On March 16, 2017 Provecs Medical GmbH, a cancer immunotherapy company developing novel treatments to modulate the tumor microenvironment, reported the closing of a partnership with oncology pharma company Medac Gesellschaft für klinische Spezialpräparate mbH (Press release, Provecs Medical, MAR 16, 2017, View Source [SID1234571468]). The partners aim to develop, manufacture and market Provec’s cancer immunotherapy lead product Immunalon for the treatment of urinary bladder cancer. Immunalon is being developed for the treatment of a wide range of solid cancers, including urinary bladder cancer. Financial details were not disclosed.

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The collaboration combines Medac´s marketing expertise in oncology and hematology with Provecs´ development know-how, which is based on its proprietary ENVIRO technology platform for innovative immunotherapeutics.

ENVIRO is a unique, patented adenoviral platform for the targeted delivery of up to four biologicals combined in one product to the tumor site. This multivalent approach is designed to reprogram the barriers between the immune system and cancer by addressing up to four immune checkpoints simultaneously. Immunalon is Provecs Medical´s lead compound based on ENVIRO.

"It is known today that the activation and inhibition of immune cells is regulated by a wealth of molecules called checkpoint molecules," said Dr. Frank Schnieders, CEO of Provecs Medical. "Tumors establish control over checkpoints to deactivate immune cells directed against the cancer. We also know that blocking these inhibitory checkpoint molecules partially restores the immune system’s ability to control and sometimes eliminate cancer cells. Existing treatments are directed against single checkpoints only and therefore show limited efficacy. We are convinced that addressing up to four checkpoints with our ENVIRO approach makes it much more difficult for tumor cells to escape elimination."

Provecs achieved ex-vivo proof-of-concept for Immunalon using its EXVIRO platform, a unique primary cancer tissue platform for ex-vivo therapy simulation as well as pharmacodynamics and pharmacokinetics studies. This 3D tissue culture system uses patient-derived human cancer tissues to study the tumor microenvironment in its spatial context without disrupting the cellular relationships. Provecs is now developing a first-in-man study concept for Immunalon in a second indication.

"We are seeking partners for the development of Immunalon in other solid cancer indications with high medical need and a lack of standard therapies," Schnieders added.

Titan Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Mannkind has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Mannkind, 2017, MAR 16, 2017, View Source [SID1234521750]).

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XBiotech has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, XBiotech, 2017, MAR 16, 2017, View Source [SID1234521576]).

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On March 16, 2017 Mast Therapeutics, Inc. (NYSE MKT: MSTX) reported it has set a date for a special meeting of its stockholders to vote on matters related to the proposed merger with Savara Inc. (Savara), a privately-held, clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases (Press release, Mast Therapeutics, MAR 16, 2017, View Source [SID1234518206]).

The special meeting will be held at 9:00 a.m., local time, on April 21, 2017 at 3611 Valley Centre Drive, Suite 500, San Diego, California 92130. Mast’s stockholders of record as of the close of business on March 13, 2017 are entitled to receive notice of, and to vote at, the special meeting.

The merger has been unanimously approved by the boards of directors of both companies and the board of directors of Mast unanimously recommends that its stockholders vote "FOR" the special meeting proposals described in the proxy statement/prospectus/information statement declared effective by the Securities and Exchange Commission on March 15, 2017, a copy of which will be provided to Mast stockholders of record as of March 13, 2017. The proposed merger is expected to close promptly after the Mast special meeting scheduled for April 21, 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of the other closing conditions in the merger agreement between the companies.

The combined company would advance a pipeline of novel inhalation therapies for the treatment of diseases with significant unmet medical needs, featuring three product candidates, each in advanced stages of clinical development:

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AeroVanc, an inhaled dry-powder vancomycin to treat chronic methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in cystic fibrosis (CF) in preparation for a pivotal Phase 3 study;

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Molgradex, an inhaled nebulized GM-CSF to treat pulmonary alveolar proteinosis (PAP) currently in Phase 2/3 development; and

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AIR001, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction (HFpEF) currently in Phase 2 development.

Select Anticipated Upcoming Development Milestones

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Closing of proposed merger in Q2/2017.

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Initiate a pivotal Phase 3 study of AeroVanc in Q3/2017.

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Complete negotiations with the U.S. Food and Drug Administration (FDA) on the requirements for a pivotal clinical study of Molgradex in the U.S. in Q3/2017.

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Announce strategy related to Molgradex program expansion for the treatment of a rare lung infection in 2017.

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Announce top-line results from Phase 2/3 study of Molgradex, expected to be registration-enabling for the treatment of PAP in Europe and Japan, in Q1/2018.

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Announce results from ongoing Phase 2 study of AIR001 for the treatment of HFpEF being conducted by the Heart Failure Clinical Research Network in Q1/2018.

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