On December 18, 2018 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported updates related to its product pipeline, notably the significant reduction of the investment in and scope of its SRF231 program, the planned filing of two Investigational New Drug applications (INDs) in 2019 and extension of its cash runway (Press release, Surface Oncology, DEC 18, 2018, View Source [SID1234532130]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"A disciplined approach to both drug development and portfolio prioritization is central to our mission to develop truly innovative immunotherapies to help those affected by cancer," said Jeff Goater, chief executive officer of Surface Oncology. "The decision to significantly reduce the scope of our SRF231 program was driven by initial data from our ongoing phase 1 trial, the CD47 competitive landscape, as well as the continued emergence and prioritization of our CD39 and IL-27 programs."

The company is conducting a multi-center, open-label phase 1 trial of SRF231 designed to assess safety and tolerability in multiple ascending doses. To date, 18 patients have been treated with SRF231 on an every-three-week schedule. During the dose escalation portion of the phase 1, two hematologic dose-limiting toxicities (DLTs) were seen at a lower dose (12 mg/kg) than anticipated and resolved without long-term toxicity. Surface will explore additional dose administration schedules but will not open expansion cohorts in the phase 1 study.

"While the early biological activity observed in the clinic with SRF231 potentially represents novel biology, specifically a lack of hemagglutination and differential effects on white blood cells, it does not meet our standard for pursuing additional clinical expansions at this time," said Rob Ross, M.D., chief medical officer of Surface Oncology. "In the coming months we will focus on identifying a potential dose and schedule, while exploring key insights about SRF231."

This outlined activity may support business development opportunities for SRF231. The company anticipates presenting additional SRF231 data in the second half of 2019.

Surface believes the reprioritization of its programs will extend the company’s projected cash runway through 2021 based upon its current operating plan, which includes advancing its next two preclinical programs SRF617 and SRF388 into clinical studies and through initial clinical data. Phase 1 clinical work for the company’s Novartis-partnered CD73 program, NZV930, is ongoing. Based on the reallocation of capital, the company now anticipates that the SRF388 program will accelerate and be ready for IND filing before the end of 2019. Cash and cash equivalents at year end 2018 is projected to be approximately $160 million.

On December 18, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering of 26,800,000 common shares at a public offering price of US$1.40 per share, and the partial exercise by the underwriters of their option to purchase an additional 4,020,000 common shares, with 3,865,304 additional common shares purchased at US$1.40 per share (Press release, VBI Vaccines, DEC 18, 2018, View Source [SID1234532184]). As a result, the company has issued a total of 30,665,304 common shares in the offering and has received aggregate gross proceeds, before deducting the underwriting discounts and commissions and estimated offering expenses, of approximately US$42.9 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the company is 97,343,777.

BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. acted as joint book-runners for the underwritten public offering. National Securities Corporation acted as a financial advisor to VBI in connection with the offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on December 12, 2018. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on December 17, 2018, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On December 18, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) (formerly RXi Pharmaceuticals Corporation), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that Dr. Gerrit Dispersyn, President and Chief Operating Officer, will present at Biotech Showcase 2019, to be held January 7 – 9, 2019 at the Hilton San Francisco Union Square (Press release, Phio Pharmaceuticals, DEC 18, 2018, View Source [SID1234532115]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Gerrit Dispersyn will present an overview of the Company’s novel self-delivering RNAi (sd-rxRNA) technology and the multiple business development and commercial opportunities available with this proprietary platform on:

Date: Monday, January 7, 2019
Time: 9:00 a.m. PST
Room: Yosemite C (Ballroom Level)

He will also be available for investor and executive meetings throughout the conference. The presentation will be webcast and available on the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com.

About Biotech Showcase
Now in its eleventh year, Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

On December 18, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported its financial outlook for 2019 (Press release, Ligand, DEC 18, 2018, View Source [SID1234532150]). Ligand expects revenue in 2019 to be at least $212 million, with up to an additional $40 million of potential milestone and license payments. Approximately two thirds of the $212 million of revenue is expected to be royalty revenue, and the remainder is expected to consist of contract payments and material sales. With projected revenue of $212 million, adjusted earnings per diluted share for 2019 is estimated to be approximately $5.50. So far during the fourth quarter of 2018, Ligand has repurchased over 420,000 shares under its authorized share repurchase plan, and will potentially continue to execute additional repurchases going forward.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ligand is also raising its previous guidance for 2018, mostly due to higher material sales, and now expects revenue to be approximately $244 million, including royalties of approximately $123 million, material sales of approximately $28 million and license fees and milestones of approximately $93 million. Revenue for 2018 includes a milestone payment of $47 million from WuXi Biologics. With projected revenue of approximately $244 million, adjusted earnings per diluted share for 2018 is estimated to be approximately $6.63. This compares with previous guidance for 2018 revenue of approximately $240 million, and adjusted earnings per diluted share for 2018 which was previously estimated to be $6.52.

On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.