One-Year Follow-Up Shows 71.4% Progression-Free Survival in 14 Prostate Cancer Patients Treated with ProscaVax in Phase 1 Clinical Trial

On December 21, 2017 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, reported one-year follow-up results from the Company’s Phase 1 clinical trial of ProscaVax for prostate cancer (Press release, OncBioMune Pharmaceuticals, DEC 21, 2017, View Source [SID1234523264]).

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In the trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing prostate specific antigen (PSA) were treated with six intradermal injections of ProscaVax. ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

The latest data shows:

Progression-Free Survival 71.4%: 10 of 14 patients (71.4%), who have been followed for one year after initiation of ProscaVax therapy, continue to have stable disease
Overall Survival 100%: None of the 14 evaluable patients have died at one-year follow-up
As previously disclosed, four patients had disease progression within 19 weeks (3 PSA progression and 1 radiological progression). No further progression has been noted from week 19 to one year
Data continues to confirm there were no drug-related serious adverse events or dose-limiting toxicities resulting from ProscaVax therapy
Six of the 20 patients enrolled in the trial have not yet been followed for one year, evaluations to follow
"I continue to be impressed with the clinical results on ProscaVax. These results support the benefit of this first-in-class immunotherapy and offers hope to cancer patients in great need," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "These are men who have tried conventional treatments only to have their cancer return and where ProscaVax now seems to be delivering a therapeutic benefit. While Progression-Free Survival and Overall Survival are benchmarks of later-stage studies and not the primary endpoints in our Phase 1 clinical trial, it is hard to overlook the finding that patients with progressing disease now have stable disease following ProscaVax therapy. We need to conduct a larger-scale clinical trial and build more complete data sets to confirm these results, but all signs at this time are pointing to ProscaVax having a meaningful effect by increasing PSA doubling time and inhibiting tumor growth in prostate cancer. It is reason to be optimistic about the next stage of research."

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10-Q – Quarterly report [Sections 13 or 15(d)]

Spring Bank Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Spring Bank Pharmaceuticals, 2018, DEC 20, 2017, View Source [SID1234527566]).

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Vectura to present at the 36th Annual J.P. Morgan Healthcare Conference

On December 20, 2017 Vectura Group plc (LSE: VEC) ("Vectura", "the Company"), an industry-leading device and formulation business for inhaled airways products, reported that James Ward-Lilley, Chief Executive Officer, will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, on Wednesday, 10 January 2018, at 9:30am PST / 17:30pm GMT (Press release, Vectura, DEC 20, 2017, View Source;customerKey=VecturaIntranet&storyID=13758359 [SID1234522731]).

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A live webcast of the presentation and a copy of the slides will be available on the Company’s website: View Source A recording will be available following the presentation.

Vectura will issue a 2017 pre-close trading update on Thursday 4th January 2018.

– Ends –

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4SC receives Pediatric Investigation Plan Waiver for resminostat in CTCL from the European Medicines Agency

On December 20, 2017 4SC AG (4SC, FSE Prime Standard: VSC) reported that it received a Pediatric Investigation Plan waiver from the European Medicines Agency (EMA) for resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL) (Press release, 4SC, DEC 20, 2017, View Source [SID1234522733]).

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As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Pediatric Investigation Plan that outlines the clinical development strategy for studying the investigational product in children. In some instances, a waiver from developing a Pediatric Investigation Plan for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate. CTCL is extremely rare in children and if present, is usually an early stage disease that can be controlled quite well with existing therapies.

"This waiver represents an important milestone in the regulatory process for resminostat, and will allow 4SC to submit a Marketing Authorization Application for resminostat to the EMA following successful completion of the pivotal RESMAIN study without the requirement to conduct additional clinical studies in children before or after approval," said Jason Loveridge, CEO of 4SC.

Resminostat is being evaluated as maintenance therapy in advanced-stage CTCL patients in the pivotal RESMAIN study, which is currently being conducted at more than 50 clinical centers in 11 European countries. Top-line results are expected to be available in the first half of 2019.

Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

On December 20, 2017 Samsung Bioepis Co., Ltd. reported that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptini (trastuzumab) (Press release, Samsung Bioepis, DEC 20, 2017, View Source [SID1234522734]). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.

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