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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is Heating Up as Biotech Begins Production of Dendritic Cell Cancer Vaccine at Sawston Facility & Phase III Top Line Data Looms

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is one exciting biotech that has given up some gains since hitting highs of $2.50 per share but not that much and is now making another strong move on $1 as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names in pharma who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range.  

NWBO is also making rapid progress on other fronts recently reporting commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”).  The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. Now that the facility is ready for the manufacture of cell therapy products for clinical use, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.  

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotech focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial reached data lock and the Company is actively continuing to move toward announcement of top line data. Northwest has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania. 

Northwest has an integrated strategy for protection of its technology through both patents and other mechanisms, such as Orphan Drug status. Currently the Company holds 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to its DCVax products. In the US and Europe, some of its patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

DCVax® is designed to reinvigorate and educate the immune system to attack cancers. Unlike conventional cancer drugs, which use one active agent to hit one target on the cancer, DCVax uses many active agents to hit many targets on the cancer. Northwest believes that at least three key aspects of the DCVax technology contribute to the positive results seen in clinical trials to date: (1) DCVax is designed to mobilize the entire immune system, not just one among the many different categories of immune agents in that overall system. 2) DCVax is designed to target not just one but the full set of biomarkers on the patient’s tumor. And 3) DCVax is personalized, and targets the particular biomarkers expressed on that patient’s tumor.  

NWBO has a strong management team behind it, led by CEO Linda F. Powers, a high-powered executive who served on the MD Stem Cell Research Commission, and was the Commission Chair for the first two years of the state’s stem cell funding program. Ms. Powers served for more than 6 years on the Board of the Trudeau Institute, as well as several years on the Steering Committee of the National Academy of Sciences, evaluating government research funding, and has been appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. Ms. Powers also serves on the boards of a number of private biotech companies. The Company’s CSO, Alton L. Boynton used to be head of the Molecular Oncology research lab at the Pacific Northwest Research Foundation (the original foundation of Bill Hutchinson, from which the Fred Hutchinson Cancer Center was spun off). NWBO’s CTO, Marnix L. Bosch Ph.D. has led the processes for numerous regulatory submissions in both the U.S. and abroad and used to work at the Dutch National Institutes of Health (RIVM) as head of the Department of Molecular Biology, as well as in academia as a professor of Pathobiology. He has authored more than 40 peer-reviewed research publications in immunology and virology, and is an inventor on several patent applications on dendritic cell product manufacturing. 

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The DCVax technology is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax®-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax®-Direct) is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. Management believes the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. Importantly, DCVax has an excellent safety profile and is non-toxic. In clinical trials to date, stretching over a decade and including over 1,000 treatment cycles, there have been no toxicities such as chemotherapies involve – and not a single “serious adverse event” – related to the treatment.  

There have been indications that the top line date for DCVax®-L will be overwhelmingly positive; according to date published from 2018 at the Society for Neuro-Oncology Annual Meeting in New Orleans shows the following: Median overall survival (OS) from surgery in the intent-to-treat population at data cutoff was 23.1 months, the same OS benefit identified in 2017. The survival rate at year 2 was 46.4%, on par with 46.2% in 2017. In patients with methylated MGMT genes, median OS after surgery was 35.1 months, slightly better than 34.7 months observed in 2017. This represents a vast improvement over the median OS of only 14.6 months. “The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.”   

NWBO is pursuing an intensive program of manufacturing preparations and planning in preparation of the top line data from its Phase III trial of DCVax®-L; development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and certified by the UK Medicines and Health Products Regulatory Authority (“MHRA”). The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. 

NWBO Sawston, UK advanced manufacturing facility

 

The last press release from NWBO came on February 17 when the Company reported commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”). 

As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations. This included hiring and training of technical staff, preparation of approximately 1,000 regulatory documents (including Standard Operating Procedure documents and others), validation of facilities, equipment and protocols, and practice manufacturing cycles. This was followed by a review and detailed inspection by the MHRA. 

Since the issuance of the MHRA license, Advent Bioservices, NW Bio’s contract manufacturer in the UK, has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use. Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year. The Company plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system. 

Microcapdaily first reported on NWBO on November 11, 2018 when NWBO was trading at $0.20 stating at the time: “Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has been sitting at around $0.20 as Investors wait out a news vacuum since the end of August. Northwest is an exciting Company with a recent history of explosive moves up. The stock used to trade at much higher levels. Currently trading at a $105 million market valuation NWBO has $1.6 million in the treasury, some revenues reporting $410,000 in revenues for the 6 months ended June 30, 2018 and significant debt on the books. Northwest is a really exciting company; their lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product in an ongoing Phase III trial for newly diagnosed Glioblastome multiforme (GBM).” 

https://twitter.com/Jordongf2/status/1517223922407682048

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Currently trading at a $904 million market valuation NWBO has 981,374,858 shares outstanding out of 1.2 billion authorized. The Company is an SEC filer and fully reporting OTCQB. While the Company has $15.2 million in the treasury and over $40 million in assets, they also have significant debt on the books. NWBO is pre revenue but some have started to trickle in topping $1 million in sales in 2021. Northwest has been very successful raising money recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names in pharma who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range. Microcapdaily first reported on NWBO on November 11, 2018 when NWBO was trading at $0.20 per share. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.

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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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ZyVersa Therapeutics’ (NASDAQ: ZVSA) Breakthrough: A Super Tool for Tackling Inflammation in ALS and Beyond

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ZyVersa Therapeutics (NASDAQ: ZVSA) had a spectacular day on the market, with its stock surging by almost 50% following a significant announcement about one of their promising drug candidates, IC-100. This drug is designed to combat inflammation in the context of Inflammatory Diseases, and the latest data is incredibly promising. For those who are new to this field of investment, we’ve taken the liberty of rephrasing the press release in simpler terms.

The Release:

When you’re dealing with diseases like ALS that affect your brain and nerves, shutting down the inflammasome pathway NLRP3 (a multi-protein that regulates the immune system and inflammatory signaling), is not enough.

To address this, ZyVersa is working on something called Inflammasome ASC Inhibitor IC-100. It’s like a super tool designed to block not just NLRP3 but a bunch of other inflammasome pathways too – up to 12 of them. This helps keep inflammation in check, whether it’s in the central nervous system (CNS) or other parts of the body where inflammation is causing problems.

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In a recent paper published in Frontiers in Immunology, they pointed out that focusing only on NLRP3 might not do the trick when it comes to calming CNS inflammation in ALS and similar diseases. They did experiments with cells and even used mice to back up their point. Turns out, just targeting NLRP3 didn’t stop the release of those pesky proinflammatory chemicals or the damage they were causing in the spinal cord.

The authors of the paper basically said, “Maybe we should aim to tackle multiple inflammasome pathways when it comes to diseases like ALS, where lots of inflammasomes are going haywire.”

The CEO and president at ZyVersa, Stephen C. Glover mentioned “Our research shows that to really put the brakes on inflammation driven by multiple inflammasomes, we need more than just NLRP3 inhibition.” He added that IC-100 is like a superhero in the world of inflammation control. It stops the formation of different types of inflammasomes, preventing the start of the inflammation chain reaction, and also puts a halt to something called ASC specks, which keep the inflammation going. You can dive deeper into how IC 100 works by checking out their website here.

So, in plain speak, ZyVersa is cooking up a promising solution for folks dealing with inflammation-related problems, especially those tied to the brain and nerves. They’re not just focusing on one troublemaker; they’re going after a whole gang to keep things under control.

Overall ZyVersa is a company on a mission to create groundbreaking treatments for kidney and inflammatory diseases, and IC-100 could help them in this mission.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Creative Medical Technology NASDAQ: CELZ) Major Breakthrough: Allogeneic Cell Line Paves the Way for Diabetes Treatment

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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently seen a substantial intraday gain of over 15% in its share price. Despite the absence of any recent news or filings, this surge could suggest significant progress in the realm of allogeneic cell therapy.

Background:

The company is known for its regenerative approaches in various medical areas, including immunotherapy, endocrinology, urology, gynecology, and orthopedics, and made a significant announcement. In the fourth quarter of 2022,They successfully developed a new allogeneic cell line called AlloStem™. AlloStem™ is derived from human perinatal tissue and includes a Master Cell Bank and a Drug Master File. Now, with FDA approval, their program, known as CELZ-201, is being used in an early clinical trial for type 1 diabetes and will continue to be developed for both type 1 and type 2 diabetes treatment.

Additionally, the company is using the AlloStem™ line for its StemSpine® procedure to help treat chronic back pain. They report remarkable results, including over a 90% reduction in narcotic usage, more than an 80% reduction in pain scores, and over a 50% reduction in the Oswestry score in patients treated with AlloStem™.

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Allogeneic Cell Therapy:

Allogeneic Cell Therapy is a treatment that uses cells from healthy donors to treat patients with otherwise untreatable diseases. These cells can come from various sources, like bone marrow, blood, or umbilical cord blood. This approach shows great promise in the medical field.

Allogeneic cell therapy offers potentially curative options for patients when traditional treatments fall short. While still a relatively new field, ongoing research into allogeneic cell therapies holds great potential for patients suffering from these diseases. Companies like Argan Inc. are also exploring the benefits of allogeneic cells.

With FDA approval and ongoing clinical trials, Creative Medical Technology’s recent developments open doors to innovative treatments that could significantly enhance the lives of those dealing with diabetes and other diseases. The global market for allogeneic cell therapy reached $255.6 million in 2022 and is expected to grow at a rate of 27.4% from 2023 to 2030, emphasizing the importance of continued research. As the company remains dedicated to medical innovation, their efforts have the potential to improve the health outcomes of people worldwide.

Latest Release:

The company recently shared key updates on its financial status and drug pipeline for Q3 2023. The biotech company, known for its regenerative medical solutions, reported being debt-free with $14.6 million in cash and $14.4 million in working capital, sufficient to cover expenses through 2024.

Their advancements in treating type 1 diabetes include FDA clearance for a groundbreaking clinical trial using CELZ-201 (AlloStem™). The company obtained Institutional Review Board approval and partnered with Syneos Health for this study. They also filed for Orphan Drug Designation to tackle brittle type 1 diabetes.

Promising results emerged from the CELZ-001 treatment for type 2 diabetes, demonstrating substantial reductions in insulin requirements with no safety concerns.

A pilot study on the StemSpine® procedure, using donor cells (AlloStem), showed impressive reductions in narcotic usage, pain scores, and improved functionality for chronic lower back pain patients.

Creative Medical Technology’s ImmCelz platform proved efficient, requiring fewer donor cells and yielding high-quality results.

They also collaborated with Greenstone Biosciences Inc. to develop a human-induced pluripotent stem cell (iPSC) pipeline, iPScelzTM, aimed at expediting drug discovery. The development of this cell line is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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