Patent covers a use of a pharmaceutical composition comprising a therapeutically effective amount of trypsinogen and chymotrypsinogen

On January 11, 2017 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare 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 a notification of allowance for its lead patent application from the US Patent Office (Press release, Propanc, JAN 11, 2017, View Source [SID1234517356]). The patent application provides broad coverage for a method of treating a solid tumor through administering a pharmaceutical composition comprising a therapeutically effective amount of trypsinogen and chymotrypsinogen to patients.

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The allowance of this key patent application is a first in the US, representing a major milestone for the Company as it progresses its lead product, PRP, a solution for once daily intravenous administration of pancreatic proenzymes, towards first-in-man studies in 2017. Further, the Company plans to file a continuation application with the US Patent Office to pursue additional claims based off the initial allowed application.

"An allowance of a key patent application in the US is a significant event in the life of any company, particularly a biotech, and we are delighted to have achieved this milestone which provides broad protection for our lead product, PRP, for the treatment of solid tumors," said James Nathanielsz, Propanc’s Chief Executive Officer. "We have filed numerous patent applications around the world in the past 12 to 18 months, with further applications expected. All of this represents a strong result for our shareholders who wait for progression of PRP into first-in-man studies this year. We firmly believe PRP is a new therapeutic approach for the treatment of metastatic cancer from solid tumors, which represents 80% of all cancers, and we are the leaders in this field of technology from an IP perspective, which is very exciting."

The Company’s lead product, PRP, is a novel, patented, formulation consisting of two pancreatic proenzymes — trypsinogen and chymotrypsinogen. Currently in formal preclinical development and progressing towards first-in man studies, PRP aims to prevent tumor recurrence and metastasis in solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.

Celyad Announces Registration of the First Pancreatic Cancer Patient in its CAR-T NKR-2 THINK Trial in Belgium

On January 11, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported the activation of a second clinical site in Belgium for the THINK trial, with the registration of a pancreatic cancer patient at Cliniques Universitaires Saint-Luc (UCL) (Press release, Celyad, JAN 11, 2017, View Source [SID1234517407]).

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"Celyad is now conducting one of the largest clinical trials in the CAR-T space, with a highly disruptive technology. Thanks to the support of our clinical partners and team, Celyad is registering patients across the seven indications of the THINK trial and is activating the different sites of the study at a good pace," said Christian Homsy, CEO of Celyad. "The THINK trial is a world first, evaluating CAR-T NKR-2 cells in both hematological and solid tumors. Based on our outstanding of the preclinical data, our confidence in this technology is very high."

"Celyad’s ongoing preclinical work has generated impressive results in models of pancreatic cancer, a particularly devastating form of the disease with a mortality rate that has remained largely unchanged in recent decades. The registration of a first metastatic pancreatic cancer patient reaffirms our commitment to continued product development for patients", remarked Dr. Frédéric Lehmann, VP Clinical Operations and Medical Affairs at Celyad.

Prof. Ahmad Awada, Head of Medical Oncology at Institut Bordet said: "Immunotherapy is a new approach that offers another alternative to patients who are refractory to more traditional treatment options such as chemotherapy or hormonotherapy. The CAR-T NKR-2 cells therapy is very original since it uses the patient’s own immune system to fight cancer cells. We are optimistic about this approach and are now looking forward to seeing how patients will respond to the treatment."

Prof. Jean-Pascal Machiels, Head of Medical Oncology at Cliniques Universitaires St- Luc (UCL) added: "Preclinical results as well as first Phase I safety data are very encouraging. We do believe that the THINK study, which is the first to use multiple dosing in patients suffering from very aggressive solid or hematologic metastatic tumors, potentially opens a new avenue for cancer treatment."

TESARO Receives Complete Response Letter for Rolapitant IV from U.S. FDA

On January 11, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (Press release, TESARO, JAN 11, 2017, View Source [SID1234517362]).

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FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. TESARO is working expeditiously to provide the requested information.

The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient (API), which is also used for the VARUBI (rolapitant) oral product.

TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.

"Chemotherapy-induced nausea and vomiting (CINV) remains a significant unmet need, with more than half of patients treated with emetogenic chemotherapy experiencing this debilitating side effect," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TESARO is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA’s questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017."

Merck KGaA, Darmstadt, Germany Licenses Four Oncology Research and Development Programs from Vertex

On January 11, 2017 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it has entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four promising research and development programs that represent novel approaches to the treatment of cancer (Press release, Vertex Pharmaceuticals, JAN 11, 2017, View Source [SID1234517357]). As part of the agreement, Merck KGaA, Darmstadt, Germany will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Vertex will receive an upfront payment of $230 million, in addition to royalties on future net sales. Merck KGaA, Darmstadt, Germany will assume full responsibility for the development and commercialization of all the programs.

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"The Vertex R&D team has produced a portfolio of first-in-class compounds with the potential to enhance the therapy of multiple cancers," said Jeffrey Leiden, M.D., Ph.D, Chairman, President and CEO of Vertex. "We are pleased to partner with Merck KGaA, Darmstadt, Germany, a leader in oncology with exciting complementary assets that will help fully realize the value of these unique compounds and accelerate the programs’ potential benefits for patients."

"With this strategic deal, we significantly strengthen our oncology pipeline in two attractive areas where we have leading competence, DNA damage and repair and immuno-oncology – areas which also have promising therapeutic synergy," said Belen Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. "This deal underscores our commitment to accelerate innovation for cancer patients, and we are excited for the opportunity to build on Vertex’s rigorous science and advance these leading programs."

The two clinical-stage programs represent first-in-class approaches to inhibit the DNA repair pathways that are fundamental to the survival and proliferation of certain cancers:

An ataxia telangiectasia and Rad3 related (ATR) protein kinase inhibitor program comprised of two compounds, VX-970 and VX-803. VX-970 is being investigated broadly through 10 ongoing Phase 1 and Phase 2 trials across a variety of tumors and patient subtypes expected to be responsive to ATR inhibition based on biomarker data. Preliminary VX-970 clinical data were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. VX-803 is an orally dosed ATR inhibitor currently in Phase 1 trials evaluating escalating doses of VX-803 alone and in combination with chemotherapy.
A DNA-dependent protein kinase (DNA-PK) inhibitor program including the clinical candidate VX-984. A Phase 1 trial is now evaluating escalating doses of VX-984 alone and in combination with pegylated liposomal doxorubicin in subjects with advanced solid tumors. Merck KGaA, Darmstadt, Germany will combine these assets with its existing DNA-PK assets into a single development program.
The pre-clinical programs include one immuno-oncology program against an attractive target with first-in-class potential, and a program against a completely novel target. For both of these programs, Vertex research has demonstrated efficacy in relevant pre-clinical models, including demonstration of combination potential with immune checkpoint inhibition for the immuno-oncology program. Merck KGaA, Darmstadt, Germany will continue to characterize the Vertex compounds in these programs with the goal of taking them forward into the clinic.

The strength of the oncology R&D program at Merck KGaA, Darmstadt, Germany, including a leading presence in immunotherapy and DNA damage and repair, demonstrates how the company is re-imagining the way cancer can be treated.

The collaboration, and the related $230 million upfront payment, is subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

PIQUR and PIERRE FABRE Announce Partnership in Dermato-Oncology

On January 11, 2017 PIQUR Therapeutics AG, a Swiss clinical-stage pharmaceutical company, and Pierre Fabre, the second largest private French pharmaceutical group reported that they have signed a collaboration agreement for the development of PIQUR’s lead compound PQR309 in dermato-oncology (Press release, PIQUR Therapeutics, JAN 11, 2017, View Source [SID1234517355]). The exclusive deal will see PIQUR and Pierre Fabre’s R&D teams work together on the evaluation and development of dermatological formulations of PI3K/mTOR inhibitors across multiple therapeutic indications.

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Following the first stage of the collaboration, Pierre Fabre will have the option to enter into exclusive negotiations to license global rights for the program in selected skin cancer conditions. Terms and conditions of the collaboration were undisclosed.

Pierre Fabre is strategically positioned in both oncology and dermatology from discovery all the way through commercialization with multiple products at various stages of development and already launched on the market.

"The collaboration with Pierre Fabre, a worldwide leader in dermatology is an important milestone for PIQUR, validating its potential to bring novel solutions to patients for the treatment of dermato-oncology diseases with unmet medical needs," said Hervé Girsault, Chief Business Officer of PIQUR.

"We are looking forward to working with PIQUR as part of our commitment to external innovation. This collaboration with PIQUR marks an additional milestone in our partnering strategy. Combining our capabilities will accelerate the drug discovery process and bringing forward transformative therapies for patients." said Laurent Audoly, Head of Research & Development at Pierre Fabre Pharmaceuticals.