Biotech Brief: Global Market for Cancer Drug Candidates Could Exceed US$220 Billion by 2025

PALM BEACH, Florida, May 5, 2020 /PRNewswire/ -- The global market for cancer therapies is projected to reach US$220. 5 billion by 2025, driven by the rise in cancer prevalence to epidemic proportions and the still ongoing search to find effective treatments for the disease, so says a report by ReportLinker. Despite decades of research costing billions of dollars, a cure for cancer still remains elusive. This fact when juxtaposed with the epidemic spread of cancer will result in the disease emerging into the single most difficult to tackle public healthcare burden in the coming years. The pressure is therefore intensifying to research and develop newer and more effective therapies and treatment options. The reason why cancer is complex is due to its ability to continuously evolve and undergo molecular, genetic changes that affect behavior and response of tumor cells. Cancer cells evolve myriad ways to sabotage, stymie and trick the immune system preventing it from recognizing cancer cells, making the disease more resilient, aggressive and deadly. This has profound implications for the progression of the disease despite interventional therapies. Also, there are over 100 types of known cancer types. In addition, the genetic diversity of tumors especially intra-tumor genetic heterogeneity makes finding a cure a challenge which the medical community continues to grapple with. Although the Cancer Genome Atlas (TCGA) has increased understanding of the diversity of cancer types, the disease continues to elude a cure while continuing to stretch the boundaries of medical science and understanding. Significant research is still required to understand the vast diversity of tumor gene expression, mutations and drug sensitivities. Active biotech and pharma companies in the markets this week include Genprex, Inc. (NASDAQ: GNPX), AstraZeneca PLC (NYSE: AZN), Merck (NYSE: MRK), Bristol-Myers Squibb Company (NYSE: BMY), REGENXBIO Inc. (NASDAQ: RGNX).

Against the backdrop of tumor diversity, the universal "one size fits all" therapy which is the current standard of care is primitive. Therapies like chemotherapy and radiation, although help increase survival rates are beset with side-effects as they act as sledgehammers that destroy even healthy dividing cells at the cellular level. There is an urgent need for developing newer ways to target cancer's diversity and evolution. While a cure for cancer is unlikely, targeted therapies will witness huge gains for their better prognosis. Targeted therapies revolve around identifying major pathways responsible for the disease and its progression and administering specific drugs targeting these pathways. Targeted therapies have lower side effects and are more effective than conventional therapies.Genprex, Inc. (NASDAQ: GNPX)  BREAKING NEWS:  Genprex Enters Into Exclusive Worldwide Patent and Technology License Agreement for Combination of its TUSC2 Gene Therapy with Immunotherapies -  Genprex ("Genprex" or the "Company"), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that it has entered into a Patent and Technology License Agreement ("License Agreement") with The University of Texas MD Anderson Cancer Center ("MD Anderson") in which MD Anderson granted to Genprex an exclusive worldwide license to a portfolio of 16 patent applications and related technology ("Licensed IP") for the treatment of cancer using Genprex's lead drug candidate and TUSC2 gene therapy, known as "Oncoprex" or "GEN-001," in combination with immunotherapies. This is a distinct therapeutic approach from that of combining Oncoprex with targeted therapies such as osimertinib (marketed as Tagrisso® by AstraZeneca). 

Genprex was recently awarded U.S. FDA Fast Track designation for use of Oncoprex combined with Tagrisso for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company is now preparing to file an Investigational New Drug application to initiate a clinical trial of Oncoprex in combination with pembrolizumab (marketed as Keytruda® by Merck) in NSCLC.  

"We are pleased to advance the intellectual property that is covered by this License Agreement," said Rodney Varner, Genprex's Chairman and Chief Executive Officer. "We are excited to be developing two distinct therapeutic approaches to lung cancer utilizing the combination of our gene therapy with successful targeted therapies, such as Tagrisso, and immunotherapies, such as Keytruda, to potentially improve patient outcomes and increase the number of patients who may benefit from these important therapies."

Immunotherapy or immunotherapy combined with chemotherapy is now the first-line standard of care for the majority of lung cancer patients. Published preclinical data indicate that when Oncoprex is combined with immunotherapies such as Keytruda, Oncoprex is synergistic with those drugs, meaning that the combination is more effective than either drug alone. The combination of Oncoprex and Keytruda may lead to better outcomes for many lung cancer patients.

The Licensed IP covers the use of Oncoprex in combination with one or more immunotherapies, including anti-PD1 antibodies, anti-PDL1 antibodies, anti-PDL2 antibodies, anti-CTLA-4 antibodies and/or anti-KIR antibodies for the treatment of cancer. These immunotherapies include pembrolizumab (Merck's largest selling drug Keytruda), nivolumab (Bristol-Myers Squibb's Opdivo), ipilimumab (Bristol-Myers Squibb's Yervoy), and others. Use of chemotherapy in combination with Oncoprex and immunotherapy is also covered by the Licensed IP. While the initial disease indication for Oncoprex is NSCLC, the Licensed IP claims patent protection for combination use of Oncoprex in all types of cancers.

The License Agreement also provides for payment to MD Anderson of an up-front license fee and annual maintenance fees, with the potential for milestone payments, sublicensing fees, and product royalties. Read this and more news for GNPX at https://www.financialnewsmedia.com/news-gnpx/

Other recent developments in the biotech industry include:

AstraZeneca PLC (NYSE: AZN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced further positive results from the Phase III PROfound trial of LYNPARZA (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal agent (NHA) treatments (i.e., abiraterone or enzalutamide).

Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with LYNPARZA versus enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATMgene mutations, a subpopulation of HRR gene mutations. The Phase III PROfound trial had met its primary endpoint in August 2019, showing significantly improved radiographic progression-free survival (rPFS) in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population.

José Baselga, Executive Vice President, Oncology R&D, said: "Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve. We are thrilled by these results for LYNPARZA and we are working with regulatory authorities to bring this medicine to patients as soon as possible."

Bristol-Myers Squibb Company (NYSE: BMY) recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.

The NDA submission was based on the efficacy and safety results of the pivotal Phase 3 QUAZAR^® AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo.

REGENXBIO Inc. (NASDAQ: RGNX) a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV^® Technology Platform, recently provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

"I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections," said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.

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