Pharmaceutical Technology Editors

WuXi STA, a subsidiary of WuXi AppTec, is opening a new large-scale continuous manufacturing plant at its Changzhou campus. The facility will focus on increasing capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide.

The new oligonucleotide plant will be 30,570 sq. ft. and will include four large-scale oligonucleotide production lines and more than 20 small-to-mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol.

The peptide plant will be 22,260 sq. ft. and feature three new production lines with reactors that can accommodate up to 1000 L, increasing WuXi STA’s overall Solid Phase Peptide Synthesis (SPPS) total reactor volume to 6490 L.

“We are pleased to support our global partners in their efforts to develop new modality therapies for patients in need,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, in a press release. “WuXi STA is committed to enabling partners by enhancing our new modality CRDMO platform’s capacity and capability to expedite the development and commercialization of more innovative therapies to benefit patients worldwide.”

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WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant

Discovery Life Sciences (Discovery), a company specializing in biomarkers and biospecimens, announced its acquisition of AllCells, a provider of human primary blood and marrow-based cells. Discovery plans to combine its existing cell and gene therapy products and services with AllCells to create a business unit called AllCells, a Discovery Life Sciences company. AllCells CEO and President Danny Zheng will lead the entity.

“We are very excited to welcome the AllCells team to the Discovery family,” said Glenn Bilawsky, CEO, Discovery Life Sciences, in a July 12, 2022 company press release. “Bringing these two great companies together creates a scalable, end-to-end solution that gives our clients unprecedented access to reliable human cellular starting materials with integrated multi-omic analytic services to support cell and gene therapies.”

According to the press release, the acquisition grants Discovery access not only to their cell supplies, but also starting materials and analytic services to accelerate cell and gene therapy experiences. Additionally, Discovery’s newly acquired FDA-registered donor collection facilities and good manufacturing practice (GMP)-compliant cleanrooms are adjacent to characterization labs; this placement enables immediate processing and cryopreservation.

“We have built our organization to be an extension of our client's supply chain. By offering donor program consulting, high-quality apheresis collections, customization services, and GMP-compliant starting materials, our dedicated team will continue to provide a high-touch, client-focused approach to ensure our clients' needs are met with superior products and services to fit any timeline and on any scale,” said Zheng in the press release. “Our strategy parallels and reinforces Discovery's 'Science at your Service' approach, and our unified offerings will further accelerate our clients' strategic and vital cell and gene therapy programs.”

Discovery Life Sciences’ acquisition of AllCells is intended to bolster its cell and gene therapy products and services.

Discovery Life Sciences Acquires AllCells

AstraZeneca is acquiring TeneoTwo and its Phase I clinical stage B-lymphocyte antigen cluster of differentiation (CD) 19/CD 3 (CD19/CD3) T-cell engager, TNF-486, in a deal worth up to $1.26 billion. One hundred million dollars will be paid upfront, with additional payments contingent on achieving various commercial and regulatory milestones. The deal is expected to close in the third quarter of 2022.

According to a July 5, 2022 press release, TNB-486 is designed for B-cell hematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. It is a T-cell engager, a bispecific molecule engineered to redirect the immune system’s T-cells to recognize and kill cancer cells. By binding to CD19, an antigen expressed on B-cells, and the CD3 receptor on T-cells, it activates and recruits T-cells to CD19-expressing tumors. The drug is currently under evaluation for relapsed and refractory B-cell non-Hodgkin lymphoma.

“By redirecting the body’s natural immune response to target B-cell malignancies, TNB-486 alone or in combination with CD20-targeted therapy could potentially deepen clinical responses and improve patient outcomes,” said Anas Younes, senior vice-president, Hematology R&D, AstraZeneca, in the press release. “We believe this innovative molecule, which was designed to optimize the therapeutic window of T-cell activation, will enable us to explore novel combinations that have the potential to become new standards of care in this setting.”

AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.

AstraZeneca to Acquire TeneoTwo in Deal Worth Up to $1.26 Billion

On July 23, 2022, World Health Organization (WHO) announced that the monkeypox virus (MPV) constitutes a public health emergency of international concern. At the time of the announcement, approximately 17,000 confirmed infections in 75 countries have been recorded.

The announcement follows the second meeting of WHO’s International Health Regulations Emergency Committee, which was unable to reach a consensus on the issue. While WHO generally follows the recommendations of this committee (having done so following the first meeting, which advised against the declaration), the lack of consensus left the decision to WHO’s director-general Tedros Adhanom Ghebreyesus.

“We have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the International Health Regulations,” said Ghebreyesus in a statement to the press. “For all of these reasons, I have decided that the global monkeypox outbreak represents a public health emergency of international concern.”

As a result of this declaration, a set of temporary measures will be instituted; what measures each country is recommended to follow is dependent on the level of severity of MPV in that country. A full list of these measures can be found in the announcement 

WHO has determined that monkeypox constitutes a public health emergency of international concern.

WHO Declares Monkeypox Spread a Global Health Emergency

Merck, known as MSD outside the United States and Canada, announced a global development and commercialization agreement with Orion Corporation, a Finnish pharmaceutical company. Through this agreement, the companies will work together to develop and commercialize ODM-208, an oral, non-steroidal inhibitor of cytochrome P450 11A1 (CYP11A1) that is currently in a Phase II clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

According to a July 13, 2022 company press release, Merck is making an upfront payment to Orion of $290 million for the rights to co-develop and co-commercialize ODM-208, while Orion will be responsible for the manufacture of clinical and commercial supply of the drug. The agreement also covers other drugs in development by Orion that target CYP11A1.

“Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer,” said Dean Y. Li, president, Merck Research Laboratories, in the press release. “We believe ODM-208 has the potential to complement our existing program in prostate cancer and look forward to working with the team at Orion.”

The contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. If this is exercised, Merck would assume full responsibility for all accrued and future development and commercialization expenses associated with the program. In this scenario, Orion would be eligible for various regulatory and sales-based milestone payments as well as double-digit tiered royalties.

Merck, known as MSD outside the United States and Canada, and Orion Corporation are collaborating to develop and commercialize a treatment for metastatic castration-resistant prostate cancer.

Merck and Orion Announce Global Collaboration for Oncology Drug

The European Medicines Agency (EMA) announced on July 22, 2022 that its Committee for Medicinal Products for Human Use (CHMP) recommended approval for 11 medicines at its July 2022 meeting. The medicines treat a variety of conditions including cancer and type 2 diabetes.

The approved medicines included the following:

Celdoxome pegylated liposomal (doxorubicin hydrochloride) was approved for the treatment of metastatic breast cancer, advanced ovarian cancer, progressive multiple myeloma, and Kaposi's sarcoma.

Lupkynis (voclosporin) was approved to treat lupus nephritis, which is a condition caused by lupus where the kidneys are inflamed.

Mounjaro (tirzepatide) was approved for the treatment of adults with type 2 diabetes mellitus.

Opdualag (relatlimab/nivolumab) was approved to treat melanoma that has spread to other parts of the body and cannot be removed by surgery.

Tezspire (Tezepelumab) was approved as an add-on treatment in adult and adolescent patients with severe asthma.

Vabysmo (faricimab) was approved for the treatment of neovascular age-related macular degeneration and visual impairment due to diabetic macular edema in adults.

Thalidomide Lipomed (thalidomide) received a positive opinion for the treatment of multiple myeloma.

The CHMP also granted conditional marketing authorization for Tecvayli (teclistamab) for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies. Tecvayli was processed through EMA’s PRIority MEdicines scheme, which provides early scientific and regulatory support for drugs that treat unmet needs.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.