On April 19, 2018 The biopharmaceutical company MOLOGEN AG reported that it presented data of its EnanDIM molecules, a new generation of potent non chemically-modified TLR9 agonists, at the AACR (Free AACR Whitepaper) Annual Meeting 2018 (American Association for Cancer Research) in Chicago, Illinois, U.S. (14 – 18 April 2018) (Press release, Mologen, APR 19, 2018, View Source [SID1234525553]). In murine tumor models, monotherapy with EnanDIM resulted in beneficial modulation of the tumor microenvironment (TME) translating into remarkable anti-tumor effects with highly increased survival rates. In two cancer models complete tumor regression in the majority of mice was observed. Importantly, in a subsequent re-challenge study all surviving mice rejected tumor cells, which indicates a sustained anti-tumor memory of the immune system. Hence, the data provide an excellent basis for further development of EnanDIM in cancer.

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"The presented data clearly reveal the enormous potential of the EnanDIM product family. Hence, besides our late-stage candidate lefitolimod, we have strong follow-up molecules and we aim to enter EnanDIM into the clinical phase as soon as possible, of course depending on available resources", said Dr Mariola Soehngen, Chief Executive Officer of MOLOGEN.

"We are excited about the beneficial TME-modulating effects of single-agent EnanDIM which translated into remarkable anti-tumor activity, a clear pre-clinical proof of concept", said Dr Matthias Baumann, Chief Medical Officer at MOLOGEN, "and keep in mind that we have already promising pre-clinical results with EnanDIM and checkpoint inhibitors which have been presented last year. In summary, this is a clear "Go" for further development of EnanDIM in the IO space."

EnanDIM (Enantiomeric, DNA-based, ImmunoModulator), as a new generation of immunomodulators and so called Immune Surveillance Reactivators (ISR), belongs to the class of TLR9 agonists and represents one of MOLOGEN’s follow-up compounds to lefitolimod exhibiting an variable immunomodulatory pattern dependent on the specific EnanDIM molecule, a one-step production process.

The EnanDIM molecules consist entirely of natural DNA, as is also the case with lefitolimod. The main difference between MOLOGEN’s two ISR families is their molecule structure. Whereas lefitolimod is dumbbell-shaped and covalently-closed, EnanDIM molecules have a linear structure. However, as with lefitolimod, due to its specific structure, no chemical modification is needed in order to protect the molecules against degradation by enzymes.

Latest data on the EnanDIM molecules have been presented not only at the AACR (Free AACR Whitepaper) in Chicago, but also at the ITOC-5 Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference in Berlin (19 – 21 March 2018).

On April 19, 2018 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported that researchers from Medigene and Oslo University Hospital presented a poster on the generation of dendritic cell vaccines for Medigene’s ongoing Phase I/II clinical trial with Acute Myeloid Leukemia (AML) patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, USA (Press release, MediGene, APR 19, 2018, View Source [SID1234525552]).

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Dr. Kai Pinkernell, Chief Medical and Chief Development Officer (CMO/CDO) of Medigene, commented: "These results clearly demonstrate the feasibility and robustness of our production protocol for high numbers of clinical grade TLR7/8-polarized fast mature DCs from heavily pretreated AML patients, allowing for long-term vaccination of trial subjects."

A total of 20 patients with an average age of 59 years (range 24 – 73 years) were recruited to this ongoing trial. For vaccine production, autologous apheresis material was collected from each patient. Following isolation of DC precursor cells, fast DC generation was performed using Medigene’s proprietary TLR7/8-agonist containing maturation cocktail. The final DC vaccine product was cryopreserved in multiple aliquots prepared to deliver 5-10 million cells per vaccine dose.

Successful production runs of dendritic cells for vaccination were achieved for all 20 AML patients. An additional apheresis for a second production run in order to generate sufficient vaccine doses for the intended treatment period was performed during the trial for only 4 out of the 20 patients enrolled in the trial.

The production runs were performed at the Department of Cellular Therapy at the Oslo University Hospital, Norway.
To view the abstract of the poster entitled "Generation of clinical grade autologous TLR7/8-polarized fast dendritic cell vaccines for active immunotherapy of patients with AML" please visit: tiny.cc/12mtry

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced of Medigene’s highly innovative and complementary immunotherapy platforms. Currently Medigene evaluates its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

Dendritic cells (DCs) are the most potent antigen-presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of Medigene Immunotherapies scientists has developed new, fast and effective methods for generating dendritic cells ex-vivo, which are able to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or for use in combination therapies.

About Medigene’s DC vaccine clinical trial: Medigene’s Phase I/II trial (NCT02405338) includes 20 AML patients who show complete remission after standard chemotherapy, but who are not eligible for stem cell transplantation that would reduce the risk of a relapse. All patients will be vaccinated with Medigene’s DC vaccines for two years. The primary objective is to assess safety and feasibility of the active immunotherapy with Medigene’s dendritic cells. Secondary objectives of the study are induction of immune responses, overall survival (OS), progression free survival (PFS), control of minimal residual disease (MRD) and time to progression (TTP).

About acute myeloid leukaemia (AML): Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences are registered annually.

AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a drop in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.

AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately, the majority of patients suffer a relapse. Only about 15 – 20% of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

On April 19, 2018 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the Company has decided to discontinue the trial (Press release, Argos Therapeutics, APR 19, 2018, View Source [SID1234525551]).

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As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm) after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision.

The most recent interim analysis was conducted after 51 new events (deaths) had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months (95% Confidence Interval (CI): 23.4, 35.2) compared to 31.2 months (95% CI: 23.0, 44.5) for the control arm. The hazard ratio was 1.10 (95% CI: 0.85, 1.42). The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.

Based on a review of the status of its internal programs, resources and capabilities, Argos plans to explore a wide range of strategic alternatives that may include a potential merger or sale of the Company, among other potential alternatives that could maximize both near and long-term value for our shareholders. The Company has retained Stifel, Nicolaus & Company, Incorporated to serve as its financial advisor in the process.

Argos does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the process will result in any strategic alternative being announced or consummated. Argos does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

Argos also today reported that it does not expect to regain compliance with The Nasdaq Capital Market continued listing requirements by the April 24, 2018 deadline. As a result, Argos expects that its common stock will be delisted from The Nasdaq Capital Market and that trading in the Company’s common stock on The Nasdaq Capital Market will be suspended effective at the open of business on April 23, 2018. The Company has filed an application to transfer trading and quotation of its common stock to the OTCQB Venture Market, operated by OTC Markets Group Inc., under its current trading symbol "ARGS," effective as of April 23, 2018. Quotation and trading information for the common stock will be available on www.otcmarkets.com.

On April 19, 2018 TESARO, Inc. (NASDAQ:TSRO) reported that it will announce first-quarter 2018 financial results on Thursday, May 3, 2018, after the close of the U.S. financial markets (Press release, TESARO, APR 19, 2018, View Source [SID1234525550]). TESARO’s senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on May 3, 2018 to discuss the Company’s operating results for the quarter in greater detail, as well as the status of its development programs.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

TESARO will host a conference call and live audio webcast to discuss its first-quarter financial results.

WHEN: Thursday, May 3, 2018 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com

A replay will be available for 30 days at www.tesarobio.com.

On April 19, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported an advance in pre-clinical development and the presentation of new data for investigational ON 123300, a novel dual inhibitor of CDK4/6 + ARK 5 with potential application across a variety of cancers (Press release, Onconova, APR 19, 2018, View Source [SID1234525549]).

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CDK inhibitors have emerged as promising and potentially targeted large market cancer therapies. ON 123300 has the potential to overcome many of the limitations of current generation CDK4/6 inhibitors. Onconova believes that ON 123300 may act as a single agent, due to the unique targeting of ARK5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors.

Onconova and HanX Biopharmaceuticals, the Company’s Greater China collaboration partner for ON 123300, recently completed the pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (FDA). These discussions provided guidance for the manufacturing of ON 123300 and the pre-clinical development plan for the submission of an IND application.

The data from preclinical studies demonstrates that there is a differential metabolism of ON 123300 in male versus female rodents. As a result, the drug exposure is almost 2-3 fold higher in female rats. Based upon preclinical animal liver microsome studies, this differential effect appears to be limited to rodents, and is not observed in preclinical studies with human liver microsomes. Based on the metabolism data from other species, relevant species have been selected along with the dosing strategy to be implemented in GLP toxicological studies to be conducted by HanX. As a part of the pre-clinical development program, Onconova and HanX announced a collaborative program in December 2017, wherein the remaining IND enabling studies will be funded by and conducted by HanX.

Onconova previously reported that ON 123300 was found to be as active as Palbociclib (Pfizer’s Ibrance) in a preclinical Rb + ve xenograft model. Moreover, the molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib based upon this model.

Ramesh Kumar, President and CEO of Onconova, commented, "At the end of March, we received pre-IND guidance from the FDA, which provides a path towards filing an IND and then starting clinical trials. Our partner, HanX, has initiated GMP manufacturing and will be initiating GLP pre-clinical studies based on the guidance provided by the FDA, and we look forward to advancing ON 123300 into clinical development."

Faming Zhang, Ph.D., founder and Chairman of HanX, commented, "We are pleased to have completed the process chemistry and have initiated GMP manufacturing for ON 123300. GLP toxicology studies are planned and we will be undertaking additional preclinical studies to enhance the profile of this novel compound. In collaboration with Onconova, our goal is to simultaneously file the IND in the USA and China, as soon as possible. Once an IND is in place, HanX plans to initiate Phase 1 studies in China and also participate in more advanced global clinical trials."

A copy of the presentation is available by visiting the Scientific Presentations section of Onconova’s website.