On February 9, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported the presentation of positive preclinical findings in its immuno-oncology program, generated via the Company’s Immune Repertoire Capture (IRC) technology platform (Press release, Atreca, FEB 22, 2017, View Source [SID1234522956]). Atreca’s IRC technology identifies and generates sequences of native antibodies and T cell receptors (TCRs) from active human immune responses, including natively paired and complete variable regions of receptors expressed by specifically selected B- and T-cells. New findings from Atreca’s lead program are being highlighted at the 24th annual Molecular Medicine TriConference, taking place at the Moscone North Convention Center in San Francisco, CA, February 19-24, 2017.

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In a presentation, titled "The Immune Repertoire Capture (IRC) Technology Platform," Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, is presenting key preclinical findings today at 12:10 p.m. Pacific Time, including:

Atreca’s researchers have used IRC technology to generate functional antibodies from the active immune response of individuals with metastatic disease who experienced a response to therapy.
Several patient-derived antibodies have been shown to bind tumor tissue but not normal tissue, and some antibodies bind multiple tumor types, including lung and breast adenocarcinoma, and renal cell carcinoma.
In a preclinical syngeneic in vivo tumor model, administration of the human variable regions derived from a particular patient antibody (linked to a mouse constant region) resulted in clearance of tumor in a majority of the animals, with concomitant infiltration of immune system cells into tumor tissue. Potential synergy with a checkpoint inhibitor was also observed.
"We are thrilled with the continued momentum of our programs based on successful anti-tumor immune responses in cancer patients undergoing treatment," stated N. Michael Greenberg, PhD, Atreca’s Chief Scientific Officer. "Our most recent data validate our next-generation approach in monotherapy as well as combination therapy, potentially addressing the substantial need to enhance patient responses to checkpoint inhibition. The unique features and capabilities of our platform allow us to pursue diverse applications outside of cancer as well, and we look forward to our progress as we advance toward IND-enabling studies in our lead program."

Atreca applies IRC to generate sequences of native antibodies and TCRs from cancer patients who have responded well to immunotherapy and other treatments, patients with autoimmune disease, vaccinated subjects, and patients who resolve infections. Analyses of the resulting essentially unbiased and error-free repertoires yield insights into immunology, as well as potent antibodies targeting tumors, pathogens, and autoimmune epitopes.

On February 22, 2017 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the fourth quarter and year ended December 31, 2016 (Filing, 8-K, Cleveland BioLabs, FEB 22, 2017, View Source [SID1234517857]).

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Cleveland BioLabs reported a net loss, excluding minority interests, of $(1.2) million for the fourth quarter of 2016, or $(0.11) per share, compared to a net loss of $(1.4) million, or $(0.13) per share, for the fourth quarter of 2015. Net loss, excluding minority interests, for full year 2016 was $(2.7) million, or $(0.24) per share, compared to a net loss of $(12.6) million, or $(1.79) per share, for full year 2015.

As of December 31, 2016, the Company had $15.2 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-K.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The past year was one of significant progress for CBLI. We commenced or continued clinical studies designed to further substantiate the potential of our Toll-like receptor agonists, entolimod, CBLB612 and Mobilan."

"The pursuit of commercialization for entolimod as a medical radiation countermeasure remains our top priority," continued Dr. Kogan. "We are working with the U.S. Food and Drug Administration (FDA) to confirm the bio-comparability of two formulations of entolimod. As requested by the Agency, we have completed the side-by-side analytical comparability analysis of these formulations and plan to submit the report to the Agency in the first quarter of 2017. Once the FDA has reviewed these data and provided its consent, the bio-comparability study in non-human primates will commence. Following completion of the study and discussion of the submitted study results with the FDA, we expect the Agency to resume the review of our pre-EUA dossier. Products with pre-EUA status may be purchased by certain US government stakeholders for stockpiling in the event of a disaster and we believe achievement of this status may also increase interest from foreign governments. In addition, we are evaluating steps needed to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), and have taken preliminary action with the EMA, which has granted entolimod orphan drug designation for the treatment of acute radiation syndrome, and we continue to evaluate other foreign markets."

Other Operational Highlights

•
Entolimod Oncology Indications. We have completed dosing of 40 patients in a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery. The goal is to accumulate additional clinical data regarding immune cell response to administrations of entolimod to guide future oncology development. The analysis of the data is ongoing.
•
CBLB612. We have also completed dosing in a Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy and data analysis of this study is in progress.
•
Mobilan. Two randomized, placebo-controlled, dose-ranging studies of Mobilan in men with prostate cancer are currently ongoing in the Russian Federation.

All of these studies are being conducted in the Russian Federation and were supported by development contracts with the Russian Federation Ministry of Industry and Trade, or MPT.

Further Financial Results

Revenue for the fourth quarter of 2016 was $1.0 million compared to $1.3 million for the fourth quarter of 2015. Revenue for full year 2016 was $3.5 million compared to $2.7 million for full year 2015. The revenue changes are primarily due to increased revenue from our Joint Warfighter Medical Research Program (JWMRP) contract with the Department of Defense (DoD) and our recently completed MPT contracts at BioLab 612 and Panacela which were partially offset by a decrease in service contract revenue from Incuron.

Research and development (R&D) costs for the fourth quarter of 2016 were $2.2 million compared to $1.9 million for the fourth quarter of 2015. R&D costs for the full year 2016 decreased to $6.5 million compared to $7.1 million for the full year 2015. The research and development changes were primarily attributable to our streamlined focus of pursuing commercialization efforts for entolimod’s biodefense indication in the United States and European Union, which increased certain R&D costs, but were partially offset by contract performance against the recently modified scope of work for our JWMRP contract to address the formulation questions raised by the FDA during its review of the pre-EUA dossier, and completion of our MPT contracts, which increased certain R&D costs during the year.

General and administrative costs (G&A) for the fourth quarter of 2016 were $0.7 million compared to $1.2 million for the fourth quarter of 2015. G&A costs for full year 2016 decreased to $3.4 million compared to $6.4 million for full year 2015. These decreases were primarily attributable to reductions in personnel and outside professional costs.

At December 31, 2016 the Company had 10,987,166 shares of common stock outstanding. In addition, the Company has 233,367 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $41.98 and 2,148,741 shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $11.04.

On February 22, 2017 Celltrion Healthcare reported that the European Commission has approved TruximaTM (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU) (Press release, Celltrion, FEB 22, 2017, View Source;division=R [SID1234531693]). Truxima is the first biosimilar monoclonal antibody (mAb) approved in an oncology indication worldwide.[1] The approval of Truxima builds on Celltrion Healthcare’s strong global clinical biosimilar programme.

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"We are excited to offer the first biosimilar mAb in oncology. With our partners across Europe, we will work together to ensure that Truxima is available to the many patients who can benefit from this treatment", said Jung-Jin Seo, Chairman of Celltrion Group, speaking at a meeting of their European partners in Paris. "For healthcare systems burdened with high cost oncology treatments, we are pleased to provide an option that has the potential to offer significant savings whilst ensuring patients retain access to high-quality and effective treatments."

Truxima is approved in the EU for the treatment of people with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.[1] This approval is based on the totality of evidence submitted to the European Medicines Agency showing compelling similarity between Truxima and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with RA and advanced follicular lymphoma, a type of NHL.[2] These trials were conducted in over 600 patients and include data up to 104 weeks.[2]

Dr Bertrand Coiffier, the global principle investigator of the advanced follicular lymphoma study, Head of the Department of Hematology at Hospices Civils de Lyon and Professor at the University Claude Bernard, Lyon, France said, "Biosimilar rituximab has been shown to have comparable efficacy and safety to reference rituximab in a large program of trials providing convincing evidence for the similarity of the two products. This has been recognised by the regulatory authorities, and hopefully this will pave the way for further innovation in this area".

Budget saving impact

Biosimilars have the potential to offer cost savings for healthcare systems and therefore the potential to increase patient access to biological therapies.[3],[4]

"Assuming the price of biosimilar rituximab is 70% compared to reference rituximab, and the market share of biosimilar rituximab is 30% (first year), 40% (second year) and 50% (third year), over this three-year time period the budget savings across the 28 countries of the EU would be around €570 million", said Prof. László Gulácsi, Head of Department of Health Economics, Corvinus University of Budapest; HTA Consulting Budapest, Hungary. "This equates to 49,000 new RA, NHL and CLL patients who could be receiving life-changing treatment which is clearly a huge aggregate health-gain at both a national and EU level."

— Ends—

Notes to editors:

About hematological cancers

Hematological cancers begin in blood-forming tissue or cells of the immune system. There are three common types of hematological cancers: lymphoma, leukaemia and myeloma. There are many types of NHL, the most common group is B cell lymphomas, of which follicular lymphoma and diffuse large B cell lymphoma are the most common. CLL is a type of leukaemia and is characterised by accumulation of monoclonal B cells (a type of white blood cell).

About rheumatoid arthritis

In Europe more than 2.9 million people have RA, many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.[5] Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

About Truxima (biosimilar rituximab)

Truxima is a mAb that targets CD20, a protein found on the surface of most B cells. Overactive B cells can stimulate attack of healthy cells in immune-related diseases such as RA. B cells are also implicated in some types of hematological cancer including NHL and CLL. B cells express CD20 at many stages of their development making the protein a good target for treatments.

Truxima is approved in the EU for the treatment of people with NHL, CLL, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for Truxima are available in the summary of product characteristics (SmPC).[1]

Overview of Truxima studies

Phase 1 clinical data demonstrated the PK of Truxima and reference rituximab were statistically equivalent over 24 weeks after a single course of treatment, and that their efficacy, PD, immunogenicity and safety were similar up to 2 courses of treatments (up to 72 weeks).[2]

A phase 1 open label extension study showed that switching to Truxima from reference rituximab was similarly effective with comparable safety to continuing Truxima for two years.[2]

Three phase 3 studies in patients with RA, advanced follicular lymphoma and low-tumor-burden follicular lymphoma (LTBFL) are ongoing:

· Truxima showed highly similar efficacy, PK, PD, immunogenicity and safety profiles to reference rituximab in people with RA up to 48 weeks[2]

· Truxima showed equivalent PK to reference rituximab with similar efficacy, PD, immunogenicity and safety profiles up to 8 cycles of treatment (every 3 weeks) in people with advanced follicular lymphoma[2]

On February 22, 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 the Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase 3 ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis (Press release, Argos Therapeutics, FEB 22, 2017, View Source [SID1234517784]). The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that rocapuldencel-T was generally well-tolerated in the trial.

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In conjunction with its clinical and scientific advisors, the company is analyzing the preliminary ADAPT trial data set and plans to discuss the data with the U.S. Food and Drug Administration (FDA). The company plans to leave the ADAPT trial open while the company conducts its ongoing data review and discussions with FDA. Based on these analyses and discussions, the company will make a determination as to the next steps for the rocapuldencel-T clinical program.

"We are extremely disappointed with these results, which included seventy-five percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study," said Jeff Abbey, president and chief executive officer of Argos Therapeutics. "We sincerely appreciate the patients and investigators who have participated in the ADAPT Phase 3 trial, and remain convinced in the ability of precision immunotherapy to improve the lives of patients."

Rocapuldencel-T is an individualized immunotherapy that is designed to capture mutated and variant antigens that are specific to each patient’s tumor and induce an immune response targeting that patient’s tumor antigens. The randomized Phase 3 ADAPT trial evaluating rocapuldencel-T plus sunitinib/standard-of-care therapy versus standard-of-care therapy alone in newly diagnosed mRCC patients was opened in January 2013 and completed enrollment in July 2015. A total of 462 mRCC patients were randomized to the trial. The primary endpoint of the trial is a statistically significant improvement in overall survival.

bluebird bio has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, bluebird bio, FEB 22, 2017, View Source [SID1234517797]).

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