Therapeutic Class

Abzena and MilliporeSigma up services on ADC outsourcing demand

The high clinical failure rate of antibody-drug conjugates (ADCs) and the tendency to outsource development have driven both Abzena and MilliporeSigma to launch new service offerings. The first ADC, Wyeth’s Mylotarg (gemtuzumab ozogamicin) was approved in 2000, but nearly 20 years on there are only a handful of such therapies on the market. However, ADCs remain a viable and financially tempting oncology treatment and according to MilliporeSigma there more than 300 projects in development. Writing in ADC Directory earlier this…

Avacta teams with ADC Therapeutics on Affimer conjugates

Avacta Group and cancer drug developer ADC Therapeutics SA have entered into a collaboration agreement. The partnership – financial terms of which were not made public – will develop drugs combining ADC Therapeutics’ pyrrolobenzodiazepine-based cytotoxic warheads with Avacta’s Affimer targeting platform. ADC Therapeutics will cover all Avacta’s costs during the project. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization. Matt Vincent, Avacta’s VP of Therapeutics Business Development, told us:…

Manufacturing assessments critical in ADC development, says AZ

Manufacturing is key to bringing ADCs to the clinic faster says AstraZeneca, which stresses the importance of carrying out developability assessments. When a new molecule enters AstraZeneca’s portfolio, one of the first things the Anglo-Swedish biopharma firm does is carry out a developability assessment to understand the challenges in bringing the candidate through the clinic. Like other drug developers, the firm has a series of processes to move a project from lead optimization to candidate profiling, before moving into the…

Bio-Techne confirms $50m reagents plant to support CGTs

Bio-Techne will build a 50,000 square-foot plant in Minnesota with an initial capacity of $140 million of E. coli-derived recombinant proteins to support cell and gene therapy developers. After months of talk, life sciences services and consumables firm Bio-Techne has laid concrete plans to build a facility in St Paul, Minnesota to produce GMP reagent proteins for use in cell and gene therapy applications. “The facility is expected to go through qualifications in approximately one year, with commercial sales expected…

Gene therapy demand drives Cytovance pDNA expansion

Cytovance Biologics has added plasmid DNA (pDNA) production capacity at its Oklahoma City facility citing growing demand from gene therapy developers. The single-use production system is capable of making both critical reagent grade – for research – and cGMP grade pDNA in quantities ranging from 1g to 50g. It can manufacture smaller quantities for R&D. Jesse McCool, Cytovance chief technology officer (CTO), framed the investment as part of the firm’s effort to position itself as a key gene therapy supply…

Zolgensma: Manufacturing questions delay decision in EU and Japan

Novartis has asked the EMA to inspect its Zolgensma plant in San DIego after the agency – and Japan’s PDMA – delayed approval decisions and asked for more details of how the gene therapy is made. Zolgensma is a gene therapy. It is designed to halt progressive spinal muscular atrophy (SMA) – motor neurone loss and muscle wasting – in kids with a defective version of a gene called SMN1. The drug encodes a functional copy of the gene enabling sustained…

Biogen’s services revenues fall; Aducanumab re-emerges

Biogen saw its manufacturing services revenue slide in Q3 following the sale of its plant in Hillerod, Denmark. According to Biogen’s Q3 report the firm’s “other revenues” –those not generated by drug product sales – fell 26% year on year to $110m. CFO Jeff Capello attributed the decline to the divestiture of the firm’s biologics manufacturing in Hillerod facility to Fujifilm. “Total other revenues in the third quarter decreased 26% versus the prior year driven by the decline in our…

Glenmark takes bi-specific stance in Ichnos spin-out

Glenmark spin-out Ichnos Sciences wants its pipeline of biologic and small molecule drug candidates to be generating clinical data within two years. New Jersey Ichnos announced its plan this week to coincide with the official launch of the company. It said it will progress its most advanced assets – the cancer drugs GBR 1302 and GBR 1342, the autoimmune disease MAb GBR 830, and the non-opioid pain meds GRC 27864 and GRC 17536 – through trials by 2021. Biologics The…

CAR-T at a crossroad as industry looks to allogeneic

As cell therapies move through the clinic towards commercialization, respondents to a KNect365 industry survey are beginning to look to allogeneic – or off-the-shelf – products as the next big thing. Almost 200 people contributed to the Cell Therapy Analytics Report from KNect365, revealing their current position within the burgeoning cell and gene therapy space and offering up their thoughts and predictions for the future. The majority worked within companies developing oncology products, and the largest group – 41% –…

J&J downgrades biosimilar threat as Q3 pulls in $10bn+ in pharma sales

J&J reported its sixth consecutive quarter with sales above $10 billion in its pharmaceutical division and has lowered its biosimilar headwind forecast to $2 billion. For the third quarter 2019, Johnson & Johnson (J&J) reported sales across all its units of $20.7 billion (€18.8 billion). Its pharmaceutical division pulled in roughly half of the total, $10.8 billion, up 5.1% on the same quarter last year. “This was our sixth consecutive quarter with sales above $10 billion,” Jennifer Taubert, EVP and…