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Propanc Biopharma Receives Acceptance of Key Patent Application for Cancer Treatment in China

On July 20, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that it received notification of acceptance for its lead patent application from the Chinese Patent Office (Press release, Propanc, JUL 20, 2017, View Source [SID1234519834]). The patent application provides broad coverage of a pharmaceutical composition of trypsinogen and chymotrypsinogen to treat certain cancers.

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The acceptance of this key patent application is a first in China, representing yet another significant milestone for the Company, as it progresses its lead product, PRP, towards First-In-Human studies. Given that China accounts for more than 20% of the world’s population, significant growth in this pharmaceutical market is anticipated due to greater healthcare coverage for a rising middle class. The Company is considering filing a divisional application with the Chinese Patent Office to pursue additional claims based off the initial accepted application.

"Acceptance of our first Chinese patent is a significant achievement for our Company, and indicates the strong growth of intellectual property portfolio worldwide," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "We continue to advance a number of different patent applications in key regions around the world. This provides a solid foundation for future licensing discussions. By having major regions and territories covered, it means we have greater flexibility selecting strategic partners, either by global reach, or local market penetration."

The Company’s key patent application has now been accepted, or granted, in Australia, Indonesia, Israel, Japan, China, New Zealand, Singapore, South Africa and the US.

The Company’s lead product, PRP, is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

CureVac to Receive Patent Claiming the Combination of mRNA Vaccines with Anti-PD-1 Antibodies

On July 20, 2017 – CureVac AG, a fully-integrated biopharmaceutical company pioneering the field of mRNA-based drugs, reported it has been granted a Notice of Allowance from the European Patent Office (EPO) for its patent application (EP 2958588) entitled, "Combination of Vaccination and Inhibition of the PD-1 Pathway"(Press release, CureVac, JUL 20, 2017, View Source [SID1234519946]).

The patent claims both composition of matter and methods of treatment for a vaccine/inhibitor combination comprising an mRNA vaccine and an anti-PD-1 antibody. Further, the patent covers a pharmaceutical composition and a kit of parts comprising such a vaccine/inhibitor combination, particularly for the prevention or treatment of tumor or cancer diseases and infectious diseases.

Dr. Franz-Werner Haas, Chief Corporate Officer of CureVac, stated, "We are convinced there is tremendous potential in combining mRNA-based vaccines with PD-1 checkpoint inhibitors for the treatment of a wide range of cancers and infectious diseases. Anti-PD-1 antibody therapy is becoming standard of care in several cancer indications, and combination approaches are now recognized as optimal for the development of mRNA cancer vaccines. Therefore, this patent adds considerable value to our company and our IP estate. Together with our extensive experience in the development of mRNA-based cancer vaccines this encourages us to advance and expand our RNActive Cancer Immunotherapy pipeline."

In total, CureVac holds a broad IP portfolio comprising more than 100 patent families covering different aspects of its mRNA platform enabling the use and production of mRNA across a wide range of treatment modalities and disease indications.

U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia

On July 20, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML) (Press release, Astellas, JUL 20, 2017, View Source [SID1234519842]). The Orphan Drug Designation program assigns status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of diseases or disorders that affect fewer than 200,000 people in the United States.

"Fewer than 10,000 Americans will be diagnosed with FLT3 mutation-positive AML this year and while that may be a small percentage of the overall population, it is an important group of patients who are deserving of potential new treatments," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We are grateful to the FDA for acknowledging the unique needs of rare diseases and for providing a path forward for gilteritinib in supporting these patients."

Gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in the growth of cancer cells. Gilteritinib has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in up to one third of patients with AML. AML is a cancer that impacts the blood and bone marrow and most commonly experienced in older adults. According to the American Cancer Society, in 2016 there were an estimated 21,000 new cases of AML diagnosed in the United States and about 10,600 cases resulted in death.

Astellas is currently investigating gilteritinib in various AML patient populations through several planned and already initiated Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML.

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release are not intended to constitute an advertisement or medical advice.

Aptevo Therapeutics and Alligator Bioscience Announce Plans to Co-Develop Novel Bispecific Antibody for Tumor-Directed Immunotherapy

On July 20, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, and Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that they have entered into an agreement to co-develop a novel immunotherapy bispecific antibody candidate, ALG (Press release, Aptevo Therapeutics, JUL 20, 2017, View Source [SID1234519840]).APV-527, based on Alligator’s first generation bispecific antibody, ATOR-1016. The new bispecific candidate was developed using Aptevo’s bispecific technology platform and includes proprietary binding elements generated by Alligator’s ALLIGATOR-GOLD antibody library. Initiation of cell line development for the manufacturing of clinical material is expected to begin shortly.

Working under a previously executed material transfer agreement, the companies have engineered and selected ALG.APV-527 as a lead bispecific antibody candidate, featuring a novel mechanism of action targeting 4-1BB, a member of the TNFR superfamily of co-stimulatory receptors found on activated T cells, and an undisclosed tumor antigen widely overexpressed in a number of different types of cancer.

Under the terms of the agreement, the parties will jointly own and share equally in the development costs associated with advancing this candidate through to the end of Phase 2 clinical development. At that time, the parties may opt to out-license the candidate or continue further development separately or in partnership. In addition, the agreement provides an option for the companies to develop a second bispecific antibody candidate based on this novel mechanism of action, which would also be jointly owned and funded by Aptevo and Alligator.

The co-stimulatory receptor 4-1BB is known to play an important role in modulating and augmenting the immune response to cancer by promoting the activation, expansion and enhanced effector function of tumor-specific T cells. It is, therefore, an especially promising target for new immunotherapeutic approaches for cancer treatment. If successfully developed, this new bispecific antibody candidate could have utility in the potential treatment of a broad spectrum of cancers including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers. While this tumor antigen is widely expressed in multiple types of solid tumors, it shows limited expression on normal tissues, suggesting the potential for tumor-directed immunotherapy with improved efficacy and fewer side effects.

"Our collaboration with Alligator Bioscience has unlocked tremendous synergies, enabling us to capitalize on our companies’ respective expertise in therapeutic antibody engineering," said Marvin L. White, President and Chief Executive Officer of Aptevo. "The addition of a 4-1BB bispecific candidate expands and diversifies Aptevo’s portfolio while demonstrating the flexibility of our ADAPTIR platform in addressing novel mechanisms of action, in addition to redirected T-cell cytotoxicity. Also, importantly, it allows us to pursue an exciting new therapeutic opportunity with broad potential application in the treatment of non-hematological cancers. If proven successful, this new approach would be a significant advance in cancer immunotherapy. We’re extremely pleased to collaborate with Alligator Bioscience in the development of novel tumor-targeting bispecific antibody therapies."

"With five immuno-oncology programs currently in development, each with first- or best-in-class potential, this partnership with Aptevo allows us to further build on the promise of bispecific therapeutics for tumor-directed immunotherapy," said Per Norlén, Chief Executive Officer of Alligator Bioscience. "Our technology platform enables the generation of highly functional antibodies with optimal stability and manufacturing properties, merged into an exceptional bispecific antibody using Aptevo´s ADAPTIR platform. We look forward to advancing our collaboration with Aptevo on this promising new therapeutic approach."

Diffusion Pharmaceuticals Achieves Drug Production Milestone For Planned Phase 3 Clinical Trial In Inoperable GBM Brain Cancer

On July 20, 2017 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported the completion of a major production run of its lead drug candidate trans sodium crocetinate (TSC) (Press release, Diffusion Pharmaceuticals, JUL 20, 2017, View Source [SID1234519838]). This drug supply will be used in its planned Phase 3 trial which will test TSC in the treatment of newly diagnosed inoperable glioblastoma (GBM) brain cancer patients and is of sufficient quantity to support the entire trial. Diffusion plans to initiate this clinical trial by the end of 2017.

"Diffusion has reached an important milestone for initiating the Phase 3 trial with this successful manufacture of Phase 3-ready TSC," said David Kalergis, Diffusion’s Chairman and CEO. "In its End-of-Phase-2-Meeting response, the FDA required that any TSC used in upcoming Phase 3 studies must be made using commercially-ready processes, both for the active pharmaceutical ingredient (API) and formulated drug product. The necessary advanced production and formulation processes were implemented over the last eighteen months and were cleared with the FDA in June, immediately prior to the successful clinical trial supply production run earlier this month."

Diffusion is now interacting with the FDA on details regarding the design and execution of the planned Phase 3 study, with initiation planned for later this year. The study will focus on newly diagnosed GBM patients who have been judged by their medical team to be inoperable, usually because of the size or location of the tumor. Because of their poor prognosis, these patients are often excluded from participation in other GBM clinical trials. In the Company’s Phase 2 GBM study, the TSC-treated group showed a nearly four-fold increase in survival at two years, when compared to the historical controls.