Saniona participates in formation of Scandion Oncology and spins out clinical program and related ion channel platform

On May 3, 2017 Saniona, a leading biotech company in the field of ion channels, reported that it has partici-pated in formation of Scandion Oncology A/S, a company focused on developing drugs for treatment of cancer. (Press release, Saniona, MAY 3, 2017, View Source [SID1234573560]). Saniona AB owns 51% of Scandion Oncology, which has subsequently acquired a clinical candidate and related platform from Saniona A/S. Scandion Oncology management and Saniona is currently considering various alternatives for financing the company including a private placement and a public listing, which may potentially include the distribution of Saniona’s shares in Scandion Oncology to Saniona’s shareholders in accordance to Lex ASEA under the Swedish income tax act.

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"The founders of Scandion Oncology have discovered that one of Saniona’s development compounds (termed SCO101) is able to reduce cancer growth by increasing the effects of standard chemotherapy through a new mode of action. The founders of Scandion Oncology and Saniona have filed a patent application covering this invention. By combining the invention with the knowledge of the Scandion Oncology Founders and the technology from Saniona, we can create a new interesting company to the benefit of cancer patients and Saniona’s shareholders," says Jørgen Drejer, CEO of Saniona.

"Scandion Oncology will be able to initiate Phase 2 clinical trials within a relatively short time frame and thereby provide proof of concept for the technology, which addresses one of the most important problems in modern oncology. With approximately 14 million new cancer cases worldwide annually, the business potential for an effective new drug, which improve the efficacy of standard chemotherapy is expected to reach that of a blockbuster," says Kim Arvid Nielsen, CEO of Scandion Oncology.

The program, which Scandion Oncology acquires from Saniona, comprises a development compound, SCO101, which has been evaluated in Phase 1 studies and a platform comprising a large series of chemical analogues as well as associated know-how. Saniona acquired these assets from NeuroSearch in 2012. Saniona was not planning to develop these assets internally since a clinical program in a different therapeutic indication was not successful. In 2015, Saniona granted scientists at the University of Copenhagen, Denmark, rights to test some of the compounds in their screening systems leading to the discovery that compounds with this mechanism of action enhance the effect of standard chemotherapy. The parties filed a patent and have subsequently been awarded a grant from Innovation Fund Denmark. Apart from mentioning the grant in a press release on July 5, 2016, Saniona has not discussed these assets publicly previously.

For clarity, the founders, management and the other shareholders of Scandion Oncology are independent of Saniona’s board, management and major shareholders of Saniona.

10-Q – Quarterly report [Sections 13 or 15(d)]

Altimmune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Altimmune, 2017, MAY 3, 2017, View Source [SID1234521236]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Pipeline Review Check

Preclincal investigations are ongoing in combining BI1361849/CV9202 with checkpoint inhibitor or PD1 after chemo-radiation in NSCLC (Company Pipeline, CureVac, MAY 2, 2017, View Source [SID1234518776]).

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ZIOPHARM Oncology Announces FDA Acceptance of IND for CD33-Specific CAR-T Cell Therapy Targeting Relapsed/Refractory Acute Myeloid Leukemia

On May 2, 2017 ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on new immunotherapies, reported that an investigator-initiated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 trial infusing the Company’s CD33-specific CAR+ T therapy for relapsed or refractory acute myeloid leukemia (AML) is now active, with the first patient to be enrolled in the study expected to begin treatment in the third quarter of 2017 (Press release, Ziopharm, MAY 2, 2017, View Source [SID1234518785]). The CD33-specific CAR+ T cells incorporate a kill switch designed to eliminate the modified T cells under potential adverse safety conditions.

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"Relapsed AML is an aggressive disease with very poor outcomes," said William G. Wierda, M.D., Ph.D., Professor and Center Medical Director, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and principal investigator for the CD33 study. "In vivo preclinical animal studies have demonstrated that these CAR-T cells targeting CD33 exhibit specific killing of AML cells, eliminating disease burden, and significantly enhancing survival compared to controls, and I look forward to evaluating the safety and effectiveness of this gene therapy for patients with AML."

Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM added, "CAR-T cells expressing CD33 have shown promise in preclinical studies, but to-date, there has been limited experience in humans, representing a significant white space for us in treating AML. We look forward to seeing the positive preclinical results with our CD33-specific CAR-T cells translate to the clinic for relapsed/refractory AML patients who have far too few treatment options. In parallel with this Phase 1 study, we have also begun preclinical studies to evaluate rapid non-viral manufacturing of CAR+ T CD33-specific therapy for treatment of AML under point-of-care."

AML is a rapidly progressing cancer of the blood and bone marrow characterized by uncontrolled proliferation of immature blast cells with multiple associated gene mutations. The American Cancer Society estimates that there were approximately 20,000 new cases of AML and over 10,000 patient deaths from AML in the United States in 2016. A majority of AML patients relapse or present with refractory disease and have overall poor prognosis.
This will be the second CAR target for genetically modified T cells to be studied at The University of Texas MD Anderson Cancer Center under the research and development agreement among ZIOPHARM, Intrexon Corporation (NYSE:XON), and MD Anderson.