On October 16, 2014 Aduro BioTech reported that it has entered into its second agreement with Janssen Biotech part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to certain product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform (Press release Aduro BioTech, OCT 16, 2014, View Source [SID:1234500839]). Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30 million up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817 million. In addition, Aduro is eligible to receive high single-digit to double-digit tiered royalties on worldwide net sales upon successful launch and commercialization.

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Under the agreement, Janssen will have exclusive rights to develop and commercialize LADD product candidates in lung cancer and will assume responsibility for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. Aduro may provide assistance in any of these areas upon request and will receive additional fees for these support activities.

"Since our initial agreement with Janssen in May of this year for new immunotherapies for prostate cancer, they have been terrific partners and we’ve established a strong collaboration focused on advancing our technologies forward in their licensed indications," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe our LADD technology also offers tremendous promise as a potential treatment for lung cancer and we are pleased to expand our relationship with Janssen, a company with significant experience and resources focused in both lung and prostate cancer. Separately, Aduro continues to make progress with our broad array of immunotherapy platforms in a number of other oncology indications, including pancreatic cancer, mesothelioma and glioblastoma among others."

The transaction is subject to clearance by the US antitrust authorities under the Hart-Scott-Rodino Act and will become final as soon as such clearance has occurred.

In May of this year, Aduro announced its first agreement with Janssen Biotech, Inc. granting the company an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform. Under that agreement, also facilitated by the Johnson & Johnson Innovation center in California, Aduro is eligible to receive up to $365 million in upfront and development and commercialization milestones.

On October 16, 2014 Pharmacyclics reported that it has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (Press release Pharmacyclics, OCT 16, 2014, View Source [SID:1234500840]). The agreement allows for multiple studies to be considered and conducted. Initially, a Phase 3 study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

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Both products are approved and marketed for the treatment of CLL. IMBRUVICA is used to treat CLL in patients who have received one prior therapy, and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated chronic lymphocytic leukemia. The use of these products in combination is investigational only.

"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, Chairman & CEO, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."

The study of the investigational combination of IMBRUVICA and GAZYVA through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.

Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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(Press release, Arch Biopartners, OCT 15, 2014, file:///C:/Users/LYDIAS~1.PPT/AppData/Local/Temp/_pdfdocs_00008603_20141015131316_02267912-00000001-00008603-s@torontonathan_cole973130-pdf.pdf [SID:1234505979])

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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.

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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.