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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.

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"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."

The Union For International Cancer Control And Pfizer Announce New Phase Of Global Grants Initiative Supporting Metastatic Breast Cancer Patients

On February 4, 2019 In conjunction with World Cancer Day, the Union for International Cancer Control (UICC) and Pfizer Inc. reported the third round of the Seeding Progress And Resources for the Cancer Community (SPARC): Metastatic Breast Cancer (MBC) Challenge: their pioneering grants initiative designed to support the implementation of projects worldwide that address the specific needs of women with metastatic breast cancer in local communities – many of which extend beyond treatment (Press release, Pfizer, FEB 4, 2019, View Source [SID1234533050]).

A total of US$275,000 in funding will be awarded to 10 new organizations, bringing the SPARC awardees network to 50 cancer organizations from all across the globe with a total funding of US$1,565,000. As part of this new round, five grantees from Round 2 of the SPARC MBC Challenge will receive additional funding to continue their projects.

In addition to receiving the seed grant to support their projects, the new awardees will benefit from trainings, best-practice sharing workshops, and mentoring. They will also have the opportunity to participate in key global convening cancer events to network, share knowledge, and showcase their work.

Dr Cary Adams, Chief Executive Officer of the Union for International Cancer Control, said: "We are proud that, together with Pfizer, we will continue to improve the lives of people living with metastatic breast cancer cross the world through this unique programme that combines seed grants, mentoring and peer-to-peer
learning."

The impact of the SPARC MBC Challenge has been significant. Since the initiative launched in 2015, over 8,000 patients from 30 countries have been reached directly through SPARC projects, and more than 125,000 people have benefitted from SPARC advocacy campaigns and information materials. Organizations such as Project Pink Blue and Run for a Cure Africa have reached the next level receiving international awards and additional funds after receiving the SPARC grant. In particular, SPARC contributed to:
Supporting metastatic breast cancer patients through projects such as the creation of an online app to guide patients in finding financial resources to cover some of the expenses of the disease in Canada; a project for young women to better cope with MBC through integrative oncology techniques (occupational therapy, expressive creative techniques, mind body intervention, and acupuncture) in Mexico and training for patients on the importance of treatment adherence in Bulgaria
Strengthening advocates and supporting the development of a positive national policy environment for MBC. SPARC projects have delivered training on advocacy for metastatic breast cancer for individuals from 47 European countries, supported the recent inclusion of medicines for MBC in the National Essential Medicines list in Kyrgyzstan and contributed to the development of supportive national legislation on cancer in Brazil and Nigeria.
Reducing the information gap for patients, with information materials and advocacy campaigns created in 26 local languages. SPARC enabled the creation of the first navigational programs in Nigeria and Trinidad & Tobago.
Building local capacity. Nearly 2,000 health professionals were trained on how to manage the specific needs of MBC patients across all SPARC projects. In Australia, an e-learning training was deployed across the country to help nurses better attend to the needs of MBC patients.
"We’re proud of the far-reaching impact that the SPARC MBC Challenge has had over the past four years on metastatic breast cancer patients around the world, ranging from educational resources to tailored programming," said Andy Schmeltz, Global President, Pfizer Oncology, "With our ongoing partnership with UICC and this year’s renewal, we look forward to continuing to make a difference for breast cancer patients around the globe."

Applications to the new round of the SPARC grants will open at the end of February and new SPARC awardees will be announced in October 2019.

About the Seeding Progress and Resources for the Cancer Community (SPARC): Metastatic Breast Cancer (MBC) Challenge

The SPARC MBC Challenge aims to address critical issues for those at risk of, or living with metastatic breast cancer. The SPARC grants consist of seed-funding, capacity building and convening opportunities to launch and strengthen new projects addressing the needs of MBC patients. Awardees are integrated into the SPARC network where they can share best practices, learn from others and share resources between themselves. The awardees are selected by an independent, external steering committee, consisting of leading experts in the fields of cancer care and chaired by globally renowned oncologist and leading breast cancer advocate, Dr Fatima Cardoso.

Alnylam to Webcast Presentations at Upcoming February Investor Conferences

On February 4, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present company overviews at the following conferences (Press release, Alnylam, FEB 4, 2019, View Source [SID1234533048]):

21st Annual BIO CEO & Investor Conference on Monday, February 11, 2019 at 1:30 pm ET at the Marriott Marquis in New York City

8th Annual SVB Leerink Global Healthcare Conference onWednesday, February 27, 2019 at 10:30 am ET at the Lotte New York Palace Hotel in New York City

A live audio webcast of each presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after each event.