(Filing, Annual, Novartis, 2017, JAN 24, 2018, View Source [SID1234523540])

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On January 24, 2018 SELLAS Life Sciences Group, Inc. (SELLAS; NASDAQ: SLS) reported that an abstract highlighting the detailed description of antigen-specific immune responses and correlation thereof with clinical effects over time has been accepted for oral presentation at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting taking place March 18-21 in Lisbon, Portugal (Press release, Sellas Life Sciences, JAN 24, 2018, View Source [SID1234523569]).

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"The abstract to be presented at the EBMT Conference highlights the depth of our clinical program exploring the potential of GPS as an innovative immunotherapeutic for multiple cancer types," said Angelos M. Stergiou, MD, ScD h.c., President and CEO of SELLAS. "There has been great interest in immuno-oncology approaches for the treatment of MM and GPS offers an exciting opportunity by directly immunizing the host against a key immune target in multiple myeloma, namely WT1, particularly in view of strong differentiating attributes of our hetereoclitic immunotherapeutic as well as the other indications we are carefully pursuing."

Multiple myeloma (MM) patients with high-risk cytogenetics at baseline who also remain positive for minimal residual disease post-frontline autologous stem cell transplantation continue to experience poor clinical outcomes, despite maintenance with immunomodulatory drugs, such as lenalidomide. This is a population segment that represents approximately 15-20% of first-line MM patients. In previous reports, such patients immunized with GPS in a Phase 2 study (n=18) experienced a median progression-free survival of 23.6 months and an 18 month overall survival of 88%.

The presentation at the EBMT Conference will entail detailed correlative analyses between clinical benefit, as reflected by the rate of achievement of complete response/very good partial response, per International Myeloma Working Group criteria, and antigen-specific immuno-responses of the complete dataset from this Phase 2 study.

Details for the presentation are as follows:

Title: Clinical Benefit after Galinpepimut-S (GPS), a WT1 Immunotherapeutic, Correlates With Antigen-Specific Immune Responses in High-Risk Multiple Myeloma: Complete Analysis of the Phase 2 GPS Maintenance Study.
Presenter: Guenther Koehne, MD, PhD, Miami Cancer Institute, Baptist Health South Florida
Session: Oral Session 4 – Multiple Myeloma; Room 5B
Abstract Number: A-947-0029-01047
Date/Time: March 19, 2018, 3:50 p.m WET/ 10:50 a.m. EST
Location: Centro de Congressos de Lisboa / Lisbon Congress Centre (LCC), Room 5B
The presentation will be made available on the Presentations section of Sellas’ website at www.sellaslifesciences.com/publications immediately following the presentation.

About galinpepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immunotherapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer antigens for immunotherapy. Importantly, because the WT1 antigen is over-expressed in many malignancies, and is not found in most normal tissues, GPS has the potential to be a broad immunotherapy, effective across a multitude of diverse cancer types and patient populations.

On January 24, 2018 Pfizer Inc. reported that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-US)/MabThera1 (Press release, Pfizer, JAN 24, 2018, View Source [SID1234523567]).

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The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.

"We are pleased to report on our fifth proposed biosimilar monoclonal antibody (mAb) with positive study results. These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients," said Amrit Ray, MD, global president, Pfizer Essential Health Research and Development. "As a global leader in novel biologics, and with one of the broadest global portfolios in oncology, we are delivering on our commitment to advancing high-quality medicines for the millions of patients with cancer around the world today and in the future."

Pfizer’s biosimilars pipeline consists of seven distinct biosimilar molecules in mid to late stage development, with three of these in oncology, as well as several others in early stage development.

About the REFLECTIONS B3281006 Study

REFLECTIONS B3281006 is a randomized, double-blind clinical trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus MabThera (rituximab-EU)for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma. The primary endpoint measure, ORR, is defined according to the revised response criteria for malignant lymphoma [Time Frame: Week 26]. Results of the study will be presented in full at a future medical meeting or summarized in publication.

More information about the PF-05280586 REFLECTIONS B3281006 study can be found at www.clinicaltrials.gov.

About PF-05280586

PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin’s lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with Polyangiitis and Microscopic Polyangiitis; and other region-specific indications.

PF-05280586 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.

On January 24, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported preliminary clinical results from two ongoing open-label Phase 2 studies in head and neck and cervical cancers (Press release, Iovance Biotherapeutics, JAN 24, 2018, View Source;p=RssLanding&cat=news&id=2328242 [SID1234523547]).

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The company reported preliminary data from C-145-03, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Three of the eight patients treated with LN-145 had a reduction in tumor size of at least 30% and qualified as a Partial Response (PR) as per RECIST 1.1 criteria. The Objective Response Rate (ORR) in the study is 38% to date. These patients had a median of 4 prior treatments for their cancer and had all received prior anti-PD-1 therapy. Two of eight had also received prior anti-CTLA-4. The most common side effects were pyrexia, chills, and hypotension. Iovance will continue to enroll patients in this study to the full sample size of 47 per protocol.

The company also reported preliminary data from C-145-04, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Two patients are currently evaluable. One treated with LN-145 had a confirmed PR and one patient had stable disease.

"These early data from the head and neck study show the potential safety and efficacy of TIL therapy in tumor types other than melanoma, and demonstrate the broad utility of TIL therapy in various solid tumors. Recently approved anti-PD-1 therapies have resulted in overall response rates of 13-16% in head and neck cancer patients with a median of 2 prior therapies or similar disposition. We are therefore excited by this early data and believe that LN-145 may offer patients who have failed prior therapies, including anti-PD-1 checkpoints, an important treatment alternative," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also encouraged by the preliminary data reported today in cervical cancer. Previously published data from the National Cancer Institute (NCI) had shown a response in three of nine cervical cancer patients treated with TIL therapy. Patients with metastatic cervical cancer have limited effective treatment options, with no transformative new systemic therapies having been approved over the last several decades."

On January 24, 2018 Apexian Pharmaceuticals, a clinical-stage biopharmaceutical company, has reported the opening of a clinical trial for patients with advanced solid tumors (Press release, Apexian Pharmaceuticals, JAN 24, 2018, View Source [SID1234523543]). The study involves APX3330, an orally administered inhibitor of APE1/Ref-1, a dual-function protein that plays a critical role in promoting and maintaining a broad variety of cancers. Details of the study, including eligibility criteria, the location of participating clinical centers and referral contact information can be found at www.ClinicalTrials.gov, a website maintained by the National Institutes of Health.

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"The initiation of the APX3330 study is a significant step forward in Apexian’s mission to develop safe and effective treatments for cancer patients" said Steve Carchedi, President and CEO of Apexian Pharmaceuticals. "Despite recent advancements in cancer treatments, there continues to be a need for treatments that improve the survival of cancer patients. Apexian is committed to "moving mountains" to help these patients."

The APE1/Ref-1 protein regulates the activity of other cancer-associated proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3, proteins that control the aggressiveness of many cancers. Data indicate that Apexian’s drug APX3330 inhibits the cancer-promoting activity of APE1/Ref-1 without causing the side effects normally associated with many types of chemotherapy. Additionally, in a variety of pre-clinical studies, APX3330 has been shown to not only have an anti-cancer effect, but to also prevent, and reverse the nerve damage caused by certain forms of chemotherapy.

The clinical study is the first to explore APX3330 use in patients with advanced cancer, and is the culmination of extensive research on APE1/Ref-1 and APX3330 conducted by Dr. Mark Kelley, Professor and Associate Director of Basic Science Research at Indiana University’s Simon Cancer Center as well as other scientists worldwide. Dr. Kelley’s work on APE1/Ref-1 and APX3330 has previously resulted in significant research grants provided through the National Cancer Institute in order to explore the potential benefit to cancer patients receiving APX3330.

According to Dr. Richard Messmann, Apexian’s Chief Medical Officer, "Apexian’s research, led by Dr. Kelley, has provided us with a clear path to understanding, and an ability to measure, the clinical benefit that may be obtained when cancer patients are treated with APX3330. It also lays the foundation for determining whether patients with chemotherapy-induced peripheral neuropathy (CIPN) may benefit when receiving APX3330. The clinicians involved in the study, including those at the Simon Cancer Center and at START SA (San Antonio, TX) and START Midwest (Grand Rapids, MI) have uniformly expressed excitement regarding their participation in the study."