Pharmaceutical Technology Editors

Nanoform, a nanoparticle medicine-enabling company, has revealed that its proof of concept (PoC) project evaluating the application of the nanoforming process to Herantis Pharma’s recombinant human Cerebral Dopamine Neurotrophic Factor (rhCDNF) drug candidate has been successful.

According to a Sept. 9, 2021 press release, with the successful completion of the PoC project, demonstrating that the nanoforming process can be successfully applied to rhCDNF, the companies will now progress to a proof of process (PoP) study. In the PoP study, the size and shape of the nanoformed rhCDNF nanoparticles will be further refined and particle biodistribution after intranasal delivery will be evaluated.

“We are excited with these initial results that show nanoforming is effective with Herantis’s rhCDNF program,” said Christian Jones, chief commercial officer of Nanoform, in the company press release. “This PoC study with Herantis Pharma’s rhCDNF further validates the wide applicability of Nanoform’s technologies to a diverse range of molecules. We look forward to now moving into a PoP study and further nanoforming activities as rhCDNF continues its development.”

“This was a key milestone to achieve as part of our broader intranasal administration project for rhCDNF, one of only a few clinical stage assets focused on disease modification of Parkinson’s disease,” added Craig Cook, CEO of Herantis Pharma, in the press release. “The ability to nanoform the rhCDNF molecule improves the chances of success for intranasal administration and creates additional possibilities to impact the lives of patients. We very much look forward to progressing the work with Nanoform.”

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Nanoform and Herantis Pharma's proof of concept project evaluating the application of the nanoforming process has been successful.

Nanoform and Herantis Pharma Announce Successful Results from PoC Project

Avantor has strengthened its offering across all bioproduction platforms with the acquisition of the Masterflex bioprocessing business and related assets of Antylia Scientific on Sept. 7, 2021. The acquisition was announced in a company press release.

Valued at $2.9 billion, the all-cash acquisition is still subject to final adjustments at closing and is expected to enhance Avantor’s offerings across all bioproduction platforms, including monoclonal antibodies (mAbs), cell and gene therapies, and messenger RNA. Additionally, it is expected that the acquisition will support both therapy and vaccine manufacturing, including COVID-19 offerings, for the company.

“The acquisition of Masterflex reflects our commitment to the biopharma industry, and our ability to identify and execute on value-creation opportunities,” said Michael Stubblefield, president and CEO of Avantor, in the company press release. “The business enhances our portfolio of proprietary technologies and strengthens our position in the highest growth segments of the market. Both Avantor and Masterflex share a strong culture of innovation and excellence, and we look forward to welcoming Masterflex's highly skilled team to the Avantor family.”

“This proposed transaction helps both parties and positions the Masterflex bioprocessing business well for future growth,” added Brian Barnett, president, Masterflex Bioprocessing, in the press release. “Avantor's broad portfolio is used in virtually every stage of the most important research, development, and production activities. We are excited about combining our end-to-end fluid management solution with Avantor's comprehensive portfolio of process ingredients, chromatography resins, and excipients for biopharma customers worldwide.”

Avantor has acquired the Masterflex bioprocessing business and related assets of Antylia Scientific.

Avantor Strengthens Bioprocessing Position with Acquisition of Masterflex

Moderna announced in a Sept. 7, 2021, press release a collaboration to develop a new mRNA therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1). The goal of the collaboration is to make an mRNA therapy for the treatment of CN-1 available at no cost to patients.

Under the agreement, Moderna will license mRNA-3351 to ILCM with no upfront fees and without any downstream payments. ILCM will oversee the clinical development of mRNA-3351, including initiating clinical studies of mRNA-3351 in 2022.

It is estimated that there are only approximately 70-100 known cases of CN-1 in the world. Current standard of care treatments for CN-1 rely on phototherapy treatments of up to 12 hours a day throughout life. The only definitive treatment is a liver transplant.

“At Moderna, we believe that mRNA therapies have the potential to profoundly impact rare disease patients and their families. Ultra-rare diseases are always a challenge for our industry given the very small number of patients who could benefit from the medicine,” said Stéphane Bancel, CEO of Moderna, in a company press release. “We decided that rather than charge a high price for the medicine candidate, which is not aligned with our values, we would rather give it away for free. In this innovative partnership, the Institute for Life Changing Medicines will not pay Moderna an upfront fee or any downstream payments. Moderna will also provide the mRNA-3351 material free of charge. mRNA-3351 is a therapeutic candidate for Crigler-Najjar Syndrome Type 1 and our goal is to bring new hope for patients and their families.”

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1

Ardena—a European contract development and manufacturing organization (CDMO) with services spanning the full development life cycle—announced in a Sept. 1, 2021, press release that it has acquired Idifarma, a contract manufacturer of niche and highly-potent generic and innovative drugs that’s based in Pamplona, Spain. With the acquisition, there are now seven Ardena facilities in Europe, including its headquarters in Ghent, Belgium, three sites in the Netherlands, and two sites in Northern Europe (Sweden and Latvia).

Established in 2011, Idifarma offers various services spanning the full pharma lifecycle for highly potent drugs. Its capabilities include a platform for an accelerated path to clinic and spray drying processes that resolve solubility issues.

“At Ardena, our goal is to become a single source contractor offering an integrated set of services to meet chemical, pharmaceutical and bio-analytical needs that arise throughout the clinical supply chain, from lab to patient. This is the main driver of our M&A strategy,” Harry Christiaens, CEO of Ardena, said in a company press release. “We’re delighted to welcome Idifarma who share the science-led approach needed to deliver valuable and integrated solutions for our biopharma customers globally. The combination of Idifarma and Ardena will also create potential to accelerate growth at the Pamplona facility.”

Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.

Ardena Acquires Idifarma From Suanfarma

TCR² Therapeutics, a clinical stage cell therapy company, announced that FDA granted orphan drug designation to Gavo-cel for the treatment of cholangiocarcinoma on Sept. 2, 2021. Cholangiocarcinoma is a rare and aggressive form of cancer that forms in the bile ducts.

Approximately 80,000 individuals in the United States have some form of solid tumor expressing mesothelin, including individuals with cholangiocarcinoma. Mesothelin is a cell-surface glycoprotein highly expressed in various types of solid tumors. Overexpression of mesothelin is associated with a poorer prognosis in some cancers due to its role in both malignant transformation and tumor aggressiveness.

Gavo-cel is a novel cell therapy that recently completed a phase I/II clinical trial in patients with treatment refractory mesothelin-expressing solid tumors. The therapy consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human mesothelin fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor complex.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

TCR² Therapeutics Receives FDA Orphan Drug Designation for Gavo-cel

According to a Sept. 3, 2021, press release, AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria (ChAdOx1-S [Recombinant]), a COVID-19 vaccine. The European Commission’s legal proceedings against AstraZeneca were initiated in Brussels on April 21, 2021, and court hearings were scheduled at end of Sept. 2021.

60 million doses of Vaxzevria by Q3 2021,

75 million doses of Vaxzevria by the end of Q4 2021, and

65 million doses of Vaxzevria by the end of Q1 2022.

Regular delivery schedules will be provided to Member States, and capped rebates will apply in the event of any delayed doses. AstraZeneca and its partners have thus far supplied more than 1.1 billion doses of vaccine to more than 170 countries. Approximately two-thirds have gone to low- and middle-income countries, according to a company press release.

“I’m very pleased that we have been able to reach a common understanding which allows us to move forward and work in collaboration with the European Commission to help overcome the pandemic,” Ruud Dobber, executive vice president, biopharmaceuticals business unit, AstraZeneca, said in the press release. “We are fully committed to manufacture Vaxzevria for Europe following the release for supply of more than 140 million doses to date at no profit. We are also looking forward to working with the European Commission in a joint effort to further support COVAX.”

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria. 