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 Oasmia reported that the Private Placement has enabled Oasmia to place 26 new convertible instruments with a limited group of investors at a nominal value of SEK 1,000,000 per convertible instrument through an accelerated book building procedure (Press release, Oasmia, APR 19, 2018, View Source [SID1234556570]).

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The convertible loan is issued with the purpose of replacing the Company’s financing under the Company’s convertible loan 2017:2 in the total amount of MSEK 26, which fell due for payment 18 April 2018. The fallen due loan amount under the Company’s convertible loan 2017:2 will be paid to the convertible loan holders in May 2018 and the fallen due interest was paid in April 2018.

In order to enable the placement, the Board of Directors of Oasmia has, by virtue of the authorisation granted by the Annual General Meeting held on 25 September, 2017, resolved on a directed issue of a new convertible loan in the amount of SEK 26,000,000. The convertible instruments have been subscribed at 100 per cent of the nominal amount and the convertible loan bear an interest rate of 8 per cent per year. The conversion rate is based on the closing price of Oasmia’s shares on Nasdaq Stockholm on 18 April 2018 with premium and will amount to SEK 4.90. The term of the loan is approximately one year with a maturity date on 22 April 2019 if not converted to shares earlier. The terms of the convertible instruments are based on an accelerated book building procedure on 18 April 2018 and the Board of Directors has thereby ensured that the terms of the convertible instruments corresponds to fair market standards.

If the convertible loan is fully converted into shares, the number of shares in Oasmia increases by 5,306,122 from 176,406,372 to 181,712,494 and the share capital increases by SEK 530,612.20 from SEK 17,640,637.20 to SEK 18,171,249.40. In the event of a full conversion into shares, the dilution effect will amount to approximately 2.9 per cent.

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 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp. (NEEQ: 430187), a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported they have entered into a license agreement providing ApolloBio with an exclusive license to develop and commercialize Toca 511 & Toca FC within the greater China region, including mainland China, Hong Kong, Macao and Taiwan (Press release, Tocagen, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343446 [SID1234525579]).

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Toca 511 & Toca FC is a cancer-selective immunotherapy currently under evaluation in an international Phase 3 trial, called Toca 5, for patients with recurrent high grade glioma (HGG), a type of brain tumor. The product candidate has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).

Under the terms of the agreement, ApolloBio will make an upfront payment of $16 million to Tocagen, plus potential payments of $4 million in near-term development milestones, including completion of enrollment in the Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, low double-digit tiered royalty payments will be made based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China’s recent regulatory changes supporting the development of new medicines," said Marty Duvall, chief executive officer of Tocagen. "ApolloBio brings valuable regional expertise in product development, regulation and healthcare access, positioning our lead product to advance towards patients in the greater China region as quickly and efficiently as possible."

The total number of new diagnoses of HGG expected in 2018 is about 180,000 worldwide and about 47,000 in the greater China region. Standard treatment for newly diagnosed HGG includes safe surgical removal of as much of the tumor as possible, followed by radiation therapy and chemotherapy. However, HGG recurs in most patients even after maximal treatment and there are currently very few treatment options available.

"We are committed to accelerating the availability of novel immuno-oncology treatments to patients with high unmet medical needs in the greater China region," said Dr. Weiping Yang, chief executive officer of ApolloBio. "Toca 511 & Toca FC is a highly promising, best-in-class cancer-selective immunotherapy and we look forward to working with Tocagen to advance this innovative late-stage product towards commercialization."

The license grant to ApolloBio is subject to the satisfaction of customary conditions and is expected to become effective in the second quarter of 2018. For more details, please refer to the corresponding Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

On April 19, 2018 Alkermes plc (NASDAQ: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Apr. 26, 2018, to discuss the company’s first quarter 2018 financial results (Press release, Alkermes, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343568 [SID1234525541]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Apr. 26, 2018, through 5:00 p.m. ET (10:00 p.m. BST) on Thursday, May 3, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.