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Argos Therapeutics Announces Interim Analysis of Phase 3 ADAPT Trial to be Presented at ESMO 2017 Congress

On August 21, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that an interim analysis of data from the ongoing Phase 3 ADAPT clinical trial evaluating Rocapuldencel-T for the treatment of metastatic renal cell carcinoma (mRCC) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress to be held Sept. 8 — 12 in Madrid, Spain (Press release, Argos Therapeutics, AUG 21, 2017, View Source [SID1234520295]).

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The oral presentation, entitled, "Interim Analysis of the Phase 3 ADAPT Trial Evaluating Rocapuldencel-T (AGS-003), an Individualized Immunotherapy for the Treatment of Newly-Diagnosed Patients with Metastatic Renal Cell Carcinoma (mRCC)," will be given by Robert Figlin, MD, Professor and Chairman, Division of Hematology and Oncology at Cedars Sinai Medical Center and co-principal investigator for the ADAPT trial, on Monday, Sept. 11th at 12:00pm CEST. The presentation will provide an overview of the study data set as of the time of the interim analysis that was conducted by an independent data monitoring committee (IDMC) in February 2017, including previously disclosed data as well as additional subsequent analyses based upon the data set. Dr. Figlin will also discuss the rationale for continuing the ADAPT trial.

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BioLineRx Announces Regulatory Submission of Phase 3 Registrational Study for BL-8040 in Stem Cell Mobilization

On August 21, 2017 BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the filing of regulatory submissions required to commence a randomized, controlled Phase 3 registrational trial of BL-8040 for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma (Press release, BioLineRx, AUG 21, 2017, View Source [SID1234520291]). The trial, named GENESIS, is expected to commence by the end of 2017, following receipt of regulatory approvals.

The Phase 3 GENESIS trial is aimed at evaluating the safety, tolerability and efficacy of the combination treatment of BL-8040 and granulocyte colony-stimulating factor (G-CSF), as compared to the control arm of placebo and G-CSF. The trial will be conducted in two parts: The first part, designed to validate the optimal dosing of BL-8040, is a lead-in, open-label, multi-center study that will include 10-30 patients, in order to assess the efficacy and safety of treatment with BL-8040 and G-CSF. This part will be followed by a randomized, placebo-controlled, multi-center study in approximately 180 patients. The primary endpoint will be the proportion of subjects mobilizing ≥6.0 x 106 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous transplantation after a single administration of BL-8040 and G-CSF, as compared to placebo and G-CSF.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "We are excited to move forward with BL-8040 into a Phase 3 registration study. We have previously reported positive results supporting BL-8040 as a one-day dosing and up-to-two-day collection regimen for rapid mobilization of stem cells. This represents a significant improvement over the current treatment, which requires four-to-eight daily injections of G-CSF and one-to-four apheresis sessions. We therefore hope that this Phase 3 trial will further support these results and help improve the standard of care for multiple myeloma patients."

"In parallel, we are continuing to expand the potential of our robust BL-8040 oncology platform, by advancing multiple clinical studies for additional indications that are ongoing or expected to commence during 2017. These include a large, randomized, controlled Phase 2b study in AML, as well as several Phase 2 combination studies with immune checkpoint inhibitors in solid tumors and hematological malignancies," added Mr. Serlin.

About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. 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 from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Stem Cell Mobilization
High-dose chemotherapy followed by stem cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after chemotherapy. This type of treatment often replaces the use of traditional bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.

Cancer Research UK and Newcastle University extend successful multi-project drug discovery alliance with Astex Pharmaceuticals

On August 17, 2017 Cancer Research UK* and Newcastle University reported a three year extension to their major strategic drug discovery alliance with Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics (Press release, Cancer Research Technology, AUG 17, 2017, View Source [SID1234523162]).

The alliance, which was formed five years ago, brings together world-leading researchers in structural and cellular biology, and medicinal chemistry with the innovative fragment-based small molecule drug discovery and development capabilities of Astex.

The researchers at the Cancer Research UK Drug Discovery Programme at the Northern Institute for Cancer Research (NICR), Newcastle University, will work to identify and develop new cancer drugs and associated biomarkers.

The existing portfolio of research consists of multiple projects spanning target validation and early stage medicinal chemistry, with projects progressing towards the more advanced stages of preclinical development.

The new agreement also includes provisions for further extension of the alliance towards the end of the new three year term.

Astex retains the right to an exclusive worldwide licence to take the most promising projects forward into pre-clinical and clinical drug development. In return, Cancer Research UK and Newcastle University are eligible to receive milestone and royalty payments on any compounds that Astex takes into clinical development and successfully commercialises.

Dr Iain Foulkes, Cancer Research UK’s executive director of research and innovation, said: "We’re delighted to extend this major collaboration which accelerates the development of Cancer Research UK’s world class work into new treatments for patients.

"Promising new compounds resulting from this partnership are now progressing towards the next stage of development. Multi-project alliances like this are powerful engines for innovation and drug discovery and this announcement underlines Cancer Research UK’s exceptional track record of bringing these together successfully."

Steve Wedge, Professor of Stratified Cancer Medicine Discovery at Newcastle University, said: "The innovative academic-industry collaborative model pioneered with Astex has been a genuine success and we are thrilled to be able to continue working in partnership on our drug discovery research.

"The alliance benefits significantly from complementary expertise and provides a route to progress promising novel therapies towards clinical use."

Dr Harren Jhoti, President and Chief Executive Officer of Astex, said: "The extension of our agreement with Newcastle and Cancer Research UK underlines the success of our existing alliance and the importance we place on collaboration with world leading academic research groups to strengthen our efforts to discover new treatments for patients.

"We look forward to continuing our important work and to continued success in bringing new compounds into development."

Atreca Completes Oversubscribed $35 Million Series B Financing to Advance Novel Cancer Immunotherapies

On August 17, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported the completion of its Series B round of financing with a total investment of $35 million (Press release, Atreca, AUG 17, 2017, View Source [SID1234522949]). The financing was co-led by new investor Wellington Management Company LLP and by a large US-based, healthcare-focused fund, participating as an existing Atreca investor. Additional participation included new investor Cormorant Asset Management, based in Boston, as well as other new and existing investors.

Proceeds from the financing will be used to accelerate and broaden Atreca’s discovery and development of antibody-based therapeutics that initiate, shape, and drive the anti-tumor immune response in cancer patients, as enabled by the Company’s proprietary Immune Repertoire Capture (IRC) technology. Atreca’s technology provides unbiased and virtually error-free antibody and T cell receptor (TCR) sequences at high throughput from single B and T cells of active human immune responses, enabling the identification, generation, and analysis of functional human antibodies and TCRs directly from such responses.

"We are very pleased with the continued support of our existing investors, as well as the commitment of our new, high-caliber investors," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "With their participation, we continue to build a foundation for long-term growth. This funding enables us to accelerate the acquisition of immune response data central to cancer immunotherapy and to expand and advance our pipeline of novel antibody therapeutics based on those data." To date, Atreca has built a library of over 400 patient-derived antibodies that bind non-autologous tumor tissue as the foundation for its pipeline and anticipates nominating a clinical candidate in its lead oncology program by the end of the year.

"Atreca’s novel and differentiated approach has the potential to address broad, compelling unmet needs in diverse immuno-oncology applications, a global market that is anticipated to exceed more than $100 billion within five years," said Brian Atwood, Atreca’s Chairman. "We are excited by the Company’s continued momentum and the top-tier financing syndicate participating in the Series B round."

WuXi Biologics and Gloria Pharmaceuticals Announce the Licensure of the Fully Human PD-1 Antibody, GLS-010, to Arcus Biosciences

On August 17, 2017 WuXi Biologics (2269.HK), a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and its Chinese partner Harbin Gloria Pharmaceuticals Co Ltd (002437.CN), reported that an exclusive license to the anti-PD-1 antibody GLS-010 has been granted to Arcus Biosciences, a US-based biotechnology company focused on the discovery and development of innovative cancer immunotherapies (Press release, WuXi Biologics, AUG 17, 2017, View Source [SID1234521934]).

Gloria contracted WuXi Biologics to discover and develop GLS-010, a novel anti-PD-1 antibody, using Ligand’s transgenic rat platform OmniRat. GLS-010 is currently being evaluated in cancer patients in phase I clinical studies in China. Arcus has licensed the exclusive development and commercialization rights of GLS-010 in North America, Europe, Japan and certain other territories.

Arcus plans on developing GLS-010 as a combination product with the other product candidates in its portfolio. Based on the terms of the agreement, Arcus will pay $18.5mm in upfront payments as well as development and regulatory milestones which could total up to $422.5mm for the development and approval of 11 products that include GLS-010 as a component. WuXi Biologics and its partner Gloria, through an existing agreement will also receive commercial milestones of up to $375mm which could result in aggregate payments from Arcus of $816mm. Arcus will pay tiered royalties that range from the high single-digits to low double-digits on net sales of GLS-010. In addition, WuXi Biologics and Arcus intend to enter into an exclusive 3-year agreement for the development of Arcus’ biologics portfolio. WuXi Biologics also will be the exclusive manufacturer for GLS-010 in the licensed territories for a specified period of time.

"We are pleased that our integrated platform has enabled companies such as Gloria to enter into biologics with an exciting program. We are also excited to enter into this agreement to expedite biologics development to treat patients globally," commented Dr. Chris Chen, CEO and executive director of WuXi Biologics. "This new partnership continues to reinforce the value of our integrated service platform, the global quality WuXi Biologics commits to, and the success of our ‘follow-the-molecule’ strategy.

"We are thrilled to gain access to GLS-010 in our territories," commented Dr. Tim Sullivan, Vice President of Business Development at Arcus. "This molecule will enable us to fully exploit the potential of our other immuno-oncology agents for the benefit of patients. Working with WuXi Biologics also ensures high-quality clinical supply of our biologics, an essential operational component of our strategy to develop a series of novel and best-in-class combination therapies for the treatment of cancer."

"Gloria has recently been focusing its R&D research on biologics, especially in the immuno-oncology area. We hope our efforts can bring more innovative medicines into the Chinese market in order to fill unmet medical needs," said Mr. Hongbing Yang, Chief Executive Officer of Harbin Gloria Pharmaceuticals. "It is the first time that an antibody envisioned by Gloria has the potential to reach patients worldwide. We are extremely pleased that, with our development in China and Arcus’ exclusive license in many other countries in the world, each working with WuXi, that GLS-010 may become available in both China and worldwide."

About GLS-010

GLS-010, also referred to as WBP3055, is an investigational fully human monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in the downregulation of the immune system by preventing the activation of T-cells. Other anti-PD-1 antibodies have been approved by the US FDA in multiple cancer settings. It is estimated that more than 500 clinical trials are ongoing to continue to investigate this class of biologics for more than 20 different cancer indications.