On June 17, 2019 Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors (Press release, Boehringer Ingelheim, JUN 17, 2019, View Source [SID1234537108]). The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor.

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"We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes for patients with difficult-to-treat cancers," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim.

"We are excited to begin first-in-human testing with this novel SIRPα-targeting compound, which we believe has first-in-class potential in the treatment of solid tumors," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. "This marks one of many anticipated milestones in the collaboration agreement with our partner Boehringer Ingelheim, and we look forward to advancing rapidly this potentially transformative treatment through the clinic. Milestones such as this one for the novel compounds our R&D teams develop have provided OSE with a stable financial base to grow steadily our first-in-class immuno-oncology pipeline."

The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. Under the terms of the collaboration and license agreement, the clinical trial authorization obtained in March 2019 and dosing of the first patient in this Phase 1 trial triggers milestone payments of a total of €15 million to OSE Immunotherapeutics from Boehringer Ingelheim. This trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumours.

ABOUT BI 765063 (formerly OSE-172)
BI 765063 is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα. BI 765063 prevents the SIRPα ligand CD47, from binding to SIRPα thereby preventing cellular signalling that can reduce the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells. In March 2019, OSE Immunotherapeutics received Clinical Trial Authorization for a Phase 1 study by two health agencies (France and Belgium) to evaluate BI 765063 in patients with advanced solid tumors. The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, originally signed in April 2018.

On June 17, 2019 Candel Therapeutics (a.k.a. Advantagene, Inc.) reported that it has completed enrollment of the "ULYSSES" trial, a Phase 2 study of ProstAtak for prostate cancer patients choosing Active Surveillance (PrTK04- NCT02768363) (Press release, Candel Therapeutics, JUN 17, 2019, View Source [SID1234537124]). Enrollment is still open for prostate cancer patients choosing radiation therapy as their primary treatment (PrTK03- NCT01436968). ProstAtak is Gene Mediated Cytotoxic Immunotherapy (GMCI – aglatimagene besadenovec (AdV-tk) plus oral valacyclovir) for treatment of prostate cancer. GMCI is an "off the shelf", low-toxicity immunotherapy that stimulates a patient’s own immune system to generate a robust and precise response against their cancer.

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In the USA, about 175,000 men are diagnosed with localized prostate cancer each year. Approximately one third of these patients choose Active Surveillance (AS), a strategy to monitor rather than radically treat their disease. If the disease progresses, radical surgery or radiation are still options. AS is chosen primarily to avoid or postpone the significant risk of urinary incontinence and sexual dysfunction often associated with radical treatments. The number of patients on AS has been steadily increasing over the past 5 years.

The ULYSSES study enrolled 190 patients at 22 clinical sites. The size of the study was expanded from an originally planned 156 patients due to investigator and patient demand. The primary endpoint for the trial is change in tumor-risk markers such as tumor grade and extent of disease. Other endpoints of interest include time to radical treatment and safety. Topline data is expected late next year.

"Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy," said Dr. Scott Eggener, Professor of Surgery and Radiology and Director of the Prostate Cancer Program at University of Chicago and a lead investigator in the Ulysses study. "It would be very exciting if there was an easily delivered and safe intervention that significantly lowers the likelihood of these men ever requiring surgery or radiation."

Candel is also conducting PrTK03, a registration trial with ProstAtak for the treatment of intermediate-high risk localized prostate cancer patients undergoing radiation under a Special Protocol Assessment approved by the U.S. Food and Drug Administration. If proven efficacious, ProstAtak will be the first and only therapeutic pharmaceutical available for newly diagnosed prostate cancer. The company is conducting additional GMCI clinical studies in pancreas, lung, and brain cancers with impressive clinical results to date.

"We are thrilled with the progress of the Ulysses study," stated Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel, "we are grateful to the patients and doctors that are participating and are very hopeful that their efforts will result in better outcomes for future cancer patients. With side effects similar to those of a flu shot, ProstAtak could one day become a first-line ‘Pro-Active Surveillance’ option for the thousands of men diagnosed with low-risk prostate cancer every year."

On June 17, 2019 BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported that the first-in-human Phase I/IIa study with DuoBody-PD-L1x4-1BB has been initiated (Press release, BioNTech, JUN 17, 2019, View Source [SID1234537109]). DuoBody PD-L1x4-1BB is a bispecific antibody in joint development with Genmab A/S, which is being studied in patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy. DuoBody-PD-L1x4-1BB is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic. The objective of the collaboration, signed in 2015 and expanded in 2016 to include additional targets and technologies, is to develop and commercialize multiple novel bispecific antibodies with superior in vivo efficacy that specifically activate the immune system against cancer cells.

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"The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab," said Prof. Ugur Sahin, CEO of BioNTech. "DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment options to our overall cancer pipeline. It also serves BioNTech’s strategy of exploiting novel targets and mechanisms to harness the full potential of the immune system for cancer immunotherapy."

DuoBody-PD-L1x4-1BB is a novel bispecific antibody that combines checkpoint blockade of the inhibitory PD-1:PD-L1 signaling axis with conditional stimulation of T cells by activation of the 4-1BB receptor, thereby enhancing the proliferation of activated T cells to efficiently target cancer cells. The original idea and concept for this approach to combine immune-brake removing (PD-L1) and acceleration properties (4-1BB) to combat cancer are based on research conducted at BioNTech. The open-label safety trial of DuoBody-PD-L1x4-1BB (ClinicalTrials.gov Identifier NCT03917381) consists of two parts: a dose escalation part (Phase I, first-in-human) and an expansion part (Phase IIa). As primary endpoint, the multi-center trial will foremost assess safety including dose limiting toxicity and adverse events.

On June 17, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the presentation of preclinical data for TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, highlighting the synergistic effect of TG-1801 in combination with ublituximab, the Company’s anti-CD20 monoclonal antibody and umbralisib, the Company’s PI3K-delta inhibitor (Press release, TG Therapeutics, JUN 17, 2019, View Source [SID1234537110]). These data were presented over the weekend at the 24thEuropean Hematology Association (EHA) (Free EHA Whitepaper) annual congress held in Amsterdam, The Netherlands.

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Highlights from this poster presentation include:

Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

TG-1801 is a first-in-class anti-CD47-CD19 bispecific antibody that selectively targets CD47 on CD19+ B-cells, sparing red blood cells and platelets, and blocking the CD47-SIRPα macrophage checkpoint on mature B cells
Ublituximab exerts stronger ADCP and ADCC activity in B-NHL cells when compared to rituximab, and TG-1801 increased the ADCC and ADCP activities initiated by both ublituximab and the U2 combination
The triple combination of TG-1801 + U2 was found to regulate genes related to cell architecture
TG-1801 triggers synergistic tumor growth inhibition and results in prolonged remission when added to U2 in an in vivo Raji lymphoma model, which appears to be mediated by increased infiltration of immune effector cells
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "TG-1801 is a first-in-class anti-CD47/CD19 bispecific antibody targeting the ‘don’t eat me’ self-defense signal that protects cancer cells from the immune system. This agent is designed to target CD19 expressing cells to avoid off-target CD47 toxicity, representing a novel immunological therapeutic strategy with potential for synergistic or complimentary activity with our current pipeline." Mr. Weiss continued, "We are excited by the preclinical data presented today for TG-1801. The synergistic effects of TG-1801 in combination with U2 are encouraging and we look forward to evaluating TG-1801 as a single agent in our on-going TG-1801 Phase 1 clinical study and as soon as possible in combination with U2 and our other pipeline drug candidates. TG is committed to improving the outcome of patients with B-cell malignancies through combination therapy and we believe TG-1801 may play an important role in that effort."

PRESENTATION DETAILS:

The above referenced presentation is available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

On June 17, 2019 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) reported that it will offer up to $12 Million of its common stock in public offering (Press release, Ampio, JUN 17, 2019, View Source [SID1234537126]). Ampio has entered into purchase agreements for the purchase of an aggregate 25,320,000 common shares of the Company at an offering price of $0.40 per Common Share for aggregate gross proceeds of $10.1 million, before placement agent fees and other offering expenses. Ampio anticipates an additional 4,680,000 shares of its Common Stock will be sold at the same price at the close of the offering. The offering is expected to close on or about June 19, 2019.

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The Company intends to use the net proceeds from this offering for the full cost of its AP-013 clinical trial pursuant to its recently announced Special Protocol Assessment and other general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as the exclusive placement agent for this transaction.

All of the common stock in this offering were offered on a reasonable best efforts, any and all basis pursuant to an effective shelf registration statement. A prospectus supplement relating to the offering was filed by the Company with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from ThinkEquity, 17 State Street, 22nd Floor, New York, NY 10004 (646) 968-9355, Email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.