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PRIMA BIOMED COMMENCES RECRUITMENT FOR SECOND COHORT OF MELANOMA TRIAL

On January 12, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported that the first patient has been dosed for the second cohort of its clinical trial program for IMP321 in combination with KEYTRUDA being conducted in Australia (Press release, Prima Biomed, JAN 12, 2017, View Source [SID1234517368]). The second cohort will recruit up to six patients with unresectable or metastatic melanoma that have had a suboptimal response to KEYTRUDA.

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Interim data from the first patient cohort released in December 2016 indicate IMP321 is safe and well tolerated. On the basis of this safety data, the Data Safety Monitoring Board (DSMB) gave approval for the second cohort to commence.

TACTI-mel (Two ACTive Immunotherapeutics in melanoma) is a multicentre, open label, Phase I study in which patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with the PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA). The study will evaluate safety as the primary endpoint and anti-tumour activity and the immune response to the combination as secondary endpoints.

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.

CureVac Provides Clinical Update at 35th Annual J.P. Morgan Healthcare Conference

On January 11, 2017 CureVac, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, reported an update of its clinical progress at the 35th Annual J.P. Morgan Healthcare Conference in San Francisco(Press release, CureVac, JAN 11, 2017, View Source [SID1234518820]).

Interim Results of Phase I First-in-Human Clinical Trial with CV7201, an RNActive Rabies Vaccine
CureVac’s first-in-human phase I clinical trial with an mRNA-based rabies vaccine was designed to evaluate CV7201 in healthy volunteers without pre-existing immunity against the rabies virus. CV7201 encodes for the G protein of the rabies virus. To date, the vaccine appears well tolerated and no safety concerns were identified. In one cohort of 21 subjects vaccinated at the lowest dose of 80 µg with a needle-free device, virus neutralizing antibodies (VNTs) were detected in all subjects and in 17 (81%) exceeded the threshold considered protective by the WHO (0,5 IU/ml). The complete data set will be published after completion of a long-term safety valuation.
Regarding CV7201, CureVac is developing an optimized vaccine, which shows good efficacy when injected intramuscularly with a conventional needle. The company is planning to bring this vaccine into clinical testing in 2017.

Topline Result of Phase IIb Clinical Trial with CV9104, an RNActive Prostate Cancer Vaccine
CureVac’s double-blinded and placebo controlled phase IIb clinical trial with CV9104 was designed to evaluate the investigational mRNA-based cancer vaccine in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. CV9104 is composed of six protamine-formulated mRNAs, encoding individually for self-antigens that are overexpressed in prostate cancer patients.
CV9104 failed to meet the primary endpoint of improving overall survival. Progression-free survival was similar in both arms of the clinical trial. No safety concerns were identified confirming the favorable safety results of previous trials with RNActive cancer vaccines. CureVac is continuing to evaluate the data and plans to present the full set of data at an upcoming medical conference.

Clinical Results to Point Way Forward to Medical Innovation
Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac, stated: "We received encouraging data from the first ever clinical trial of a prophylactic RNActive mRNA vaccine in immune-naïve healthy volunteers indicating our vaccine is able to effectively prime immune responses against a viral antigen. These results affirm the prior preclinical proof of concept data for our vaccine format and pave the way for us to advance more potent prophylactic vaccine formulations into the clinic. Regarding our CV9104 program, we now recognize that this therapeutic vaccine fails to induce a survival benefit as a monotherapy in patients with metastatic prostate cancer receiving standard of care therapies. However, we see the path forward for our RNActive cancer immunotherapy in combination with checkpoint inhibitors."
Dr. Hoerr continued, "Having administered our RNA technologies to more than 450 human subjects and having conducted eight different clinical studies, we are confident that it can be administered safely, and based on data generated in our clinical program in rabies, we now have clear evidence that our RNActive technology induces effective immune responses in humans. As the pioneer in the mRNA field, we look forward to advancing our mRNA development and applying uniquely designed mRNA-based drugs in oncology, prophylactic vaccines and molecular therapies as CureVac strives to have the first mRNA-based product on the market for people suffering from high and unmet medical needs."

About CV7201 Phase I Clinical Trial in Rabies
The study is designed to evaluate the safety and immunogenicity of CV7201 according to (1) dose level (2) route of injection and (3) injection schedule. Rabies-specific binding and neutralizing titers will be evaluated across different injection routes using an injection schedule of 0-7-28 and 0-28-56. The trial started in 2013 and is still ongoing. To date, more than 100 subjects have been enrolled in Germany and safety follow-up is ongoing.

More details can be found here.

About CV9104 Phase IIb Clinical Trial in Prostate Cancer
The phase IIb with CV9104 was a double-blind, placebo controlled trial with 197 chemo-naïve, asymptomatic or minimally symptomatic patients with metastatic, castrate-resistant prostate cancer randomized to CV9104 or placebo. The trial which was conducted in eight European countries started in 2012 and recruitment was completed in December 2013. The primary endpoint of the study was overall survival and key secondary endpoints were progression-free survival and change of quality of life.

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.

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]).

"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]).

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."