Therapeutic Class

Enesi and BARDA partner to develop solid dose flu vaccine

The US Biomedical Advanced Research and Development Authority (BARDA) will use Enesi Pharma’s ImplaVax device and formulation technology to develop subcutaneous vaccines against influenza. The public-private collaboration, financials of which have not been divulged, will form part of BARDA’s Division of Research, Innovation, and Ventures (DRIVe) innovative health security technologies portfolio, and looks to provide a cost-effective alternative to traditional vaccines to help improve vaccination uptake. The aim is to help healthcare providers or individuals administer influenza vaccines through the…

Catalent jumps into ‘transformative’ gene therapy space with $1.2bn Paragon buy

Contract manufacturer Catalent has agreed to buy the gene therapy CDMO Paragon Bioservices for $1.2 billion. Paragon Bioservices, a private-equity backed biologics contract development and manufacturing organization (CDMO) focused on gene therapy and next-generation vaccines, will be acquired by fellow CDMO Catalent, the firms announced this morning. According to its website, 50% of Paragon’s current contracts are for gene therapy. The CDMO also supports vaccine products and has previously won contracts from clients including the US Department of Defense (DoD).…

Cell therapy vendors: News from Miltenyi and Saint-Gobain

Bellicum Pharmaceuticals has inked a supply agreement with Miltenyi Biotec; Hitachi Chemical has teamed with Saint-Gobain to address manufacturing challenges – welcome to Bioprocess Insider’s cell therapy services round-up. In an SEC filing, Houston, Texas-based cellular immunotherapy firm Bellicum Pharmaceuticals revealed it has entered a agreement with Miltenyi Biotec GmbH for the supply of “certain products in connection with the development and manufacture of certain of the Company’s products.” The firm will pay Miltenyi a €2 million ($2.3 million) upfront…

Aji Bio opens large-scale oligo production plant in Osaka

Facilitated by its 2016 acquisition of GeneDesign, CDMO Ajinomoto Bio-Pharma has opened a 21,500 square-foot plant in Japan to service the growing oligonucleotide demand. In December 2016, Japan’s Ajinomoto OmniChem acquired nucleic acid drug contract development and manufacturing organization (CDMO) GeneDesign for an undisclosed fee. Nearly two-and-a-half years on and the subsidiary has become absorbed into Ajinomoto’s Bio-Pharma Services division. “GeneDesign – now Ajinomoto Bio-Pharma Services Osaka – provides solid-phase technology for oligonucleotide synthesis capabilities from µg to 10 kg…

Celltrion jumps into ADC space through Canadian partnership

Celltrion has inked a deal with iProgen Biotech to develop a pipeline of antibody-drug conjugates (ADCs). While best known for its portfolio of marketed biosimilars, Korean drugmaker Celltrion has been investing in its internal R&D for novel biotherapeutics and has five antibodies in development for diseases ranging from rabies to influenza. Now the firm is aiming to develop up to four antibody-drug conjugates (ADCs), including one targeting breast cancer, through a partnership agreement with Canadian firm iProgen Biotech. Financial details…

RNAi: Regeneron pumps $800m into ‘potentially game-changing science’

Regeneron will look to develop RNA interference (RNAi) therapeutics for eye and CNS diseases by teaming with and investing in Alnylam Pharmaceuticals. RNA interference (RNAi) therapies are a new class of drugs that work by inhibiting gene expression or translation by neutralizing targeted mRNA molecules. The first – and only – commercial RNAi therapy is Alnylam’s Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) last August for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis…

Lonza goes live with microbiome CMO joint venture

Lonza says GMP know-how and drug delivery tech are core to its live biotherapeutics joint-venture formed with Chr. Hansen. The Swiss contractor and Danish bioscience firm set up the contract manufacturing organization (CMO) in April, citing biopharma interest as the driver. Live biotherapeutic products (LBPs), as the name suggests, are living organisms. Unlike probiotics used to try to improve general health, LBPs are drugs intended to treat or cure disease. “LBPs are regulated as drugs and have to go through…

GeoVax targets WHO goal with multi antigen malaria vaccine

GeoVax Labs says the malaria vaccine it is developing with Leidos could achieve efficacy levels called for by the WHO. US firms GeoVax and Leidos agreed to develop a P. falciparum vaccine in March, expanding on an R&D partnership they formed last November. Under the deal, GeoVax will make a vaccine able to deliver DNA coding for parasite proteins. Cells ‘infected’ by the vaccine will express the proteins, provoking an immune response. Leidos spokeswoman Erin Tindell told us the DNA…

Freeze company: Orchard reformulating HSC gene therapies

Orchard Therapeutics says it is launching a cryopreserved formulation of its lead candidates to overcome the limitations of fresh hematopoietic stem cell gene therapies. Orchard Therapeutics’ pipeline includes Strimvelis, the former GSK autologous ex vivo hematopoietic stem cell (HSC) gene therapy approved by the EMA in 2016, along with five clinical stage programs. The firm launched its initial public offering (IPO) last year and in its first public year-end financial conference call last week spoke of the potential upcoming milestones…

Samsung Bio to make $1bn worth of CytoDyn’s HIV antibody

CytoDyn has contracted Samsung BioLogics to produce the drug substance for its candidate leronlimab and says it will need at least two CMOs once the HIV inhibitor is approved. CytoDyn’s lead candidate leronlimab (PRO 140) has demonstrated antiviral activity and shown to significantly reduce viral burden in people infected with HIV in Phase II clinical trials. The fully humanized IgG4 monoclonal antibody blocks the predominant HIV (R5) subtype entry into T-cells by masking the required co-receptor, CCR5. The firm has…