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DCVax®-L Phase III Top-Line Data Imminent; the Rise of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO)

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has rocketed past the $1 mark after the Company announced Data Lock for the Phase III trial of DCVax®-L for Gliobastoma Now the statisticians are proceeding with analyses of the raw data and preparing summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication. This comes after a long 13 – year wait for investors.

Expectations are sky high for DCVax-L; unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 as NWBO are well aware of. A cornerstone of NWBO expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility.

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.”  The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers.  It has completed a 40-patient Phase I trial, and is preparing for 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.

NWBO lead produt DCVax-L is made with cancer antigens from tumor lysate from the patient’s own tumor tissue. As such, DCVax-L incorporates the full set of tumor antigens, making it difficult for tumors to find ways around it. This is the DCVax product that has been used in NW Bio GBM brain cancer and ovarian cancer clinical trials, and is currently in its Phase III trial. DCVax-L is expected to be used for any solid tumor cancers in situations in which the patient has their tumor surgically removed as part of standard of care. DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. On May 29, 2018, interim blinded data from the Phase III trial collected in March 2017 were published in a peer reviewed scientific journal. On November 17, 2018, updated interim blinded data from the Phase III trial collected in October 2018 were presented at the Society for Neuro-Oncology annual meeting.

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NWBO

Last month NWBO filed a form D related to the Flaskworks acquisition here. The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing. Flaskworks has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.  It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs. Flashworks technical team has joined NW Bio as part of the acquisition.

On October 5 NWBO announced the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked. With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial.  Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

NWBO CEO Linda Powers stated: “We are excited to be so close to the finish line now, after such a long road. We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer. We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges. We are also very grateful to our shareholders for their patience and support, which has made all this possible.”

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has rocketed past the $1 mark and is currently moving higher after the Company reported the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked and top line data results are imminent. This comes after a long 13 – year wait for investors. Expectations are sky high as Phase III interim data revealed that patients showed a median overall survival (OS) of 40.5 months and were considered “extended survivors”; this population consisted of 30% of the total patients enrolled in the trial. Considering that the median OS for GBM patients is around 15 months, this data is quite astonishing. Patients who experienced tumour recurrence were permitted to cross over to receive DCVax-L. Out of all 331 patients that took part in the study, approximately 90% received treatment with DCVax-L, which included crossover use.  DCVax-L is unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 as the shorts know. Bohsie smartly notes “after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse-case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily 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.” Microcapdialy has been covering NWBO since the stock was $0.15 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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Enveric Biosciences (NASDAQ: ENVB) Pioneering the Future of Anxiety Disorder Treatment

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Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news.

Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.

The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.

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Enveric’s commitment to innovation extends beyond EB-373. They have also submitted additional patent applications to the USPTO, exploring psilocin prodrugs with unique crystalline molecular structures. Moreover, they have taken proactive steps to pursue global coverage of the EVM201 and EVM301 Series through companion Patent Cooperation Treaty and non-US national patent applications. Encouragingly, positive International Search Reports and written opinions have been received under the Patent Cooperation Treaty for most of these applications.

Joseph Tucker, Ph.D., Enveric’s director and CEO, underlined the significance of the USPTO’s favorable decision concerning their lead candidate, EB-373. He highlighted the innovative designs of their psilocin prodrugs within the EVM201 series, differentiating them from conventional counterparts like psilocybin. These novel designs hold the potential to deliver more rapid therapeutic effects, precise control, and reduced gastrointestinal side effects. Tucker emphasized that securing a robust intellectual property portfolio for their new chemical entity prodrugs is pivotal to Enveric’s value proposition and integral to their business strategy of developing cutting-edge small-molecule therapeutics to address mental health disorders.

We will update you on ENVB when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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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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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) Secure Partnership

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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan's proprietary target discovery platform.

TScan to Receive $30 Million Upfront With Potential Development and Commercial Milestone Payments of Over $500 Million.

Collaboration Brings Together TScan’s Proprietary Target Discovery Platform and Amgen’s Inflammation Therapeutic Expertise and Research Capabilities

Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease.

All things considered, this is among one of the largest deals you’ll see for a micro-cap biopharma company. As many of you know, companies in this sector of this size and scale are typically not profitable – mainly focusing on R&D until their drug or technology is fully approved/commercially viable. 

The critical thing to note with this deal between TScan and Amgen is that the cash milestones ensure a cash runway for TCRX, potentially even until they become commercially viable and profitable. 

Here’s a breakdown of the press release in layman’s terms, so anyone without background or knowledge in this space can better understand: 

Amgen and TScan Therapeutics are teaming up to find new treatments for Crohn’s disease, a chronic condition that causes inflammation in the gut. TScan has a unique platform called TargetScan that can identify the proteins recognized by the immune system in people with the disease. Amgen will use this information to create new drugs to treat Crohn’s disease.

As part of the deal, TScan will get an upfront payment of $30 million from Amgen and could earn more than $500 million if the collaboration is successful. Amgen will have the rights to develop and sell any new drugs from this partnership.

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Both companies will be responsible for their research costs, and Amgen can expand the collaboration to include another condition called ulcerative colitis. This partnership could lead to new and better treatments for people with Crohn’s disease, who currently have limited options for managing their symptoms.

Here are a couple of blurbs from the management team

“Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen. “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”

“We’re excited to apply our target discovery platform to the autoimmunity space,” said Gavin MacBeath, Ph.D., acting chief executive officer and chief scientific and operating officer at TScan. “Our TargetScan platform, which we have now extended to identify MHC class II targets of CD4+ T cells, is well-suited for the discovery of antigens targeted by the immune system in inflammatory bowel disease. We look forward to developing the value of our platform both in this partnership with Amgen and in other autoimmune diseases.”

What’s retail saying?

As per usual, with gains of around 135%, you can probably guess that retail is all over it. Investors practically all over the internet keep their eye on the stock for potential entry points utilizing various day trading techniques. 

Interestingly, some traders are surprised it managed to trade such massive volumes early intraday. If you look at their chart from the prior months, the average volume was relatively minuscule – sometimes trading as low as 5K shares a day.  Compared to the ~27M shares traded at the time of writing, that’s a massive shift.

We will update you on TCRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with TCRX.

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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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ContraFect Corp (NASDAQ: CFRX): A Low Float Runner

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On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual.

On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual. Although the surge may be linked to the news from the previous day, it is difficult to determine as there was not much movement on April 26.

However, sometimes it only takes the right attention from investors to create such positive rallies. It is worth noting that $CFRX has a low float of 1.53M, which can lead to extreme volatility and provide retail traders an opportunity to make significant gains.

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Summary of latest PR on April 26, 2023

ContraFect Corporation is a clinical-stage biotechnology company developing new treatments for antibiotic-resistant infections. They recently announced that they initiated a Phase 1b/2 study to test the safety, drug disposition, and efficacy of their drug candidate, Exebacase, in patients with chronic prosthetic joint infections (PJI) of the knee. The study is in France and is randomized, double-blind, and placebo-controlled, meaning some patients will receive the drug, while others will receive a placebo. The study will have two parts: Part I will evaluate the drug’s efficacy, safety, and pharmacokinetics at an early six-week time point, while Part II will assess the long-term clinical safety and efficacy of the drug for up to two years. The CEO of ContraFect Corporation is optimistic about the potential of Exebacase to replace the current surgical treatment for chronic PJI, which has not shown significant improvement in clinical outcomes in recent decades.

What are retail traders saying?

https://twitter.com/RealWillTopol/status/1651553835801001986?s=20

It is worth noting that there has been some speculation about the events that have unfolded and the underlying factors that have led to them. 

We’ve observed a subset of traders that capitalize on the volatility by adopting a watchful approach towards stocks, including $CFRX, to generate quick profits. 

However, it is essential to exercise caution when considering following their lead, given the high risk associated with their investment strategies and the prevailing market conditions. While we do not typically recommend emulating their investment decisions, it may be an intriguing endeavor for those willing to assume a certain level of financial risk with funds they can afford to lose.

About ContraFect Corp (NASDAQ: CFRX)

ContraFect is a company that focuses on finding new ways to treat life-threatening infections resistant to antibiotics. Antibiotic-resistant infections are responsible for an estimated 700,000 deaths each year worldwide. ContraFect is developing new medical treatments called DLAs that include lysins and amurin peptides. Lysins are antimicrobial proteins that can quickly kill target bacteria, including those in biofilms, and can work with traditional antibiotics. Amurin peptides can fight many antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. ContraFect believes that lysins and amurin peptides will effectively fight antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections. The company has completed a Phase 2 clinical trial for their lead lysin candidate, exebacase, designated by the FDA as a Breakthrough Therapy for treating MRSA bloodstream infections, including right-sided endocarditis, when combined with traditional antibiotics.

We will update you on CFRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with CFRX.

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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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