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INmune Bio Inc. Announces Closing of Initial Public Offering and Trading on the Nasdaq Capital Market Under the Ticker Symbol “INMB”

On February 4, 2019 INmune Bio, Inc. ("INmune" or the "Company"), an immunotherapy company focused on developing therapies that harness the patient’s innate immune system to fight disease, reported that the Company’s common stock is expected to commence trading on The Nasdaq Capital Market, on Monday, February 4, 2019 under the ticker symbol "INMB" (Press release, INmune Bio, FEB 4, 2019, View Source [SID1234533090]).

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On February 1, 2019, INmune closed its initial public offering ("IPO") of 1,020,560 shares of its common stock at of $8.00 per share for a total of $8,166,560 in gross proceeds before placement agent fees and offering expenses.

Univest Securities, LLC served as the lead placement agent for the IPO. WallachBeth Capital, LLC and WestPark Capital, Inc. were co-placement agents.

A registration statement relating to this U.S. offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective by the SEC as of December 19, 2018. The offering of the securities was made only by means of a prospectus, forming a part of the registration statement. Copies of the final prospectus relating to the U.S. offering may be obtained from Univest Securities, LLC. 375 Park Avenue Unit 1502, New York, NY 10152, by telephone at +1 212 343 8888 or email at [email protected]. In addition, a copy of the prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.

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

PRA Health Sciences to Report Fourth Quarter 2018 Earnings

On February 4, 2019 PRA Health Sciences, Inc. (NASDAQ: PRAH) reported that it will release its fourth quarter and year end 2018 results after the market closes on Wednesday, February 27, 2019 (Press release, PRA Health Sciences, FEB 4, 2019, View Source;p=RssLanding&cat=news&id=2385970 [SID1234533080]). The Company will also host a conference call on Thursday, February 28, 2019 at 9:00 a.m. (ET) to discuss the results with members of the investment community.

To participate via telephone, investors and analysts should dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes prior to the call start time. The conference ID for the call is 8697447. An audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 8697447.

A live audio broadcast will be available on the investor relations section of the PRA Health Sciences website. Following the teleconference, an audio playback of the call will be available at the same website.

Surface Oncology Retains Worldwide Rights for its First-in-Class Antibody Targeting IL-27, SRF388

On February 4, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the retention of worldwide rights for its novel antibody, SRF388, targeting IL-27 (Press release, Surface Oncology, FEB 4, 2019, View Source [SID1234533066]). This program was previously subject to Surface’s collaboration with Novartis. IL-27 is a novel target in immuno-oncology, believed to play a significant and broad role in tumor-related immunosuppression via the regulation of checkpoint protein expression.

"SRF388 is an ideal program for Surface Oncology. We have conducted significant preclinical and translational work to understand IL-27’s role in specific tumor types and have a focused translational strategy as we advance this program into clinical development," said Jeff Goater, chief executive officer of Surface Oncology. "We are pursuing an aggressive development timeline for SRF388, with an IND filing planned for the fourth quarter of this year."

Based on the terms of the 2016 agreement with Novartis, IL-27 was one of a set of predefined targets for which Novartis had a right to purchase an option, subject to certain financial conditions. Novartis has elected to not purchase an option for SRF388 and as a result full rights remain with Surface Oncology.

Currently, Surface Oncology is conducting IND-enabling studies for both SRF388 and its wholly owned CD39 program, SRF617, and anticipates submission of both INDs in Q4 of 2019.

ABOUT SRF388

SRF388 is a fully human anti-IL-27 antibody. In preclinical studies, treatment with SRF388 was observed to block IL-27 signaling and its downstream immunosuppressive effects. Preclinical combination with a PD-1 inhibitor increased the production of key inflammatory cytokines. SRF388 also demonstrates preclinical anti-metastatic tumor activity.

BioLineRx Announces Proposed Underwritten Public Offering of its American Depositary Shares and Warrants

On February 4, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has commenced an underwritten public offering of American Depositary Shares ("ADSs"), each representing one of its ordinary shares with each ADS to be sold together in a fixed combination with a warrant to purchase ADSs (Press release, BioLineRx, FEB 4, 2019, View Source;p=RssLanding&cat=news&id=2385978 [SID1234533063]). All of the securities in the offering are to be sold by BioLineRx. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

BioLineRx anticipates using the net proceeds from the proposed offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.

Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering.

The securities described above will be issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release does 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.

Actinium Initiates Second Dosing Cohort of Novel Combination Trial with Actimab-A and CLAG-M Salvage Regimen at Medical College of Wisconsin

On February 4, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that the Medical College of Wisconsin (MCW) has started dosing patients in the second cohort of its novel trial of Actimab-A in combination with CLAG-M in patients with relapsed or refractory AML or Acute Myeloid Leukemia (Press release, Actinium Pharmaceuticals, FEB 4, 2019, View Source [SID1234533052]). This trial is evaluating the impact that the addition of targeted internalized radiation via Actimab-A to the salvage chemotherapy regimen CLAG-M will have on safety and tolerability, response rates, rates of BMT or bone marrow transplant, PFS or progression-free survival, and OS or overall survival.

Dr. Mark Berger, Chief Medical Officer of Actinium, said, "This trial represents an exciting advancement of our CD33 program that is aligned with our clinical strategy to pursue combinations utilizing our ARC drug candidates. We are pleased to be moving ahead with MCW to the second cohort of this trial and we are optimistic that our ARC combination strategy will have a positive impact on patient outcomes by improving response rates, duration of responses and/or increasing the rate of patients receiving a bone marrow transplant. Chemotherapy and external radiation are routinely used in combination in several cancers but despite being radiation sensitive, AML is not treated with external radiation given its diffuse nature. Therefore, the ability to deliver radiation internally in a targeted fashion to AML cells with potency and tolerability gives us great confidence in our ARC approach. In addition, this trial is particularly important as AML patients with relapsed or refractory disease face a poor prognosis with limited treatment options."

In this Phase 1 combination trial patients are administered the salvage chemotherapy regimen CLAG-M, which consists of cladribine, cytarabine, filgrastim, and mitoxantrone, followed by a single dose of Actimab-A. Actimab-A is an ARC or Antibody Radiation-Conjugate that consists or the CD33 targeting monoclonal antibody lintuzumab labelled with the alpha-particle emitting isotope Ac-225 or Actinium-225. In the first dose cohort, patients received 0.25 uCi/kg of Actimab-A. This combination trial is designed as a 3+3 dose escalation study. No dose limiting toxicities (DLTs) were reported in the first patient cohort. As a result, and per the study protocol, the Institutional Review Board (IRB) at MCW has authorized the initiation of the second dosing cohort, in which patients will receive 0.50 uCi/kg of Actimab-A. Assuming no DLTs are observed in the second cohort, three patients will be treated and the study will progress to the third and final cohort will study Actimab-A at a dose of 0.75 uCi/kg.

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer of Actinium, said, "In recent months, Actinium’s R&D and clinical teams have worked together to identify opportunities to further utilize our ARCs in combination with other therapeutic modalities. As a result, we are exploring multiple R&D and clinical initiatives with ARC based combination therapies. With the ARC combination strategy solidified as a corporate focus, we are delighted to see this positive progress from our first Actimab-A combination trial with CLAG-M. We are confident that the use of targeted radiation will prove synergistic with multiple modalities and open several therapeutic opportunities that are not possible with any other technology. We look forward to making continued progress on this front including the planned clinical trials with Actimab-A and venetoclax."