Feliza Mirasol is the science editor for 

Feliza Mirasol

The management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process.

Drug Digest: The Rush for Quality Data and the Means to Protect It

In this episode of Drug Digest, industry experts discuss why data is the biopharma industry’s most valuable asset today. The discussion also delves into the means by which the industry as a whole is learning to upgrade data integrity practices to better protect their data and the use of innovative technologies, such as advanced graph technologies, to better shape the drug discovery and development process.

Nathalie Batoux, Product Manager, Research Innovation, IDBS

Nathalie Batoux left the lab and joined IDBS in 2005, driven by her passion to help scientists with workflows and informatics tools to expedite their research. At IDBS, Batoux is a product manager for Research and Innovation. In her role, she regularly interacts with customers and researchers to gain an understanding of their data management needs and drives the development of platform capabilities to provide a solution. Batoux is an organic chemist by training and started her career as a post-doctoral researcher in chemistry working in the domain of nucleoside and dinucleotide analogues.

Thierry Dorval, Head of Data Science & Data Management, Servier

Thierry Dorval received a PhD in image analysis and artificial intelligence (AI) from University Pierre & Marie Curie and then joined the institut Pasteur Korea in 2005 as a group leader specializing in high content screening applied to cellular differentiation and toxicity prediction. In 2012, he joined AstraZeneca, where he focused on developing and advising on quantitative image and data analysis solutions in support of high content phenotypic screening. In 2015 he joined Servier, France, to lead the Data Sciences & Data Management pole of activities where he is in charge of optimizing the early stages of the drug discovery process by taking advantage of cutting-edge computational approaches. This includes usage of AI, knowledge graph database, system modeling and sequences design applied to multiple modalities including small molecules, antibodies, and oligonucleotides.

Jeremy Grignard, Data & Research Scientist, Servier

Jeremy Grignard holds a PhD in computer science, data, and artificial intelligence (AI) from École Polytechnique. He also earned a master’s degree in applied mathematics in Data Science and an engineering degree in computer science and big data. In 2019, he joined the Servier Research & Development Institute to complete his thesis with Inria Saclay, during which he developed computational methods using knowledge graphs, data science, and mathematical modeling to improve early drug discovery. Since 2022, he has been designing and implementing AI projects related to gene inference, explainable machine learning, heteromodality algorithms, biologically constrained deep learning models, knowledge graphs, and large language models.

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This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.

On Feb. 26, 2024, Nona Biosciences, a wholly owned subsidiary of HBM Holdings Limited, announced that it has entered into a collaboration agreement with Boostimmune, a biotech company specializing in next-generation anti-cancer therapies via modulating immune systems, to develop antibody-drug conjugates (ADCs) against novel targets using Nona’s proprietary Harbour Mice H2L2 (two light and two heavy chain) platform.

The platform technology generates fully human monoclonal antibodies in the classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) format. Nona focuses on integrating its Harbour Mice platform with a single B cell cloning platform to innovate the development of next-generation drugs.

“By leveraging our accumulated knowledge of ADC discovery and utilizing our advanced therapeutic antibody platforms validated by partners worldwide, this collaboration will expedite the development of first-in-class ADCs targeting cancer. Working alongside Boostimmune, we anticipate delivering transformative treatments, ultimately improving outcomes for all patients affected by cancer,” said Jingsong Wang, chairman of Nona Biosciences, in a company press release.

“We are excited to collaborate with Nona Biosciences. Our strategic alignment of resources and knowledge will accelerate the development of ADC therapies against novel targets. Through this collaboration, we are confident in making significant strides in addressing the unmet needs of cancer patients,” said Gwanghee Lee, founder and CEO of Boostimmune, in the release.

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Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.

Nona Biosciences Partners with Boostimmune on ADC Development

Genezen, a cell and gene therapy contract development and manufacturing organization (CDMO), announced on Feb. 21, 2024 that it has entered into a licensing agreement with biotechnology company CSL for CSL’s proprietary stable lentiviral vector (LVV) production system, Cytegrity, which Genezen will implement in its Fishers, Ind., facility.

The system allows for scalable and cost-effective generation of LVVs at clinically effective titers for both gene and cell therapies, according to a company press release. Cytegrity is validated through early clinical testing and has demonstrated safety and efficacy. Traditionally, LVVs are produced at limited scale using plasmid-based transient transfection technology. Cytegrity offers continuous production from a stably transfected adherent or suspension cell line, which eliminates the need for costly plasmid, reduces process complexity, and allows for large-scale batch production. The system also allows for multiple harvests and less batch-to-batch variability, according to the press release.

"I am excited that Genezen is the first CDMO to license the Cytegrity cell line. We have significant, hands-on experience scaling up and producing LVV using this stable production system at our GMP [good manufacturing practice] vector facility in Fishers, Indiana,” said Steve Favaloro, president and CEO of Genezen, in the release. “Stable producer cell lines can be developed for clients in under four months, and this system will help alleviate the current global viral vector shortage by providing customers with a scalable, high-quality vector platform. This licensing capability is a significant value-add for our current and future LVV customers and furthers our collective mission to bring gene and cell therapies more efficiently to patients."

"We are excited to share access to the Cytegrity cell line with Genezen and the broader cell and gene therapy community, including innovators and manufacturers. Following many years of investment in the development of the cell line at CSL in collaboration with our partners, the Cytegrity cell line will potentially lower cost of goods and enable quicker scaleup to clinical and commercial manufacture which, in turn, will benefit patients in gaining access to therapies faster," said Vicky Pirzas, senior vice-president, Biopharmaceutical Product Development, CSL, in the release.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen. 

CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously treated with other therapies (a programmed cell death protein 1-blocking antibody and, if BRAF V600-mutation positive, a BRAF inhibitor with or without a mitogen-activated protein kinase inhibitor).

Amtagvi is a tumor-derived autologous T-cell immunotherapy comprising a patient’s own T cells. It was approved through the accelerated approval pathway. According to clinical study results, among the 73 patients treated with Amtagvi at the recommended dose, 31.5% exhibited an objective response rate, including three patients (4.1%) who had a complete response and 20 patients (27.4%) who had a partial response. Among those patients who responded to the treatment, 56.5%, 47.8%, and 43.5% continued to maintain responses without tumor progression or death at six, nine, and 12 months, respectively, according to the FDA press release. A confirmatory trial is ongoing to verify Amtagvi’s clinical benefit. Amtagvi has also received orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations.

Amtagvi is manufactured via a proprietary process that collects and expands a patient’s unique T cells from a portion of their tumor. Authorized treatment centers will administer the therapy to patients as part of a treatment regimen that includes lymphodepletion and a short course of high-dose Proleukin (aldesleukin), according to an Iovance company press release.

The therapy will be manufactured at the Iovance Cell Therapy Center (iCTC) in Philadelphia, Pa. The center has the capacity for up to several thousand patients annually, including a nearby contract manufacturer. Additional expansion at the center is underway that is expected to significantly increase capacity over the next few years, Iovance stated in its press release. According to the company, the iCTC is the first FDA-approved, centralized, and scalable manufacturing facility dedicated to producing tumor-infiltrating lymphocyte cell therapies for patients with solid tumors.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the agency press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The accelerated approval of [Amtagvi] is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, interim chief executive officer and president of Iovance, in a company press release. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

BioVaxys Technology announced on Feb. 12, 2024 that has acquired the entire portfolio of discovery, preclinical, and clinical development-stage assets from IMV Inc., Immunovaccine Technologies, and IMV USA. These assets were being developed in the oncology, infectious disease, antigen desensitization, and other immunological fields and were based on IMV’s DPX immune educating platform technology.

As part of the transaction, BioVaxys also acquired the extensive technology portfolio of these assets from HIMV, LLC, an acquisition division formed by Horizon Technology Finance and IMV’s other secured creditors. HIMV was formed for the purpose of acquiring IMV’s intellectual property through a secured party credit bid. The transaction is anticipated to close by Feb. 22, 2024.

Under the deal, BioVaxys will pay $750,000 upfront in cash. It will also make various clinical development and regulatory milestone payments and will pay a 15% share in license revenues as well as a 6% gross sales royalty on product sales. BioVaxys will also pay in shares of its common stock, valued at an aggregate of $250,000.

Through the acquisition, BioVaxys gains maveropepimut-S (MVP-S), a DPX-formulated cancer vaccine designed to deliver antigenic peptides from survivin, a cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T-cell helper peptide. MVP-S was recently in Phase IIb clinical trials for advanced relapsed-refractory diffuse large b cell lymphoma and platinum-resistant ovarian cancer. It is also being clinically evaluated in bladder and breast cancer.

The DPX antigen delivery platform is designed to stimulate a specific, coordinated, and persistent anti-tumor immune response and can package a wide range of bioactive molecules in a single formulation, such as multiple nucleic acids/messenger RNA (mRNA), proteins, peptides, virus-like particles, innate immune activators, and small molecules. Thus packaged, these molecules can then be “fed” to dendritic cells and antigen presenting cells to stimulate a specific immune response.

“The DPX platform and addition of maveropepimut-S to our pre-existing clinical pipeline immediately positions BioVaxys as a major player in ovarian cancer and expands our pipeline to include advanced relapsed-refractory diffuse large B cell lymphoma (DLBCL), bladder, and breast cancer,” said Kenneth Kovan, president and chief operating officer, BioVaxys, in a company press release.“We see tremendous commercial potential with the DPX platform, which was a major driver of the transaction. The range of antigens that can be packaged and the cargo capacity of DPX present the opportunity for BioVaxys to monetize multiple development partnerships such as in the multi-valent and mRNA vaccine fields, expand our own immunotherapeutric pipeline, and establish what we believe will be an almost perpetual string of new BioVaxys IP derived from novel DPX formulations. We envision DPX enabling new immunotherapeutics not just from BioVaxys, but from a number of other companies via business development partnerships.”

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

BioVaxys Acquires Full Portfolio of Former IMV

Samsung Biologics announced on Feb. 7, 2024 that it has signed a partnership agreement with LegoChem Biosciences, a biotech company focused on antibody-drug conjugate (ADC) programs, to develop and manufacture an antibody for an ADC candidate.

Under the deal, Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences’ ADC program for treating solid tumors. LegoChem Biosciences intends to submit an investigational new drug application to FDA in the first half of 2025. According to a company press release, non-clinical data has shown promising efficacy results.

Samsung Biologics is on track to adding ADCs to its pipeline. The company expects to have a new standalone, dedicated ADC facility—currently being constructed—to be operational within 2024.

“Collaboration between Samsung Biologics and LegoChem Biosciences will enable us to deliver on our common goal to develop and manufacture efficient and safe therapeutics for patients,” said John Rim, CEO and president of Samsung Biologics, in the press release. “We look forward to working with LegoChem Biosciences to support their pipeline of innovative ADC candidates and secure new opportunities in the fast-growing ADC field.”

“LegoChem Biosciences had previously supplied antibodies for ADC through only overseas companies, but we expect that we will be able to secure a stable domestic supply chain through this contract,” said Yong-Zu Kim, CEO and president of LegoChem Biosciences, in the release.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.