Author Archives: Gareth Macdonald

From Mylotarg to Polivy: Ebbs and flows, successes and woes of ADCs

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Interest in antibody drug conjugates (ADC) is surging with more combined MAb and warhead candidates entering clinical trials than ever before. The biopharmaceutical industry has had a difficult few years with ADCs. There have been successes like Besponsa (inotuzumab ozogamicin) – which Pfizer cited as a driver in 2018 – and Roche and Seattle Genetics’ Polivy (polatuzumab vedotin-piiq) which won fast-track approval in the US this year. Likewise, Kadcyla (trastuzumab emtansine) – also made by Roche – has been cleared…

November 1, 2019

Avacta teams with ADC Therapeutics on Affimer conjugates

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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:…

November 1, 2019

Cesca and HealthBanks jump on the CAR-TXpress in cell banking JV

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Cesca Therapeutics and HealthBanks Biotech say their cell processing tech and banking JV will target CDMOs and immunology researchers. Under the agreement Cesca’s subsidiary ThermoGenesis will grant the newly formed joint venture – to be called ImmuneCyte Life Sciences – an exclusive license to its CAR-TXpress technology. The system is used to isolate blood components in a cGMP compliant manner. According to Cesca it is 16 times more efficient than ficoll gradient centrifugation-based cell processing methods. In addition to offering…

October 30, 2019

Gene therapy demand drives Cytovance pDNA expansion

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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…

October 25, 2019

Zolgensma: Manufacturing questions delay decision in EU and Japan

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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…

October 25, 2019

Biogen’s services revenues fall; Aducanumab re-emerges

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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…

October 25, 2019

Glenmark takes bi-specific stance in Ichnos spin-out

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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…

October 22, 2019

Chinese CMC: CMAB to make bi-functional antibody for BJ

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BJ Bioscience has contracted CMAB Biopharma to provide research, development and manufacturing services for a candidate therapeutic antibody called BJ-005. Under the deal, CMAB will conduct CMC development and manufacturing to support the planned submission of an IND for the candidate drug in China and the US. No further details about BJ-005 were provided. According to BJ Biosciences’ website the drug is a bi-functional antibody intended for the treatment of “cancer.†On the firm’s pipeline page the timing for IND…

October 22, 2019

Vector market moving in right direction: Shortage driving CDMO M&A

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Demand for viral vectors has emerged as a major M&A driver in the gene therapy CDMO space says an industry expert. Viral vectors are hollow viruses developers can fill with genetic material. When one of these vectors ‘infects’ a cell the genes inside are inserted and expressed as proteins. Vectors are vital for the production of gene therapies, including new products like Spark Therapeutics’ Luxturna (voretigene neparvovec-rzy) and AveXis’ Zolgensma (onasemnogene abeparvovec-xioi). The problem is that, for the past few…

October 1, 2019

China laws settle CDMO status but leave regulator lacking capacity for oversight

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New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…

September 20, 2019