Feliza Mirasol is the science editor for 

Feliza Mirasol

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.”

Articles

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.

Samsung Biologics Partners with LegoChem Biosciences on ADCs 

On Feb. 5, 2024, Novartis announced that it intends to acquire MorphoSys, a Germany-based biopharmaceutical company focused on oncology therapeutics, for €68 per share, or €2.7 billion (US$2.9 billion) in aggregate, in an all-cash transaction. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. Until closing, MorphoSys will continue to operate as a separate, independent company.

With the acquisition, Novartis gains pelabresib (CPI-0610), a late-stage investigational small-molecule bromodomain and extra-terminal domain (BET) inhibitor for treating myelofibrosis (MF). Pelabresib is being evaluated in combination with ruxolitinib as a potential first-line treatment for MF. The combination recently met its primary endpoint of spleen volume reduction in a Phase III clinical trial (MANIFEST-2) in Janus kinase inhibitor-naive MF patients. A regulatory filing is planned with FDA for the second half of 2024.

Novartis also gains tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins currently being tested in patients with solid tumors or lymphomas.

“We are excited about the opportunity of bringing pelabresib, a potential next-generation treatment combined with ruxolitinib, to people living with myelofibrosis, a rare and debilitating form of blood cancer,” said Shreeram Aradhye, president, Development, and chief medical officer, Novartis, in a company press release. “With the planned acquisition of MorphoSys, we aim to further strengthen our … pipeline and portfolio in oncology, adding to our capabilities and expertise. Building on our long-standing development partnership with MorphoSys, we look forward to continuing our work together to realize the full impact and value of their investigational medicines for patients with unmet needs.”

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

Novartis to Acquire MorphoSys for Roughly $2.9 Billion

On Feb. 6, 2024, Purolite, an Ecolab company and a manufacturer of synthetic and agarose-based bioprocessing resins, and Repligen announced that they have commercially launched Praesto CH1, a new 70 μm (micron) agarose-based affinity resin designed. The resin is designed to purify specialized monoclonal antibodies (mAbs) such as bispecifics and recombinant antibody fragments.

This latest innovation was developed for commercialization by Purolite under a multi-year strategic partnership with Repligen. The innovation combines Purolite’s manufacturing process for its patented Jetted beads with Repligen’s ligand technology. The goal is to address previously unmet challenges in specialized mAb purification.

The new CH1 purification resin strengthens Purolite’s current protein A resin portfolio as it has been shown to demonstrate high selectivity for antibodies and related fragments containing the human first-constant domain of the heavy chain, or the CH1 domain. According to a company press release, this characteristic allows for the capture of bispecific antibodies and antibody fragments, as well as the removal of mis-paired species. The new CH1 resin thus offers an effective alternative for the purification of antibody variants when protein A resins are not suitable, according to the release.

“The launch of Praesto CH1 represents the latest offering in Purolite’s growing innovation toolbox for the purification of biologics. Our strategic partnership with Repligen brings leading technologies together to unlock new purification strategies that address our customers’ increasingly diverse biotherapeutic molecules, and the unique purification challenges that these can present,” said Jennifer Sorrells, vice-president of Research and Development, Purolite, in the release.

“It’s fantastic to see the Praesto CH1 resin come to market through our partnership with the Purolite team … This cross-linked agarose-based resin was specifically and successfully engineered for high dynamic binding capacity to the CH1 region of antigen-binding fragments from human immunoglobins (IgGs) and monoclonal antibodies (mAbs), and we believe it is particularly well positioned for market success,” said Ralf Kuriyel, senior vice-president of Research and Development, Repligen in the release.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

Purolite and Repligen Launch New Affinity Resin

On Feb. 5, 2024, Quantum-Si, a US-based protein sequencing company, announced the launch of new platform enhancements for its Platinum protein sequencing platform. The new enhancements, Protein Sequencing Kit V2, allow for:

increased sequencing performance with assay improvements, which include the addition of a new amino acid recognizer

the ability to identify unknown proteins with advanced analytical and inference tools

approximately a three-fold reduction in cost per amino acid.

In tandem with the launch, the company’s CEO and executive team released a video outlining the recent enhancements, highlighting the significance of the newly launched kits. The team also outlines the company’s strategic initiatives for 2024. The video can be viewed on the company’s website.

“Our newly introduced capabilities will provide researchers with additional insights into the proteome that have the potential to unlock scientific discovery only possible at the level of single amino acid recognition,” said Jeff Hawkins, CEO, Quantum-Si, in a company press release. “With Platinum, we are striving to make protein sequencing accessible to every lab everywhere, and, now, with our V2 Sequencing Kits, more insights are possible with greater cost efficiency so that even more scientists can easily incorporate Platinum into their workflow.”

“These advancements not only ensure increased robustness and performance but also introduce novel protein inference analysis software, empowering customers to discover unknown proteins in their samples,” said Grace Johnston, chief commercial officer, Quantum-Si, in the press release. “With this launch, Quantum-Si is set to deliver unparalleled insights into protein characterization and function, catering to the evolving needs of our diverse customer base. Further, it reflects the value of next-generation protein sequencing as we expect that our platform will open new doors to unprecedented biologic insights and the molecules of life.”

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.