On July 11, 2016 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, and Servier, the largest non-listed pharmaceutical company in France, reported a license and collaboration agreement for the development, manufacture and commercialization of products using Sorrento’s fully human immuno-oncology anti-PD-1 monoclonal antibody (mAb) STI-A1110 (Press release, Sorrento Therapeutics, JUL 11, 2016, View Source [SID:1234513813]). Schedule your 30 min Free 1stOncology Demo! Sorrento’s proprietary G-MAB library platform was used to identify and generate STI-A1110, which targets PD-1, one of the key targets in the rapidly developing immuno-oncology therapy market. The agreement provides Servier with an exclusive worldwide license to Sorrento’s STI-A1110 mAb asset, covering all indications including hematological and solid tumor cancers. Servier also obtains full rights to develop, register and commercialize the products and will bear all costs for these activities.
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The financial terms of the agreement include, among other things, a non-refundable upfront payment to Sorrento of €25 million. Sorrento may also receive development milestone payments for the initial product and each additional product. Sorrento may receive up to €710 million in various payments based on commercial sales milestones related to annual net sales levels for the initial product and then also for each additional product. In addition to the commercial sales milestones, Sorrento will be entitled to receive variable royalties on the sales of all commercialized products ranging from high single-digit to double-digit percentages.
"We are excited about partnering on our anti-PD-1 immune checkpoint antibody with Servier, which is recognized for its scientific excellency and as a pioneer in CAR-T therapies. This agreement represents validation for Sorrento’s antibody technologies and R&D capabilities," stated Dr. Henry Ji, President and CEO of Sorrento. "This also further establishes Sorrento as a notable immuno-oncology company with a comprehensive portfolio of clinical stage and preclinical immunotherapies. We look forward to working closely with the Servier team and growing this global partnership."
"We have tested STI-A1110 in preclinical studies conducted at Servier and we believe that, used in combination with several products from our portfolio, it will lead to the development of new treatments for hematological as well as solid tumor cancers," added Dr. Jean-Pierre Abastado, Director of the Oncology Innovation Therapeutic Pole for Servier.
Month: July 2016
PIERIS PHARMACEUTICALS ANNOUNCES PRESENTATION OF DATA FOR ITS LEAD IO BISPECIFIC PROGRAM, PRS-343, AT THE 2016 CRI-CIMT-EATI-AACR INTERNATIONAL CANCER IMMUNOTHERAPY CONFERENCE
On July 9, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer and other diseases reported that it will be presenting a poster at the 2016 CRI-CIMT-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) -Translating Science into Survival, taking place in New York City, September 25-26, 2016 (Press release, Pieris Pharmaceuticals, JUL 9, 2016, View Source [SID:1234515005]).
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The poster entitled "Costimulatory T-cell engagement by PRS-343, a CD137 (4-1BB)/HER2 bispecific, leads to tumor growth inhibition and TIL expansion in humanized mouse model," will be presented on September 26, 2016.
Session Title: Poster Session
Session Subtitle: New Agents and Their Mode of Action in Animals and Humans
Poster Number: B016
Session Date: Monday, September 26, 2016
Presentation Time: 5:15 p.m. to 7:45 p.m. ET
Session Location: New York Hilton Midtown – Grand America Hall I
About PRS-343
PRS-343 is a bispecific monoclonal antibody/Anticalin fusion protein comprised of a HER2 tumor-targeting mAb genetically linked to a potent anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the Tumor Micro-Environment (TME). 4-1BB is an established marker for tumor-specific infiltrating T lymphocytes (TILs) and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.
Alligator contracts BioInvent for process development and cGMP manufacturing of the immuno-oncology drug candidate ADC-1015
On July 8, 2016 Alligator Bioscience AB is a privately held Swedish biotech company developing immuno-oncology antibodies for tumor-directed immunotherapy (Press release, Alligator Bioscience, JUL 8, 2016, View Source [SID1234538692]). Alligator reported has contracted BioInvent for process development and cGMP manufacturing of the immuno-oncology drug candidate ADC-1015. The agreement will supply Alligator with ADC-1015 Drug Product for early clinical trials.
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Alligator has a strong pipeline consisting of 5 drug candidates. ADC-1013 is an immune activating antibody directed against CD40, developed for treatment of metastatic cancer. Clinical trials in cancer patients were initiated early 2015, and ADC-1013 was later the same year out-licensed to Janssen Biotech, a Johnson & Johnson oncology company. ADC-1015 is a bispecific immune activating antibody that targets OX40 and CTLA-4. Since both OX40 and CTLA-4 are expressed on T cells in the tumor area, ADC-1015 is expected to induce strong tumor-directed immune activation. ADC-1015 has the potential to become first-in-class in this category of immune activating bispecific antibodies. In addition to ADC-1013 and ADC-1015, Alligator has three drug candidates in research phase.
For further information, please contact:
Per Norlén, CEO Alligator Bioscience AB, Office number: +46 46 2864280
ENGOT and TESARO Partnership Generates Positive Data From ENGOT-OV16/NOVA Phase 3 Trial
On July 08, 2016 ENGOT (European Network of Gynaecological Oncology Trial Groups), reported that the Phase 3 ENGOT-OV16/NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS) (Press release, TESARO, JUL 8, 2016, View Source [SID:1234513775]). This trial is led by NSGO (Nordic Society of Gynaecological Oncology) in partnership with TESARO, Inc. and is the first successful Phase 3 trial of a PARP inhibitor to be completed in ovarian cancer. More than 500 patients with recurrent disease who were in response to their most recent platinum-based chemotherapy regimen enrolled in the trial.
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As previously reported, this trial demonstrated that niraparib significantly prolonged PFS compared to control among patients who are germline BRCA mutation (gBRCAmut) carriers, among patients who are not germline BRCA mutation (non-gBRCAmut) carriers but who have homologous recombination deficient (HRD) tumors as determined by the Myriad myChoiceHRD test, and overall in patients who are not germline BRCA mutation carriers.
"The data suggest that niraparib, if approved, will be a step forward in the management of our patients and a potential new treatment option for ovarian cancer patients," said Mansoor Raza Mirza, M.D., Study Chair and Medical Director of NSGO.
"ENGOT with their collaborative clinical trial groups has put a lot of effort to bring this trial to success and this is a great example how today international collaboration between academic groups and industry can benefit patients," said Christian Marth, President of ENGOT.
"We are extremely grateful to the patients, caregivers, and investigators, including our partners at ENGOT, who participated in this trial. The results of this study demonstrate that a single, daily, oral dose of niraparib is superior to control in prolonging PFS in women with recurrent ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "In keeping with our mission of responsible drug development, ENGOT-OV16/NOVA was designed to define those patients most likely to benefit from niraparib treatment and, in so doing, optimize the benefit/risk profile for patients. We believe we have achieved that goal and look forward to our presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress in October."
About the Phase 3 ENGOT-OV16/NOVA Clinical Trial
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that planned to enroll 490 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut). The non-gBRCAmut cohort included patients with HRD-positive tumors, including those with somatic BRCA mutations and other HR defects, and patients with HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS2, overall survival, and other measures of safety and tolerability.
The most common (≥10%) treatment-emergent grade 3/4 adverse events among all patients treated with niraparib were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). Adverse events were generally managed via dose modifications. The discontinuation rate was 14.7% for niraparib treated patients and 2.2% for control.
More information about this trial is available at View Source
Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA or any other regulatory agencies.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes the Phase 3 trial in patients with ovarian cancer (the NOVA trial) as described above; a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial); and a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial). Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan
BioInvent enter process development and manufacturing collaboration with Alligator
On July 8, 2016 BioInvent International (BINV) reported that it has signed an agreement with Alligator Bioscience AB to provide process development and manufacturing services for Alligator’s new bispecific antibody, ADC-1015 (Press release, BioInvent, JUL 8, 2016, View Source [SID:1234513774]). Schedule your 30 min Free 1stOncology Demo! "The agreement with Alligator to manufacture its new bispecific antibody ADC-1015 speaks to our leading expertise when it comes to manufacturing of antibodies. Our manufacturing facility will be upgraded during 2016 which includes installation of a Single Use Bioreactor (SUB). This enables delivery according to timelines defined by Alligator. The agreement is expected to generate revenues of more than SEK 20 million," says Michael Oredsson, President and CEO of BioInvent.
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‘We are pleased that BioInvent has committed to process development and manufacturing of the bispecific immune-activating antibody ADC-1015. Alligator has very high expectations of this candidate drug which could be the first of its kind within immuno-oncology. BioInvent’s long experience and upgraded GMP certified manufacturing facility meet our needs for the coming clinical trial and will enable us to move ADC-1015 through to the clinic according to plan", says Per Norlén, CEO of Alligator Bioscience AB.
The agreement includes payments for development services and GMP manufacturing for the coming clinical trial. The revenues are expected to be generated in the period 2016-2018, with the majority in 2017. Other terms will not be disclosed.