IMV to Provide Updated Clinical Data at 2019 ASCO Annual Meeting on Lead Candidate DPX-Survivac in Ovarian Cancer and Other Solid Tumors

On April 18, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that two of its abstracts have been accepted for presentation at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which takes place May 31 – June 4 in Chicago, IL (Press release, IMV, APR 18, 2019, View Source [SID1234535206]).

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"Despite advances in other cancer treatment regimens, ovarian cancer remains a particularly difficult-to-treat disease, and one that represents one of the most underserved areas of the treatment landscape," said Frederic Ors, Chief Executive Officer at IMV. "Our presentations at ASCO (Free ASCO Whitepaper) will allow us to update this important scientific audience on the potential of DPX-Survivac monotherapy and on the progress we have made since our groundbreaking ASCO (Free ASCO Whitepaper) 2018 presentation."

Presentation details are as follows:

Poster Title: "DPX-Survivac and intermittent low-dose cyclophosphamide (CPA) with or without epacadostat (E) in the treatment of subjects with advanced recurrent epithelial ovarian cancer (DeCidE1 trial): T cell responses and tumor infiltration correlate with tumor regression."
Abstract Number: 5576
Session Title: Gynecologic Cancer
Date and Time: June 1, 2019, 1:15 – 4:15 p.m. CT

Poster Title: "Early response assessment through multiparametric MRI based endpoints in a phase II multicenter study evaluating the efficacy of DPX-Survivac, intermittent low dose cyclophosphamide (CPA) and pembrolizumab combination study in subjects with solid tumors."
Abstract Number: e14245
Session Title: online publication only on May 15, 2019, 5:00 p.m. ET

ASCO will publish the official abstracts on its meeting website in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting at 5:00 p.m. ET on May 15. The cut-off date for inclusion of data in the abstract was February 12, 2019. The final conference presentation will include additional data collected between the abstract submission cutoff and the presentation itself.

Obsidian Therapeutics Announces Leadership Transition and Appoints Paul K. Wotton, Ph.D., as Chief Executive Officer

On April 18, 2019 Obsidian Therapeutics, a biotechnology company developing cell-based therapeutics with controllable operating systems, reported the appointment of Paul K. Wotton, Ph.D., as Chief Executive Officer (Press release, Obsidian Therapeutics, APR 18, 2019, View Source [SID1234535205]). He succeeds Michael Gilman, Ph.D., who will focus on Arrakis Therapeutics and continue to serve on Obsidian’s Board of Directors .

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"I am thrilled that we are able to bring an outstanding leader like Paul to Obsidian," said Dr. Gilman. "Paul’s substantial experience, his strategic business savvy, together with his in-depth of knowledge of cell and gene therapies make him a natural choice to lead the Obsidian team and advance its next generation cell and gene therapies into the clinic."

Dr. Wotton brings significant global biotechnology and pharmaceutical industry leadership experience spanning scientific research, product development and corporate growth gained over a thirty-year career. Dr. Wotton most recently served as the Founding President and CEO of Sigilon Therapeutics, Inc. Prior to Sigilon, Dr. Wotton served as President and Chief Executive Officer of Ocata Therapeutics until its acquisition by Astellas Pharma where he was also Co-Chairman of the Office of Integration. In previous roles, he served as President and Chief Executive Officer of Antares Pharma as well as Chief Executive Officer of Topigen Pharmaceuticals. Dr. Wotton is a named inventor on numerous patents and was the Ernst & Young Entrepreneur of the Year Regional (NJ) Winner Life Sciences in 2014. He serves on the Boards of Directors of Vericel Corporation (NASDAQ: VCEL), Veloxis Pharmaceuticals A/S (Copenhagen: VELO) and Cynata Therapeutics (ASX: CYP).

"We welcome Paul to lead Obsidian through its next phase of growth," said Peter Barrett, Ph.D., Chairman of the Board of Obsidian and Partner at Atlas Venture. "His deep experience in managing platform growth opportunities will be invaluable in building Obsidian to its full potential. The Board would also like to thank Mike Gilman for leading Obsidian’s significant progress to date and building a strong company foundation."

"I am excited to be joining Obsidian Therapeutics at a pivotal time for the company," said Dr. Wotton. "Mike and the team have built a world-class organization, executed on a strategic transformative partnership, and established Obsidian’s technology as the premier synthetic biology platform for regulating gene and cell-based therapeutics. It is clear that Obsidian is well positioned for future growth, and I look forward to working with the Board and the team to execute on our shared vision and advance this breakthrough technology rapidly to improve therapeutic outcomes substantially for many patients with life-threatening diseases, including cancer."

MATEON ENTERS INTO MERGER AGREEMENT WITH ONCOTELIC

On April 18, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) and Oncotelic Inc., a privately-held, late clinical-stage cancer immunotherapy company, reported that they have entered into a definitive agreement with respect to a merger, creating a publicly traded immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma (Press release, Mateon Therapeutics, APR 18, 2019, View Source [SID1234535204]).

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"We believe that the merger of Oncotelic and Mateon will create a combined company that can generate shareholder value through a promising pipeline of next generation immunotherapies targeting several significant cancer markets where there is a paucity of therapeutic options and lack of an effective immunotherapy protocol," said Vuong Trieu, Ph.D., Co-Founder, Chairman and Chief Executive Officer of Oncotelic. "We chose Mateon due to the synergies between the two organizations’ pipelines, including the natural synergy of Mateon’s CA4P necrotic cell death product candidate and Oncotelic’s proprietary self-immunization protocol (SIP) platform, particularly our TGF-β inhibitor OT-101."

"Our priority has been to continue our mission to help patients and to provide meaningful value to our stockholders," said William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "After a review of their pipeline, and a thorough consideration of potential strategic alternatives, we have concluded that a merger with Oncotelic, which has multiple late clinical-stage product candidates in areas of unmet medical need, offers our best opportunity to create such value. I look forward to completing this merger expeditiously and working with the full Oncotelic team as clinical trial milestones occur in 2019 and beyond."

SIP Platform

Oncotelic’s SIP Platform is based on novel and proprietary sequential treatment of cancers with OT-101, an antisense against TGF-β2 combined sequentially with widely used chemotherapies. This sequential treatment has resulted in many instances in patients’ self-immunization against their own tumors, resulting in robust response and survival. In some cases, this was curative. The use of OT-101 has lifted the immunosuppression in local tumor environment allowing for effective initial priming of the immune response. The subsequent chemotherapy-released neoantigens have served as a boost to bolster the immune system against the tumors. Judicious placement of immune expanders such as IL-2 and/or checkpoint inhibitors within the immunization protocol is expected to have dramatic impact on survival.

Growing Product Pipeline

Oncotelic is developing OT-101 in combination with chemotherapy for the treatment of gliomas and pancreatic cancers. Oncotelic plans to initiate several Phase 3 registration trials for OT-101 in multiple cancer indications, including gliomas and pancreatic cancers.

During phase 2 clinical trials in gliomas (Study G004) and pancreatic cancer, melanoma, and colorectal cancers (Study P001), meaningful clinical benefits were observed with favorable safety profiles. These clinical benefits included long term survival as well as tumor reduction. These findings have been presented at recent scientific conferences recently and are available for viewing at www.oncotelic.com.

Merger Terms

In the transaction, Mateon will issue 41,000,033 shares of common stock and 193,713 shares of newly designated Series A preferred stock to Oncotelic shareholders. Each share of Series A preferred stock will be convertible into 1,000 shares of common stock, and will be automatically converted into common stock following stockholder approval of additional authorized shares of common stock or a reverse split. Assuming the conversion of all preferred shares, current Oncotelic stockholders would own 85% of the combined company, and current Mateon stockholders will own 15%.

In addition to their ownership position in the newly combined company, Mateon stockholders of record as of the business day immediately preceding the closing date of the merger will receive a contingent value right (CVR) related to Mateon’s drug candidates OXi4503 and CA4P. CVR holders are entitled to receive 75% of the net proceeds in excess of $0.5 million from a sale of assets relating to these two drug candidates for a four-year period following the merger. The CVRs will not be registered to trade on any stock exchange, and new discoveries related to these drug candidates are not subject to payment obligations under the CVR.

The merger is subject to customary conditions to closing including the approval by Oncotelic’s shareholders. Approval is expected within one business day, and the merger is expected to close on or about April 22, 2019.

In connection with the merger agreement, the company has entered into a series of bridge financing agreements for the issuance of debentures with a face amount of up to $1.2 million. The first tranche of convertible debentures with a face value of $600,000 is expected to fund shortly following the closing of the merger. A second tranche of convertible debentures, also aggregating $600,000, is available if requested by the company. The debentures will be issued at a discount of 10% and convertible into common stock at a fixed price of $0.10 per share for six months, if not repaid by the company. The company can repay the debentures in accordance with a sliding schedule of premiums over a six month period, after which the debentures are convertible into common stock at a discount to the stock price at the time of conversion.

Management Team

Following the close of the merger transaction, the management team will be comprised of

Chief Executive Officer – Vuong Trieu, PhD, Co-Founder, Chairman, CEO of Oncotelic
Chief Medical Officer – Fatih Uckun, MD, PhD
Chief Technology Officer – Chulho Park, PhD, Co-Founder and Chief Business Officer of Oncotelic
Chief Financial Officer – Matthew M. Loar, currently Chief Financial Officer of Mateon.
Board of Directors

At the close of the merger, the board of directors will consist of Vuong Trieu, PhD, Co-Founder, Chairman, CEO of Oncotelic and William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon.

Following a requisite period of notice to stockholders, additional directors will include:

Steve King, formerly CEO of Peregrine and its subsidiary Avid Bioservices for over 15 years during which time the company advanced its lead compound though phase 3 development while growing annual revenues to over $55M
Anthony Maida MBA PhD, Audit chair at three Nasdaq listed companies. Dr. Maida has been involved in the clinical development of immunotherapy for 27+ years at various C levels.

4SC provides Q1 2019 update

On April 18, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the Q1 Announcement 2019, presenting all material developments up to 31 March 2019 and the Company’s current outlook (Press release, 4SC, APR 18, 2019, View Source [SID1234535203]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continued to deliver on its targets in the first quarter of 2019, moving our products through clinical trials and towards market approval. In particular, the SENSITIZE and EMERGE studies of domatinostat are progressing well and we expect data read-outs for both during the course of this year. Both studies are expected to provide the foundation for clinical trials in the aggressive rare skin cancer Merkel cell carcinoma (MCC). Furthermore, we have recruited more than two-thirds of patients in the pivotal RESMAIN study of resminostat in the rare cancer cutaneous T-cell lymphoma (CTCL), with positive safety outcomes so far, and expect top-line data in the first half of 2020."

Key highlights in Q1 2019 and beyond

More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage CTCL; positive safety outcomes to date.
Started third dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma.
Started investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors.
Dynavax Technologies Corporation (Dynavax) presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) on the combination of orally available domatinostat with Dynavax’s intra-tumoral TLR9 agonist SD-101. Dynavax also compared domatinostat to other class‑I-selective HDAC inhibitors, with domatinostat demonstrating the most significant benefit in combination with SD‑101.
A clinical cooperation partner presented preclinical data at the AACR (Free AACR Whitepaper) that confirmed domatinostat’s mode of action in the aggressive skin cancer Merkel cell carcinoma.
As part of the agreement concluded in September 2016 to sell 4SC’s non-core immunology portfolio, 4SC now became a small shareholder of Immunic Inc. (NASDAQ: IMUX) and continues to be entitled to receive royalties.
Business outlook

Top-line data of the pivotal RESMAIN study expected in H1 2020.
Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
SENSITIZE study expected to complete in H1 2019.
Safety data of EMERGE expected in Q3 2019 and early efficacy data in Q4 2019.
Expand development for domatinostat and initiate clinical trials in MCC.
Development of cash balance in Q1 2019 and financial forecast

As of 31 March 2019, 4SC holds cash balance/funds of €21.2 million as compared to €25.0 million as of 31 December 2018. The monthly use of cash from operations amounted to €1.263 million on average in the first quarter of 2019 (Q1 2018: €1.812 million) and was below the range of €1.4 million and €1.6 million forecast for 2019.

The decrease in the monthly use of cash as compared to Q1 2018, and the decrease in cash balance/funds in the first quarter of 2019 as compared to the end of 2018, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE.

The Management Board of 4SC believes that these funds should be sufficient to finance 4SC into Q2 2020.

Ligand to Report First Quarter 2019 Results on May 2nd

On April 18, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported plans to report first quarter 2019 financial results on May 2, 2019 (Press release, Ligand, APR 18, 2019, View Source [SID1234535198]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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First Quarter 2019 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates
When: Thursday, May 2, 2019
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 6375579

Webcast:

Live conference call webcast and replay accessible at www.ligand.com