On 8 January 2014 AstraZeneca reported that MedImmune, its global biologics research and development arm, has entered into an oncology research collaboration and licensing agreement with Immunocore Limited, a privately-held, UK-based biotechnology company. Both companies will research and develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology Schedule your 30 min Free 1stOncology Demo! .
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This platform of biological medicines, or ImmTACs, exploits the power of the body’s own immune system to find and kill diseased cells. ImmTACs direct a patient’s T cells to specifically destroy only the cancerous cells, avoiding damage to healthy cells.
Under the terms of the agreement, Immunocore and MedImmune will work together to generate ImmTACs against selected cancer targets. AstraZeneca and MedImmune will have the right to further develop and commercialise ImmTAC products to add to their immune-mediated cancer therapy portfolio. Immunocore will receive an upfront payment of $20 million per programme and the company is then eligible to receive up to $300 million in development and commercial milestone payments for each target programme and significant tiered royalties if the programmes are successful.
"We look forward to collaborating with Immunocore on this promising area of cancer research that has the potential to further enhance our immune-mediated cancer therapy portfolio for patients with a range of cancer types," said Dr. Bahija Jallal, Executive Vice President, MedImmune. "Immunocore has a strong track record with its innovative ImmTAC technology, and presents a significant opportunity for us to achieve treatment breakthroughs in the area of immune-mediated cancer therapies."
Oncology is a core therapy area for AstraZeneca spanning both small molecule and biologics research and development. The company is developing a comprehensive portfolio in immune-mediated cancer therapies, and the collaboration with Immunocore will help expand MedImmune’s portfolio of agents that harness the patient’s own immune system to fight cancer in a very tumour-targeted way.
"We are delighted to be collaborating with MedImmune, a leader in the development of biotherapeutics with particular strengths in oncology," said James Noble, Chief Executive Officer, Immunocore. "We look forward to working together to develop ImmTAC therapies against cancer targets and address the unmet medical needs of many thousands of cancer patients."
NOTES FOR EDITORS
About ImmTACs
Immunocore’s ImmTAC (Immune mobilising mTCR Against Cancer) technology enables the immune system to recognise and kill cancer or viral cells.
T Cell Receptors naturally recognise diseased cells and Immunocore’s competitive advantage is its ability to engineer high affinity T Cell Receptors and link them to an anti-CD3 antibody fragment, which can activate the immune system to kill the targeted cancer or viral cells. These biological medicines, called ImmTACS, have the potential to be extremely potent anti-cancer or anti-viral agents. For more information: www.immunocore.com.
Author: [email protected]
Apogenix to Present Phase II Results with APG101 for the Treatment of Recurrent Glioblastoma at Biotech Showcase in San Francisco
January 13, 2014 Apogenix, a clinical stage biopharmaceutical company, reported the successful completion of its phase II proof-of-concept trial with APG101 in patients with recurrent glioblastoma. All endpoints of the randomized controlled trial that compared the efficacy and safety of a combination therapy of APG101 and radiotherapy versus radiotherapy alone were achieved or exceeded. During treatment with APG101 for up to two years, no drug-related serious adverse events were observed, underlining the excellent safety profile and very good tolerability of APG101. The study’s primary endpoint – progression-free survival at six months (PFS6) – was met with a statistically significant fivefold improvement in the rate of patients reaching PFS6, as previously reported (Press release, Apogenix, JAN 7, 2014, View Source [SID1234524581]). The results demonstrate that patients having a newly-identified epigenetic biomarker associated with the CD95 ligand – the target of APG101 – experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant (p=0.003) prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 6.5 months in patients treated with radiotherapy alone. This biomarker will be validated in future clinical trials and in additional indications.
"The results of the trial have exceeded our expectations," said Harald Fricke, M.D., Chief Medical Officer of Apogenix. "Besides Temodar and Gliadel, APG101 is the first drug candidate in nearly 20 years that has demonstrated a substantial increase in overall survival in a randomized controlled phase II trial. All clinical endpoints show a clear advantage of the treatment group over the control group and thus demonstrate the clinical efficacy of APG101 in the treatment of recurrent glioblastoma."
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"We are currently developing a companion diagnostic to identify patients who will most likely respond best to treatment with APG101, so glioblastoma patients can benefit from a personalized treatment approach. Apogenix is in close consultation with the regulatory authorities EMA and FDA to agree on a development strategy toward rapid approval of APG101 for the treatment of glioblastoma," Harald Fricke added.
The complete data set will be published in a high-impact medical journal. Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix, will present a summary of the results at the Biotech Showcase in San Francisco. The presentation will take place on Tuesday, Jan. 14, at 4 p.m. PST at the Parc 55 Wyndham San Francisco – Union Square.
About the Phase II Trial in Recurrent Glioblastoma
A total of 84 patients at 25 clinical sites in Germany, Austria, and Russia participated in this randomized controlled phase II efficacy trial in recurrent glioblastoma. Patients were eligible for inclusion if they suffered from first or second relapse of glioblastoma and were refractory to standard therapy. Patients randomized into the APG101 arm were treated until further disease progression. At this time, there are still seven surviving patients in the treatment group and one patient in the control group who are being monitored in order to collect overall survival data.
(Press release, Horizon Discovery, JAN 7, 2014, View Source,%20collaboration%20and%20license%20agreement%20with%20astrazeneca [SID:1234505071])
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Sutro Biopharma to Collaborate With Memorial Sloan-Kettering Cancer Center to Produce Bispecific Antibodies for the Treatment of Neuroblastoma
On January 7, 2014 Sutro Biopharma reported that it has entered into a collaboration agreement with Memorial Sloan-Kettering Cancer Center to use Sutro’s proprietary cell-free protein synthesis technology to produce bispecific antibodies that were discovered by Memorial Sloan-Kettering for the treatment of neuroblastoma in children (Press release Sutro Biopharma, JAN 7, 2014, View Source [SID:1234500756]).
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"Neuroblastoma is the most common extra-cranial solid tumor in children, and long-term survival for children with advanced disease diagnosed after 18 months of age is unsatisfactory despite aggressive chemotherapy," said Trevor Hallam, Ph.D., chief scientific officer of Sutro. "Sutro’s technology allows the generation, and importantly, the rapid screening of a large number of variations of bispecific antibodies. This will enable us to take bispecific antibodies with the desired characteristics faster into the clinic and potentially provide pediatric neuroblastoma patients with a much needed effective treatment option to combat this disease."
Under the collaborative agreement Sutro will use its cell free protein synthesis technology to produce four different bispecific antibodies discovered by Memorial Sloan-Kettering. These antibodies will be directed against CD3 on T-cells and, as the second target, against the ganglioside GD2, which is expressed on the surface of human neuroblastoma cells, as well as in melanoma and osteosarcoma. Nai-Kong V. Cheung, M.D., Ph.D., head of Memorial Sloan-Kettering’s Neuroblastoma program, will use preclinical models to test the bispecific antibodies manufactured by Sutro.
Dr. Cheung added, "We and others have previously shown that the use of an anti-CD3 and anti-GD2 bispecific antibody has a strong scientific rationale, and anti-GD2 monoclonal antibodies targeting the ganglioside GD2 have demonstrated efficacy in clinical trials in pediatric neuroblastoma. We hope that the use of Sutro’s technology will facilitate a more rapid, high-throughput optimization of these bispecific antibodies in the future, and allow us to investigate novel variants of these molecules quickly before bringing the winner to the clinic."
Eleison Announces Achievement of Enrollment Milestone in its Phase II Trial of ILC for Pediatric Bone Cancer
On January 3, 2014 Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, reported that it has passed the half-way point for enrollment in the first stage of its ongoing Phase II study of ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of patients with pediatric osteosarcoma (bone cancer) (Press release, Eleison Pharmaceuticals, JAN 3, 2014, View Source [SID1234517400]). The single-arm trial employs a Simon two-stage design and is evaluating the safety and efficacy of ILC. Currently, eight centers in the U.S. are open for patient enrollment, and additional sites are expected to open in the coming weeks. More information about the study may be found at the www.clinicaltrials.gov website.
"Osteosarcoma often spreads to the lungs, which unfortunately is difficult to treat and has a poor prognosis," commented Dr. Forrest Anthony, CMO of Eleison Pharmaceuticals. "ILC has been designed to treat patients with lung metastases, and thus the ongoing Phase II study is enrolling patients who have recently experienced a first or second pulmonary recurrence," indicated Dr. Anthony.
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