On October 18, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the stage 1 of the Phase 2 study evaluating the combination therapy of its cancer immunotherapy, CV301, and Roches’s checkpoint inhibitor, atezolizumab (TECENTRIQ), for the treatment of patients with locally advanced or metastatic urothelial bladder cancer did not meet the efficacy threshold to progress into stage 2 with expanded enrollment (Press release, Bavarian Nordic, OCT 18, 2019, View Source [SID1234542361]). No serious adverse events were observed in the study to date.

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In the first stage of the trial, 27 patients were enrolled into two cohorts: the first cohort was first-line treatment of patients (n=14) with urothelial bladder cancer who were not eligible for cisplatin-containing chemotherapy; and cohort 2 was a second-line treatment of patients (n=13) who had previously been treated with cisplatin-based chemotherapies. Despite the detection of clinical efficacy in a number of patients, neither cohort met the pre-defined criteria for clinical efficacy to expand enrollment into the second stage of the trial.

The study was sponsored by Bavarian Nordic, and two other, investigator-sponsored Phase 2 trials evaluating CV301 in combination with checkpoint inhibitors, are still ongoing in colorectal and pancreatic cancer. Bavarian Nordic will continue to follow and support these ongoing trials, while the Company’s primary focus and resources will be directed towards BN-Brachyury and the new immuno-oncology strategy involving intravenous and intratumoral administration as well as new and more advanced constructs.

The Company’s novel vaccine candidate, BN-Brachyury, is currently being evaluated in a Phase 2 trial in patients with advanced chordoma. This trial, which also uses a two-stage design, indicated clinical activity in the first stage, allowing for expansion of enrollment, which was recently completed. Conclusive data from this study are expected within 12 months. Another trial of BN-Brachyury administered intravenously is planned and will initiate shortly.

"We have diversified our immuno-oncology strategy over the past years, which is reflected in smaller studies seeking to evaluate different aspects of our technology. While the results of this study are disappointing, they contribute to our overall understanding of our platform and provide important learnings to refine our approach to equip the body’s immune system with more weapons to fight cancer from within," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

On October 18, 2019 Kitov Pharma Ltd is presented the corporate Presentation (Presentation, Kitov Pharmaceuticals , OCT 18, 2019, View Source [SID1234542360]).

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On October 18, 2019 INNATE PHARMA S.A. (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq Global Select Market: IPHA) ("Innate" or the "Company"), a French biotechnology company focused on discovering, developing and commercializing first-in-class therapeutic antibodies designed to harness the immune system for the treatment of oncology indications with significant unmet medical need, reported that the underwriters of its global offering of an aggregate of 12,500,000 new ordinary shares, comprising an offer of 8,047,227 ordinary shares in the form of American Depositary Shares ("ADSs"), each representing one ordinary share, and a concurrent private placement of 4,452,773 ordinary shares in Europe (including France) and other countries outside of the United States (the "Global Offering"), have exercised in full their option to purchase up to 1,875,000 additional ADSs (Press release, Innate Pharma, OCT 18, 2019, View Source [SID1234542359]). The additional ADSs will be delivered concurrently with the closing of the Global Offering.

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As a result, the total number of ordinary shares and ADSs issued in the Global Offering amounts to 14,375,000 ordinary shares, including 9,922,227 in the form of ADSs, bringing the gross proceeds of the Global Offering to approximately $79.1 million (€71.4 million)*.

Citigroup Global Markets Inc., acting as the stabilizing agent on its own behalf and on behalf of the other underwriters, reported that no stabilization activities had been carried out. The period during which stabilization activities could be carried out is now closed.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On October 18, 2019 Immunomic Therapeutics, Inc. reported that it will present data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice (Press release, Immunomic Therapeutics, OCT 18, 2019, View Source [SID1234542358]). UNITE fuses a tumor-associated antigen, in this case a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPyV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the First International Symposium on Merkel Cell Carcinoma in Tampa, Florida.

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"ITI-3000 is an innovative and novel targeted approach to a MCPyV vaccine," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by this data and look forward to continuing to advance ITI-3000 toward the clinic."

The majority of Merkel cell carcinomas (MCC) are associated with MCPyV infection, making LT an attractive target for therapeutic cancer vaccines. MCPyV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their migratory capacity. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Hence, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPyV-LT may drive robust anti-tumor immune responses.

Poster Title: Lysosomal-associated membrane protein-1-targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses

Poster Session Date and Time: Monday, October 21, 2019 11:15 am–12:45 pm

Location: Moffitt Cancer Center, Stabile Research Building, 12902 USF Magnolia Drive
Tampa, Florida

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On October 18, 2019 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, November 1, 2019 to discuss its third quarter operating results (Press release, ImmunoGen, OCT 18, 2019, View Source [SID1234542357]). Management will also provide a brief update on the business.

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CONFERENCE CALL INFORMATION
To access the live call by phone, dial (877) 621-5803; the conference ID is 8865657. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.