On January 3, 2018 Syntimmune, Inc., a clinical-stage biotechnology company focused on FcRn biology, reported that the company has appointed Jean-Paul Kress, M.D., as President and Chief Executive Officer. Dr. Kress, who will also serve as a director of the company, brings senior leadership experience in pharmaceutical and biotechnology firms, with a focus on operations and commercialization of innovative products addressing unmet medical needs across diverse disease indications (Press release, Syntimmune, JAN 3, 2018, View Source [SID1234522846]). David de Graaf, Ph.D., has stepped down from his position as CEO and resigned from the company’s Board of Directors. Syntimmune co-founder Laurence Blumberg, M.D., will continue to serve as Syntimmune’s Chief Operating Officer and as a member of the Board.

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"Jean-Paul possesses decades of experience bringing to market therapies based on breakthrough science," stated Burt Adelman, M.D., Syntimmune’s lead independent director and advisor to the company. "We are very pleased to welcome this industry veteran at the helm of Syntimmune. We believe Jean-Paul’s leadership brings vision and expertise that will be transformational as the company matures toward becoming a late-stage development organization and continues to rapidly advance therapies targeting FcRn biology to patients."

Dr. Blumberg added, "We are grateful for David de Graaf’s many contributions during a period of substantial progress at Syntimmune, during which we initiated two mid-stage clinical trials of our lead candidate, SYNT001, and completed a successful Series B financing that has positioned us well for further advancement."

Prior to joining Syntimmune, Dr. Kress served as Executive Vice President and President, International, and Head of Global Therapeutic Operations at Biogen Inc., overseeing the company’s rare and specialty disease teams. Previously, Dr. Kress was Senior Vice President, Head of North America at Sanofi Genzyme, where he was instrumental in launching several therapeutic products, including dupilumab, the first biologic agent approved in atopic dermatitis. Prior to this, he was President and Chief Executive Officer of Sanofi Pasteur MSD, a vaccines joint venture of Sanofi and Merck & Co. Dr. Kress also held leadership roles at Gilead, serving as Vice President, US Sales and Marketing, and Vice President, General Manager for France. He began his industry career with Eli Lilly in France and held commercial and business development roles in the US and Europe at Abbott (now AbbVie). Dr. Kress received an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.

"I am excited to join the accomplished team at Syntimmune, which possesses world-class expertise in immunology and FcRn biology applicable to a broad range of autoimmune diseases," said Dr. Kress. "Syntimmune has made important strides in advancing its clinical development pipeline, and I look forward to the progress of the company’s ongoing Phase 1b/2a clinical trials of SYNT001 in pemphigus and warm autoimmune hemolytic anemia, as well as the anticipated commencement of clinical studies in additional indications."

On January 3, 2018 Syntimmune, Inc., a clinical-stage biotechnology company focused on FcRn biology, reported that the company has appointed Jean-Paul Kress, M.D., as President and Chief Executive Officer (Press release, Syntimmune, JAN 3, 2018, View Source [SID1234522867]). Dr. Kress, who will also serve as a director of the company, brings senior leadership experience in pharmaceutical and biotechnology firms, with a focus on operations and commercialization of innovative products addressing unmet medical needs across diverse disease indications. David de Graaf, Ph.D., has stepped down from his position as CEO and resigned from the company’s Board of Directors. Syntimmune co-founder Laurence Blumberg, M.D., will continue to serve as Syntimmune’s Chief Operating Officer and as a member of the Board.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Jean-Paul possesses decades of experience bringing to market therapies based on breakthrough science," stated Burt Adelman, M.D., Syntimmune’s lead independent director and advisor to the company. "We are very pleased to welcome this industry veteran at the helm of Syntimmune. We believe Jean-Paul’s leadership brings vision and expertise that will be transformational as the company matures toward becoming a late-stage development organization and continues to rapidly advance therapies targeting FcRn biology to patients."

Dr. Blumberg added, "We are grateful for David de Graaf’s many contributions during a period of substantial progress at Syntimmune, during which we initiated two mid-stage clinical trials of our lead candidate, SYNT001, and completed a successful Series B financing that has positioned us well for further advancement."

Prior to joining Syntimmune, Dr. Kress served as Executive Vice President and President, International, and Head of Global Therapeutic Operations at Biogen Inc., overseeing the company’s rare and specialty disease teams. Previously, Dr. Kress was Senior Vice President, Head of North America at Sanofi Genzyme, where he was instrumental in launching several therapeutic products, including dupilumab, the first biologic agent approved in atopic dermatitis. Prior to this, he was President and Chief Executive Officer of Sanofi Pasteur MSD, a vaccines joint venture of Sanofi and Merck & Co. Dr. Kress also held leadership roles at Gilead, serving as Vice President, US Sales and Marketing, and Vice President, General Manager for France. He began his industry career with Eli Lilly in France and held commercial and business development roles in the US and Europe at Abbott (now AbbVie). Dr. Kress received an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.

"I am excited to join the accomplished team at Syntimmune, which possesses world-class expertise in immunology and FcRn biology applicable to a broad range of autoimmune diseases," said Dr. Kress. "Syntimmune has made important strides in advancing its clinical development pipeline, and I look forward to the progress of the company’s ongoing Phase 1b/2a clinical trials of SYNT001 in pemphigus and warm autoimmune hemolytic anemia, as well as the anticipated commencement of clinical studies in additional indications."

On January 3, 2018 Foundation Medicine reported that Troy Cox, chief executive officer, is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 3:30 p.m. PST in San Francisco (Press release, Foundation Medicine, JAN 3, 2018, View Source [SID1234522851]). Additionally, Troy Cox will participate in a panel discussion focused on the Food & Drug Administration and Centers for Medicare and Medicaid Services Parallel Review process on Monday, January 8, 2018 at 5:15 p.m. PST.

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Live, listen-only webcasts of these presentations can be accessed by visiting the investors section of the Foundation Medicine website at investors.foundationmedicine.com. A replay of the webcasts will be available shortly after the conclusion of the presentation and archived on the company’s website for two weeks following the presentations.

On January 3, 2018 Rasna Therapeutics, Inc. (OTCQX: RASP), a clinical stage biotechnology company focused on the development of disease-modifying drugs for hematological malignancies, reported follow up Phase II clinical data showing that 4 out of 9 (44%) evaluable AML patients carrying the NPM1 gene mutation treated with actinomycin D ("Act D"), achieved complete remission (CR) (Press release, Rasna Therapeutics, JAN 3, 2018, View Source [SID1234522873]). Treatment with Act D was well tolerated, except that patients experienced oral mucositis as the major toxicity. Rasna Therapeutics has developed a proprietary nanoparticle based formulation of Act D (RASP-101), which is anticipated to maximize efficacy while minimizing oral mucositis. RASP-101 could potentially be a first-in-class modality for treatment of NPM1-mutated acute myeloid leukemia (AML).

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NPM1-mutated AML is a specific genetic leukemia entity that accounts for approximately one-third cases of AML in adults. As we reported previously, intravenous treatment of refractory or relapsed NPM1-mutated AML patients with Act D (12.5 µg or 15 µg/day) for 5 consecutive days produced hematological complete response in some of them (Falini et al., N Eng J Med. 373: 12, 2015).

In a follow-up phase II clinical study (ActD-AML-PG01, EudraCT 2014-000693-18) in refractory/relapse (R/R) AML patients carrying NPM1 gene mutation, treatment with Act D at 15 µg/kg/day for 5 days every 28 days induced CR in 4 out of the 9 evaluable patients (44.4%) with only 1 or 2 cycles of therapy. Three out of the 4 (75%) patients who obtained CR relapsed after 3, 5 and 7 months, respectively. One patient underwent haploidentical allogeneic PBSC transplantation at 3 months after CR achievement and is alive in molecular CR (MRD-negative) after 24 months.

"The precise mechanism of action of Act D in NPM1-mutated AML is still not clearly understood. Follow up data confirms our earlier findings and further support the use of Act D to induce complete hematological remissions with possible long-term molecular responses in NPM1-mutated AML patients. To note, our first previously reported NPM1-mutated AML patient (resistant to hypomethylating therapy) treated with Act D remains in molecular remission at over 3 years since CR achievement," said Dr. Brunangelo Falini, a member of the scientific advisory board of Rasna Therapeutics, Inc.

"We have developed a proprietary formulated Act D (RASP-101), which we anticipate will produce a superior clinical outcome with improved efficacy and safety profile. Emerging data from the multicenter clinical studies will allow us to develop a biomarker strategy to select responsive patients and improve clinical outcome for this unmet clinical need" commented Alessandro Padova, Chairman of Rasna.

About Actinomycin D (Dactinomycin)

Actinomycin D, also known as dactinomycin, a cytotoxic antibiotic produced by Streptomyces parvullus, was approved for medical use in the United States in 1964. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. It is believed to work by blocking RNA synthesis. The drug has been used to treat a number of types of cancers, including Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer.

About Dr. Brunangelo Falini, M.D.

Brunangelo Falini is the head of the Institute of Hematology and Hemopoietic Stem Cell Transplantation at the University of Perugia, Perugia, Italy. His research activity has mainly focused on the genetic characterization of lymphomas and leukemias using monoclonal antibodies and, more recently, NGS technologies. He led the research group who discovered NPM1 mutations in AML in 2005 and the BRAF-V600E mutation in hairy cell leukemia in 2011. Both these seminal discoveries have already translated into a better diagnosis and therapy of patients affected by these hematological malignancies. Dr. Falini is the recipient of numerous prestigious prizes, including the "Josè Carreras Award" from EHA (Free EHA Whitepaper) (Barcelona, 2010), the "Leopold Griffuel Prize" from ARC (Paris, 2015) and the "Prize for Excellence in Medicine" from the American-Italian Cancer Foundation (New York, 2017).

On January 3, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, reported that Allergan has exercised two options to develop and commercialize DARPin product candidates from its 2012 discovery alliance agreement with Molecular Partners (Press release, Molecular Partners, JAN 3, 2018, View Source [SID1234522825]). Upon receipt of approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, Molecular Partners will grant Allergan an exclusive license to the selected DARPin molecules for use in ophthalmology.

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Molecular Partners and Allergan entered into a broad discovery alliance in ophthalmology in 2012 aiming to develop novel multi-DARPin molecules for diseases with high unmet medical need. This alliance broadened the initial collaboration on abicipar, which is now in phase 3 development in wet AMD.

All amounts payable under these two option exercises are included in the aggregate milestone payments and the tiered royalty payments previously disclosed in our July 21, 2015 press release. Molecular Partners is entitled to certain success based development, regulatory and sales milestone payments aggregating up to USD 640 million, as well as tiered royalty payments (up to low double digit percentage range) on any future product sales. Allergan will be responsible for all future development costs.

"The DARPin platform is a key part of our strategy to develop highly differentiated drugs in ophthalmology," said David Nicholson, Chief R&D Officer, Allergan. "Our partnership with Molecular Partners continues to deliver such differentiated drug candidates and by exercising these options we will obtain exclusive rights to develop and commercialize these molecules and expand our efforts to address important diseases in ophthalmology. "

"We are excited to support our long-standing partner Allergan in advancing multi-DARPin product candidates. This is an important showcase of the value of the DARPin platform to deliver potential patient benefit in ophthalmology in addition to the work Molecular Partners is doing in oncology. I would like to thank the teams on both sides of the collaboration for their efforts and the achievement of this important milestone," commented Patrick Amstutz, CEO of Molecular Partners.

About abicipar
Abicipar is a long-acting mono-DARPin drug candidate that inhibits vascular endothelial growth factor A (VEGF-A) and is currently under investigation for the treatment of two major causes of blindness worldwide:
neovascular, or wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Abicipar has the potential to require less frequent injections into the eye than the current anti-VEGF standards of care, while providing equal or better improvements in vision, both seen as mayor patient benefits in these indications. Molecular Partners granted an exclusive license to Allergan for Abicipar in May 2011.

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and has entered into Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has just moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.