(Filing, 10-Q, Champions Oncology, DEC 15, 2015, View Source [SID:1234508576])

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On December 15, 2015 Neon Therapeutics, an immuno-oncology company developing neoantigen-based therapeutic vaccines and T cell therapies to treat cancer, reported a clinical trial collaboration with Bristol-Myers Squibb. The collaboration will evaluate the combination of Neon Therapeutics’ proprietary personalized neoantigen vaccine, NEO-PV-01, and Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor (Press release, Neon Therapeutics, DEC 15, 2015, View Source [SID1234517522]).

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Neon Therapeutics’ lead program, NEO-PV-01, is a fully personalized neoantigen vaccine based on DNA mutations from patients’ individual tumors. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. The Phase 1b clinical trial will evaluate the safety, tolerability and preliminary efficacy of NEO-PV-01 in patients receiving Opdivo in melanoma, smoking-associated non-small cell lung cancer and bladder cancer. The trial also will evaluate neoantigen-specific immune responses in peripheral blood and tumor tissue, as well as other indicators of immune response such as PD-L1 expression. Neon Therapeutics plans to initiate the study at multiple clinical sites in the U.S. in 2016.

"We are excited to be working with Bristol-Myers Squibb, a proven leader in immuno-oncology," said Cary Pfeffer, M.D., interim chief executive officer of Neon Therapeutics. "We believe this collaboration will accelerate the development of fully personalized neoantigen therapies, and provide additional data around the potential synergy of complementary immune-mediated mechanisms of action."

The study will be conducted by Neon Therapeutics. Additional details of the collaboration were not disclosed.

On December 15, 2015 Regeneus (ASX: RGS), a clinical-stage regenerative medicine technology company, reported that the Australian Patent Office has granted a patent covering the use of cancer vaccine technology for the treatment of a range of cancers in humans and animals (Press release, Regeneus, DEC 15, 2015, View Source [SID1234519523]).

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Under the licence agreement from Northern Sydney Local Health District, Regeneus has exclusive rights to develop and commercialise the cancer vaccine technology for human and animal health applications in all major territories.

Australian patent number, 201320386, entitled "Vaccines for the treatment or prevention of cancer" provides commercial rights in Australia through to 11 April 2033. This patent is also being pursued for grant in other key territories including the USA, Japan and Europe.

The technology uses a patient’s own cancer cells combined with an immunostimulant that is designed to re-educate the immune system to target cancer cells in both existing and new tumours.

The technology was developed by researchers at the Bill Walsh Translational Cancer Research Laboratory, which is the research arm of the Medical Oncology Department at Royal North Shore Hospital and part of the Kolling Institute, Northern Sydney Local Health District. In a pre-clinical brain tumour model, vaccination led to remission rates of up to 60% and significantly extended survival in all vaccinated animals. Re-challenging animals in remission demonstrated 100% tumour rejection indicating acquired immunity.

The patent supports the company’s RGSH4K and Kvax clinical programs. RGSH4K is being used in a Phase 1 safety study in humans on a wide range of tumours. Kvax is the subject of a US study for the treatment of canine osteosarcoma which is fully recruited. Kvax is also the subject of a recently announced study for the treatment of canine lymphosarcoma in combination with chemotherapy.

Regeneus has 49 patents or patent applications across 14 patent families.

On December 14, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported the establishment of an agreement with a major Canadian cancer cooperative group, The Canadian Brain Tumour Consortium (CBTC), for the phase 3 registrational trial of its cancer immunotherapy ICT-107 in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, DEC 14, 2015, View Source [SID:1234508569]). Established in 1998, and including a national investigator network of over 100 brain tumor specialists and researchers, the CBTC partners with industry to evaluate and execute clinical trials of promising new agents in a timely and cost-effective manner. The CBTC’s major goals are furthering brain tumor research and development and supporting patients and their families who are affected by glioblastoma.

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "Partnering with the highly respected CBTC is a critical component of our clinical trial infrastructure, and further strengthens the multi-national clinical trial network for our ICT-107 phase 3 trial. With complementary collaborations in place with cooperative groups in the US and, Europe, the CBTC collaboration can enable us to execute this international clinical program in a high quality and efficient manner. As the lead asset in our cancer immunotherapy pipeline, we believe that ICT-107 represents a valuable opportunity for ImmunoCellular. As the phase 3 program progresses, we also intend to continue to build our cancer immunotherapy platform, including our Stem-to-T-cell program, with the goal of expanding our anti-cancer technological and therapeutic approaches."

The ICT-107 phase 3 registrational trial is open for enrollment in the US with additional sites anticipated to open in Canada and Europe in the coming weeks and months.

On December 14, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), reported the presentation of preclinical data demonstrating the molecular basis for the development of CYC065 in triple negative breast cancer (TNBC), and in particular basal-like TNBC. CYC065 is a highly-selective, second-generation cyclin dependent kinase (CDK) inhibitor targeting CDK2/9 dependent tumors (Press release, Cyclacel, DEC 14, 2015, View Source [SID:1234508697]). The data were presented at the San Antonio Breast Cancer Symposium (SABCS), taking place December 8-12, 2015.

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"We have recently reported that CYC065 can target malignancies driven by CDK2/9 dependent oncogenic and leukemogenic pathways such as MLL-rearranged leukemias and tumors overexpressing MYC", said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. "The data presented at SABCS show CYC065 could be active in breast cancer patients with a poor prognosis and that its mechanism induces breast cancer cell death by apoptosis. In addition, we have identified approved and investigational anticancer agents, including our own sapacitabine, which combine effectively with CYC065. A first-in-human, Phase 1 clinical trial with CYC065 has commenced and we look forward to reporting data from this study."

Data presented at SABCS (Program Number: P5-03-10, View Source) demonstrated in particular the mechanistic rationale for clinical development of CYC065 in basal-like TNBC, a cancer with poor prognosis frequently associated with BRCA1 mutations. Molecular characteristics of TNBC include amplification or overexpression of Cyclin E, the partner protein of CDK2, and MYC. CYC065 directs a pro-apoptotic mechanism in breast cancer cell lines, which includes transcriptional down regulation of key pro-survival and oncogenic regulators, including MCL-1 and MYC.

CYC065 was shown to rapidly induce cell death in breast cancer cell lines, while transiently inducing G1 cell cycle arrest in non-malignant breast lines. CYC065’s potent anticancer activity has been confirmed in breast cancer xenograft animal models. CYC065 effectively combined with Cyclacel’s sapacitabine in breast cancer cell lines, as was the case with seliciclib, Cyclacel’s first generation CDK2/9 inhibitor, when combined with sapacitabine.

An oral regimen of seliciclib and sapacitabine is being evaluated in an on-going Phase 1 all-comer study of patients with various advanced cancers. In previously reported initial data from this study, durable partial responses have been observed in breast, ovarian and pancreatic cancer patients with germline mutations in Homologous Recombination (HR) repair genes, specifically BRCA1 or BRCA2.

CYC065 is in a first-in-human, Phase 1 clinical trial.