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.

On December 21, 2017 FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system against cancer, reported the completion of a $60 million Series C private financing (Press release, FLX Bio, DEC 21, 2017, View Source [SID1234522770]). The financing included new investments from GV (formerly Google Ventures) and other undisclosed investors as well as existing investors including The Column Group, Kleiner Perkins, Topspin Partners and Celgene Corporation.

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"With a discerning syndicate of investors committed to our science, our strategy and our team, we look forward to using the proceeds of this Series C financing to advance our robust pipeline of small molecule immuno-oncology compounds focused on regulatory T cell and tumor myeloid cell modulation," said Brian Wong, M.D., Ph.D., President and CEO. "In addition to initiating Phase 1 testing for our lead molecule FLX475, a highly potent and selective oral CCR4 antagonist for the treatment of cancer, we intend to select a clinical candidate targeting USP7 and continue advancement of our GCN2 program, with all three programs representing differentiated and important mechanisms to stimulate an immune response within the tumor microenvironment."

Initiation of Phase 1 Clinical Study of FLX475, CCR4 Antagonist
In addition to announcing its financing, FLX Bio recently dosed its first subject in a Phase 1 clinical trial for FLX475, a best-in-class, oral small molecule antagonist of CCR4. The company’s strategy is to accelerate early clinical development in cancer patients by first rapidly obtaining pharmacokinetic, pharmacodynamic, and preliminary safety data in healthy volunteers. Findings from the healthy volunteer study will enable a more focused and efficient Phase 1 study in cancer patients, potentially resulting in faster achievement of clinical proof of concept.

"We are pleased to move our lead program forward into the clinic," commented Bill Ho, M.D., Ph.D., Chief Medical Officer of FLX Bio. "Regulatory T cells are highly potent suppressors of the adaptive immune response and their presence in most tumors are correlated with a poor prognosis. With very few agents in development selectively inhibiting these cells, we believe targeting CCR4 represents a differentiated and exceptionally promising approach to treating cancer."

About FLX475
FLX475 is a best-in-class oral, small molecule antagonist of CCR4. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the antitumor effects of various checkpoint inhibitors including anti-PD-L1 and anti-CTLA4 antibodies as well as immune agonists such as anti-4-1BB. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. Unlike antibodies to CCR4, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site, and does not deplete cells beneficial to an anti-tumor response or regulatory T cells in healthy tissue such as blood, spleen and skin cells. In addition to the study ongoing in healthy volunteers, FLX Bio intends to initiate a clinical trial of FLX475 alone and in combination with a checkpoint inhibitor in oncology patients in 2018.

About USP7
Ubiquitin specific protease 7 (USP7) plays a key role in two important cancer pathways: it promotes the formation and function of regulatory T cells by deubiquitinating and stabilizing FOXP3; and it maintains low levels of p53, a prevalent tumor suppressor protein, thereby allowing the tumor to grow unchecked. USP7 is an enzyme that removes a tag called ubiquitin from proteins and stabilizes the expression of those proteins in the cell. USP7 stabilizes a regulatory protein called FOXP3 found within regulatory T cells, and promotes the number and activity of regulatory T cells. In addition, USP7 stabilizes MDM2, causing p53 levels go down, thus allowing cancer cells to proliferate. A USP7 inhibitor elicits two beneficial effects – increased immune system response to the tumor and enhanced tumor suppression by p53. FLX Bio expects to select a clinical candidate in late 2018.

About GCN2
GCN2 is a myeloid-derived suppressor cell (MDSC) target that works downstream of IDO and arginase. GCN2 inhibition has the potential for superior efficacy as it can reverse immune-suppression caused by depletion of both tryptophan and arginine. We are developing orally-bioavailable, highly-selective GCN2 inhibitors that stimulate an immune response by limiting myeloid derived suppressor cell functions as well as encouraging effector T cell proliferation in the amino acid-deprived tumor microenvironment.

On December 21, 2017 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that Bill Enright, President and Chief Executive Officer, will provide a corporate overview at the 10th Annual Biotech Showcase, being held January 8-10, 2018 at the Hilton San Francisco Union Square in San Francisco, California (Press release, Altimmune, DEC 21, 2017, View Source [SID1234522748]).

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Altimmune will also be hosting institutional investor and partnering meetings at the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018.

To schedule a meeting with Altimmune, investors can register on the online system managed by the Company’s US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at [email protected].

On December 21, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported initiation of the Phase 3 GENESIS clinical trial, in which BL-8040 will be compared to placebo, on top of granulocyte colony-stimulating factor (G-CSF), for the mobilization of hematopoietic stem cells (HSCs) used for autologous transplantation in multiple myeloma patients (Press release, BioLineRx, DEC 21, 2017, View Source;p=RssLanding&cat=news&id=2323740 [SID1234522740]).

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The GENESIS study is a Phase 3, randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The study will commence with a lead-in period for dose confirmation, which will include 10-30 patients, and progress to the placebo-controlled main part, which is designed to include 177 patients in more than 15 centers. Treatment will include 5-8 days of G-CSF, with a single dose of BL-8040 or placebo on day 4. Apheresis for stem cell collection will be performed on day 5. Further apheresis sessions may be conducted if needed in order to reach the benchmark of ≥ 6×106 mobilized HSCs.

The primary objective of the study is to demonstrate that BL-8040 on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6×106 HSCs in up to 2 aphereses. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "The initiation of our first Phase 3 trial for BL-8040 is an important milestone in the robust development plan of our lead oncology platform. Treatment with BL-8040 as a single administration and up-to-two-day collection regimen for rapid mobilization of stem cells could represent a significant improvement over the current treatment, which requires up to four apheresis sessions. We look forward to top-line results from the study expected in 2020."

Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, and lead investigator of the study, stated, "I am very excited to test the role of BL-8040, a novel CXCR4 inhibitor with G-CSF for the mobilization of peripheral blood stem cells from patients undergoing autologous transplant for multiple myeloma. I am hopeful that this will provide another approach to the optimal hematopoietic stem cell collection in this challenging group of patients".

About BL-8040

BL-8040 is a short peptide for the treatment of stem cell mobilization, acute myeloid leukemia and solid tumors. BL-8040 has demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. It functions as a high-affinity antagonist for CXCR4, with long receptor occupancy. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.