1stOncology™: Cancer Intelligence Service – Page 18179 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

(Filing, 10-K, Propanc, OCT 14, 2014, View Source [SID:1234504723])

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Spotlight Innovation signs Letter of Intent to Acquire Memcine Pharmaceuticals

On October 14, 2016 Spotlight Innovation Inc. (OTCQB:STLT) reported that it has signed a Letter of Intent to acquire majority ownership in Memcine Pharmaceuticals Inc., located at the University of Iowa Research Park in Coralville, Iowa (Press release, Spotlight Innovation, OCT 14, 2014, View Source [SID:1234514016]). Memcine Pharmaceuticals is developing its Immunoplex vaccine platform technology, which is designed to use the body’s own naturally occurring targeting system to deliver vaccine components to immune cells and stimulate a robust response.

Cris Grunewald, President and CEO of Spotlight Innovation, said, "Memcine Pharmaceuticals’ mission directly supports Spotlight Innovation’s goal of positively impacting the health and well-being of as many people as possible. Memcine Pharmaceuticals’ Immunoplex technology has shown enormous potential with broad applicability in both infectious diseases and oncology immunotherapy. We look forward to closing this transaction, furthering the development and fulfilling the promise of this exciting, potentially life-saving technology."

MOLOGEN AG presents EnanDIM: A new generation of immunomodulators

On October 14, 2014 MOLOGEN reported that it has presented preclinical data on its EnanDIM technology at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in San Diego, United States (Press release Mologen, OCT 14, 2014, View Source [SID:1234501174]). EnanDIM represents a new generation of the company’s immunoactivating TLR-9 agonists that is expected to trigger a broad immune activation while being well tolerated. Potential applications include the fields of anti-tumor and anti-infective therapies.

DNA-based TLR-9 agonists are potent activators of the innate immune system and of a variety of immune cell populations. So far, two different types of TLR-9 agonists have been established. The first consists of linear, single-stranded DNA molecules. Most of these linear TLR-9 agonists are chemically modified to protect them against degradation, which is known to produce off-target effects and toxicity. MOLOGEN’s lead product, the cancer immunotherapy MGN1703, represents the second type of TLR-9 agonist, a covalently-closed, dumbbell-shaped DNA molecule. As it consists entirely of natural DNA components, it is safe and well tolerated.

EnanDIM (Enantiomeric, DNA-based, ImmunoModulator), the new class of linear TLR-9 agonists, combines the immunoactivatory properties of molecules containing only natural DNA components with the advantages of linear molecules. Despite its linear structure, no chemical modifications are needed as the specific linear structure of EnanDIM protects the molecules against degradation. This protection is achieved by incorporation of mirror-imaged components, which are chemically identical to the naturally occurring DNA components but that are not recognized by DNA-degrading enzymes. Consequently, a favorable safety and tolerability profile is expected to be shown in the planned subsequent preclinical and clinical development.

The broad immune activation induced by EnanDIM in preclinical models has been presented at OTS in an oral presentation. Therefore, the mode of action should enable the use in various cancer indications either as monotherapy, in combination with other targeted therapies or immune modulators, such as so called checkpoint inhibitors or with other immunotherapeutic approaches. Furthermore, it could potentially be used in the field of infectious diseases.

Dr. Matthias Schroff, CEO of MOLOGEN AG, commented: "We are very pleased about the positive feedback at the OTS meeting. EnanDIM is expected to have a safety and tolerability profile in clinical tests comparable to the profile of our lead product MGN1703. Based on its broad immune activation potential EnanDIM may be used in a variety of indications including cancer immunotherapy. This again shows our innovative capacity and expertise in the field of immune therapies and in immuno oncology in particular."

Detailed information on EnanDIM, as discussed at the oral presentation, is summarized in the poster with the title "EnanDIM: A new class of enantiomeric oligodeoxynucleotides for TLR‐9 activation" (poster no. 056).

For more information please visit the OTS website www.oligotherapeutics.org.

8-K – Current report

On October 14, 2014 Sorrento Therapeutics reported positive results from recently analyzed pharmacokinetic (PK) data from the first eight (8) patients enrolled in its ongoing TRIBECA (TRIal establishing BE between Cynviloq and Albumin-bound paclitaxel) registrational trial (Filing 8-K , Sorrento Therapeutics, OCT 14, 2014, View Source [SID:1234500829]). The data from these patients supports earlier completion of the study with the aim of seeking to establish bioequivalence (BE) to albumin-bound paclitaxel to obtain Food and Drug Administration (FDA) marketing approval for Cynviloq (paclitaxel polymeric micelle for injection).

Sorrento amended the current BE cross-over design protocol of the TRIBECA study to un-blind the first 8 patients to reassess the sample size of 100 patients estimated from simulation of historical PK data. Based on the cross-over data and the analyses of relevant paclitaxel plasma PK data performed by two independent PK consulting groups, the success of the BE approach for seeking approval of Cynviloq remains subject to FDA review and discussion. Sorrento does not plan to un-blind additional patient data. Current sample size point estimates suggest that the enrollment target for the current study can be reduced to nearly half of the original target.

"We are pleased that the favorable PK data from actual patients treated have thus far exceeded our expectations", said Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento. "Guided by these promising data, Sorrento plans to reduce the TRIBECA patient sample size to accelerate filing for FDA approval."

U.S. FDA GRANTS PRIORITY REVIEW STATUS TO NDA FOR ANTICANCER AGENT LENVATINIB

On October 15, 2014 Eisai reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc for its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer and granted the NDA Priority Review status (Press release Eisai, OCT 14, 2014, View Source [SID:1234500833]).

The FDA’s Priority Review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) for lenvatinib of April 14, 2015, eight months after the NDA was submitted.

Applications for marketing authorization approval of lenvatinib were submitted in Japan for the indication of thyroid cancer in June 2014 and in Europe and the U.S. for the indication of progressive, radioiodine-refractory differentiated thyroid cancer in August 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the U.S. Lenvatinib was also granted an accelerated assessment by the European regulatory authority, as it is a new medicine expected to be of major public health interest, particularly from the viewpoint of therapeutic innovation.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of several different RTKs including VEGFR, FGFR, PDGFRα, KIT and RET, involved in angiogenesis and tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the kinase activities of FGFR as well as VEGFR.

The number of patients newly diagnosed with thyroid cancer in 2012 in the U.S. was estimated to be approximately 52,000. Although treatment is possible for most types of thyroid cancer, there are very few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.