N4 Pharma Develop Nanoparticle Technology to Deliver Vaccine

MOHIT JOSHI | April 13, 2019 | 79 views

Nuvec is a non-viral adjuvant delivery system that is based on silica nanoparticles. This technology is likely to aid in commercializing cancer immunotherapy drugs and improving the effectiveness of viral vaccines. These nanoparticles have a unique irregular surface structure along with polyethyleneimine (PEI). PEI traps and protects nucleic acid when it travels to the cells. On reaching the cell, the nucleic acid is released to activate the immune system. Moreover, Nuvec attracts large number of antigen presenting cells, which results in strong activation of T-cells. 

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Regulus Therapeutics

Regulus Therapeutics Inc. (Nasdaq:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | July 13, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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MEDTECH

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | July 12, 2022

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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MEDICAL

Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | July 14, 2022

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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Regulus Therapeutics

Regulus Therapeutics Inc. (Nasdaq:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.

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CELL AND GENE THERAPY

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

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Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

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MEDICAL

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

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CELL AND GENE THERAPY

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression. The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression. With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work." Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis. While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve." Dr. Anthony Japour, Chief Executive Officer of iTolerance.

Read More

MEDICAL

Anitoa Launches Molecular Test (PCR) for Monkeypox

Anitoa | June 30, 2022

Anitoa Systems, market leader in fast, portable molecular testing, today announced the availability of a CE-marked turn-key PCR solution for testing Monkeypox. This portable solution includes one of a family small foot-print real time PCR instruments called the Maverick qPCR, with an extraction-free multiplex PCR reagent that tests OPXV/MPXV gene-targets in the skin lesion sample from patients suspected of infection with Monkeypox. Anitoa's Monkeypox test is designed to be carried out on-site, near patient, thus avoiding the need to transport patient samples to central labs for testing. The World Health Organization reported that over 2,100 people in 42 countries have been diagnosed with monkeypox as of June 15, nearly all during the past two months. As of June 17, the CDC reports 24 confirmed monkeypox cases in California, US. Although The CDC reports that the threat to the general U.S. population is considered low, it is important for healthcare providers worldwide to have a preparedness plan. Already having a presence in Africa, Anitoa Systems has started deloying its near-patient Monkeypox test in selected clinics in Africa. Anitoa is prepared to deliver its Monkeypox test solution world-wide when the need arises. Anitoa's Maverick line of multiplex real time PCR devices are lab-accurate, fast, portable and calibration-free. They can operate on battery power (including car battery) and takes up very little bench space. Maverick qPCR instruments are built on Anitoa's proprietary CMOS biosensor technology. They have been used widely for on-site testing of food, environment samples and agriculture products due to its rugged all solid-state design, small form factor, and lower operation cost. Anitoa's Monkeypox detection solution is part of an on-going program at Anitoa to develop tests to help combat a series of neglected tropical diseases in low resource settings. These tests currently include IVDR tests for Dengue, Yellow Fever, and Malaria We are closely monitoring the situation of Monkeypox infections around the world and tailoring our test solutions to the needs of the people affected." Zhimin ding, CEO of Anitoa Systems, LLC About Anitoa Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and portable bio-sensor devices for molecular detection, based on its unique CMOS image sensor-based fluorescence and chemiluminescence molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa's ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments and test kits in Hangzhou, China and Fremont, California.

Read More

MEDICAL

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors. HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer. Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics. We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.” Randy Milby, Hillstream’s Chief Executive Officer. We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.” Dr. Jugnu Jain, CEO, Sapien Biosciences.

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