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Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study

On March 26, 2019 Lipella Pharmaceuticals Inc., a clinical stage biopharmaceutical company based in Pittsburgh, PA, reported the investigational new drug (IND) approval for a phase-2a, multi-center, double-blind, placebo-controlled clinical study measuring the safety and efficacy of LP-10 for cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy (Press release, Lipella Pharmaceuticals, MAR 26, 2019, View Source [SID1234534642]).

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Cancer survivorship is becoming an important priority for patients, caregivers and health care providers. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers, in approximately 12% of patients, leads to chronic hemorrhagic cystitis that can be severe and uncontrollable. Certain chemotherapy agents can also cause hemorrhagic cystitis. There are no approved therapies to treat hemorrhagic cystitis, which can severely diminish a patient’s quality of life, and, in some cases lead to death.

LP-10 is a liposomal tacrolimus formulation under development for the treatment of hemorrhagic cystitis, an orphan indication with no currently approved therapies. "The approved protocol allows for dose escalation as well as a lipid vehicle control arm," stated Jonathan Kaufman, PhD, Chief Executive Officer of Lipella. "We are looking forward to the collection of additional human data, as we seek opportunities for future collaboration. Oncology supportive care is an important strategic direction for us, and we are excited to advance our clinical pipeline."

About LP-10

LP-10 is a proprietary product developed for intravesical delivery to hemorrhagic cystitis patients. LP-10 has received US FDA Orphan Designation.

Caution: LP-10 is currently not approved for commercial use in any indication in the United States and is limited by U.S. federal law to investigational use only.

Initial Phase 2 Data From an IMV Clinical Study Continues to Demonstrate DPX-Survivac’s Prior Trend as a Potential Monotherapy Treatment for Advanced Ovarian Cancer

On March 26, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported preliminary data from the phase 2 cohort of the DECIDE clinical study (Press release, IMV, MAR 26, 2019, View Source [SID1234534641]). Six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) have reached the first CT scan assessment with key related findings as follows:

83% of the subjects (5 of 6) show stable disease (SD), including two tumor regressions
80% (4 of 5) with stable disease are in subjects with a lower baseline tumor burden (BTB), which also includes the two tumor regressions
"This initial phase 2 data confirms the earlier trends we saw in the phase 1b portion of the study," said Frederic Ors, Chief Executive Officer. "It supports the potential of DPX-Survivac as a monotherapy and the use of our patient selection strategy. We are encouraged by these early initial results and are committed to advancing this program quickly with the goal of providing an additional treatment option to patients with advanced ovarian cancer."

Importantly, in earlier stages of this trial, durable clinical responses occurred after 140 days, and have now lasted for 20 months or more. Additional data at the 140 day mark of this cohort will be available by the end of the first half of 2019.

This amended phase 2 study evaluates the safety and efficacy of DPX-Survivac monotherapy with mCPA in patients with advanced recurrent ovarian cancer. As of the March 25, 2019 data cut-off date, 13 patients have been enrolled in the phase 2 portion of the trial in addition to the 53 enrolled in the phase 1b cohort. Five patients were randomized into the DPX-Survivac monotherapy cohort. Seven patients had been randomized into DPX-Survivac/mCPA in combination with epacadostat before the phase 2 protocol was amended to stop enrollment in the combination arm. One of the patients in the combination arm elected to switch to the monotherapy arm of the trial. Positive data from the phase 1b portion of the trial led IMV to amend the study to monotherapy in patients with lower tumor burden.

The amended phase 2 cohort of the DECIDE trial is targeting an enrollment of at least additional 16 patients in the population with a lower tumor burden. Enrollment is ongoing at multiple sites in the U.S. and Canada.

Exicure to Present at Spring Investor Summit 2019

On March 26, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CFO, David Snyder, will give a company presentation on Tuesday, April 2, 2019 at 9:30 am ET at the Spring Investor Summit (Press release, Exicure, MAR 26, 2019, View Source [SID1234534640]). The presentation will be made at the Essex House in New York City.

A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

Ichor Medical Systems Announces Collaboration and Research License Agreement with AstraZeneca to Develop DNA-based Monoclonal Antibody Platform

On March 26, 2019 Ichor Medical Systems, Inc. (Ichor) reported that it has entered into a collaboration and research license agreement with AstraZeneca (LSE, SSE, NYSE: AZN) for the development and clinical assessment of plasmid DNA constructs (Press release, Ichor Medical Systems, MAR 26, 2019, View Source [SID1234534639]). The plasmids will encode monoclonal antibodies developed by AstraZeneca and will be delivered using Ichor’s TriGrid Delivery System. Under the terms of the agreement, Ichor will receive upfront and annual payments along with development milestones.

The development and optimization of in vivo expression of DNA-encoded antibodies delivered by the TriGrid is a particularly attractive product strategy in the recombinant monoclonal antibody market. Utilizing this approach, the TriGrid platform works to deliver DNA-encoding monoclonal antibodies directly into a person, after which that person’s own cells can begin to manufacture the antibodies.

"We are very excited to be working alongside AstraZeneca in this burgeoning field. Our goal is ultimately to increase access to antibody therapies for a wide range of disease indications affecting diverse global populations, thereby expanding new patient markets," said Ichor CEO Bob Bernard.

Ichor’s patented TriGrid system uses electroporation, a potent delivery method in which brief electrical pulses are applied to a target tissue to facilitate entry of plasmid DNA into cells, resulting in high expression of genes encoded on the plasmid. The TriGrid has been utilized in numerous clinical studies of prophylactic and therapeutic DNA vaccines. Improved vaccine potency with TriGrid delivery versus conventional injection, as well as induction of antibody and T cell responses, has been demonstrated in humans.

Prometic to report its fourth quarter and 2018 year-end financial results and hold conference call / webcast

On March 26, 2019 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) ("Prometic" or the "Corporation") reported that it will report its financial results for the fourth quarter and year ended December 31, 2018 on Monday April 1, 2019 after market close (Press release, ProMetic Life Sciences, MAR 26, 2019, View Source [SID1234534638]).

Prometic will host a conference call at 11:00am (ET) on Tuesday April 2, 2019. The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available as of Tuesday April 2, 2019 at 2:00pm (ET). The numbers to access the audio replay are 416-849-0833 and 1-855-859-2056 using the following password (3198209).

A live audio webcast of the conference call will be available via: View Source About Prometic Life Sciences Inc.