cells, including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells, and Uterine Sarcoma cells. Clinical trials for Pancreatic Cancer indication are planned to be conducted at McGill University’s Jewish General Hospital in Montreal, Canada. Sunshine Biopharma is the owner of all patents and intellectual property pertaining to Adva-27a.”
Onconova Therapeutics, Inc. (NASDAQ: ONTX) reported last month the filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for ON 123300, the Company’s proprietary, differentiated, first-in-class multi-kinase inhibitor. The IND seeks permission to begin a Phase 1 trial with ON 123300 in relapsed/refractory advanced cancer including patients with HR+ HER 2- metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors. “We believe that ON 123300, based on its novel mechanism of action, presents an innovative approach to study advanced cancers including in HR+ HER 2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors. We are delighted to have filed our IND on schedule, and look forward to enrolling patients in the U.S. to complement the ongoing Phase 1 dose-escalation study underway in China by our partner HanX Biopharmaceuticals,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “The HanX Phase 1 ON 123300 study, which began in September 2020, has enrolled three patients to date and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified. We believe that data from these two studies will generate important information to inform anticipated later-stage studies.”
Ocugen, Inc. (NASDAQ: OCGN) reported back in October that it has entered into an agreement with Kemwell Biopharma Pvt. Ltd. (Kemwell) to manufacture OCU200, Ocugen’s novel biologic product candidate in preclinical development for treating severely sight-threatening diseases like Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Wet Age-Related Macular Degeneration (Wet-AMD). Under this agreement, Kemwell will manage all CMC and clinical manufacturing activities as well as provide OCU200 supplies for IND-enabling toxicology studies and Phase 1/2a clinical trials. Kemwell offers proven expertise in supporting companies with process development, clinical and commercial manufacturing of biologicals at their state-of-the-art facilities located in Bangalore, India. “Biological manufacturing is critical and rate-limiting for Phase 1/2 clinical trials and this partnership paves the way for us to potentially enter the clinic by 1H2022 as planned. We are picking a CMO with commercial capabilities with a goal of ensuring product consistency throughout development and minimizing regulatory issues as we drive the development of OCU200,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.”
Advaxis, Inc. (NASDAQ: ADXS) announced earlier last month the presentation of data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. ADXS-503 is the first drug construct from the Company’s ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as another proprietary, tumor-associated antigens. The data presented across three cohorts; Part A monotherapy, Part B combination with KEYTRUDA®, and Part C combination with KEYTRUDA® in the first line setting for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy, together, demonstrate that ADXS-503 was safe and well tolerated, and may restore or enhance sensitivity to checkpoint inhibitors as an off-the-shelf, neoantigen immunotherapy.
Moleculin Biotech, Inc. (NASDAQ: MBRX) announced earlier in October results from an independent laboratory validating internal animal studies showing the ability of Annamycin to target lung localized tumors. The relevance of targeting lung localized tumors is that it could provide a means to address a significant unmet need in cancer therapy. Specifically, there are limited treatment options for lung metastases resulting from a primary tumor, even though the primary tumor may have been treatable. For example, a primary soft tissue sarcoma can often be initially successfully treated (most often by removal), but if it has spread to the lungs, the anthracycline Adriamycin (doxorubicin), the approved treatment for patients whose lung-localized metastases cannot be surgically removed, has only limited efficacy. Research sponsored by Moleculin and recently presented at the American Association of Cancer Research (AACR) Annual Meeting held from June 22nd-24th, 2020 suggested a possible reason for this limited efficacy may be the inability of doxorubicin to sufficiently accumulate in the lungs in concentrations required to kill tumor cells.
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