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Galera Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Accomplishments

On March 10, 2020 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2019, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, MAR 10, 2020, View Source [SID1234555343]).

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"Galera capped off a strong 2019 with the closing of an IPO for total gross proceeds of approximately $65 million, which positions us for growth and the continued advancement of our pipeline in 2020," said Mel Sorensen, M.D., President and CEO of Galera. "We kicked off 2020 by taking a critical step toward broadening our understanding of the breadth of our lead candidate avasopasem manganese’s (GC4419) utility in addressing radiation toxicities with the initiation of a Phase 2a trial in a second radiation toxicity, esophagitis, in patients with lung cancer. We also presented data showing that avasopasem manganese maintained tumor outcomes, and remain on track to read out data from our ongoing pilot Phase 1b/2a safety and anti-cancer trial in patients with locally advanced pancreatic cancer in the second half of this year. The Phase 3 ROMAN trial continues to progress, and we look forward to reporting topline data in the first half of next year."

Recent Corporate Highlights

In February 2020, presented full tumor outcomes results from the two-year follow-up of patients with head and neck cancer treated with avasopasem manganese (GC4419) for severe oral mucositis (SOM) in a Phase 2b clinical trial in a late-breaking oral presentation at the 2020 Multidisciplinary Head and Neck Cancers Symposium. At the final two-year mark, tumor outcomes were maintained in both avasopasem manganese dose groups (30 mg and 90 mg) compared to placebo. Specifically, outcomes for the 90 mg dose group, the dose currently being evaluated in the ongoing Phase 3 ROMAN trial, were comparable to placebo across all four measures – overall survival, progression-free survival, locoregional control and metastasis-free survival.

In February 2020, received a $20.0 million payment from Clarus, investment funds managed by Blackstone Life Sciences, for achievement of the third specified clinical milestone in our Phase 3 ROMAN trial under our royalty purchase agreement with Clarus.

In January 2020, announced the first patient dosed in a Phase 2a clinical trial of avasopasem manganese to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer. Esophagitis, or mucositis of the esophagus, is a common and painful complication of radiation therapy for lung cancer. Symptoms can be life-threatening and include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss, and may require hospitalization.

In the fourth quarter of 2019, completed an initial public offering of common stock and raised net proceeds of $58.0 million.

Continued enrollment in two ongoing clinical trials evaluating avasopasem manganese. Enrollment in the Phase 3 ROMAN clinical trial of avasopasem manganese for the treatment of SOM in patients with locally advanced head and neck cancer receiving radiotherapy is on track to be completed in the second half of 2020, with topline data anticipated in the first half of 2021. Topline data from the pilot Phase 1b/2a safety and anti-cancer efficacy clinical trial of avasopasem manganese in patients with locally advanced pancreatic cancer are expected in the second half of 2020.

Fourth Quarter 2019 Financial Highlights

Research and development expenses were $13.3 million in the fourth quarter of 2019, compared to $7.1 million for the same period in 2018. The increase was primarily attributable to avasopasem manganese and GC4711 development costs. Galera initiated the Phase 3 ROMAN clinical trial in October 2018, progressed chronic toxicology studies of avasopasem manganese to support registration, and progressed a Phase 1 clinical trial and additional toxicology studies of GC4711.

General and administrative expenses were $2.9 million in the fourth quarter of 2019, compared to $1.7 million for the same period in 2018. The increase was primarily the result of employee-related costs from increased headcount and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(16.7) million, or $(1.31) per share, for the fourth quarter of 2019, compared to a net loss of $(8.6) million, or $(35.24) per share, for the same period in 2018.

As of December 31, 2019, Galera had cash, cash equivalents and short-term investments of $112.3 million. Galera expects that its existing cash, cash equivalents and short-term investments, including the $20.0 million payment received from Clarus in February 2020 for the achievement of the third clinical milestone in the Phase 3 ROMAN clinical trial, together with the $20.0 million payment from Clarus expected to be received upon the achievement of the remaining specified clinical milestone in the ROMAN trial, will enable Galera to fund its operating expenses and capital expenditure requirements into 2022.

Full Year 2019 Financial Highlights

Research and development expenses were $42.3 million for the year ended December 31, 2019, compared to $18.7 million for the year ended December 31, 2018. The increase was primarily attributable to avasopasem manganese and GC4711 development costs. Galera initiated the Phase 3 ROMAN clinical trial in October 2018, began chronic toxicology studies of avasopasem manganese to support registration, and initiated a Phase 1 clinical trial and additional toxicology studies of GC4711.

General and administrative expenses were $8.4 million for the year ended December 31, 2019, compared to $5.6 million for the year ended December 31, 2018. The increase was primarily the result of employee-related costs from increased headcount and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(51.9) million, or $(16.31) per share, for the year ended December 31, 2019, compared to a net loss of $(23.7) million, or $(98.42) per share, for the year ended December 31, 2018.

Surface Oncology Reports Financial Results and Corporate Highlights for Fourth Quarter and Full Year 2019

On March 10, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2019, as well as anticipated corporate milestones for 2020 (Press release, Surface Oncology, MAR 10, 2020, View Source [SID1234555334]).

"We have made tremendous progress readying our lead programs, SRF617 and SRF388 for clinical trials. With opened INDs for both of these highly differentiated investigational immunotherapies, we are looking forward to initiating a new phase in our mission to deliver breakthrough treatments to help those affected by cancer," said Jeff Goater, chief executive officer. "Furthermore, with strengthened preclinical data packages across our portfolio, we continue to explore collaborations to enhance our clinical development strategy for each of our lead product programs, an example of which is the clinical collaboration we recently signed with Arcus Biosciences. We look forward to providing initial clinical updates for both SRF617 and SRF388 by the end of 2020."

Recent Corporate Highlights:

Entered into a clinical collaboration with Arcus Biosciences (NYSE: RCUS) in January 2020, to evaluate SRF617 (targeting CD39) in combination with AB928 (a dual A2a/A2b adenosine receptor antagonist) in clinical trials

FDA clearance of the Investigational New Drug applications (INDs) for both SRF617 and SRF388 (targeting IL-27) in January 2020

Continued progression of the ongoing phase 1/1b trial of NZV930 (targeting CD73) by Surface Oncology’s partner Novartis

Promotion of Liisa Nogelo to chief legal officer and Alison O’Neill to senior vice president, clinical development

Selected 2019 Corporate Highlights:

Filed INDs for both SRF617 and SRF388

Strengthened its team and Board of Directors with key additions, including the board appointment of Ramy Ibrahim, M.D., the chief medical officer of the Parker Institute for Cancer Immunotherapy

Announced a development candidate, SRF813 (CD112R), targeting the activation of natural killer and T cells

Published a peer-reviewed manuscript in the scientific journal ImmunoHorizons1 describing the biological activity of IL-27, an immunosuppressive cytokine and the target of SRF388

Gave multiple preclinical data presentations related to Surface Oncology’s pipeline programs at key scientific conferences, including the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting and the Brisbane Immunotherapy 2019 Conference

Secured a debt financing facility for up to $25 million from K2 HealthVentures

Held Surface Oncology’s inaugural Investor and Analyst Day

Selected Anticipated 2020 Corporate Milestones:

Initiation of phase 1 trial for SRF617 in the first half of 2020

Initiation of phase 1 trial for SRF388 in the first half of 2020

Multiple preclinical data presentations anticipated at key medical and scientific conferences throughout 2020, including at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April

Initial clinical updates for both SRF617 and SRF388 anticipated by the end of 2020

Financial Results:

As of December 31, 2019, cash, cash equivalents and marketable securities were $105.2 million, compared to $158.8 million on December 31, 2018.

Research and development (R&D) expenses were $11.7 million for the fourth quarter ended December 31, 2019, compared to $10.5 million for the same period in 2018. This increase was primarily driven by additional spend incurred for SRF617 and SRF388 associated with the IND filings in the fourth quarter of 2019. R&D expenses were $52.1 million for the full year 2019, compared to $52.5 million for the same period in 2018. This decrease was primarily driven by a reduction of manufacturing spend on the SRF231 (CD47) program, which was partially offset by increased spend on SRF617 and SRF388 associated with the IND filings in the fourth quarter of 2019. R&D expenses included $2.4 million in stock-based compensation expense for the full year 2019.

General and administrative (G&A) expenses were $5.1 million for the fourth quarter ended December 31, 2019, compared to $4.8 million for the same period in 2018. G&A expenses were $20.6 million for the full year 2019, compared to $16.1 million for the same period in 2018. The increase in G&A expenses for both the fourth quarter of 2019 and the full year 2019 was primarily due to increased personnel costs and professional fees. G&A expenses included $3.6 million in stock-based compensation expense for the full year 2019.

For the fourth quarter ended December 31, 2019, net loss was $16.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.57. Net loss was $4.7 million for the same period in 2018, or basic and diluted net loss per share attributable to common stockholders of $0.17. For the full year ended December 31, 2019, net loss was $54.8 million, or basic and diluted net loss per share attributable to common stockholders of $1.97. Net loss was $6.6 million for the same period in 2018, or basic and diluted net loss per share attributable to common stockholders of $0.33.

Financial Outlook:

1 DeLong, et al. ImmunoHorizons 3(1), pages 13–25 (2019)

Following the strategic restructuring implemented in January, Surface Oncology’s current cash and cash equivalents are projected to fund the Company into 2022. Anticipated milestones under the NZV930 collaboration with Novartis and additional capital potentially available under the K2 HealthVentures debt financing, in aggregate, would extend Surface Oncology’s cash runway into the second half of 2022.

3S Sunshine Guojian Partner Numab Therapeutics Closes Series B Financing

On March 9, 2020 Numab reported the closing of its Series B financing round at a total volume of CHF 22M (approximately USD 22.6M) (Press release, Numab, MAR 9, 2020, View Source [SID1234637794]). New investors in this round included 3SBio Group’s subsidiary Sunshine Guojian Pharmaceutical（Shanghai）Co., Ltd., Mitsubishi UFJ Capital Co., Ltd. and Eisai Co., Ltd. as well as Numab’s board member Dr. Daniel Vasella. Numab’s existing shareholders also contributed to the financing round. Sunshine Guojian invested CHF15M in this series B financing in December 2019. Dr. Zhenping Zhu, MD, PhD, President of Research and Development, Chief Scientific Officer of 3SBio, has joined the Numab’s board of directors. With the financing secured, Numab plans to further broaden its proprietary pipeline and accelerate the development for a number of programs towards the clinic. The company also plans to initiate a clinical trial for its lead oncology program ND021 during the course of 2020.

Mitsubishi UFJ Capital is one of Asia’s leading venture capital firm focusing on life science, information and communications technology and high technology investments. Numab and Eisai entered into a global research and option agreement to discover and develop a portfolio of multi-specific antibody immunotherapies for cancer in October 2019. In December 2019, Numab added a regional alliance with Sunshine Guojian to its growing roster of pharmaceutical partnerships.

"We are very pleased to have attracted a renowned institutional investor in Mitsubishi UFJ Capital to the Numab story and likewise appreciate the additional display of confidence in our platform and pipeline strategy by our partners as well as by our existing Series A investors and our board member Dr. Daniel Vasella," commented Dr. David Urech, Chief Executive Officer of Numab Therapeutics.

"3SBio is committed to developing innovative cancer cures. The investment and collaboration with Numab are consistent with our strategies. we are looking forward to collaborating with the Numab team to explore cutting edge immunotherapies in oncology." said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio。

Multi-specific antibodies have the potential to unlock entirely novel modes-of-action aiming at superior benefit-to-risk profiles relative to conventional cancer immune therapies. Numab’s proprietary MATCH technology platform represents one of the most versatile and flexible sources for multi-specific antibodies. MATCH molecules can incorporate up to six binding specificities in true plug-and-play fashion. The individual antibody Fv building blocks are designed for maximum stability and developability.

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review

On March 9, 2020 Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V.(NASDAQ: MYL) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway (Press release, Biocon, MAR 9, 2020, View Source [SID1234594758]).

The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.

Biocon and Mylan’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for the cancer patients in the U.S. It is currently available in India and other developing markets.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: "The US FDA’s acceptance of our BLA for a proposed biosimilar bevacizumab co-developed by Biocon Biologics and Mylan is an important milepost in our journey of enabling access to affordable cancer therapies for patients. Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the U.S. and bevacizumab will further expand our oncology portfolio."

Mylan President Rajiv Malik commented: "As we continue toward our goal of expanding access to cancer treatments for oncology patients, the FDA acceptance of our application for proposed biosimilar bevacizumab is another important step forward to increase competition, drive health system savings and expand our growing oncology portfolio to provide a broad range of offerings. We’re encouraged by the results of our scientific program to date and look forward to advancing the review of our application."

The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin.

The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.

A total of 671 patients were randomized. At week 18, the study met the primary endpoint and the 90% confidence interval for the best ORR (objective response rate) ratio was within the pre-specified equivalence margin. The safety which included immunogenicity was found to be similar to Avastin.

About the Biocon and Mylan Partnership
Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our proposed biosimilar bevacizumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review

On March 9, 2020 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway (Press release, Mylan, MAR 9, 2020, View Source [SID1234565288]).

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.

Mylan and Biocon’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for cancer patients in the U.S. It is currently available in India and other developing markets.

The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin. The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.