PharmiWeb.com - Global Pharma News & Resources
25-Mar-2019

Therapies Trying to Fight Against Cancer

FinancialBuzz.com News Commentary

NEW YORK, March 25, 2019 /PRNewswire/ -- Over the past two decades, U.S. cancer-related deaths have significantly declined. As of 2015, the death rate for both men and women declined by 26% from its peak in 1991, according to the American Cancer Society. Additionally, the decline in cancer mortality is particularly attributable to the advancements within the cancer biotechnology industry. Certain players within the industry have developed more efficient and effective forms of treatment for patients in order to suppress or ultimately eradicate their cancers. Other biotech players have also manufactured early detectors for cancer in order to find signs before cancer even develops. Lung cancer, which is one of the leaders in cancer-related deaths, saw related deaths decrease by 45% from 1990 to 2015. Similarly, deaths associated with breast cancer, prostate cancer, and colorectal cancer all declined drastically in the past two decades. Despite the dwindling number of deaths, the number of cancer-related cases still continues to grow, as the National Cancer Institute suggested that in 2018 there would approximately 1.73 million new cancer-related cases and projected that 609,640 will die from the disease within the U.S. According to data compiled by Allied Market Research, the global oncology and cancer drugs market was valued at USD 97.40 Billion in 2017 and is expected to reach USD 176.51 Billion by 2025. Additionally, the market is also projected to grow at a CAGR of 7.6% from 2018 to 2025. SourcingLink.net, Inc. (OTC: SNET), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Agenus Inc. (NASDAQ: AGEN), CEL-SCI Corporation (NYSE: CVM), Aptose Biosciences Inc. (NASDAQ: APTO) (TSX: APS)

With the advancement of the cancer therapy market, new forms of treatment are now being studied and manufactured. Chemotherapy remains one of the most common treatments for cancer, however, with the expansion of the market, new therapies such as personalized medicine, immunotherapy, CAR T-cell therapy, radiation therapy, and targeted therapies have become highly popular in their own right. In particular, the targeted therapies market is one of the fastest growing. Targeted therapies are drugs that block the growth and spread of cancer by interfering with specific molecules involved in the growth, progression, and spread of cancerous cells, according to the National Cancer Institute. Targeted therapies differ from chemotherapy as they act upon specific molecules and deliberately choose their target. On the other hand, chemotherapy normally attacks and kill rapidly dividing cancerous cells. Targeted therapies can aid patients by detecting cancer early on, as well as helping the patient through treatment. "Everything today is becoming more and more personalized. With cancer treatments, the genomic information on the tumor is increasingly becoming available as the cost of sequencing continues to drop. We can expect a future where we will have much more precise treatments based upon the genomic signature of the patient," said Sean Marett, Chief Brand Officer and Chief Commercial Officer of German immuno-oncology company BioNTech. "A pharmacy will no longer be selling tablets off the shelf. We're going to be delivering a specific treatment only for the patient."

SourcingLink.net, Inc. (OTC: SNET) just announced breaking news this morning that, "it entered into an exclusive worldwide licensing agreement with NanoSmart Pharmaceuticals, Inc. for the right to use NanoSmart's nanoparticle platform technologies to develop and commercialize improved formulations of doxorubicin for the treatment of human cancers. The license includes access to one of NanoSmart's lead drug formulations, ANA- Conjugated Liposomal Doxorubicin, which has been previously granted Orphan Drug Designation by the US Food and Drug Administration. Under the terms of the agreement, NanoSmart will receive an upfront fee, restricted common shares of SNET stock, an annual maintenance fee, and a high single-digit royalty on net sales of formulations that incorporate NanoSmart's intellectual property.

SourcingLink.net stated, "We are pleased to have licensed the application of NanoSmart's tumor-targeting technology to improve doxorubicin formulations. This is a significant extension of our oncology product portfolio to address the growing need for improved cancer therapies. We look forward to initiating nonclinical development, clinical trials, FDA submission, and commercialization of a tumor-targeting drug product and to explore combination with our proprietary liquid biopsy platform to potentially deliver personalized treatment paradigms that are safer and more effective than existing options."

Doxorubicin is a well-established anthracycline chemotherapeutic drug used for treating a broad range of cancers such as ovarian, breast, bladder, Kaposi's sarcoma, lymphomas, thyroid, neuroblastoma and lung cancers. Commercializing a targeted doxorubicin formulation provides the opportunity to impact millions of cancer patients worldwide and to provide better therapy options for the growing global cancer population, including rare cancers with unmet needs. Dr. James Smith, President and CEO of NanoSmart Pharmaceuticals, stated, "Our initial non-clinical testing on ANA-conjugated liposomal doxorubicin is very promising, and we believe that SNET's involvement will enable the efficient commercialization of one of our lead candidate formulations and further validate the performance of our proprietary drug delivery platform technologies."

About SourcingLink.net - SourcingLink.net, Inc. ("SNET") is a pioneering oncology company dedicated to developing, manufacturing and commercialization of therapeutics. SNET licensed Tulynode's patent pending Autologous Immuno-therapy for durable therapy response using an extracorporeal device. SourcingLink.net prides itself for having a world-class Advisory Board that keeps the Company leadership in the forefront of developing technologies in cancer research, biotechnology and healthcare. SourcingLink.net is currently engaging in research and development of therapeutics for oncology. SourcingLink.net is committed to its core corporate mission and values of highest U.S. Pharma Code of Conduct standards of behavior for being in compliance with the laws, regulations, company directives and guidance.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio Pharmaceuticals, Inc. recently announced that a second patient with HPV-related head and neck cancer treated with INO-3112 (now called MEDI0457) in a Phase 1 trial achieved a sustained complete response (full remission) after subsequent treatment with a PD-1 checkpoint inhibitor. This marks the second patient with metastatic cancer observed in full remission (complete response) after treatment with a synthetic DNA vaccine followed by a PD-1 checkpoint inhibitor. Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer said, "Achieving sustained complete responses with immunotherapy in metastatic cancer patients is what you hope for with novel cancer treatments. The fact that the treatment with our synthetic DNA vaccine followed with two different PD-1 inhibitors in this HPV-related cancer patient population showed a complete response in 2 out of 4 progressors is very encouraging as the best complete response rate by PD-1 inhibitors as a monotherapy in metastatic head and neck cancer is approximately 4%. While additional data from Phase 2 clinical studies will provide more insights to the power of synthetic DNA vaccine, this newly reported data provides additional validation for Inovio's overall cancer combination strategy using a T cell activator combined with a checkpoint inhibitor against an array of cancers with big pharma partners providing various checkpoint inhibitors. In addition to our partnership around HPV-related cancers, Inovio is also collaborating with F. Hoffman-La Roche Ltd./Genentech and Regeneron in efficacy trials coupling Inovio's INO-5401 with their checkpoint inhibitors designed to increase response rates in metastatic bladder and GBM, respectively, with interim efficacy data expected later this year."

Agenus Inc. (NASDAQ: AGEN) is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer.  Agenus Inc. and Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the companies have entered into an immuno-oncology (I-O) partnership focused on the development and commercialization of up to five novel immuno-oncology therapies. Under the terms of the agreement, Agenus will receive USD 150 Million upon closing, which includes a USD 120 Million upfront cash payment and a USD 30 Million equity investment. The agreement also includes approximately USD 1.7 Billion in potential future fees and milestones. Gilead will receive worldwide exclusive rights to AGEN1423, which has an estimated IND filing by year-end 2018. Gilead will also receive the exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus has filed the IND for AGEN1223 and has a planned IND filing for AGEN2373 in the first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead will also receive right of first negotiation for two additional, undisclosed preclinical programs. "Gilead is an ideal partner for Agenus for the rapid advancement of our pipeline," said Garo Armen, PhD, Chairman and Chief Executive Officer, Agenus. "By year-end, our discovery platforms will have resulted in six INDs in 2018 and 13 INDs by the 1H2019. Gilead's established global presence and commitment to disruptive therapies, combined with our track-record in building a broad pipeline in I-O, has the potential to yield breakthrough I-O treatments for patients with cancer."

CEL-SCI Corporation (NYSE: CVM) believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. CEL-SCI Corporation recently reported its financial results for the quarter ended December 31, 2018. CEL-SCI's Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016. The U.S. Patent and Trademark Office issued two new patents for CEL-SCI's LEAPS platform technology. The inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating immune response through the use of specific peptides. During the first quarter, CEL-SCI's LEAPS platform technology continued its development program as a therapeutic vaccine for rheumatoid arthritis under a USD 1.5 Million grant from the U.S. National Institutes of Health (NIH). Between January 1, 2019 and February 13, 2019, the Company received approximately USD 2.1 Million through the exercise of warrants to purchase shares of the Company's common stock. "During the first quarter of fiscal 2019, we continued to follow patients in our Phase 3 head and neck cancer trial, as we await a readout of topline results from this pivotal study, which may result in the first new approved first-line therapy for advanced primary (not yet treated) head and neck cancer in over 60 years. Concurrently, we continue to advance our LEAPS platform through studies with the NIH while fortifying our intellectual property around this unique vaccine technology," stated CEL-SCI Chief Executive Officer, Geert Kersten.

Aptose Biosciences Inc. (NASDAQ: APTO) (TSX: APS) is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology. Aptose Biosciences Inc. recently announced that it has submitted an Investigational New Drug (IND) application for CG-806 to the U.S. Food and Drug Administration (FDA) requesting approval to initiate its Phase 1 clinical trial program. CG-806 is an oral, first-in-class small molecule inhibitor of all known forms of FLT3 and BTK kinases being developed for the treatment of patients with select hematologic malignancies, including chronic lymphocytic leukemia (CLL/SLL) and non-Hodgkin's lymphomas, as well as for patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Pending regulatory allowance, Aptose plans to conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and non-Hodgkin lymphomas (NHL) who failed or are intolerant to standard therapies. Pending the collection of predictive pharmacokinetic data in humans, Aptose would seek allowance from the FDA to move into the AML/MDS patient population in a separate Phase1 trial.  The initial goal of both trials is to evaluate safety, tolerability and pharmacokinetics of CG-806 in these patient populations. "In preclinical studies, Aptose and collaborators demonstrated that CG-806 potently inhibits all known forms of FLT3 and BTK and suppresses multiple oncogenic pathways to cripple the malignant cells and avoid rapid emergence of drug resistance, but is not a "dirty" drug that inadvertently inhibits numerous targets associated with toxicity. CG-806 delivers safety and durability of cures in animal models of cancer and readily differentiates from competitor FLT3 and BTK inhibitors," said William Rice, Ph.D., Chairman, President & Chief Executive Officer. "Principle investigators from across the country have voiced their eagerness to enroll patients in both clinical trials, and we hope CG-806 can serve as a new tool for clinicians to treat patients critically ill with hematologic cancers, particularly those who discontinued other BTK or FLT3 inhibitors."

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Last Updated: 25-Mar-2019