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Tag: cancer

  • Exelixis, Inc. (EXEL) Stock Plummets Following Disappointing Interim Results for COSMIC-312 Clinical Trial

    Exelixis, Inc. (EXEL) Stock Plummets Following Disappointing Interim Results for COSMIC-312 Clinical Trial

    Exelixis, Inc. (EXEL) stock prices were down by a significant 19.46% as of the market opening on June 28th, 2021, bringing the price down to USD$18.86 early on in the trading day.

    COSMIC-312 Trial

    June 28th, 2021 saw EXEL announced that its COSMIC-312 Phase 3 pivotal trial met a primary endpoint, wherein the treatment demonstrated substantial improvement in progression-free survival at the planned primary analysis. The trial is designed to evaluate CABOMETYX in combination with atezolizumab versus sorafenib in patients reporting untreated advanced hepatocellular carcinoma.

    Interim Analysis

    Being conducted concurrently, a prespecified interim analysis for the secondary endpoint of overall survival indicated results that favored a CABOMETYX and atezolizumab combined treatment. The data did not reach statistical significant and the company does not expect a high probability of the final analysis resulting in the reaching of statistical significance. The trial is currently ongoing, with plans to continue through to the final analysis of OS, the results of which are forecasted for early 2022.

    Strength of Combined Treatment

    In the evaluation of the primary endpoint of PFS in the PFS intent-to-treat population, the risk of disease progression or death was 37% lower with CABOMETYX in conjunction with atezolizumab, as compared to treatment with CABOMETYX and sorafenib. The combined treatment’s safety was consistent with existing safety profiles of the individual medicines, with no new safety signals being identified. The company is discussing trial results while strategizing its next steps for regulatory filing with the U.S. FDA.

    Shortcomings of Treatment

    While the combined treatment of CABOMETYX in conjunction with atezolizumab has indicated encouraging results for the reduction of the risk of disease progression or death, it fell short of proving significant improvement in OS as compared to the comparator arm. The company is exploring the data it has generated, identifying factors that contributed to the results, including patient demographics, subsequent anti-cancer therapy, and the effects of the pandemic on the trial.

    Scope of Treatment

    With more than 900,000 new cases of liver cancer being diagnosed around the world annually, 90% of the cases are HCC. HCC is a leading cause of cancer-related fatalities, with forecasts of the disease claiming 1 million lives every year by 2030. It is the fastest-rising cause of cancer-related death in the U.S, with patients having a median survival period of 1-1.5 years.

    Future Outlook for EXEL

    With the recent developments with its highly-anticipated trial, EXEL is poised to capitalize on the opportunities afforded to it in order for it to bounce back stronger than ever. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • CEL-SCI Corp. (CVM) Stock Prices on the Rise Following Continued Development of Multikine

    CEL-SCI Corp. (CVM) Stock Prices on the Rise Following Continued Development of Multikine

    CEL-SCI Corp. (CVM) stock prices were up by 5.20% as of the market closing on June 25th, 2021, bringing the price per share up to USD$25.08 at the end of the trading day. Subsequent premarket fluctuations have seen the stock rise by 7.42%, bringing it up to USD$26.94.

    Bought Deal

    June 11th, 2021 saw the company announce its entering into an underwriting agreement with Kingswood Capital Market. As per the agreement, the underwriter made a purchase of 1.4 million shares of CVM’s common stock. Each share was priced at USD$22.62, with gross proceeds amounting to USD$31.7 million before the deduction of expenses related to the offering. The agreement also included a 30-day option for underwriters to purchase up to an addition 210,000 shares to cover over-allotments.

    MultikineTrial

    December 2020 saw the company’s Phase 3 head and neck cancer study complete database lock and enter the statistical analysis phase. Independent contractors have been hired to conduct the analysis process so as to ensure CVM stays blind to the study data. The company hopes to meet FDA safety and efficacy requirements, with the statistical analysis plan following the protocol states objectives. Furthermore, the company is keen to compile the clinical benefits the Multikine has the potential to provide patients that are newly diagnose, but not yet treated, for advanced primary squamous cell carcinoma of the head and neck.

    Multikine Production Facility

    With the commercial launch of Multikine looming closer, CVM has been allocating resources towards the expansion and upgrading of its proprietary cGMP manufacturing facility for Multikine. Construction began in 2020, with completion anticipated for the next several months. Upon completion, the company plans to double the facility’s capacity to accommodate two shifts for maximum production of Multikine.

    Financial Reports

    The six month period ended March 2021 saw the company report an operating loss of USD$17.3 million, up from the USD$13.6 million reported for the six month period ended March 31st, 2020. Operating loss for the quarter ended March 31st, 2021 was USD$8.5 million, up from the USD$6.7 million reported for the same time period of the prior year. The six and three-month periods ended March 31st, 2021, respectively reported USD$6.9 million and USD$3.3 million in capitalized costs.

    Future Outlook for CVM

    Armed with the nearing commercialization of Multikine, CVM is poised to continue its trajectory of success by allocating resources towards Multikine’s proliferation in the U.S and global markets. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • BriaCell Therapeutics Corp. (BCTX) Stock Undergoes Volatility Ahead of Expanded Cancer Platform Technology Announcement

    BriaCell Therapeutics Corp. (BCTX) Stock Undergoes Volatility Ahead of Expanded Cancer Platform Technology Announcement

    BriaCell Therapeutics Corp. (BCTX) stock prices were up by a hefty 8.96% as of the market closing on June 16th, 2021, bringing the price per share up to USD$6.57 at the end of the trading day. After-hours trading, however, saw the stock drop by 9.28%, bringing it down to USD$5.96.

    Oncology Therapeutics

    The company announced on June 16th, 2021 the advancement of its targeted oncology therapeutics into various respective immunotherapy cell lines. Among these are Bria-Pros for prostrate cancer, Bria-Mel for melanoma, and Bria-Lung for lung cancer. The treatment was most effective in breast cancer when patient HLA-type matched with the targeted immunotherapy, owing to the potential afforded to Briacell to identify patients most likely to respond to the treatment.

    HLA-Type Testing

    This innovative approach makes use of human leukocyte antigen (HLA-type) testing, which is both simple to use and widely available, making it a highly accessible resource. With the use of its proprietary cell engineering technology, the company is now developing off-the-shelf personalized immunotherapy for various cancer indications, which utilizes the HLA-matching platform technology.

    Bria-Pros

    Bria-Pros is an off-the-shelf personalized treatment for prostate cancer, which is the second most common cancer among men in the US and one of the leading causes of cancer deaths in men. Existing treatments for metastatic prostate cancer include immunotherapy, hormone therapy, chemotherapy, and targeted treatments. However, there is much ground left to be broken in prostate cancer therapies, seeing how none of the existing ones are curative.

    Bria-Mel

    Bria-Mel is personalized immunotherapy for melanoma, with off-the-shelf availability. With more than 80,000 melanoma diagnoses being administered in the US alone, the disease claims the lives of more than 8000 patients every year. Immunotherapy, targeted therapy, and chemotherapy are options in the treatment for advanced melanoma, with there being a large unaddressed need for new safe and effective therapies for melanoma.

    Bria-Lung

    Bria-Lung is designed as personalized immunotherapy for lung cancer, being available off-the-shelf. Being the third most common type of cancer in the world, more than 130,000 Americans succumb to it every year. The most common form of lung cancer is called non-small cell lung cancer (NSCLC) and its spread (metastasis). With treatments including targeted therapies, immunotherapy, and chemotherapy, no treatment is likely to cure the cancers, indicating a large unmet need.

    Future Outlook for BCTX

    Armed with the development of accessible treatments that the company hopes will address large sections of unmet need, BCTX is poised to push for the proliferation of the treatments to expand and consolidate their market footprint. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Innate Pharma S.A. (IPHA) Stock Surges During After Hours Trading Ahead of Progress Update Meeting

    Innate Pharma S.A. (IPHA) stock prices were down by a marginal 1.87% as of the market closing on June 16th, 2021, bringing the price per share down to USD$3.9350. After-hours trading saw the stock rally by an impressive 10.55%, bringing it up to USD$4.40.

    Disclosure of New Data

    The company announced on June 10th, 2021 that it will present the most recent preclinical data from it’s next-gen, proprietary, multi-specific NK cell engager platform, ANKET. The presentation will be held at the Federation of Clinical Immunology Societies (FOCIS) meeting, showcasing Antibody-based NK cell Engager Therapeutics.

    FOCIS Presentation

    The presentation will see IPHA share new data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage both NKp46 and CD16, the former of which is a tumor antigen and the latter a cytokine (IL-2 variant) in a single molecule. This newest development makes use of the advantages of harnessing NK cell effector functions against cells affected by cancer. It also facilitates the provision of the proliferation and activation The data set generated is founded on the company’s existing tri-specific NK cell engager technology. This technology has a proven track record of potent NK cell activation, cytotoxicity, and efficient management of tumor growth in preclinical models.

    Scope of ANKET

    Preclinical studies demonstrated the ability of in vitro tetra-specific ANKET to induce human NK cell proliferation, cytokine production, and cytolytic activity against cancer cells expressing the targeted antigen. Tetra-specific ANKET was also reported to have demonstrated in vivo anti-tumor efficacy in several tumor models, which allows for the regression of exiting tumors. Control of metastasis is also facilitated, with its associations with increased NK cell infiltration, and cytokine and chemokine production at the tumor site. The treatment also exhibited the pharmacodynamic effect, low systemic cytokine release, and a manageable safety profile in non-human primates.

    IPH6101

    The company’s leading ANKET asset is IPH6101, which has exhibited anti-tumor activity in preclinical models, including, but not limited to, facilitating pharmacokinetic pharmacodynamic and safety data in preliminary non-human primate studies. January 2021 saw the progression of the program into IND-enabling studies, with a recently announced research collaboration facilitating a second research program.

    Future Outlook for IPHA

    Armed with the development of their proprietary ANKET NK cell engager platform, IPHA is poised to continue its trajectory of success. The company is keen to continue working towards the commercialization and proliferation of their technology to usher in further gains. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.