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 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective medicines to treat a wide range of cancers, reported the appointment of Jeffrey D. Bloss, M.D., as Chief Medical Officer (Press release, Tarveda Therapeutics, SEPT 12, 2018, View Source [SID1234529408]). In addition, the company strengthened its clinical leadership team with the appointment of Steven A. Hamburger, Ph.D. as Vice President, Regulatory Affairs and Laura Mei as Vice President, Clinical Operations.

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"We are very pleased to have Jeff join Tarveda at this exciting time for our Company. Jeff brings deep expertise and over two decades of experience leading the clinical development and medical affairs of oncology programs at both biotech and pharmaceutical companies. His track record of success, including taking numerous oncology drug programs through development and approval, will be invaluable to Tarveda as we continue to advance our two clinical stage drug programs and pipeline," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "Further, with the additions of Laura and Steve leading Clinical Operations and Regulatory Affairs, respectively, we have greatly strengthened our ability to optimize and execute the development of our two current clinical programs as well as future pipeline opportunities."

In the second quarter of 2018, Tarveda announced the initiation of the Phase 2a expansion portion of its Phase 1/2a trial for PEN-221 in patients with somatostatin receptor 2-expressing neuroendocrine tumors and small cell lung cancer. In the same quarter, Tarveda also announced the commencement of the dose escalation portion of its Phase 1/2a trial for PEN-866 in patients with solid malignancies.

"I am pleased to join Tarveda and am impressed with the novel approach of our new class of selective and potent miniature conjugates as well as by the clinical data from our two clinical stage drug programs," said Dr. Jeffrey Bloss. "Both PEN-221 and PEN-866 have the potential to dramatically improve the treatment of patients with solid tumors by leveraging the small size of the conjugates to rapidly penetrate deep into solid tumors while leading to the prolonged accumulation of their potent therapeutic payloads in the tumor versus healthy tissues. I am eager to advance the clinical development of both clinical stage drug programs and look forward to working side by side with Laura, Steve and the entire team to fully explore the potential of our drugs in treating patients with cancer."

Jeffrey D. Bloss, M.D., Chief Medical Officer
During his career encompassing more than 25 years in oncology, Dr. Bloss has held many leadership roles and has been responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar, Tarceva, Sorafenib, Tykerb, Xtandi and others. Prior to joining Tarveda, Dr. Bloss served as Chief Medical Officer and Senior Vice President, Medical Affairs at Aegerion. He has also held senior level positions at Astellas, GlaxoSmithKline, Xencor, Onyx, Genentech, and Eli Lilly. Before joining the biotech industry, Dr. Bloss held a series of roles of increasing responsibility at the University of Missouri, Ellis Fischel Cancer Center and at the USAF Medical Corps. He holds an M.D. from Thomas Jefferson University Medical College and a B.S. from Juniata College. Dr. Bloss completed his Residency in Obstetrics & Gynecology at Wilford Hall USAF Medical Center and his Fellowship in Gynecologic Oncology at the University of California, Irvine.

Steven A. Hamburger, Ph.D., Vice President, Regulatory Affairs
Prior to joining Tarveda, Dr. Hamburger served as Vice President, Regulatory Affairs and Quality Assurance at BERG. He has led global regulatory efforts for both biotech and large pharmaceutical companies including Castle Creek Pharmaceuticals, Baxalta and Immunomedics. Dr. Hamburger has also held senior regulatory positions at Millennium/Takeda, Johnson & Johnson, Eli Lilly, and Zeneca Pharmaceuticals. He has had significant involvement in the development and/or global registration of many drugs including Krystexxa, Onivyde, Oncaspar, Velcade, Alimta, DOXIL and Accolate. Dr. Hamburger holds a Ph.D. in Pharmacology and Toxicology from Indiana University School of Medicine, an M.S. from Butler University and a B.S. from the University of Iowa.

Laura Mei, Vice President, Clinical Operations
Prior to joining Tarveda, Ms. Mei served as Executive Director, Global Clinical Operations and Metabolic Franchise Head at Alexion Pharmaceuticals. She has also held management positions at several biotech and pharmaceutical companies including Senior Director, Clinical Operations at Synageva Biopharma, Senior Director, Clinical Operations and GCP Compliance at Alexza Pharmaceuticals and Associate Director, R&D Compliance at Biogen. Ms. Mei holds a B.A. in physics and zoology from Connecticut College.

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

On September 12, 2018 Surefire Medical, Inc. (Surefire) reported the company is changing its name to TriSalus Life Sciences to better reflect the company’s contribution to patient care (Press release, Surefire Medical, SEPT 12, 2018, View Source [SID1234529409]). TriSalus is focused on developing drug delivery technology for use in solid tumors and improving the administration of immuno-oncology (IO) therapies.

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"The re-naming of our company to TriSalus Life Sciences reflects an important step in our journey to build a leading oncology drug delivery company," said TriSalus CEO Mary Szela. "As researchers identify more ways to fight cancer, successful outcomes for patients are increasingly being defined by three strategic pillars for oncology treatment: the administration of the right therapeutic, the stimulation of the immune system, and equally important: a targeted delivery system to augment the therapeutic index."

TriSalus derives from the Roman goddess Salus, who represents health, prosperity, safety and welfare, while tri, represents the three strategic pillars of integrated cancer treatment. "The new name inspires our organization to make a meaningful difference for patients undergoing cancer treatment," added Szela.

The name change is one of many milestones supporting the transformation of the company. In 2018, the company:

Advanced its pipeline of drug delivery therapies with plans to launch its next-generation platform in 2019
Presented interim data from a national patient registry showing high tumor response rates among hepatocellular carcinoma patients treated with the company’s Pressure-Enabled Drug Delivery (PEDD) technology
Published a paper in the Journal of Vascular and Interventional Radiology indicating that further development of chimeric antigen receptor T cells (CAR-T) therapy should be done in combination with novel devices to allow for regional delivery of therapy into solid tumors
Closed a $5 million convertible note and initiated plans for Series E funding of $25 million to support investment in the company’s technology in combination with immuno-oncology therapy
About Pressure-enabled Drug Delivery (PEDD)

The high intratumoral pressure created by the tumor microenvironment limits the flow and accumulation of therapy in solid tumors. Pressure-Enabled Drug DeliveryTM (PEDD) can improve drug delivery to the tumor by creating a favorable pressure gradient that penetrates the hostile tumor microenvironment and increases drug concentration in the tumor without increasing systemic toxicity. Locoregional infusion with the company’s patented technology has been used in nearly 8,000 procedures worldwide for liver cancer and can be applied to a variety of other high-pressure solid tumors.