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Advaxis Provides Clinical Update for Phase 1/2 Trial of ADXS-HPV Immunotherapy Product Candidate in Anal Cancer

On October 15, 2014 Advaxis reported preliminary data from its Phase 1/2 study of ADXS-HPV in human papillomavirus (HPV) associated anal cancer that indicate a “clinical complete response” in all 7 patients who have completed the treatment regimen (Press release Advaxis, OCT 15, 2014, View Source [SID:1234500828]).

“We are pleased with this preliminary data,” commented Dr. Howard Safran, Medical Director of Brown University Oncology Research Group (BrUOG) and principal investigator of the study. “We are now in the process of opening this study at other institutions.”

Conducted by BrUOG, the Phase 1/2 trial is a non-randomized, open-label, multi-center study of 25 patients designed to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer in patients who have a high risk of recurrence based on their disease. The primary efficacy objective of the study is to assess the proportion of patients maintaining a clinical complete response at the 6 month mark. Based on historical clinical experience in similar high risk patients and pursuant to the study protocol, the addition of ADXS-HPV will be considered promising if the 6 month complete response rate is greater than 80%.

At present, 7 of 8 patients out of the planned total accrual of 25 patients have completed the treatment regimen. The 7 patients are without evidence of disease. Preliminary safety findings indicate flu-like symptoms were the most common adverse reaction lasting for about 24 hours.

Patients have been treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). With these results, the study is being expanded to Ohio State University and Rutgers University, and these sites are in the process of activation.

Daniel J. O’Connor, President and CEO of Advaxis, remarked, “Though we recognize that the data is preliminary, it suggests a positive therapeutic response in the treated patients that warrants further investigation. Our strategy is to provide an immunotherapeutic treatment option to patients with HPV-associated anal, cervical and head & neck cancer – each of which Advaxis has obtained orphan drug status.”

(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."