On March 22, 2019 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the year ended December 31, 2018 and provided an update on recent corporate developments (Press release, Gossamer Bio, MAR 22, 2019, View Source [SID1234534560]).

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!

"Since the launch of Gossamer just over a year ago, we have built a robust and balanced pipeline of product candidates, including three clinical-stage assets and multiple preclinical programs, all with potential to meet high unmet medical needs across multiple disease areas," said Sheila Gujrathi, M.D., Gossamer’s Co-Founder and Chief Executive Officer. "With the recent successful completion of our initial public offering, we added to our already strong cash position, extending our runway and providing additional resources to rapidly advance our product candidates. I am extremely proud of all that the Gossamer team has accomplished to date. Our objective is to leverage our deep experience in immunology to enhance and extend the lives of patients with inflammatory and immune-related diseases, including cancer, and I look forward to sharing our progress as we work to bring forth important new medicines to patients."

Recent Highlights

Commenced Phase 2b trial for GB001. In October 2018, Gossamer commenced a Phase 2b trial of the company’s lead candidate, GB001, an oral antagonist of prostaglandin D2 receptor 2 (DP2), in patients with moderate-to-severe eosinophilic asthma. Gossamer expects to conduct an interim analysis for this trial in the first half of 2020 and to announce topline data from the trial in the second half of 2020.

Completed initial public offering (IPO). In February 2019, Gossamer closed its IPO of 19,837,500 shares of its common stock at a price to the public of $16.00 per share. Gossamer raised aggregate gross proceeds of $317.4 million from the offering, prior to deducting underwriting discounts and other offering expenses.

Full-Year 2018 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2018 were $228.7 million. Subsequent to year end, Gossamer raised approximately $295.2 million in its IPO, net of underwriting discounts.
Research and Development (R&D) Expenses: For the year ended December 31, 2018, R&D expenses were $55.3 million, which included $6.0 million of costs related to personnel and external consultants.
In-Process Research and Development (IPR&D) Expenses: For the year ended December 31, 2018, IPR&D expenses were $49.7 million, which was primarily attributable to approximately $27.5 million of costs related to up-front in-licensing and product acquisition payments related to GB004 and GB1275, and $19.1 million of costs associated with the issuance of stock in connection with the acquisition of GB001.
General and Administrative (G&A) Expenses: For the year ended December 31, 2018, G&A expenses were $44.1 million, which was primarily attributable to $30.3 million in stock-based compensation costs, $6.0 million in personnel-related costs, $3.7 million in professional fees, $1.3 million in legal fees and $0.8 million in facility-related costs.
Net Loss: For the year ended December 31, 2018, net loss was $147.0 million, or a loss of $22.59 per share.

On March 21, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported it will release its audited annual financial results for the year ended December 31, 2018 on Thursday, March 28, 2019, before the US markets open (Press release, BioLineRx, MAR 21, 2019, View Source;p=irol-newsArticle&ID=2391959 [SID1234534528]).

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 Company will host a conference call on Thursday, March 28, 2019 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-229-7198 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 30, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5938 internationally

On March 21, 2019 WARF Therapeutics reported a new partnership with Sanford Burnham Prebys Medical Discovery Institute (SBP) (Press release, WARF Therapeutics, MAR 21, 2019, View Source [SID1234644191]). SBP is an independent, nonprofit institution dedicated to understanding basic human biology and disease, and to advancing scientific discoveries to profoundly impact human health. SBP’s Conrad Prebys Center for Chemical Genomics (Prebys Center) is one of the most advanced drug discovery centers in the nonprofit world.

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!

WARF Therapeutics was established as a major new program of the Wisconsin Alumni Research Foundation (WARF) in 2018. Its mission is to identify promising biological discoveries on the UW-Madison campus that are relevant to human disease. WARF Therapeutics will invest in validated targets, design and develop drug-like molecules, and ultimately partner them with the venture capital community, pharmaceutical organizations and biotech companies. Jonathan Young, Ph.D., an industry veteran with over 20 years of experience in large pharma and biotech, was recently hired, after a nationwide search, to build and lead WARF Therapeutics.

Young says, "WARF’s collaboration with SBP will help us accelerate translation of promising research by providing the essential discovery and early development expertise required. Furthermore, this partnership will help WARF Therapeutics continue the legacy of pharmaceutical innovation at UW-Madison and ultimately deliver novel medicines to patients with unmet medical needs."

Under the terms of the 5-year agreement, WARF and UW-Madison scientists will work with scientists at SBP’s Prebys Center to transition clinically relevant targets to early-stage drug discovery, including assay development and high-throughput screening to identify chemical compounds that modulate the activity of the targets. The Prebys Center’s compound library is a collection of more than 1 million diverse chemicals. Validated "hits" from this library can be developed into prototype drugs.

"The Prebys Center is like a magnet that attracts collaborators and partnerships with like-minded researchers who seek to discover new therapeutics for diseases with serious clinical unmet needs," says Michael Jackson, Ph.D., senior vice president of drug discovery and development at SBP. "We look forward to a productive partnership with WARF that will lead to therapies for diseases in need of a cure."

SBP holds an analogous partnership with the Mayo Clinic that began in 2012. The Mayo-SBP agreement outlines efforts to build a pipeline of therapeutic drugs aimed at a variety of diseases with serious unmet clinical needs.

On March 21, 2019 Provectus (OTCQB: PVCT) reported that updates on the Company’s metastatic uveal melanoma drug development program for its lead investigational cancer agent PV-10 (Press release, Provectus Biopharmaceuticals, MAR 21, 2019, View Source [SID1234534529]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells1-4, which may lead to a functional recruitment of the immune system.

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!

Update #1. Presentations about PV-10 treatment of metastatic uveal melanoma will be given by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center at:

The International Society of Ocular Oncology (ISOO) Biennial Conference in Los Angeles, California from March 22-26, entitled "Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastasis." ISOO is a non-profit corporation with the specific and primary purpose to advance and promote the practice of ocular oncology, and

The spring meeting of the Ophthalmic Oncology Group (OOG) in London, England from April 11-13, entitled "A Phase 1 Study of Percutaneous Oncolytic Rose Bengal Disodium (PV10) for Metastatic Uveal Melanoma to the Liver." OOG is an independent scientific group devoted to clinical ophthalmic oncology and related basic-science research.
Update #2. The Company will host a round table involving metastatic uveal melanoma patients at CURE OM’s Eyes on a Cure: Patient & Caregiver Symposium in Raleigh, North Carolina from April 5-7. The Community United for Research and Education of Ocular Melanoma (CURE OM) is the Melanoma Research Foundation’s initiative to increase awareness, education, and research funding for ocular melanoma, while improving the lives of people affected by this disease.

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.5,6 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.5,6,7 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.8

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers. In February 2019, orphan drug designation status was granted to PV-10 by the U.S. Food and Drug Administration for the treatment of ocular melanoma.

On March 21, 2019 Samsung Bioepis Co., Ltd. reported findings of a three-year follow-up study comparing biosimilar ONTRUZANT (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer (Press release, Samsung Bioepis, MAR 21, 2019, View Source [SID1234534530]). The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

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!

"With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

[P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]
ONTRUZANT (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT.iii With the adoption of CHMP’s positive opinion for ONTRUZANT 420 mg vial presentation, ONTRUZANT will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.