Amgen & Xencor to Co-Develop Novel Antibody; Deal Worth $500 Million
Xencor, Inc. and Amgen recently announced they will collaborate to develop XmAb5871, an Fc-engineered monoclonal antibody dually targeting CD19 and CD32b. XmAb5871 is currently in late-stage preclinical development for the treatment of autoimmune diseases.
Under the terms of the agreement, Amgen has the option to an exclusive worldwide license following the completion of a predefined Phase II study. Xencor will lead all clinical development until that time. Xencor will receive up-front and early development milestone payments. If Amgen does exercise its option, Amgen will assume responsibility for future development, Xencor will receive an option-exercise fee, which combined with the up-front and early development milestones, will total $75 million, and Xencor could receive up to an additional $425 million in clinical, regulatory, and commercialization milestone payments. Xencor will receive tiered royalties on future sales of XmAb5871.
Xencor’s CD32b technology is a novel immunomodulatory platform consisting of engineered Fc domains with selective high affinity binding to FcyRIIb (CD32b), a receptor with dominant inhibitory activity on B cells and other immune cells. The CD32b pathway has never been therapeutically exploited and applied to high affinity antibodies targeting immune cells.
“XmAb5871 provides a novel approach to suppress B-cell function, which will enhance Amgen’s internal efforts in inflammatory diseases,” said Joseph P. Miletich, MD, PhD, Senior Vice President, Research & Development at Amgen. “We are delighted to have the opportunity to partner with Xencor in exploring their novel immunomodulatory approach.”
“Amgen’s long-time leadership in antibody development for oncology and inflammatory diseases aligns seamlessly with Xencor’s pipeline development,” said Bassil Dahiyat, PhD, CEO of Xencor. “We expect that XmAb5871 will soon become the fifth XmAb-engineered antibody in clinical development. This program is a testament to the progress we’ve made expanding the XmAb platform into autoimmune disease with our CD32b technology, which is at the core of the XmAb5871 compound. The option deal structure allows us to continue to lead the development of XmAb5871 while also leveraging Amgen’s experience in developing novel biologics for unmet medical needs.”
Xencor, Inc. engineers superior biotherapeutics using its proprietary Protein Design Automation® technology platform, and is a leader in the field of antibody engineering to significantly improve antibody half-life, immune-regulatory function and potency. The company is advancing multiple XmAb® antibody drug candidates into the clinic, including XmAb®5871 targeting CD32b and CD19 for autoimmune diseases, an anti-CD30 candidate XmAb®2513 which completed a Phase 1 clinical trial for the treatment of Hodgkin’s lymphoma, and a portfolio of biosuperior antibodies that are versions of blockbuster antibody drugs engineered for superior half-life and dosing schedule.
Xencor’s antibody engineering technology has been licensed through multiple partnerships with industry leaders, such as Pfizer, Centocor, MorphoSys, Boehringer Ingelheim, CSL Ltd., and Human Genome Sciences. In these partnerships, Xencor is applying its suite of proprietary antibody Fc domains to improve antibody drug candidates for traits such as sustained half-life and potency.
Evonik & Boehringer Ingelheim Sign Agreement on the
Evonik Industries and Boehringer Ingelheim Pharma GmbH & Co. KG recently signed an agreement on the sale of the Resomer® business to Evonik. The completion of the transaction is subject to various conditions and closing is expected in early March 2011.
Under the agreement, the entire product portfolio of standard and customized polymers used in the manufacturing of medical devices and pharmaceutical formulations will be transferred to Evonik. Based on lactic and glycolic acids, the Resomer polymers are fully biodegradable in the body. The addition of this polymer platform and associated application areas will complement the EUDRAGIT® business of Evonik, a leader in functional excipients for oral dosage forms, and will strengthen Evonik’s pharmaceuticals market segment in line with its stated strategic intent. Both companies agreed not to disclose information on the sale price.
“By acquiring the Resomer business, we are strengthening our position as a strategic partner and solution provider to the pharmaceutical industry,“ said Dr. Klaus Engel, CEO of Evonik Industries AG. “This affords us the opportunity to service new pharmaceutical application areas and achieve greater value creation and growth.”
“In Evonik, we are convinced we have found a company that acts responsibly and will succeed in further developing the Resomer business according to clear strategic objectives,” added Prof. Dr. Wolfram Carius, member of the Board of Managing Directors of Boehringer Ingelheim responsible for operations.
Evonik intends to use the acquisition of the Resomer pharmaceutical biodegradable polymers to strengthen its position as a formulation solution provider to the industry. Biodegradable polymers are used, for example, in cancer treatment for depot formulations containing peptide active ingredients. These formulations ensure a therapeutic effect for up to 6 months. The lactic acid polymers are also used in the manufacturing of surgical screws, nails, and plates. The advantage is that these biodegradable devices disintegrate after a defined life-span in the body without a negative impact, making further surgery to extract them unnecessary. Additionally, Resomer polymers make it possible to imbed APIs, such as growth factors or antibiotics to support the healing process.
The pharmaceutical industry favors the use of biodegradable polymers for the formulation of innovative drugs based on biotechnological active ingredients. While the growth of the entire pharmaceuticals market stagnated, the biotechnological active ingredients market has shown significant growth. With the new Resomer platform, the Pharma Polymer Business Line of Evonik is now equipped to enter the dynamic growth market of biotechnological active ingredients.
Evonik’s Pharma Polymers Business Line develops, produces, and markets functional polymethacrylates for pharmaceutical formulations. Through its EUDRAGIT brand in particular, Pharma Polymers has a leading position in the global market of pharmaceutical excipients.
Synageva BioPharma & to-BBB to Collaborate on Brain Drug Delivery for Rare Diseases
Synageva BioPharma Corp. and to-BBB technologies BV, the Dutch drug brain delivery company, have recently entered into a research collaboration to evaluate the potential of transporting therapeutic proteins across the blood-brain barrier (BBB) into CNS. The BBB, a protective filter for the CNS, can be an obstacle for protein therapeutics and prevent these treatments from reaching their site of action within the CNS. A number of rare diseases that could benefit from protein therapeutics have a CNS component and require the therapies to be transported across the BBB. This research collaboration will be the basis for a development program for therapies for multiple such rare diseases, including Lysosomal Storage Diseases (LSDs).
“Synageva is pleased to have entered into this collaboration with to-BBB to evaluate their drug delivery technology,” said Anthony Quinn, Synageva’s Chief Medical Officer and Head of R&D. “This collaboration, which combines Synageva’s proprietary compounds and technology with to-BBB’s expertise in CNS delivery, provides Synageva with an opportunity to extend the therapeutic benefits of our pipeline products targeting rare diseases with CNS manifestations.”
“We are very pleased to collaborate with Synageva,” added Pieter Gaillard, CSO of to-BBB. “to-BBB’s brain delivery technology combined with Synageva’s significant rare disease expertise should result in substantial progress toward the development of innovative medicines for untreated CNS diseases.”
Synageva BioPharma Corp. is dedicated to discovering, developing, and commercializing therapies for patients with rare conditions and high-unmet medical need. The company has developed a pipeline of novel therapeutics for under-served populations and has assembled a team with a proven record of bringing orphan therapies to patients.
to-BBB is a private biotechnology company focusing on enhanced drug delivery across the BBB. The company is developing novel treatments for devastating brain disorders, such as brain cancer, neurodegenerative diseases, and lysosomal storage diseases, by combining existing drugs with the G-Technology, to-BBB’s proprietary brain delivery platform. This technology combines the well-established drug delivery approach of pegylated liposomes with the endogenous tripeptide glutathione as targeting ligand in a novel and safe way. Together with several top tier pharma and biotech companies, to-BBB is investigating the versatility of the G-Technology for drugs that are unable to reach the brain within a tolerable therapeutic window. to-BBB is applying the G-Technology for the delivery of doxorubicin for the treatment of brain cancer as its internal lead product 2B3-101.
TransPharma Announces Successful Results of a Phase I Clinical Trial for Musculoskeletal Disorders
TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, recently announced successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders, such as osteoarthritis and musculoskeletal pain.
The Phase I study was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ViaDerm-Calcitonin in 12 post-menopausal women treated with four different transdermal Calcitonin doses (60 to 300 mcg) compared to 100 IU of Miacalcin, the subcutaneous injected form of the Calcitonin.
Study results demonstrated a clear PK dose response corresponding to the escalating doses of the ViaDerm-Calcitonin patches. Furthermore, a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin. All doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.
Calcitonin is commercially available in subcutaneous, intramuscular, and nasal routes for the treatment of post-menopausal osteoporosis, hypercalcemia, and Paget’s disease. Calcitonin is a very safe drug that has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.
“We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection,” said Dr.
TransPharma’s ViaDerm drug delivery system incorporates a hand-held electronic device, which creates microscopic passageways through the outer layer of the skin, allowing for transdermal delivery of a wide variety of drugs from a patch. The system provides a cost-effective, easy-to-use, virtually pain-free, self-administered solution that enables the safe, reproducible, and accurate delivery of a broad range of product candidates, including hydrophilic small molecule, such as peptides and proteins.
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing its proprietary active transdermal drug delivery technology. The company aims to develop multiple drug products through strategic partnerships with leading pharmaceutical companies and through independent product development. TransPharma currently has three drug products in clinical trials: ViaDerm-hPTH (1-34) product for the treatment of osteoporosis developed in collaboration with Eli Lilly and currently in Phase IIb clinical studies; ViaDerm-GLP1 agonist for the treatment of type II diabetes that has completed Phase Ib clinical study; and the ViaDerm-Calcitonin which has completed a Phase I clinical trial.
ZIOPHARM & Intrexon Announce Worldwide Partnership for Synthetic Biology DNA-Based Oncology Therapeutics
ZIOPHARM Oncology, Inc., a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next-generation synthetic biology company, recently announced a global exclusive channel partnership in oncology in which ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon’s UltraVector Technology. Under the partnership, ZIOPHARM will utilize Intrexon’s advanced transgene engineering platform for the controlled and precise cellular production of anti-cancer effectors.
ZIOPHARM will have rights to Intrexon’s entire human in vivo effector platform within the field of oncology, which includes two lead clinical-stage product candidates, one of which is in an advanced Phase I study and another which will be the subject of an
Intrexon employs its modular genetic engineering platform in the areas of therapeutics, protein production, industrial, and agriculture products. The exclusive channel partnership between Intrexon and ZIOPHARM has been established specifically for the field of human oncologic therapeutics. Under the partnership, Intrexon remains responsible for technology discovery efforts and managing the patent estate as well as for certain aspects of manufacturing. ZIOPHARM will be responsible for conducting preclinical and clinical development of candidates, as well as for other aspects of manufacturing and the commercialization of the candidates.
Intrexon’s core synthetic biology technology is designed to create Better DNA at industrial scale, enabling unprecedented control over the function and output of living cells by providing external control over in vivo activation and regulation of potent effectors. This platform, called UltraVector, provides speed, flexibility, consistency, and precision to the design, production, and testing of rationally designed complex transgenes and their encoded genetic circuits. These qualities allow an iterative and rational approach to transgene design, which can be continually engineered until their performance is optimized. Through this process, Intrexon is able to overcome the challenges inherent in current therapeutic strategies, including recombinant protein therapies and constitutive gene therapies, thereby enhancing capabilities, improving safety and lowering cost for human therapeutics.
The lead oncology product candidate developed using Intrexon’s technologies is currently in Phase Ib clinical study for metastatic melanoma. ZIOPHARM expects to submit an
“Controllable, scalable synthetic biology, the tightly regulated delivery of therapeutic proteins from within the body, is an aspirational and disruptive technology that Intrexon has brought from scientific theory to medical application,” said Jonathan Lewis, MD, PhD, CEO and CMO of ZIOPHARM. “As the sole channel partner for in vivo therapeutic candidates for human oncology, ZIOPHARM plans to leverage this technology for next-generation products targeting key pathways used by cancers to grow and metastasize. Intrexon has developed a technology that is uniquely flexible, scalable and controllable, adding significantly to our small molecule drug development capabilities and our ability to translate science to the patient using our world-class global team.”
“We are very pleased to collaborate with ZIOPHARM, which, under the leadership of Jonathan Lewis, is building an industry-leading oncology company with a strategic vision regarding cancer medicine. ZIOPHARM’s oncology expertise, development capabilities, as well as its excellent reputation within the oncology community make ZIOPHARM an exceptional investment for Intrexon and ideal partner to rapidly achieve the full therapeutic benefit and commercial potential of Intrexon’s disruptive technologies,” added RJ Kirk, Intrexon’s Chairman and CEO. “This collaboration leverages the capabilities and strengths of each partner and has the potential to create significant value for shareholders.”
NuSil Announces Two New Thermally Conductive Silicones
NuSil Technology LLC, a global leader in silicone materials for the healthcare and pharmaceutical industries, recently introduced two thermally conductive healthcare silicone elastomers. These elastomers can be used as a cure-in-place adhesive or potting compound between electrical/electric components and heat sinks as part of a thermal management regime to keep medical devices operating at their optimal levels.
MED-2980 and MED-2955 are able to wet out on a variety of substrates to ensure excellent contact between uneven surfaces. The low modulus characteristic of these elastomers ensures that during operational thermal cycling, the bond line will not warp or break sensitive electronic components.
MED-2980, a versatile 1.6 W/(mK) thermally conductive silicone, is available in a two-part configuration and is excellent for larger devices. MED-2955 is designed to have low volatility and low ionic content for more sensitive electronic devices or processes. The low volatility makes MED-2955 an excellent choice for processing environments in which high heat and/or vacuum conditions require minimal contamination on adjacent parts. It is also ideal for hermetically or near hermetically sealed environments in which low volatility is required. MED-2955 provides a thin bond line and low thermal resistance with a bulk thermal conductivity of 0.63 W/mK. Both the MED-2955 and MED-2980 can be cured at low temperatures or be heat accelerated and are non-cytotoxic.
“Miniaturization of electronic packages in medical devices has led to using thinner and more fragile materials, and the medical device industry has many challenges due to the risks involved,” said Brian Nash, Vice President, Sales and Marketing. “By formulating adhesives such as these, we are applying our years of expertise in the regulatory environment, as well as designing advanced silicones for electronics, to fully support companies operating in this exciting, yet challenging, industry.”
NuSil is a leading formulator of silicone compounds for healthcare, aerospace, electronics, and other applications requiring precise, predictable materials performance. ISO 9001-certified since 1994, NuSil operates state-of-the-art laboratories and processing facilities in
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