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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On December 21, 2017 Hookipa Biotech AG ("Hookipa"), a clinical stage biotech company pioneering an innovative class of immune activation therapies for oncology and infectious diseases, reported that CEO Joern Aldag will be presenting at the 36th Annual J.P. Morgan Healthcare Conference that is being held in San Francisco, CA from January 8-11, 2018 (Press release, Hookipa Biotech, DEC 21, 2017, View Source [SID1234522766]). The Company’s presentation is scheduled for Wednesday, January 10 at 04:30 PM Pacific Standard Time.

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Mr. Aldag will provide an overview of the Company´s strategy as well as an update on its development programs, including its progress on two proof-of concept clinical trials and its plan to expand its technology platform into other disease areas.

On December 21, 2017 Prima Biomed presented Investor Update (Presentation, Prima Biomed, DEC 21, 2017, View Source [SID1234522742]).

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On December 21, 2017 ABIVAX (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV and treatments for inflammatory/autoimmune diseases and cancer, reported that its senior management team will host institutional investor and partnering meetings at the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018 (Press release, Agilent, 21 21, 2017, View Source [SID1234522747]).

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To schedule a meeting with ABIVAX, investors can registeron the online system managed by the Company’s US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it..">[email protected].

On December 21, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa as monotherapy indicated for "the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)" (Press release, Chugai, DEC 21, 2017, View Source [SID1234522732]). In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).

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"Following approval for first line treatment in the US in November 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in the EU. An improvement in prognosis is expected in patients with ALK-positive advanced NSCLC who receive treatment with Alecensa at an early stage," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "In addition to the J-ALEX study (JapicCTI-132316) conducted in Japan, results of the ALEX study (NCT02075840) conducted overseas also showed that this will be great news for patients. We are convinced that Alecensa can contribute to the treatment of many patients in the world."

This additional approval is based on results from the phase III ALEX study (NCT02075840).
The ALEX study (NCT02075840) evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line). In the study, Alecensa significantly reduced the risk of disease worsening or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.001) compared to crizotinib as assessed by investigators. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib as assessed by independent review committee. The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

About Alecensa
Alecensa is a highly selective oral ALK inhibitor discovered by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.

Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU and Turkey for the treatment of first line therapy on ALK-positive metastatic NSCLC.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."

1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients
2) Soda et al., Nature. 448: 561-566 (2007)
3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)
4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011)

Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.