10-Q – Quarterly report [Sections 13 or 15(d)]

Apellis Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Apellis Pharmaceuticals, 2018, APR 30, 2018, View Source [SID1234527569]).

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Humanigen Names Dr. Tarek Sahmoud as Chief Medical Officer

On April 30, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments, reported Tarek Sahmoud, M.D., Ph.D., as its chief medical officer, initially a part-time role reporting to the company’s chief executive officer (Press release, Humanigen, APR 30, 2018, View Source [SID1234525836]).

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Dr. Sahmoud brings more than 25 years of experience in oncology drug development and medical and regulatory affairs to Humanigen. During his career, Dr. Sahmoud has led global oncology drug development programs in solid tumor and hematologic malignancies through regulatory approval and has advised on CAR-T programs. Dr. Sahmoud currently consults with leading CAR-T companies on their clinical and regulatory plans. He recently served as chief medical officer for H3 Biomedicine, a precision medicine company, and prior to that, he was vice president, oncology clinical development and medical affairs (USA), and global associate therapeutic area head (global) at Boehringer Ingelheim. He has served at Celgene as corporate vice president and global head of clinical development in solid tumors and immunoncology. Previously, Dr. Sahmoud was at Novartis as vice president and senior global clinical program head, oncology global drug development. He also held roles at Bristol-Myers Squibb as executive director, global medical affairs, oncology and at AstraZeneca as senior global medical director and US physician for breast cancer. In addition, he served at EORTC where he was responsible for all clinical trials coordination for several of the disease groups. Dr. Sahmoud received his medical degree from Cairo University Medical School, Egypt, and he holds a Ph.D. in public health, epidemiology and biostatistics from the University of Bordeaux II, France.

"Tarek is a strong addition to the Humanigen team, as he brings world-class abilities in oncology drug development and global regulatory strategy, coupled with domain expertise in the rapidly evolving CAR-T and immunoncology fields," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "Tarek will be instrumental in helping to guide the impending start of our clinical work to show lenzilumab’s potential to optimize CAR-T therapy to make it safer, better and more routine – and position our platform portfolio for maximum value for our stakeholders."

"I am excited to work with Humanigen and its clear opportunity and scientific rationale in granulocyte-macrophage colony-stimulating factor’s (GM-CSF) role in CAR-T-induced toxicities, including the unmet need of neurotoxicity, and optimizing CAR-T therapy overall," said Dr. Sahmoud. "I look forward to guiding the strategy and execution of Humanigen’s development programs to fulfill the ultimate goal of helping patients with significant unmet needs in oncology."

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic treatment to minimize neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase 1 trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML) with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well-tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo.

Editas Medicine to Present New Data Demonstrating Progress Towards Creating Genome Editing Medicines at the American Society of Gene & Cell Therapy Annual Meeting

On April 30, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that 10 scientific abstracts, including three from research collaborations, have been accepted for presentation at the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Editas Medicine, APR 30, 2018, View Source;p=RssLanding&cat=news&id=2345605 [SID1234525852]). The meeting will take place May 16-19 in Chicago. The Company is presenting data on its pipeline and platform technologies to support ongoing development programs.

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Key Editas Medicine presentations at ASGCT (Free ASGCT Whitepaper) will include data demonstrating:

EDIT-101, the Company’s experimental medicine for the treatment of Leber Congenital Amaurosis type 10, administered to non-human primates via subretinal injection was well-tolerated;
Therapeutically relevant editing levels in non-human primates regardless of pre-existing or induced immunity to Staphylococcus aureus Cas9;
Specificity of EDIT-101 with no verified off-targets in the human genome as assessed by a two-staged approach using orthogonal methods;
In vitro validation of an exon deletion editing strategy with the potential to treat Usher Syndrome type 2a (USH2A)-associated retinal disease;
In vivo proof-of-concept in animal models for developing a CRISPR-based medicine for the treatment of ocular herpetic keratitis caused by latent herpes simplex virus-1 (HSV-1); and
Fetal hemoglobin induction by editing of novel therapeutic sites identified through saturation genomic CRISPR screening of the beta-globin locus as a potential treatment for sickle cell anemia.
In addition, Editas Medicine’s Chief Scientific Officer will speak at the ASGCT (Free ASGCT Whitepaper) Gene Editing Workshop, a pre-meeting program, on May 15.

"We are making significant scientific advances in our programs to unlock the potential of CRISPR genome editing for making medicines," said Charles Albright, Ph.D., Chief Scientific Officer, Editas Medicine. "At ASGCT (Free ASGCT Whitepaper), we will showcase our recent scientific advances as we make progress towards the clinic and towards our goal of making medicines for people living with serious diseases."

The complete list of Editas Medicine presentations is below. Abstracts can be accessed on the ASGCT (Free ASGCT Whitepaper) website at View Source

Oral Presentation:
Evaluation of Tolerability and Immunogenicity of EDIT-101 Following Subretinal Injection in Non-human Primate
Date/Time: May 18, 4:00 – 4:15 p.m.
Location: Salon A-5
Session: Preclinical Pharmacology and Toxicology Studies and Assessment of Gene Therapy in Large Animal Models

Editas Medicine Poster Presentations:

Treatment of Herpetic Keratitis with CRISPR/Cas9 Gene Editing in a Rabbit Disease Model
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases) I

Potent HbF Induction Following ssODN-Mediated Repair of Cas9-Induced DSB at the HBG Promoter in CD34+ HSPC
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Saturated Mutagenesis Surrounding Beta-globin Locus Identifies Novel Therapeutic Targets for Fetal Globin Induction and Treatment of Sickle Cell Anemia
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases I

Improving Efficacy of CAR T cells Through CRISPR/Cas9 Mediated Knockout of TGFbR2
Date/Time: May 16, 5:30 – 7:30 p.m.
Location: Stevens Salon C, D
Session: Cancer – Targeted Gene & Cell Therapy I

Efficient Targeted Integration in Human T cells with CRISPR-Cas9 for the Treatment of X-Linked Hyper-IgM Syndrome
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases II

Gene Editing Specificity Assessment for EDIT-101, an LCA10 Therapeutic Candidate
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Pharmacology/Toxicology Studies or Assay Development

Research Collaboration Poster Presentations (Editas Medicine Author):

Development of an Assay to Detect Pre-existing Anti-Cas9 Antibodies and an Estimate of the Prevalence of Anti-Staphylococcus- and Streptococcus-Cas9 Antibodies in the US Population
Date/Time: May 17, 5:15 – 7:15 p.m.
Location: Stevens Salon C, D
Session: Gene Targeting & Gene Correction II

Preclinical Modeling Highlights the Therapeutic Potential of the Adoptive Transplant of Gene Corrected T cells in X-Linked Hyper-IgM Syndrome
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Hematologic & Immunologic Diseases

Evaluation of Therapeutic Potential of Human USH2A Gene Lacking Exon 13 (USH2A-∆Ex13) for Restoring Ciliogenesis
Date/Time: May 18, 5:45 – 7:45 p.m.
Location: Stevens Salon C, D
Session: Neurologic Diseases (Including Ophthalmic and Auditory Diseases)

10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

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ISA Pharmaceuticals Appoints Leon Hooftman as Chief Medical Officer

On April 30, 2018 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, reported the appointment of Leon Hooftman, MD, to the position of Chief Medical Officer (CMO), effective May 1, 2018 (Press release, ISA Pharmaceuticals, APR 30, 2018, View Source [SID1234525837]). He brings many years of experience in drug development and academic research and has a strong track record in early- and late-stage clinical development with specific expertise in immuno-oncology.

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"As we are planning to start two new clinical programs with ISA101b together with Regeneron as well as other clinical trials, we are happy to further strengthen the team with a new Chief Medical Officer. We are delighted to welcome Leon Hooftman to the ISA team, he brings very valuable experience in the clinical development of immuno-oncology therapies in big pharma as well as in biotech companies." said Ronald Loggers, CEO of ISA. "We would like to thank Rick Stead for his valuable support over the recent years and are pleased that he will continue to be involved as an advisor to ISA."

After academic medicine, Leon Hooftman became an accomplished pharmaceutical physician with more than 20 years of experience in drug development in immunology, haematology, and oncology, and with several New Drug Applications to his credit. Previous positions include Head of Clinical Development at Celltech Group Plc (UCB), and Chief Medical Officer of Chroma Therapeutics. Dr. Hooftman joins ISA from Allecra Therapeutics Ltd, a French-German biopharmaceutical company, where he served as CMO. Before moving into biopharmaceutical drug development, Leon was Director Clinical Science, Oncology and Immunology, at F. Hoffmann-LaRoche, where, amongst others, he led the clinical team that successfully completed a registration study with rituximab which gave the antibody its first approval in a first-line cancer indication (first-line NHL). Dr. Hooftman is an experienced clinician and has initiated and successfully completed multiple clinical studies in immunology, oncology and immuno-oncology. He is also an accomplished scientist and author of more than 50 scientific papers and publications.

"I am excited to join the team at ISA Pharmaceuticals," said Leon Hooftman. "The clinical data generated with ISA’s SLP- and AMPLIVANT-based product candidates so far look very promising and I am looking forward to advancing these unique therapeutic candidates closer towards pivotal development stage which will benefit patients with early as well as advanced cancer."