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Cristiana Bernini

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Positive Clinical Trial results for Antibody drugs conjugates

Antibody-drug conjugates represent an innovative and important therapeutic approach to targeting cancer. Seattle Genetics (www.seattlegenetics.com) announced that multiple abstracts will be presented in December at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Francisco, California, highlighting:

  • clinical trial results of phase 3 AETHERA clinical trial results for ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma (HL) patients at risk of relapse;
  • multiple presentations of ADCETRIS data in CD30-positive lymphomas, including frontline, salvage and relapsed HL, as well as diffuse large B-cell lymphoma (DLBCL) and cutaneous T-cell lymphoma (CTCL);
  • first interim clinical data for SGN-CD33A in acute myeloid leukemia (AML);
  • updated phase 1 clinical data to be presented for SGN-CD19A in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL);
  • additional results from the phase 2 ROMULUS study assessing two ADC candidates that utilize Seattle Genetics’ proprietary technology being developed by Genentech: polatuzumab vedotin and pinatuzumab vedotin (ADCs targeting CD79b and CD22, respectively).

SGN-CD33A is a novel ADC targeted to CD33 utilizing Seattle Genetics’ newest ADC technology. The CD33 antibody is attached to a highly potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the site-specific conjugation technology (EC-mAb) allows uniform drug-loading of the cell-killing PBD agent to the anti-CD33 antibody. The ADC is designed to be stable in the bloodstream and to release its potent DNA binding agent upon internalization into CD33-expressing cells. SGN-CD19A is an ADC targeting CD19, a protein expressed broadly on B-cell malignancies. SGN-CD19A is comprised of an anti-CD19 monoclonal antibody linked to a synthetic cytotoxic cell-killing agent, monomethyl auristatin F (MMAF). The ADC is designed to be stable in the bloodstream, and to release its cytotoxic agent upon internalization into CD19-expressing tumor cells.

 

Bi-specific antibody therapies

Roche has acquired the Austrian biotech company Dutalys, a specialist in the discovery and development of bi-specific antibodies, for a total sum of $489 million. Dutalys was founded in April 2010 with seed financing from Austria Wirtschaftsservice. Roche will make an upfront cash payment of $133.75 million and additional payments of up to $355 million if certain predetermined milestones are reached. The deal strengthens Roche’s leading position in the development of therapeutic antibodies.

Bi-specific antibody therapy is an emerging technology based on artificial proteins composed of fragments of two different monoclonal antibodies, which can bind in two different places in a disease pathway. Dutalys’ proprietary technology is able to create fully human bi-specific antibodies and is still at an early stage in the drug development process. According to Roche, it could provide novel molecules for several therapeutic areas.

Alliance for translational research

Sigma-Aldrich Research business unit has announced an alliance with VIB, a leading life science research institute based in Flanders, Belgium, focused on translational research in medical, agricultural and industrial applications. The alliance will focus on the commercialization and supply of new tools and technologies to help meet the evolving needs of translational researchers.

The VIB collaboration is the second partnership of its kind that Sigma-Aldrich has made to expand its portfolio and provide new innovations and products. Sigma-Aldrich recently announced an agreement with Scripps Research Institute to accelerate the commercialization of research reagents.

Licensing agreement to treat AMD

iCura Vision and Columbia Technology Ventures have announced the licensing of iCura Vision’s intellectual property portfolio and associated research and development program for a investigational oral medication intended to slow or halt the progression of “dry” age-related macular degeneration (AMD). Under the terms of the licensing agreement, the NIH’s Blueprint Neurotherapeutics Network, which has funded the medication’s discovery and early development, will continue to provide financial support through phase I.

The first candidate, ICR-14967, should enter clinical phase development in 2016. ICR 14967 will be administered orally and it is just one of a rich pipeline of compounds covered under the agreement. It works by reducing the delivery to the eye of retinol, a key component of vision, which may lead to the formation of toxic byproducts that build up under the retina to produce dry AMD.

Big data project for rare diseases

BioXcel Corp., a global company specialised in providing cloud-based solutions for discovering novel products, has announced the initiation of a big data project with biopharmaceutical company Alexion to characterize and prioritize pertinent sets of rare diseases for relevant therapeutic modalities. The project will utilize BioXcel’s Big Data Innovation Lab, that applies recursive mapping and big data algorithms. Alexion activities focus on delivering life-transforming therapies to patients with severe and life threatening disorders.

BioXcel’s proprietary Orphan Disease Suite encompasses more than 9,000 rare & ultra-rare diseases, 4,000 -5,000 associated genes, 1,500 disease pathways, and distinct target-indication tiles for antibody, protein, RNA, small molecule and gene therapy modalities. A live multi-dimensional platform enables partners to make informed decisions for a rare disease indication and the associated ideal mode of pharmacotherapy with parameters that include strategic, medical, scientific and commercial aspects.

New deal for vaccines

GSK has announced the acquisition of Swiss-based GlycoVaxyn, a specialist vaccine biopharmaceutical that was incorporated in 2004 as a spin-off from the ETH Zurich, Switzerland.

Since forming a scientific collaboration in 2012, GSK has held a minority stake in GlycoVaxyn and has now acquired the remaining shares for US $190 million in cash to take full ownership of the company.

The innovative biological conjugation platform technology developed by the Swiss company has the potential to play an important role in the development of new prophylactic and therapeutic vaccines for a range of bacterial diseases. It could also enable GSK to develop a simplified conjugate vaccine manufacturing process.

Under the terms of the transaction, GSK will additionally acquire a small number of early stage vaccines in development against bacterial infections such as pneumonia, Pseudomonas, Staphylococcus aureus and Shigellosis, supplementing the company’s existing vaccines pipeline.

Licensing partnership for fast-acting insulin

Eli Lilly and French biotech Adocia have reached an agreement for a worldwide licensing partnership to develop an ultra-rapid insulin to treat patients with type 1 and type 2 diabetes. The deal will strengthen the position of Eli Lilly into the very competitive diabete’s market.

The product is currently in early-stage phase Ib studies and aims to control glucose levels better during and after meals. According to the companies, Adocia will receive an upfront fee of $50 million, potential future payments of up to $280 million if the product reaches certain development and regulatory milestones, and sales milestones of up to $240 million.

Lilly will also pay royalties on sales of the drug, if approved, and reimburse Adocia for some of its research and development expenses, for an unspecified amount.

Deal for API technologies

Catalent, the American company specialised in advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced the acquisition of Micron Technologies, a leading global provider of particle size engineering technologies.

The operation represents an important advance, according to Catalent, in its strategy to provide the best drug delivery technologies, with the goal to partner with more pharmaceutical innovators at the earliest stages of the drug development process.

Micron Technologies developed a versatile portfolio of particle size reduction, micronization and milling technologies used to overcome bioavailability, stability and manufacturability challenges.

The deal follows the acquisition of Redwood Bioscience, with its Antibody-Drug Conjugate (ADC) technology platform, in October 2014.

New facilities for large-scale biologics production

Bristol-Myers Squibb (BMS) announced plans to construct a new state-of-the-art, large-scale biologics manufacturing facility in Ireland. The new site will produce multiple therapies for the company’s growing biologics portfolio, including approved and investigational biologic medicines across multiple therapeutic areas (oncology, virology and immunoscience).

The 30,000-square meter project will house six 15,000-liter bioreactors and a purification area as well as office and laboratory space. The plant will be built on the grounds of the existing bulk pharmaceutical manufacturing plant and will host approx. 350 to 400 professionals.

The full cost of the facility, expected to be finalized in the second half of 2015, is anticipated to be comparable to the approximately $900 million investment made for the company’s biologics manufacturing facility in Devens, Massachusetts. The facility, including commissioning and validation, is estimated to be operational in 2019.

Respiratory business deal for AstraZeneca

AstraZeneca announced the intention to reach a definitive agreement for the acquisition of the rights to Actavis’ branded respiratory business in the US and Canada. The deal shall reach $600 million on completion and includes low single-digit royalties above a certain revenue threshold.

AstraZeneca will own the development and commercial rights in the US and Canada to aclidinium bromide inhalation powder and to roflumilast, the only once-daily oral PDE4 inhibitor currently on the market for COPD.

AstraZeneca will also own development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist in a dry powder inhaler, which has been already approved in the European Union.

The transaction strengthens AstraZeneca’s respiratory position globally and builds on the acquisition of Almirall’s respiratory portfolio in 2014.

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