On May 19, 2015 Ipsen reported the signature of an agreement to acquire OctreoPharm Sciences (referred to as OctreoPharm), a private German life sciences company focusing on the development of innovative radioactive labeled compounds for molecular imaging diagnostics and therapeutic applications (Press release, Ipsen, MAY 19, 2015, View Source [SID:1234504593]). Ipsen plans to maintain the company location and staff to ensure successful transition of know-how and expertise. Ipsen expects to complete its acquisition once closing conditions have been cleared. Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, which is subject to closing conditions, OctreoPharm’s shareholders are eligible to receive up to a total of approximately €50 million for the purchase of 100% of the company’s shares in the form of an upfront payment and downstream payments contingent upon clinical and regulatory milestones.
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The transaction fits into Ipsen’s strategy to extend the scope of its portfolio and its leadership in neuroendocrine tumors (NET). OctreoPharm is developing an innovative theranostic approach for the management of NET based on a somatostatin receptor antagonist peptide. The therapeutic compound is a tumor cell-selective somatostatin antagonist peptide labeled with 177Lutetium ( 177Lu) for use as ‘peptide receptor radionuclide therapy’ (PRRT) for the treatment of neuroendocrine tumors, and is currently in preclinical development. The diagnostic compound is an NET imaging tool utilizing positron emission tomography (PET, PET/CT), and is currently in clinical development.
The acquisition includes an agreement with Eckert and Ziegler, one of OctreoPharm’s shareholders, to provide contract manufacturing services for the radio-labeling of the therapeutic compound.
Marc de Garidel, Chairman and CEO of Ipsen stated: "The acquisition of OctreoPharm will enlarge our footprint in the NET field, and gives Ipsen access to a new scientific field where OctreoPharm has a unique expertise in antagonist peptides for the diagnosis and treatment of neuroendocrine tumors. This is an important step in our ambition to become a global leader in the management of NET, and illustrates the pertinence of our business development strategy."
Advaxis and Sorrento Form Collaboration to Evaluate Combinations of Advaxis’s Lm-LLO Immunotherapy Technology and Sorrento’s Immunomodulatory Antibodies
On May 19, 2015 Advaxis reported it has entered into a non-exclusive research and clinical trial collaboration agreement with Sorrento Therapeutics to evaluate combinations of Advaxis’s Lm-LLO cancer immunotherapy technology platform, including ADXS-HPV, ADXS-PSA and ADXS-HER2, with Sorrento’s fully human antibodies targeting immune checkpoints, including GITR, OX40, LAG-3 and TIM-3 (Press release, Advaxis, MAY 19, 2015, View Source [SID:1234504592]). Sorrento has one of the largest and most diverse fully human antibody libraries in the industry designed to facilitate rapid identification and selection of highly specific therapeutic monoclonal antibody (mAb) product candidates. Schedule your 30 min Free 1stOncology Demo! Advaxis’s preclinical program for ADXS-HPV previously examined its therapeutic potential in combination with agonistic research antibodies, including anti-OX40 and anti-GITR. Preclinical data demonstrated that the combination of ADXS-HPV with agonistic research antibodies led to significant inhibition of tumor growth and prolonged survival in tumor-bearing mice. Complete regression of established tumors occurred in 40% and 60% of animals treated with ADXS-HPV in combination with anti-OX40 and anti-GITR antibodies, respectively (AACR Abstract #LB-229). Know more, wherever you are: "We welcome the collaboration with Sorrento to evaluate its immunomodulatory antibodies in combination with our Lm-LLO immunotherapy technology platform," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "Leveraging Sorrento’s fully human antibody library and Advaxis’s Lm-LLO immunotherapy technology offers a significant opportunity to target multiple cancer indications and extend the potential of our respective company’s technologies."
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Latest on Antibodies in Oncology, book your free 1stOncology demo here.
Under the terms of the agreement, Advaxis will conduct the studies and the companies will equally share the expenses. The companies hope to commence the first of the two planned combination studies in 2016. Results from the studies will be used to determine whether further clinical development of specific combinations is warranted.
"Clinical collaborations are an integral part of Sorrento’s strategy to accelerate the development of our diverse portfolio of immuno-oncology antibodies against a broad range of cancers," said Dr. Henry Ji, President and Chief Executive Officer at Sorrento. "We are encouraged by the data presented by Dr. Khleif at the AACR (Free AACR Whitepaper) Annual Meeting 2015, and believe there could be an important clinical benefit from the combination of our antibodies with Advaxis’s Lm-LLO immunotherapies."
Destum Partners acted as advisor to Advaxis for this collaboration agreement.
Genmab Enters Commercial DuoBody® Technology Agreement with BioNTech in Field of Immuno-oncology
On May 19, 2015 Genmab reported it has entered an agreement with BioNTech AG to jointly research, develop and commercialize bispecific antibody products using Genmab’s DuoBody technology platform (Press release, Genmab, MAY 19, 2015, View Source [SID:1234504586]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, BioNTech will provide proprietary antibodies against key immunomodulatory targets that play an important role in activating the immune system against cancer, while Genmab provides access to its DuoBody technology platform. Genmab will pay an upfront fee of USD 10 million to BioNTech and additional potential near-term payments of up to USD 5 million if certain BioNTech assets are selected for further development. If the companies jointly select any product candidates for clinical development, development costs and product ownership will be shared equally going forward. If one of the companies does not wish to move a product candidate forward, the other company is entitled to continue developing the product on predetermined licensing terms. The agreement also includes provisions which will allow the parties to opt out of joint development at key points. Know more, wherever you are: "This collaboration with BioNTech focuses on two very interesting areas in the antibody therapeutic space — bispecific antibodies and immuno-oncology – and supports Genmab’s strategy of creating a broad pipeline of differentiated next-generation antibody therapeutics," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
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Today’s agreement does not impact Genmab’s 2015 financial guidance.
OPKO Announces 4Kscore® Abstracts at the 2015 American Urological Association (AUA) Annual Meeting
On May 18, 2015 OPKO Health, Inc. (NYSE:OPK) reported six important new clinical trial results pertaining to the 4Kscore test presented at the 2015 American Urological Association (AUA) annual meeting, May 15 to May 19, 2015, in New Orleans (Press release, Opko Health, MAY 18, 2015, View Source [SID:1234506562]).
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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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Date and time, title and location of the 4Kscore presentations at the New Orleans Morial Convention Center (NOMCC):
Friday, May 15, 1:00 pm – Moderated poster MP6-04: The 4Kscore Test predicts high-grade prostate cancer on biopsy with PSA less than 4 ng/mL; NOMCC #220-221
Sunday May 17, 11:10 am – Urologic Oncology Forum podium presentation: Screening for lethal prostate cancer using PSA and related blood biomarkers; NOMCC #356-357
Sunday May 17, 12:50 am – Urologic Oncology Forum podium presentation: Use of commercial blood biomarkers to identify risk of aggressive prostate cancer; NOMCC #356-357
Monday, May 18, 8:00 am – Moderated poster MP60-06: The performance of the 4Kscore for predicting high-grade cancer on biopsy of the prostate does not depend on the age of the patient; NOMCC #206-207
Monday May 18, 10:30 am – Podium presentation PD38-03: The 4Kscore is associated with more advanced disease at radical prostatectomy; Results from a multi-Institutional prospective trial; NOMCC #215-216
Tuesday, May 19, 8:00 am – Moderated poster MP77-20: Among men with low-grade prostate cancer on prostate biopsy, the 4Kscore predicts more aggressive prostate cancer at prostatectomy; NOMCC 228-230
In addition to the regular AUA program presentations, the OPKO 4Kscore test will also be featured on Tuesday May 19th in an industry program titled "Biomarkers and Genomic Testing in Prostate Cancer: Integration Into Clinical Practice" from 10:00 – 11:00 am at NOMCC Science and Technology Hall #1043
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2). These biomarkers are combined with a patient’s age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between a Urologist and patient.
R&D alliance restructure presents new DNA damage response partnership opportunities including leading PolQ project
On May 18, 2015 Cancer Research Technology (CRT) reported that Teva Pharmaceutical Industries Ltd has returned a portfolio of DNA Damage Response (DDR) projects to CRT (Press release, Cancer Research Technology, MAY 18, 2015, View Source [SID1234523205]). The move, which follows a strategic decision by Teva to focus on market-ready or close-to-market assets in oncology, presents new partnership opportunities including a leading PolQ project.
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The alliance, which bought together world-leading Cancer Research UK scientists in the field of DDR research, CRT’s drug discovery team (CRT’s Discovery Laboratories) and Teva, has successfully established an early DDR portfolio that will continue to be developed by CRT’s Discovery Laboratories whilst a new partner is sought.
The portfolio includes a drug discovery programme targeting PolQ. PolQ is implicated in a wide range of roles including double strand break repair. It is anticipated that Inhibitors of PolQ will induce radiosensitisation in a range of cancers, and potentially exhibit stand alone activity in Homologous Recombination (HR) deficient tumours**.
The DNA damage response pathways can activate cell cycle checkpoints to stop cells dividing, or they can activate specific DNA repair pathways in response to certain types of DNA damage. Some of the proteins in these pathways are mutated, or non-functional in human tumours. This can cause cancer cells to be more reliant on an intact DNA repair pathway for survival providing a therapeutic window. Developing new drugs that target DDR is a promising new avenue of research to tackle this problem.
Dr Phil L’Huillier, said: "Together with Teva, CRT has created an exciting portfolio, backed by a world-class hub of expertise in DDR-related basic, translational, and clinical research, that we will continue to develop through our in-house drug discovery laboratories.
"This restructure represents a unique new partnership opportunity to research and develop first-in-class cancer drugs that exploit DNA damage and repair response processes to fight cancer."
. The move, which follows a strategic decision by Teva to focus on market-ready or close-to-market assets in oncology, presents new partnership opportunities including a leading PolQ project.
The alliance, which bought together world-leading Cancer Research UK scientists in the field of DDR research, CRT’s drug discovery team (CRT’s Discovery Laboratories) and Teva, has successfully established an early DDR portfolio that will continue to be developed by CRT’s Discovery Laboratories whilst a new partner is sought.
The portfolio includes a drug discovery programme targeting PolQ. PolQ is implicated in a wide range of roles including double strand break repair. It is anticipated that Inhibitors of PolQ will induce radiosensitisation in a range of cancers, and potentially exhibit stand alone activity in Homologous Recombination (HR) deficient tumours**.
The DNA damage response pathways can activate cell cycle checkpoints to stop cells dividing, or they can activate specific DNA repair pathways in response to certain types of DNA damage. Some of the proteins in these pathways are mutated, or non-functional in human tumours. This can cause cancer cells to be more reliant on an intact DNA repair pathway for survival providing a therapeutic window. Developing new drugs that target DDR is a promising new avenue of research to tackle this problem.
Dr Phil L’Huillier, said: "Together with Teva, CRT has created an exciting portfolio, backed by a world-class hub of expertise in DDR-related basic, translational, and clinical research, that we will continue to develop through our in-house drug discovery laboratories.
"This restructure represents a unique new partnership opportunity to research and develop first-in-class cancer drugs that exploit DNA damage and repair response processes to fight cancer."