On September 13, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has approved orphan medicinal product designation (OMPD) for galinpepimut-S (GPS), the Company’s lead product candidate, for the treatment of multiple myeloma (MM) (Press release, Sellas Life Sciences, SEP 13, 2018, View Source [SID1234529423]). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has also been granted orphan drug designation and fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of MM.

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"This OMPD endorsement by the COMP of the EMA for GPS in MM complements the orphan designation awarded by the US FDA for this product in the same indication," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The results from our open-label Phase 2 study reinforce the potential of GPS to serve as a therapy for high-risk MM patients in the post-autotransplant maintenance setting. The innovative nature and unique mechanism of action for GPS provide a promising potential addition to the current arsenal of therapies in this indication. We continue to work closely with the FDA and EMA, as well as multiple myeloma KOLs to further advance the clinical development of GPS in this malignancy and look forward to gaining further insights on the potential therapeutic role of GPS in high-risk MM patients."

The EMA orphan medicinal product designation is granted to medicines being developed for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition with a prevalence of not more than five in 10,000 people in the European Union. Orphan designations are granted by decisions of the European Commission based on opinions from the Committee for Orphan Medicinal Products within EMA. EMA orphan drug designation benefits include protocol assistance, access to the EU centralized authorization procedure, reduced EU regulatory filing fees and 10 years of market exclusivity across the EU.

About the Phase 2 Trial of GPS in Multiple Myeloma

The open-label Phase 2 study consisted of 19 patients with multiple myeloma who had high-risk cytogenetics at initial diagnosis and remained at least minimal residual disease (MRD)-positive after a successful autologous stem cell transplant ("ASCT"). GPS was administered to patients in the study who achieved a stable disease or better status (per International Myeloma Working Group criteria) following ASCT. GPS was evaluated as consolidation therapy (on top of lenalidomide or bortezomib) to potentially stimulate a highly-specific immune response against WT1 in order to prevent or delay myeloma progression. Median progression-free survival (PFS) of 23.6 months was reported in this high-risk disease setting, compared to historically inferior outcomes while on an immunomodulatory drug (IMID) or proteasome inhibitor post-ASCT maintenance. Median overall survival has not been reached to date. GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses (IRs) specific for all four WT1 peptides within GPS, two of which are heteroclitic (mutated, by design). In addition, GPS stimulated similar IRs against the two counterpart native peptides. The IRs were confirmed in up to 91% of patients across HLA allele types, with multivalent IRs emerging in up to 64% of patients. Multifunctional cross-epitope T cell reactivity was observed in 75% of patients to antigenic epitopes against which hosts were not specifically immunized, in a pattern akin to epitope spreading. A link of clinical activity to antigen-specific immune responses was suggested.

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 overexpressed 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 September 13, 2018 ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported the appointment of James Kupiec, MD, to the position of Chief Medical Officer (Press release, ProMIS Neurosciences, SEP 13, 2018, View Source [SID1234529443]). In this newly created role, reporting to both the Executive Chairman and CEO, Dr. Kupiec will lead ProMIS’ clinical development programs, in particular the initiation of clinical trials of PMN310 for the treatment of Alzheimer’s disease (AD) in the second half of 2019.

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"We are very pleased to welcome Dr. Kupiec to our senior management team," said ProMIS Executive Chairman, Eugene Williams. "Jim’s expertise and experience as an accomplished leader of clinical development programs in Alzheimer’s disease and other neurodegenerative disorders will be a great source of strength for ProMIS. He will not only provide outstanding clinical trial leadership but will also play a significant role in interaction with regulatory authorities, key neuroscience opinion leaders and potential pharmaceutical partners."

Dr. Kupiec is a physician-scientist with over two decades of broad, hands-on experience in translational, early- and late-stage neuroscience drug development in the pharmaceutical industry.

"I am thrilled to join the ProMIS leadership team at this critical stage," said Dr. Kupiec. "ProMIS’ innovative approach selectively targeting toxic oligomers for treatment of neurodegenerative disorders is unique and provides a real opportunity for transformative, novel therapies. I am delighted to contribute to the advancement of the ProMIS clinical pipeline."

Dr. Kupiec most recently served as VP, Global Clinical Leader for Parkinson’s Disease, and Clinical Head of the Neuroscience Research Unit in Cambridge for Pfizer, Inc. He joined Pfizer in 2000 after seven years at Sanofi-Synthelabo, and two years with Ciba-Geigy Pharmaceuticals. During his career at Pfizer, he had extensive governance, business development, alliance and leadership responsibilities. Much of his work during the last decade has focused on developing potential disease modifying and symptomatic therapies for Alzheimer’s disease and other neurodegenerative disorders, including monoclonal antibodies. As project leader and Clinical Head, Dr. Kupiec created and implemented global drug development strategies, met with worldwide regulatory authorities, and chaired numerous joint development committees with other pharmaceutical companies.

He earned his BS with Honors in Biochemistry at Stony Brook University and his MD from the Albert Einstein College of Medicine. He completed his residency training at the Strong Memorial Hospital, University of Rochester School of Medicine, and is certified by the American Board of Internal Medicine.

On September 13, 2018 ERYTECH Pharma (Euronext Paris: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported that members of its management team will present and host investor meetings at the following investor conferences in September 2018 (Press release, ERYtech Pharma, SEP 13, 2018, View Source;p=RssLanding&cat=news&id=2367187 [SID1234529508]):

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Conference Details:

Morgan Stanley Global Healthcare Conference
Attendee: Gil Beyen, Chief Executive Officer
Location: New-York
Date / Presentation Time: September 13, 2018 at 4:40 PM EST
Webcast details: The presentation will be webcast live and can be accessed on Erytech’s Investor Relations website at View Source An archived version will be available within approximately two hours of the live presentation and can be accessed at the same location for 60 days.

BoursoCap/Investir Event
Attendee: Eric Soyer, Chief Financial Officer & Chief Operating Officer
Location : Groupe Les Echos – Le Parisien, Auditorium "10 Grenelle" Paris, France
Date / Presentation Time: September 18, 2018 at 06:00 PM CET

On September 12, 2018 Novocure (NASDAQ:NVCR), a global oncology company developing a proprietary platform technology called Tumor Treating Fields, and Zai Lab (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported an exclusive license agreement for Tumor Treating Fields, including the brand name Optune, in Greater China and a global strategic development collaboration (Press release, NovoCure, SEPT 12, 2018, View Source [SID1234529407]). This agreement will enable Novocure to access the Chinese market and is intended to accelerate clinical trial enrollment. For Zai Lab, this agreement will add a complementary commercial stage oncology asset to its innovative pipeline.

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"The Zai Lab team is passionate about bringing innovative treatments to patients in need, a passion we share at Novocure," said Novocure’s Executive Chairman Bill Doyle. "We believe this collaboration supports our mission of making Tumor Treating Fields available to patients throughout the world and will accelerate the development of Tumor Treating Fields in indications beyond glioblastoma (GBM)."

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields is currently marketed under the brand name Optune in the U.S., the EU, Switzerland, Japan and certain other countries for the treatment of GBM and is in advanced clinical development for multiple solid tumor indications. Novocure reported trailing 12-month revenues from Optune of $217 million as of June 30, 2018, representing 60 percent year-over-year revenue growth Q2 2018 versus Q2 2017. While Optune is not yet approved for commercialization in China, the technology was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2016.

"There are approximately 45,000 newly diagnosed GBM patients annually in China," said Lvhua Wang, Associate Director of China National Cancer Center and Vice President of China Society of Clinical Oncology. "Temozolomide is currently the only approved therapy for GBM in China so there are limited choices for one of the most deadly cancers. I am eagerly anticipating Tumor Treating Fields approval in China."

Novocure granted Zai Lab an exclusive license to commercialize Tumor Treating Fields in China, Hong Kong, Macau and Taiwan. Zai Lab will be responsible for regulatory submissions in Greater China and will work to establish Tumor Treating Fields as an oncology treatment in this territory.

Preclinical and clinical research demonstrated that Tumor Treating Fields’ mechanism of action affected fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. In addition to GBM, Novocure and Zai Lab will collaborate on development activities for Tumor Treating Fields in multiple solid tumor indications, including Novocure’s ongoing phase 3 pivotal trials in non-small cell lung cancer (NSCLC) and pancreatic cancer, and a phase 3 pivotal trial in ovarian cancer planned to open later this year. In addition, Zai Lab will conduct a phase 2 pilot trial to investigate Tumor Treating Fields in gastric cancer in China. China has one of the highest incidence rates of gastric cancer in the world, with approximately 680,000 new cases annually. Gastric cancer is the second leading cause of cancer death in men and women in China.

"Optune has demonstrated strong efficacy in a very challenging and difficult to treat cancer, GBM," said Dr. Samantha Du, CEO of Zai Lab. "Optune was approved in Japan without the need for a local bridging trial and we hope for similar rapid development in China. In addition, Tumor Treating Fields has the potential to treat a variety of solid tumors, which we believe are complementary to Zai Lab’s existing late-stage oncology assets and represent strong commercial synergy for us."

Novocure will receive a $15 million upfront payment and is eligible to receive additional payments upon achievement of certain development, regulatory and commercial milestones. Novocure is also eligible to receive a royalty on net sales of the licensed products in Greater China ranging from 10 percent to the mid-teens.

China Renaissance served as sole financial advisor to Novocure for the transaction.

On September 12, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the first patient has been enrolled in the Phase I dose escalation and expansion study (STELLAR-001*) evaluating IPH5401 in combination with durvalumab (Imfinzi), an anti-PD-L1 immune checkpoint inhibitor, for the treatment of patients with solid tumors, including non-small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC) (Press release, Innate Pharma, SEP 12, 2018, View Source [SID1234529425]).

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"We are pleased to have started the first clinical study for IPH5401," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "Despite significant recent advances in immunotherapy, immune escape of tumor cells remains a major challenge. We believe that IPH5401 has a high potential for cancer patients in multiple indications and could play an important role in PD-1/PD-L1 combination strategies for patients who are non-responsive, have a poor response or who have stopped responding to PD-1/PD-L1 immunotherapies."

Both durvalumab and IPH5401 are cancer immunotherapies, a potent class of treatments that use the body’s own immune system to help fight cancer. Durvalumab blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors (CRI-CIMT-EATI-AACR ICI 2017, poster #B184). Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.

The two-part study design includes an initial dose escalation phase to explore three doses of IPH5401 in combination with durvalumab in selected solid tumors. The first cohort will include a two-week run-in period evaluating the safety of IPH5401 prior to performing the combination dosing. At the highest dose of IPH5401, two dosing schedules will be evaluated. The recommended dosing regimen will then be used in the subsequent expansion part of the study in NSCLC with secondary resistance to IO and IO-naïve HCC; both tumors constitute patient populations with a high unmet medical need.

In January 2018, Innate Pharma and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a non-exclusive clinical trial collaboration to evaluate the combination of IPH5401 and durvalumab in a Phase I study for patients with selected solid tumors. The study is conducted by Innate and the costs are equally shared by both parties.

Clinical trial sites are located in France and the US. For more information on the STELLAR-001 clinical study (NCT03665129), please visit clinicaltrials.gov.