Pharmaceutical Technology Editors

ProductLife Group (PLG), a regulatory compliance and outsourcing services specialist, and Juuka Advisory, an operations consulting company, have teamed up to form a new consulting offering, ProductLife Consulting. The partnership was announced in a Sep. 20, 2021 press release.

Both PLG and Juuka will draw from their expertise and operational experience to provide an end-to-end services portfolio for the pharma, biotech, medtech, and cosmetics markets through the new venture. ProductLife Consulting will be headed by Jean-Luc Taborin, who is Jukka’s CEO.

“I’m proud to join PLG, a leader in regulatory compliance outsourcing services,” said Taborin, in the press release. “With their knowledge of drug development, we’ll be able to tackle any perspective of the development of pharma, biotech, medtech, or cosmetics companies end-to-end.”

“This is a key milestone in PLG’s roadmap to strengthen its consulting offering with senior principals such as Jean-Luc and his team,” added Xavier Duburcq, CEO of ProductLife Group, in the press release. “PLG’s service offering and global footprint can now be proposed as a follow-up to any strategic recommendation that ProductLife Consulting makes to groups that want to accelerate and perform in their markets.”

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ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting. 

ProductLife Group and Juuka Advisory Partner Up on New Consulting Venture

FDA granted accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, according to a Sept. 20, 2021, FDA press release. According to the Seagen company press release, Tivdak is the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

In the innovaTV 204 clinical trial, 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen, received Tivdak. The trial showed a 24% objective response rate with a median duration of response of 8.3 months.

Tivdak is approved under FDA’s accelerated approval program based on tumor response and the durability of the response, according to Seagen’s press release. Verification and description of clinical benefit in confirmatory trials will impact any continued approval.

“TIVDAK’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them,” said Jan van de Winkel, CEO, Genmab, in Seagen’s press release. “The journey towards the approval of TIVDAK started nearly two decades ago with innovative research by scientists at Genmab and Seagen and reflects on our purpose of making an impact in the lives of cancer patients and their families. Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators and our collaborators for their participation in our clinical studies.”

The biologics license application for Tivdak was submitted in Feb. 2021 and accepted with priority review in April 2021. The submission was based on the innovaTV 204 trial results.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA. 

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

In a Sept. 21, 2021, press release, Boehringer Ingelheim announced the acquisition of Abexxa Biologics, a biopharmaceutical company developing precision medicines for cancer treatments. The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell (rather than those expressed on the cell membrane).

Abexxa’s platform allows the targeting of intracellular antigens of cancer cells by recognizing their presentation on the cell surface by MHC class 1 molecules. While the Abexxa platform addresses the more common HLA-A2 peptide presentation, the company developed specific expertise in the nonclassical MHC class 1 molecule HLA-E, which has the potential to impact a broader set of cancer patients’ antigens, according to the press release.

Additionally, Abexxa developed a T-cell receptor-like antibody that can be used to disrupt the NKG2A:HLA-E immune checkpoint axis in oncology. Abexxa molecules are also being formulated to recruit immune cells targeting HLA-E peptide complexes on tumors.

“The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully to enable immune-targeting of cancer cells,” said Clive R. Wood, corporate senior vice-president and global head of discovery research, Boehringer Ingelheim, in the press release. “By expanding our portfolio of antibodies binding novel intracellular tumor antigens, we are striving to develop unique and broadly applicable new immunotherapeutic approaches for cancer patients.”

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

Boehringer Ingelheim Acquires Abexxa Biologics, Expanding Cancer Treatment Potential

Celsion Corporation, a clinical-stage company with a focus on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co., a generics manufacturer, announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine in a Sept. 17, 2021, press release. Under the terms of the amended agreement, Poly Pharm will manufacture clinical and commercial batches (pending approval for use for the latter) for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

Poly Pharm is experienced with chemistry, manufacturing, controls, process development, and current good manufacturing processes, including process optimization and manufacturing services to help customers advance new drug development projects. FDA, EMA, China’s National Medical Products Administration, and the World Health Organization have approved its sites and compounds, according to the company press release.

Madame Fang, CEO of Hainan Poly Pharm, said in the press release. “Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in highly cost-effective manufacturing of nucleic acid based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA vaccine technology platform is a promising platform as it may address global vaccine storage and distribution needs.”

“This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm,” said Michael Tardugno, chairman, president, and CEO of Celsion in the press release. “Our first collaboration is GEN-1, which incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is being evaluated in the Phase I/II OVATION 2 Study in combination with chemotherapy for patients with newly diagnosed advanced ovarian cancer. We have enjoyed a productive working relationship with Poly Pharm delivering quality product efficiently and are delighted to expand our contract manufacturing agreement with them.”

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Celsion and Poly Pharm to Manufacture Celsion’s DNA-Based Vaccine

Verrica Pharmaceuticals, a dermatology therapeutics company, announced FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) in a Sept. 20, 2021, press release. Previously, FDA extended the Prescription Drug User Fee Act goal date for the NDA by three months (to September 23, 2021) to allow FDA additional time to review information submitted by Verrica in response to comments from FDA regarding the company’s human factors study.

FDA identified deficiencies at a contract manufacturing organization (CMO) facility in the CRL, which—according to the company press release—are not directly related to the manufacturing of VP-102. Instead, these deficiencies raise general quality issues at the facility. The company adds in the press release that, prior to the CRL, they had not been notified by FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that their general investigation of the facility would have any impact on the NDA. To date, FDA did not identify any clinical, safety, or product specific chemistry, manufacturing, and controls deficiencies related to VP-102.

The CMO working with Verrica has implemented corrective actions to address FDA’s concerns, according to the press release, and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility’s identified deficiencies within the next 30 business days. During this timeframe, Verrica says they will engage with FDA to demonstrate that their good manufacturing practices, controls, and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety, or quality of VP-102.

“We remain confident that we have a path forward for VP-102 as a potential treatment option for molluscum, a highly contagious viral skin disease affecting approximately six million people in the United States—primarily children—for which there are currently no FDA-approved treatments,” said Ted White, president and CEO, Verrica, in the press release.

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

Verrica's Molluscum Treatment Rejected by FDA Following CMO Facility Deficiencies

AstraZeneca announced on Sept. 23, 2021, that it had entered into a research collaboration with VaxEquity, a biotechnology company founded by Imperial College London that focuses on self-amplifying RNA (saRNA). The goal of this collaboration is to work toward the discovery, development, and commercialization of the proprietary saRNA therapeutics platform developed by Imperial College London.

According to an AstraZeneca press release, saRNA is a platform for the development of medicines and vaccines that is similar to mRNA. Where the two differ is that saRNA has the ability to self-amplify, which allows it to express proteins for longer periods of time, ultimately resulting in higher protein levels per dose level. This difference may allow saRNA’s to be delivered at lower concentrations than mRNA therapeutics, which broadens the range of potential applications while also lowering dosing requirements, frequency, and costs.

AstraZeneca will support VaxEquity with research and development funding. Should AstraZeneca advance any of the research programs into its pipeline, VaxEquity could achieve milestones totaling up to $195 million and royalties. AstraZeneca may collaborate with VaxEquity on up to 26 drug targets.

“This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox,” said Mene Pangalos, executive vice-president of BioPharmaceuticals R&D at AstraZeneca, in the press release. “We believe self-amplifying RNA, once [optimized], will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest.”

The research collaboration between AstraZeneca and VaxEquity aims to discover and develop self-amplifying RNA therapeutics.