On July 22, 2021 ANOCCA AB reported that it WILL USE A just completed $47m Series B financing to advance its industrialised cellular biology platform and pipeline of TCR-T cellular therapies into Phase I/IIa oncology clinical trials, its CEO tells Scrip (Press release, Anocca, JUL 22, 2021, View Source [SID1234591029]).

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Developing next-generation T-cell immunotherapies using proprietary technology and in-house manufacturing is how privately owned Anocca AB will use a $47m Series B financing that brought the Swedish biotech’s cash mound to more than $100m, its CEO and co-founder Reagan Jarvis told Scrip.

Since its founding eight years ago, Anocca has generated a preclinical pipeline of engineered T-cell receptor therapies for use against multiple antigen classes, including targets that are shared amongst tumours, against specific genetic mutations that drive cancer, and against viruses that cause cancer.

Like CAR-T cell therapy, engineered T-cell receptor (TCR) therapy involves treating cancer with activated T lymphocytes from the body. Both strategies attach new receptors to the cells’ surfaces, enabling them to attack different forms of cancer.

"Our TCR assets pipelines address a range of HLA restrictions, expanding the reach of TCR-modified T-cell therapies to many more patients. Anocca is also deploying our technology to systematically isolate TCRs for neoantigens identified from tumours on an entirely individualised basis," Jarvis said in an interview.

The series B financing was completed 22 July and netted SEK400m. It will be used to advance the company’s industrialised cellular biology platform and progress its pipeline of TCR-T cellular therapies into Phase I/IIa oncology clinical trials by the end of 2022. Anocca is based in Södertälje, Sweden.

"These will be relatively modest sized trials, as they usually are for cell therapies. But we’ll be aiming to bring in multiple assets into that design. Whether that’s on a single protocol and multiple protocols, that doesn’t really matter as that’s just different paperwork. The point is that you can match patients to assets, based on target expressions," Jarvis said.

The biotech’s technology platform is composed of various proprietary cell biology and molecular genetics technologies that enables the scalable high-precision analysis needed to develop highly targeted therapeutics that leverage T-cell immunity. The platform is underpinned by proprietary, fully integrated, information management and bioinformatic software tools developed in-house.

"This series B takes us to well over $100m raised since our founding in 2014 and represents a further strong endorsement of our approach to industrialised high-precision analysis of T-cell biology, which can be applied to any therapy area and which can reach an unprecedented number of intracellular and extracellular druggable targets in liquid and solid tumours, as well as other therapeutic areas, such as infectious diseases and autoimmune disorders," Jarvis said.

The financing was led by advisor Danske Bank and included new investors such as Swedbank Robur Ny Teknik, Ramsbury Invest, as well as existing investors Mellby Gård, Nidoco and Anocca co-founder Mikael Blomqvist.

On July 22, 2021 Anocca AB reported that it raised $47 million in a series B round to advance its T-cell-based immunotherapies expressing recombinant T-cell receptors (TCRs) toward clinical trials in cancer and to build out its manufacturing capacity at its base in Södertälje, Sweden (Press release, Anocca, JUL 22, 2021, View Source [SID1234591028]).

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The company is by no means a newcomer to the immunotherapy space, but it has consciously adopted a low profile since its formation in 2014. "We’ve been working on our technology for nearly eight years now," co-founder and CEO Reagan Jarvis told BioWorld.

Its ability to do so was a function of its investors. Jarvis, a New Zealander who had been working as a post-doctoral researcher at the Heidelberg-based German Cancer Research Center (DKFZ), sketched out the company’s technology from what he calls "ideas on paper." This was enough to get the backing of seed investor and co-founder Mikael Blomqvist, a serial entrepreneur, who put $30 million into the fledgling company. Another early investor – and current chairman – is Hans Stråberg, one of Sweden’s most high-profile business leaders, who spent almost a decade as CEO of the Stockholm-based appliance maker Electrolux AB.

In all, Anocca has now raised more than $100 million in equity finance, and it is developing "dozens of assets" based on its industrialized approach to generating TCR-T cell therapies. "What we’ve disclosed publicly in our pipeline is just a fraction of what we’re working on," Jarvis said. Many firms have limited their TCR- based therapies to a fraction of the dominant human leukocyte antigen (HLA) haplotypes, whereas Anocca plans to achieve broad HLA coverage, in order to address a majority of the world’s population.

Disclosed projects include therapies targeting shared tumor antigens, including New York esophageal squamous cell carcinoma 1 (NY-ESO-1), L antigen family member 1A (LAGE1A) and melanoma-associated antigen 4 (MAGE-A4), among others. It has several projects that target prominent oncogenic cancer drivers, including the KRAS mutations G12D and G12V, neither of which is targeted by Amgen Inc.’s recently approved small- molecule KRAS G12C inhibitor, Lumakras (sotorasib), as well as RAC1P29S and BRAFV600E. It is developing multiple therapies directed at antigens associated with Epstein-Barr virus- transformed cancers. It is also engaged in discovering TCRs that target tumor neoantigens that occur in individual patients.

Its technology platform has been consciously designed to address indication areas outside of cancer, including vaccines against infectious disease and the inducing tolerance in patients with autoimmune disease. The company has active projects in these areas and in the development of immunosurveillance toolsets for patient monitoring and stratification.

Key to its approach has been the development of libraries of engineered human T cells and antigen presenting cells, which enable it to screen and validate T-cell targets and TCRs at scale. The reproducibility of its cell-based assays avoids the variability that can arise from approaches based on material from patients and healthy donors. "It’s just very low signal, very high noise," Jarvis said. Anocca’s approach is informed by empirical cell biology work, rather than genomics. "We barely touch next- generation sequencing," he said. "This is real biological data – there’s no AI."

The company’s long-term vision is to develop allogeneic cell therapies, but it will start with autologous therapies initially. The privately held firm already has 65 staff on the payroll, a large majority of whom are scientists, and it is operating from a former Astrazeneca plc research site for central nervous system disorders, which is about 20 miles southwest of Stockholm. It has 3,000 square meters of lab space and another 5,000 square meters for manufacturing. "We’re built for scale," Jarvis said.

It aims to be ready to move its first projects into clinical trials by the end of 2022. The big push to produce COVID-19 vaccines has had a knock-on effect on timelines, because of the manufacturing supply chain constraints it has introduced.

Anocca has yet to enter any licensing deals. "That’s a matter of opportunity and timing," Jarvis said. The company is engaged in a research collaboration with the Johnson & Johnson subsidiary Janssen Research and Development LLC, which is exploring its technology. It is also part of a European Commission-backed project in rheumatoid arthritis, RTCure, which is funded by the Innovative Medicines Initiative. And it is engaged in project with Solna-based Scilifelab on the biophysical and structural characterization of the interactions between TCRs and the major histocompatibility complex.

The present round was limited to Nordic investors – it could have been bigger had the company wanted to take on more capital at this time. "We’ve not been greedy," Jarvis said. The process was led by advisers Danske Bank and brought in new investors Swedbank Robur Ny Teknik, a managed equity fund, investment managers Ramsbury Invest AB, and several family offices, including those of veteran venture capital investors Harald Mix and Robert Andreen. Existing investors, including Mellby Gård, Nidoco and Blomqvist’s investment vehicle, Michano, also participated.

On July 22, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the signature of a license and option agreement with ProfoundBio, an emerging oncology biotherapeutics company (Press release, Synaffix, JUL 22, 2021, View Source [SID1234590210]).

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The deal provides access to multiple novel linker-payload technologies developed by Synaffix and includes access to the GlycoConnect glycan conjugation and HydraSpace polar spacer technologies, both of which are known to optimize the therapeutic properties (efficacy and safety) of ADCs. Upon signature, ProfoundBio was granted non-exclusive license rights to deploy the above technologies for one therapeutic program that targets an undisclosed specific tumor associated antigen (TAA). Additionally, ProfoundBio retains license option rights to a second TAA that can be nominated later.

Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $246 million, plus tiered royalties­­ on net sales. No further financial details are disclosed.

ProfoundBio will be responsible for the research, development, manufacturing and commercialization of the ADC products. Synaffix will closely support ProfoundBio’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, and HydraSpace technologies.

Baiteng Zhao, CEO of ProfoundBio said:

"Selecting the right linker-payload for each ADC is critical for success. Through our collaboration with Synaffix, we can access multiple potent ADC linker-payloads and efficiently optimize the competitive position of our therapeutic pipeline."

"With the solid experience and track record of our founding management team and a strong venture capital syndicate behind us, we are well positioned to rapidly progress multiple best-in-class and first-in-class ADC candidates to the clinic. We look forward to working closely with Synaffix to achieve this."

Peter van de Sande, CEO of Synaffix said:

"This collaboration is another example of Synaffix’ proprietary technologies helping biotech and pharma companies optimize the competitive positions of their ADC pipelines."

"The ProfoundBio team brings multiple decades of valuable ADC development experience from Seattle Genetics (now Seagen) and MSD. into our collaboration. We are looking forward to continuing our close collaboration with ProfoundBio on their emerging ADC portfolio and supporting the development of multiple ADCs into the clinic and beyond."

On July 22, 2021 LUMICKS, a leading next generation life science tools company renowned for its innovative platforms for Dynamic Single-Molecule and Cell Avidity analysis, reported that it has installed its ground-breaking z-Movi Cell Avidity Analyzer at INmune Bio (NASDAQ: INMB) (Press release, LUMICKS, JUL 22, 2021, View Source;utm_medium=rss&utm_campaign=inmune-bio-acquires-lumicks-z-movi-cell-avidity-analyzer-to-accelerate-the-selection-of-nk-cell-products-for-cancer-treatments [SID1234586006]).

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INmune Bio is a clinical stage biotechnology company developing new therapies that modulate the innate immune system to treat cancer and neurodegenerative diseases, such as Alzheimer’s. Its Natural Killer Cell Priming Platform, INKmune is a "pseudokine" which drives a patient’s own natural killer (NK) cells to memory-type NK cells which kill persistent tumors that survive initial treatments.

INmune Bio is employing the z-Movi cell avidity analysis platform to demonstrate that the mechanism of action of the tumor-priming is the increase in NK cell:tumor cell avidity. Early data acquired by the z-Movi support their hypothesis that increased cell avidity enhances NK cell killing of tumor cells. This allows screening of batches of INKmune for potency and provides a potential biomarker of in vivo activity by measuring the tumor avidity of NK cells isolated from patients before and after INKmune treatment.

"The z-Movi is the first high throughput tool I have seen to reliably measure cell:cell avidity, allowing us to dissect the temporal nature of the formation of NK cell:tumor cell synapse as well as the critical components required for synapse stability and NK cell triggering. These data are incredibly valuable for our continued development of INKmune but, equally importantly, establishing the mechanism of action of INKmune as "increasing NK avidity" gives us a perfect tool and assay to measure potency of batches of INKmune, which is required by drug regulatory agencies" said Professor Lowdell, CSO of INmune Bio.

The z-Movi Cell Avidity Analyzer is a unique platform that measures the binding strength between target and immune cells, which is a key event in the mode of action of immune products. Furthermore, the z-Movi platform provides these measurements across a large population of cells, rapidly, with single-cell resolution. Cell avidity solutions have the potential to shorten the drug development cycle for adoptive cell therapies and other immune-therapies and reduce failure rates in clinical trials.

"We are excited to work together with INmune Bio, a pioneer in immunotherapy that harnesses the innate immunity of patients to combat solid and liquid cancers," said Dr. Andrea Candelli, CSO and co-founder of LUMICKS. "We strive to provide the benefits of fast, predictive, and reproducible cell avidity measurements to partners like INmune, in order to continue to advance science and accelerate the entry of cell-based therapies into clinical trials."

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