On April 9, 2018 Oncology Venture AB (OV:ST) ("OV" or the "Company") reported that it has entered into an agreement with Novartis Pharma AG (Basel, Switzerland) for the exclusive global rights to develop and commercialize dovitinib (TKI258), a small molecule, multi- tyrosine kinase inhibitor (TKI) (Press release, Oncology Venture, SEP 9, 2018, View Source [SID1234525604]). Novartis will receive an upfront payment, development milestones, and royalties on sales. Today’s announcement follows on an earlier agreement between the companies, that included an option for OV to in-license dovitinib at predetermined conditions. As part of the agreement, Novartis will be issued a convertible debt-to-equity note in a spinout company that OV has created to advance clinical development of the drug. Further terms of the agreement were not disclosed. In a Phase 3 trial in metastatic renal cell carcinoma, dovitinib achieved therapeutic equivalence with the current standard of care, sorafenib. Earlier stage studies explored its potential utility in multiple therapeutic indications including liver cancer, breast cancer and various solid tumors. OV intends to advance the compound in clinical trials together with a validated, drug-specific DRP biomarker as a companion diagnostic.

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"Dovitinib has demonstrated clinically relevant efficacy in renal cancer and breast cancer and good efficacy in several other solid tumors, and we are excited to accelerate the development of the compound. We are confident that, by using our Drug Response Predictor (DRP) biomarker for dovitinib to select likely responder patients – and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda) in renal cancer – we will raise the chances of success for dovitinib in further clinical development. The Dovitinib DRP biomarker could then be consequentially filed together with the Marketing Authorisation Application and used as a predictive companion diagnostic to select likely responders," said Peter Buhl Jensen, M.D., CEO of Oncology Venture.

During the prior option period, OV validated its proprietary DRP biomarker for the compound against anonymized biopsy data from the Novartis Phase 3 renal cancer study. A consistent signal was seen indicative of this biomarker’s ability to predict clinical benefit of dovitinib.

Under the global license agreement, OV will further refine the Dovitinib DRP biomarker to hone its predictive ability by analyzing data from additional biopsies and genomic data sets from other previous, relevant clinical studies with this promising compound. Dovitinib DRP will then be used to prospectively select patients most likely to respond to the compound for inclusion in a planned Phase 2 trial of the drug for the treatment of breast and liver cancer.

Oncology Venture recently announced positive interim results from another DRP-guided oncology program. In a prospective Phase 1/2 study of LiPlaCis (a targeted liposomal formulation of cisplatin) in heavily pre-treated breast cancer patients, in which enrollment was guided by the LiPlaCis DRP biomarker, clinical benefit was shown in 7 out of 10 evaluable patients. By comparison, conventional cisplatin treatment of metastatic breast cancer has reported a response rate of only 10 percent in previously conducted trials. This suggests that the LiPlaCis DRP successfully identified likely responders for inclusion into the clinical trial.

For further information, please contact

Ulla Hald Buhl, COO and Chief IR & CommunicationsMobile: +45 2170 1049E-mail: [email protected] Or Peter Buhl Jensen, CEOMobile: +45 21 60 89 22E-mail: [email protected]
About the Drug Response Predictor – DRP Companion Diagnostic

Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.

The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by MPI for Personalized Medicine. The DRP is used by Oncology Venture for drug development

On April 9, 2018 Allogene Therapeutics, Inc. (Allogene) reported the completion of the previously announced transaction between Pfizer Inc. (NYSE: PFE) and Allogene for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer (Press release, Cellectis, APR 9, 2018, View Source [SID1234525478]).

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On April 3, 2018, Allogene and Pfizer announced that the companies had entered into a definitive asset contribution agreement for Pfizer’s allogeneic CAR T portfolio. As a result of the completed agreement, Allogene has received from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-­‐ expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. UCART19 utilizes TALEN gene editing technology pioneered and owned by Cellectis.

With the agreement completed, Allogene is well-­‐positioned to rapidly advance the portfolio of CAR T assets contributed by Pfizer into potential innovative new therapies, and ultimately to reach patients in need more quickly. "The completion of our agreement with Pfizer represents a bold undertaking by leaders in the field to expedite the development of the next wave of cancer immunotherapies," said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene.

Pfizer will continue to participate financially in the CAR T portfolio’s development through a 25 percent ownership stake in Allogene. Prior to the agreement completion, Gilead Sciences joined Allogene’s premier Series A investment consortium that already included TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others.

Centerview Partners acted as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Cooley LLP served as legal counsel to Allogene, Vida Venture and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.

On April 9, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that clinical safety and efficacy data from two phase II clinical trials evaluating treatment of thymic carcinoma and thymoma patients with milciclib will be presented at the ASCO (Free ASCO Whitepaper) on June 1-5, 2018 in Chicago IL (Press release, Tiziana Life Sciences, APR 9, 2018, View Source [SID1234525410]). In these studies, milciclib, a small molecular pan-inhibitor of cyclin dependent kinases ("CDKs") met primary and secondary endpoints of the studies. The treatment regimen with milciclib (150mg/day; 7days On/7days Off) was safe and well-tolerated with some patients continuing therapy of up to 5 years.

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The presentation, "Efficacy of milciclib (PHA-848125AC), a pan-cyclin d-dependent kinase inhibitor, in two phase II studies with thymic carcinoma (TC) and B3 thymoma (B3T) patients" will be given in the "Lung Cancer-Non-Small Cell Local-regional/Small Cell/Other Thoracic Cancers" session on June 3, 2018 from 4:45 PM to 6:00 PM by the principal author and investigator, Benjamin Besse, M.D., Institut Gustave Roussy, Villejuif France. Other investigators and authors of the study include Marina Chiara Garassino, M.D., Arun Rajan, M.D , Silvia Novello, M.D., Ph.D. , Julien Mazieres, M.D., Ph.D , Glen J. Weiss, M.D., Darren Kocs, M.D., Mark Barnett, M.D. , Cristina Davite, PhD. , Patrizia Crivori, Ph.D. and Giuseppe Giaccone, M.D, Ph.D.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA
Milciclib was efficacious and met progression free survival ("PFS") as the primary endpoint and overall survival ("OS") as a secondary endpoint in two separate phase II multi-centered clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in patients with thymic carcinoma (TC) and thymoma (B3T) conducted in the USA, France and Italy.

Thymic carcinoma is an aggressive metastatic malignancy which is generally recognized as being more difficult to treat than thymoma. Milciclib treatment met primary endpoint PFS-3 (34.6 % and 53.8 %) and secondary endpoint OS (23.79 and 17.94 months) in these clinical studies.

The Disease Control Rate (DCR), defined as the percentage of patients with Stable Disease (SD), Complete Response (CR) and Partial Response (PR) in evaluable patients of TC was 69.2% in both trials. The DCR in evaluable B3T patients was 80.0% and 70.6% in CDKO-125a-006 and CDKO-125a-007, respectively.

Seven patients (5 patients in the CDKO-125A-006 study and 2 patients in the CDKO-125A-007) have been continuing treatment with Milciclib for more than 2 years with excellent safety profile. Among these, 2 patients have been treated with Milciclib for approximately 5 years, demonstrating safety of the drug for long term treatment.
"Thymic carcinoma and thymoma are unmet medical needs with no approved therapies. Particularly, it is very exciting that milciclib treatment was also efficacious in TC, which is an aggressive and difficult to treat metastatic cancer" Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented.

"Demonstration of safety and efficacy in these two phase II clinical studies in patients with TC and B3T is a major milestone in clinical development of milciclib. We will work with regulatory agencies in US and Europe to develop plans to bring these first-in-class therapies to patients in need as soon as possible" said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

About Thymic Carcinoma and Thymoma

Thymomas and thymic carcinomas are thymus tumors of epithelial origin. The incidence of thymic malignancies is approximately 1.5% of all malignancies with an overall incidence of 0.15 cases per 100,000. Thymic carcinomas are invasive and represent 0.06% of all thymic cancers, whereas thymomas tend to recur locally and are less likely to metastasize.(View Source).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, Pancreatic and colon cancer, thymic carcinoma and thymoma.

On April 9, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it will be present at the following investor events (Press release, Innate Pharma, APR 9, 2018, View Source [SID1234525314]):

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H.C. Wainwright Global Life Sciences Conference – Monaco, April 9-10, 2018
Goldman Sachs 11th European Small and Mid-Cap Symposium – London, May 1‑4, 2018
Deutsche Bank’s 43rd Healthcare Conference – Boston, USA, May 8-9, 2018

Innate Pharma is committed to meet on a regular basis with the financial community. All corporate information on the Company, such as its financial statements or its corporate presentations, is available on the Company’s website in the Investors’ section

On April 9, 2018 Protagen AG and Gustave Roussy have reported the start of a collaboration to utilize Protagen’s SeroTag technology to help identify biomarkers that predict and monitor immune-related adverse events (irAEs) in cancer patients treated with checkpoint inhibitors (Press release, Protagen, APR 9, 2018, View Source [SID1234525247]).

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Checkpoint inhibitors offer enormous potential for the treatment of many cancer indications, including melanoma and renal cell carcinoma. Yet, only a subset of patients respond favorably to treatment and it is not currently possible to predict which patients will benefit from therapy. In addition, checkpoint inhibitors can also trigger (often severe) irAEs, which has led to the FDA halting clinical trials in the past. Through this new collaboration, Protagen and Gustave Roussy will utilize Protagen’s proprietary immune system profiling platform, SeroTag, to monitor patients, detect irAEs and ultimately conduct comprehensive risk profiling for those undergoing cancer immunotherapy. This project is part of the ongoing Gustave Roussy Immunotherapy Program (GRIP), which aims at developing immunotherapy access and best practice.

Dr. Aurelien Marabelle, clinical director of the Gustave Roussy Immunotherapy Program commented: "Although immunotherapies like checkpoint inhibitors have shown great promise for treating those suffering from cancer, response rates for these therapies are still low (often around 10-20%). In addition, our efforts to improve therapeutic outcomes via the implementation of combination therapies can increase the risk of the patient developing debilitating and sometimes fatal irAEs." He continued: "It is therefore vital that we try to understand more about the immunological responses patients are exhibiting to cancer, both before and during therapy. Utilizing Protagen’s SeroTag platform will enable us to ask these questions, and we very much look forward to this collaboration."

Dr. Peter Schulz-Knappe, Protagen’s Chief Scientific Officer, added: "Our unique SeroTag technology has already demonstrated its ability to stratify patients into homogenous disease subgroups for a number of autoimmune indications, thereby supporting the development of novel therapies. Due to the strong link between immuno-oncology and autoimmune disease, we believe that applying our technology and approach to the immuno-oncology field will result in improved patient selection for novel immuno-therapies and support the risk profiling of patients for the development of irAEs. We feel privileged that Gustave Roussy shares this view and we are excited about our collaboration."

About Gustave Roussy

Gustave Roussy, the largest comprehensive cancer center in Europe, is a pole of expertise dedicated to the comprehensive care of patients, employing 3100 health professionals for health care, research and teaching. Gustave Roussy is the European leader in cancer immunotherapy in terms of clinical trials and number of patients treated – www.gustaveroussy.fr/en