Moderna, Inc. is a biotechnology company that is focused on creating a transformative medicines based on messenger RNA (mRNA). The Company’s mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane, or secreted proteins that have a therapeutic or preventive benefit with the potential to address a range of spectrum of diseases. The Company develops technologies that enable the development of mRNA medicines for diverse applications. The Company has created modalities, including Prophylactic vaccines, Systemic secreted and cell surface therapeutics, Cancer vaccines, Intratumoral immuno-oncology, Localized regenerative therapeutics, and Systemic intracellular therapeutics. Its diverse development pipeline which consists of 27 development candidates across its 24 programs.
BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases. It develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.
Zynerba New Patent “Treatment of Autism Spectrum Disorder with Cannabidiol”
The USPTO has issued Zynerba Pharmaceuticals (NASDAQ:ZYNE), Patent No. 10,314,792, titled “Treatment of Autism Spectrum Disorder with Cannabidiol” which includes claims directed to methods of treating autism spectrum disorder by administering a therapeutically effective amount of synthetic cannabidiol.
The new patent will expire in 2038.
The issuance of this patent comes as enrollment progresses in Phase 2 BRIGHT study evaluating the safety, tolerability and efficacy of Zygel for the treatment of children and adolescents with Autism Spectrum Disorder.
EXEL $19.33 -0.46 (-2.32%)
Exelixis is on a Mission to Help Cancer Patients Recover Stronger and Live Longer
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need.
Our discovery efforts have resulted in four approved products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO™ (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
ZIOPHARM Oncology, Inc., a biotechnology company, focuses on acquiring, developing, and commercializing a portfolio of immuno-oncology therapies for treating heterogenous solid tumors and unknown antigens. The company develops two immuno-oncology platform technologies, including Sleeping Beauty (SB), which is based on the genetic engineering of immune cells using a non-viral transposon/transposase system to reprogram T-cells outside of the body for infusion; and Controlled IL-12, which delivers interleukin 12 or IL-12, a master regular of the immune system, in a controlled and safe manner to focus the patient’s immune system to attack cancer cells.
Its lead gene therapy product candidate is Ad-RTS-hIL-12 plus veledimex, which is in Phase I clinical trial, to treat patients with recurrent glioblastoma and breast cancer. The company is also developing chimeric antigen receptor (CAR) T-cell and T-cell receptor T-cell therapies. ZIOPHARM Oncology, Inc. has license agreement with Precigen, Inc. and MD Anderson Cancer Center; research and development agreement with the National Cancer Institute, and Ares Trading S.A. The company is headquartered in Boston, Massachusetts.
Multikine Immunotherapy in Head and Neck Cancer
CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It is focused on the development of Multikine (Leukocyte Interleukin, Injection), an investigational immunotherapy under development for the treatment of certain head and neck cancers, and anal warts or cervical dysplasia.
Cel-Sci Corporation (CVM) is a small-cap market ($78M) clinical stage cancer biopharmaceutical company.
Acquiring “Select”, the Leading Cannabis Wholesale Brand in the U.S.
Curaleaf Holdings (OTCPK:CURLF) announces a deal to purchase the the cannabis business of Cura Partners (owners of the Select brand) in an all-stock deal valued at just under $1B. Brings together two of the most well-known, fastest growing cannabis brands on the East Coast and West Coast
Combines the largest retail operator and the highest revenue generating wholesaler in the U.S., achieving significant operational synergies. Accelerates growth, diversifies product range and expands customer reach and accessibility
Idera Pharmaceuticals, Inc.: Lead candidate Tilsotolimod (TLR 9 agonist) used in comb w Ipi in PD1 refractory melanoma pts. Enrolling addl pts in Ph 2 expansion and Phase 3 enrollment expected to complete Q4 2019. Combo of ipi and Tilsotolimod appears to activate immune response in pts who have exhausted all options, e.g. PD1/CPIs. Fast Track des for Tilsotolimod (Nov’17).
Receives Fast Track Designation for Zygel™
DEVON, Pa., May 06, 2019 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company’s lead development candidate Zygel™ (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome (FXS). FDA’s Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs, and can lead to expedited review by FDA in order to get new important drugs to the patient earlier.
About Fast Track Designation
Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions so that a product can reach the market expeditiously. A drug that is intended to treat a serious or life-threatening condition that demonstrates the potential to address an unmet medical need may qualify for Fast Track designation. Features of this designation include opportunities for frequent interactions with the review team. These include meetings with the FDA to discuss items such as study design, extent of safety data required to support approval, dose-response concerns, accelerated approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for priority review if supported by clinical data at the time of NDA.
From $70 to $7 ~ What Happened ? Excellent Product
Endologix Inc develops, manufacture, market, and sell innovative medical devices for the treatment of aortic disorders in the United States and internationally. The company only reporting segment that is focused on the development, manufacture, marketing, and sale of EVAR and EVAS products for the treatment of aortic disorders.
It product Includes a variety of endovascular stent grafts for the treatment of abdominal aortic aneurysms such as AFX Endovascular AAA System, VELA Proximal Endograft, and Ovation Abdominal Stent Graft System. The firm generates the majority of its revenue in the United States.
Cel-Sci Corporation (CVM) is a small-cap market ($186M) clinical stage cancer biopharmaceutical company. Multikine, a cocktail combination of cytokines and chemokines, is a prospective neoadjuvant treatment and an investigational drug candidate
Cel-Sci stock has appreciated over 30% in the last 3 weeks on IDMC recommendation that the Phase 3 study should continue until the requisite number of events have occurred.
Multikine is an innovative immunotherapeutic approach in clinical development for advanced primary head and neck squamous cell carcinoma, a fatal disease with limited therapeutic options.
As first-line therapy, multikine is designed to boost/enhance the anti-tumor responses of the immune system prior to standard of care treatment.
HNSCC accounts for ~4% of all cancers in the United States. Clinical success with multikine therapy would be a medical breakthrough for patients affected by this disease.
The top-line data readout for Multikine in Phase 3 HNSCC is expected possibly in 2019.