INDUSTRIAL IMPACT

Omega Therapeutics Announces Strategic Research Collaboration with Stanford University School of Medicine

Omega Therapeutics, Inc | October 14, 2021

Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues.

Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology.

"Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines."

Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics

About Omega Therapeutics
Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of  mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

Spotlight

Vaccination is generally considered as one of the greatest public health achievements in industrialized countries during the 20th century, reducing morbidity and mortality from a broad range of vaccine-preventable diseases. Globally, over 5.9 million deaths are prevented annually through vaccination against nine major infectious diseases, including varicella, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (childhood), hepatitis B, measles, polio, and tuberculosis.


Other News
MEDICAL

Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19

Kintor Pharma | December 29, 2021

Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection. Statistical criteria were not met at an interim analysis of the phase III outpatient study, designed for testing efficacy and safety of proxalutamide for treating COVID-19 in non-hospitalized COVID-19 patients. At the interim analysis, 348 patients with mild-to-moderate COVID-19 symptoms were enrolled. Kintor Pharma will seek for Health Authorities including the U.S. Food & Drug Administration's consent to amend the protocol and continue to enroll higher risk COVID-19 patients only with multiple comorbidities and/or patients with no COVID-19 vaccination history. Based on the interim analysis, there were no safety concerns and no drug-related serious adverse events reported during the study. As of December 23, 2021, Kintor Pharma had completed the enrollment of this pivotal study according to the original protocol. More than 95 percent of the enrolled patients were from the U.S. For the interim analysis, all patients were from the U.S., where the hospitalization rate is very low. "The COVID-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics. It is important to investigate new modalities to treat those infected with the virus. We believe proxalutamide could become an important tool in the fight against COVID-19 infection and will continue to investigate its use. We will provide updates on the final data analysis from this outpatient clinical trial in due course." Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma The outpatient study is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of proxalutamide in outpatients with mild to moderate COVID-19 illness. For the interim analysis, the trial enrolled 348 male and female patients with one or more mild COVID-19-related symptoms within five days of symptoms onset. Participants were randomized to receive proxalutamide or placebo orally twice daily for 14 days. The enrolment covers the whole population including patients with a vaccination history, as well as without any risk factors. Both the treatment arm and placebo arm were given standard of care. The primary endpoint was the percentage of all-cause death and hospitalization for a period exceeding 24 hours by day 28. About Kintor's Multi-Regional Clinical Trials for Proxalutamide Kintor Pharma is conducting two registered Phase III multi-regional clinical trials of proxalutamide for the treatment of COVID-19 outpatients, and one Phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America, Asia and the European Union. The second outpatient study plans to enroll 724 patients, with the primary endpoint of percentage of subjects requiring oxygen by day 28. The inpatient study is a randomized, double-blind, placebo-controlled Phase III study. Male and non-pregnant female hospitalized adults are included. The primary endpoint is time to sustained recovery, and the key secondary endpoint is percentage of all-cause mortality. Kintor Pharma was granted an emergency use authorization for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay. About Proxalutamide Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which inhibits the overproduction of IL-6, proinflammatory cytokines, and chemokines. This mechanism of action reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne.

Read More

CELL AND GENE THERAPY

PDS Biotech Reports An Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

PDS Biotechnology Corporation | December 27, 2021

PDS Biotechnology Corporation, a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, announced that the compensation committee of the board of directors of the Company approved, on December 20, 2021, an equity award to Michael Lalond, the Company’s new Director of Quality Assurance, as a material inducement to Mr. Lalond entering into employment with PDS Biotech. An inducement grant of 20,000 shares of PDS Biotech’s common stock, in accordance with Nasdaq Listing Rule 5635(c)(4), was awarded as part of Mr. Lalond’s compensation. The award was granted under PDS Biotech’s 2019 Inducement Plan, as amended, in accordance with Nasdaq Listing Rule 5635(c)(4) and provides for the granting of equity awards to new employees of PDS Biotech. The option award has an exercise price of $8.87, the closing price of PDS Biotech’s common stock on December 20, 2021. About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells.

Read More

MEDICAL

Cardea Bio completes planned launch of CRISPR QC

Cardea Bio | April 06, 2022

Today, Cardea Bio, Inc. - the world's only mass producer of biocompatible semiconductors - announced a significant milestone with the launch of CRISPR QC Inc. as a separate business using Cardea's CRISPR-chip™ technology for a range of quality control services for CRISPR gene editing. This milestone is an important move for Cardea Bio on its mission to realizing real-world applications of their BPU™ (Biosignal Processing Unit) Platform. After recently establishing dedicated lab facilities and office spaces, as well as completing the initial investor funding, CRISPR QC is now ready to offer analysis services for R&D groups in therapeutics, animal breeding, plant biology, and academics in need of advanced insights to their CRISPR efforts. One of the challenges for successful CRISPR gene editing is a lack of understanding and standardization of processes around predicting and optimizing CRISPR assay outcomes. At CRISPR QC, we work with scientists to improve the quality of life for all. That's why we're excited to work with the Chief Scientific Officer of Cardea Bio, Dr. Kiana Aran, who recently received NIH funding to help set some of the US quality control standards for CRISPR therapies, In addition to this, CRISPR QC provides previously unavailable data and insight into the CRISPR editing process, resulting in significant time-savings and first to market application opportunities for our customers, including CRISPR/Cas technology-driven solutions which are commercially available as of now." Ross Bundy, President of CRISPR QC. With CRISPR QC going into business with valuable first-of-a-kind services in the growing CRISPR space, we can now showcase a distinct example of what our BPU Platform can enable our partners to do - products and applications otherwise not possible. That in turn drives growth opportunities and revenue for Cardea Bio, unlocking significant value for both CRISPR QC's and Cardea's stakeholders, I'm anticipating that CRISPR QC will get a number of near-term opportunities to help its customers bring transformative gene-editing insights and solutions to scientists and researchers working on CRISPR therapies, as well as other market changing applications." Michael Heltzen, CEO at Cardea Bio. About CRISPR QC Inc. CRISPR QC is a biotechnology company dedicated to improving the capabilities of scientists and researchers to improve their CRISPR assay designs through technological innovation. Using market-leading solutions, we can identify CRISPR activity in amplicons and genomic DNA and model results of the CRISPR process In vivo vs. In vitro. Our service is available to therapeutic companies and academic researchers to help them accelerate the development of their CRISPR-based therapies and to animal breeding and plant biology scientists who seek to improve the food chain for humankind. About Cardea Bio Cardea Bio is the world's only mass producer of a biocompatible semiconductor, the BPU™ (Biosignal Processing Unit). The BPU is the first and only semiconductor capable of translating real-time streams of multiomics signals into digital information. Through the BPU™ platform, Cardea's long-term vision is to democratize access to the biosignals and insights behind the most advanced technology on our planet: Nature and biology. The Internet of Biology is that way becoming possible. Cardea is headquartered in San Diego and has additional activity in Los Angeles. Cardea is a 100% American developed and built biocompatible semiconductor technology for applications across a variety of sectors including human health, agriculture, molecular diagnostics, biotechnology, environmental monitoring, and animal health.

Read More

INDUSTRIAL IMPACT

Element Biosciences Becomes the Newest Member of 10x Genomics’ Compatible Partner Program (CPP) Across Multiple Single Cell Applications

Element Biosciences, Inc. | March 01, 2022

Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, announced a partnership with 10x Genomics, a life sciences leader focused on mastering biology to advance human health, that demonstrates the seamless integration of the Element AVITI™ System and 10x Genomics’ single cell technologies. 10x Genomics’ Chromium Single Cell and Visium Spatial platforms enable researchers to examine biology at true resolution, combining hardware, chemistry, and software to give single cell and spatial views of biology at a scale and efficiency that is unprecedented. The combination of the AVITI System’s performance, cost, and flexibility with 10x Genomics’ leading single cell assays provides customers more access and choice for their biological research. “We are excited about the partnership we’ve established with 10x Genomics and our new status as a validated CPP member. As one of the most exciting new areas in NGS, we believe this will help bring 10x Genomics’ and Element Biosciences’ customers together for our combined performance and cost advantages in single cell and spatial analysis.” Shawn Levy, Senior Vice President of Applications and Scientific Affairs, Element Biosciences “At 10x Genomics, part of our commitment to supporting our customers with single cell and spatial analysis is ensuring they have access to advanced sequencing solutions through rigorous validation,” said Brad Crutchfield, Chief Commercial Officer, 10x Genomics. “We are excited to certify Element through our Compatible Partner Program and provide our customers with more ways to adopt single cell and spatial analysis to enhance their research and fuel scientific discoveries.” About 10x Genomics 10x Genomics is a life science technology company building products to interrogate, understand and master biology to advance human health. The company's integrated solutions include instruments, consumables and software for analyzing biological systems at a resolution and scale that matches the complexity of biology. 10x Genomics products have been adopted by researchers around the world including in all of the top 100 global research institutions as ranked by Nature in 2020 based on publications and all of the top 20 global pharmaceutical companies by 2020 research and development spend, and have been cited in over 3,300 research papers on discoveries ranging from oncology to immunology and neuroscience. The company's patent portfolio comprises more than 1,300 issued patents and patent applications. About Element Biosciences, Inc. Element Biosciences is a multi-disciplinary life science company currently focused on developing disruptive DNA sequencing technology for research and diagnostic markets. Through innovating every fundamental element of a sequencing system, Element will empower customers with affordable high-quality data and an improved user experience, which in turn will accelerate scientific discoveries and broaden the use of genomic medicine.

Read More

Spotlight

Vaccination is generally considered as one of the greatest public health achievements in industrialized countries during the 20th century, reducing morbidity and mortality from a broad range of vaccine-preventable diseases. Globally, over 5.9 million deaths are prevented annually through vaccination against nine major infectious diseases, including varicella, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (childhood), hepatitis B, measles, polio, and tuberculosis.

Resources