Every year, more than 1.6 million just in the United States are diagnosed with cancer, with up to nearly 600,000 yearly, unfortunate deaths. That makes it the second leading cause of death. On top of that, the cost of cancer care is only rising, expected to reach nearly $174 billion this year, according to the Centers for Disease Control and Prevention. However, there is some goods in the fight against cancer, with sizable progress being made with new drug treatments. In fact, some of the top cancer treatment companies to pay close attention to include WPD Pharmaceuticals Inc. (CSE:WBIO), Medicenna Therapeutics Corp. (NASDAQ:MDNA) (TSX:MDNA), Bristol-Myers Squibb Company (NYSE:BMY), Merck & Co. Inc. (NYSE:MRK), and Eli Lilly and Co. (NYSE:LLY).
WPD Pharmaceuticals Inc. (CSE:WBIO) BREAKING NEWS: WPD Pharmaceuticals Inc. a clinical stage pharmaceutical company, is excited to announce that a recently published study confirms the high therapeutic potential of IL-13RA2- and EphA2 receptor-targeted cytotoxins in the WPD101 drug candidate. The study found the combination of these cytotoxins as a highly effective anticancer therapy in dogs with spontaneous intracranial gliomas.
WPD101 is a cocktail of recombinant fusion/conjugate proteins designed for the treatment of Glioblastoma (GBM), one of the most aggressive malignant tumors of the central nervous system that is believed to arise from normal glial cells. Clinical development of WPD101 will allow GBM patients access to innovative molecular targeted therapies as an alternative to conventional treatment of limited effectiveness.
The Phase I clinical trial in dogs with spontaneous malignant gliomas was conducted by a team led by John H. Rossmeisl, DVM, MS, Head of Department of Small Animal Clinical Sciences at Virginia-Maryland College of Veterinary Medicine and Waldemar Debinski, MD, PhD, Professor of Cancer Biology and Director of the Brain Tumor Center of Excellence at Wake Forest Baptist Medical Center Comprehensive Cancer Center, Winston-Salem, NC, USA. Dr. Debinski is a member of WPD’s Scientific Advisory Board. The results of this first of a kind comprehensive study in dogs afflicted with brain tumors was published in “Neuro-Oncology” by Oxford University Press on behalf of the Society for Neuro-Oncology.
Canine model of spontaneous gliomas represents the closest translational model to human diseases and provide potentially more clinically relevant assessment of potential efficacy in human trials regarding biological and technological aspects of treatment. One approach to glioma treatment is the use of targeted cytotoxins that bind to plasma membrane receptors on tumor cells and are subsequently internalized to deliver a lethal toxin load to targeted cells.
Canine gliomas, as well as human GBM cells, overexpress tumor-associated IL-13RA2 and EphA2 receptors that are not present in normal brain cells. IL-13RA2 and EphA2 are conjointly present in >90% of patients and dogs with GBM.
In the published study, 17 dogs diagnosed with gliomas and immunohistochemically positive for IL-13RA2 (17/17) or/and EphA2 (11/17) receptors were treated with escalating doses of IL-13 and ephrinA1-based cytotoxins. Cytotoxins were delivered through the Convention Enhanced Delivery (CED) method. CED allowed consistent intratumoral delivery of the cocktail with a median coverage of 70% (range 40-94%) of the tumor.
No dose-limiting toxicities were observed. At 42 days of treatment, volumetric tumor reductions were observed in 15/16 dogs, with median reduction of 42% (range 5-94%). Objective tumor responses were observed in 8/16 (50%) dogs, and the median tumor volume reduction was 79% (range 65-94% of tumor volume regression).
The authors of the study conclude that the CED of IL-13RA2/EphA2 targeting cytotoxins at concentrations ranging from 0.05-1.6 mg/mL was safe and resulted in clinically relevant responses in 50% of dogs with gliomas.
The published research was supported by federal, institutional and charitable grants.
WPD is currently developing production for early phase clinical trials in humans, which should be accomplished approximately within one year. The WPD portfolio includes WPD101, WPD102, and WPD103 drug candidates. In addition WPD and its licensors have 40 patents issued or filed in the US, Canada, and EU.
Other related developments from around the markets include:
Medicenna Therapeutics Corp. (NASDAQ:MDNA)(TSX:MDNA) a clinical stage immuno-oncology company, announced that the Company’s common shares have been approved for listing on The Nasdaq Capital Market. The Corporation will retain its listing on the Toronto Stock Exchange under the symbol "MDNA" and the Company's common shares will continue to trade on the OTCQB under the symbol "MDNAF" until trading on the Nasdaq commences. “The listing of our stock on the Nasdaq represents a significant milestone in our growth as a publicly-traded company,” said Fahar Merchant, PhD, President and CEO of Medicenna. “We believe this listing will increase our visibility in the marketplace, improve liquidity, broaden and diversify our shareholder base, and ultimately enhance long-term shareholder value. I would like to thank our employees, directors and partners for their hard work in making Medicenna a member of the Nasdaq exchange, an important step that will help facilitate the continued advancement of our pipeline of Empowered CyokinesTM and Superkines for the treatment of cancer.”
Bristol-Myers Squibb Company (NYSE:BMY) announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting. “While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”
Merck & Co. Inc. (NYSE:MRK) announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of patients whose tumors are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy. Additionally, KEYTRUDA was approved for use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). With these approvals, KEYTRUDA has 13 indications across seven tumor types plus MSI-H tumors in Japan. “We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”
Eli Lilly and Co. (NYSE:LLY) announced that the New England Journal of Medicine (NEJM) published Phase 1/2 study results of the registrational trial for Retevmo™ (selpercatinib), the first and only therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RETfusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of overall response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. NEJM published separate articles focusing on efficacy and safety data in the RET fusion-positive NSCLC and RET-altered thyroid patient cohorts independently, with data demonstrating durable objective responses across both patient populations.
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