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Delcath Systems (NASDAQ: DCTH) HEPZATO KIT Achieves FDA Approval: A Pivotal Step in Liver Cancer Treatment

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On August 15th, 2023, an impressive 104 million shares were traded as Delcath Systems, Inc. (NASDAQ: DCTH) unveiled a revolutionary update about their HEPZATO KIT. Surging by 81%, the company enthusiastically revealed that their liver-directed therapy has achieved official FDA approval for the treatment of metastatic uveal melanoma (mUM).

This approval encompasses both treatment-naïve (patients who have not undergone any previous treatment the condition) and previously treated patients, without any limitations based on HLA genotype. (HLA genotype refers to the specific genetic makeup of certain immune-related genes in a person. These genes help the body’s defence system recognize what’s normal and what’s not.

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Metastatic uveal melanoma (mUM) is a rare and aggressive cancer variant, with approximately 1,000 cases reported annually in the US. ~90% of these cases involve the liver and often lead to fatal liver failure. In line with recommendations from the National Comprehensive Cancer Network (NCCN), liver-directed therapies are advised for mUM patients with liver metastases. (The presence of liver metastases indicates an advanced stage of cancer and often poses significant challenges for treatment and management).

DCTH’s HEPZATO KIT stands alone as the sole liver-directed therapy sanctioned by the FDA for addressing mUM. Moreover, the procedure of percutaneous hepatic perfusion (PHP), facilitated by HEPZATO KIT, has already been integrated into the NCCN guidelines.

Gerard Michel, CEO of Delcath, expresses his optimism about this development: “The FDA’s approval of HEPZATO KIT marks the inception of a new chapter for Delcath and underscores our unwavering commitment to providing a viable treatment option for individuals battling metastatic uveal melanoma. We eagerly anticipate collaborating with cancer centers across the nation to establish a network of treatment sites proficient in administering this innovative therapy.”

The company is poised to make the commercial product available in the fourth quarter, and patients will continue to receive enrollment and treatment through the Expanded Access Program (EAP) sites.

HEPZATO KIT got the green light mainly because of the results from the FOCUS Study (NCT02678572), the company’s phase 3 trial. In this study, they used HEPZATO (which is a drug called melphalan) and a special way to deliver it to the liver called the hepatic delivery system (HDS). They did this during a procedure called percutaneous hepatic perfusion (PHP). They did this treatment up to six times on 91 patients, with each treatment happening every 6 to 8 weeks. They wanted to see how well the treatment worked, so they measured things like how many patients responded to the treatment (called the objective response rate or ORR) and how long their responses lasted (called the duration of response or DoR). They found that around 36.3% of patients had a positive response to the treatment, and the average time this response lasted was about 14 months.

The FOCUS Study included a mix of patients with different conditions. Some had problems in the liver, and some had problems outside the liver. Also, some patients had never received any treatment before (about 56.0%), while others had gotten treatment before (about 44.0%). They looked at all these patients, no matter their HLA genotype.

HEPZATO KIT’s prescription information has important warnings. It talks about the dangers related to the procedure, the risk of your body not making enough blood cells (myelosuppression), and a plan to handle these risks called a Risk Evaluation and Mitigation Strategy (REMS). Serious problems related to the PHP procedure with HEPZATO KIT were seen in less than 5% of patients who got the treatment. These problems included things like bleeding, liver injury, and blood clot issues. Some patients also had lower counts of blood cells (like platelets and neutrophils), which are predictable side effects of melphalan and are routinely managed by doctors with standard supportive care measures.

The HEPZATO KIT REMS makes sure that the PHP procedure is done the right way by trained teams.

Vojislav Vukovic, the Chief Medical Officer of Delcath mentioned how special and unique the HEPZATO KIT is because it treats the entire liver, not just parts of it. He also mentioned that there’s new research suggesting that HEPZATO KIT might work for other types of tumors too, not just for uveal melanoma.

Another important note is that the approval has now set off the second part of the funding process related to the previously mentioned Private Investment in Public Equity (PIPE) financing announced on March 29, 2023. People who took part in the PIPE have 21 days to use their Tranche A warrants, which could bring Delcath around $34.9 million in extra funding. Moreover, if the Company declares that they’ve made at least $10.0 million in revenue from selling HEPZATO KIT in the U.S. for a quarter, the PIPE participants will also have 21 days to use their Tranche B warrants. This could lead to another $24.9 million in funding for Delcath.

About HEPZATO KIT

HEPZATO KIT is a special product that delivers a medicine called HEPZATO (also known as melphalan) straight to the liver. It uses a clever system called the Hepatic Delivery System (HDS) made by Delcath. This system helps the medicine go where it’s needed in the liver and limits toxicity in the rest of the body. Doctors can use the HDS to carefully treat the liver while the medicine is given and then washed out during a procedure called Percutaneous Hepatic Perfusion (PHP). Delcath’s HDS is what allows for PHP, ultimately giving a strong dose of melphalan directly where it’s needed.

Diving Deeper on Uveal Melanoma:

Uveal melanoma is a rare cancer that affects the eye’s melanocytes, making up about 5% of all melanomas. Each year, around 2,000 cases of primary uveal melanoma are reported in the US. While surgery or radiation can work for the main tumor, about half of uveal melanoma patients end up with metastatic disease, mainly because it’s tough to treat tiny early spread-outs. These new growths mostly happen in the liver (about 90% of patients), and sometimes in the lungs and bones.

Before HEPZATO KIT got approved, there was no approved liver-directed therapy for patients with metastatic uveal melanoma. There’s one general treatment, KIMMTRAK® (tebentafusp-tebn), approved for some cases of uveal melanoma. But because most patients, no matter their specific status, still get worse over time, there’s a need for first and second-line treatments.

Fixing liver spread-outs is super important since it’s often what causes death in uveal melanoma patients. That’s why guidelines from the National Comprehensive Cancer Network suggest treatments that target the liver, like embolization, ablative procedures, and PHP (which only works with HEPZATO KIT). PHP was actually part of the guidelines even before FDA approval.

The spread of uveal melanoma in the liver is kind of like a tiny spread-out pattern. There are lots of small growths you can see on pictures, but they’re hard to spot with a microscope. So, the best treatment should treat the whole liver and let patients get more treatment if needed. None of the current treatments like embolization or ablation can do that, and haven’t been tested in larger trials. The PHP treatment using HEPZATO KIT covers the whole liver, no matter where the growths are, and most patients can get it multiple times.

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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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Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

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Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

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Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

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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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Vaccitech (NASDAQ: VACC) Gains Unprecedented Support—What’s Behind It?

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On September 25, 2023, Vaccitech (NASDAQ: VACC) experienced a jaw-dropping 90% surge in its stock price in just one day of trading. Now, this kind of jump usually happens when a company drops a major announcement or puts out a significant SEC filing. But, surprise, surprise—there was nothing of that sort this time .So naturally we did some digging, explored further online and guess what? Turns out retail traders were also not on a main reason for this rollercoaster ride. Curious to uncover what’s really behind this financial rollercoaster? Before we go any further, let’s get to know Vaccitech a bit better. There’s some pretty important aspects on the company you might like.

 

Background:

Vaccitech operates as a clinical-stage biopharmaceutical company, dedicated to discovering and developing innovative T cell immunotherapies. These therapies are crafted to leverage the immune system’s potency for treating conditions like chronic infectious diseases, cancer, and autoimmune disorders.

What sets Vaccitech apart is their distinctive, multi-platform approach, demonstrating the capacity to generate higher quantities of T cells compared to alternative technologies. This places Vaccitech in a unique position to cater to the needs of substantial, yet underserved patient populations. Their diverse clinical-stage pipeline includes potential treatments for severe diseases with limited available treatments, presenting significant public health risks.

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Among their lead product candidates are VTP-300, an immunotherapeutic designed to contribute to a potential functional cure for chronic hepatitis B viral (HBV) infection. Additionally, VTP-200 is a non-invasive, early-stage investigational treatment targeting persistent, high-risk human papillomavirus (HPV). VTP-850 stands out as a novel T cell investigational therapy aimed at prostate cancer, while VTP-1000, a preclinical T cell therapeutic candidate, focuses on reinstating immune tolerance in celiac disease.

Vaccitech possesses well-established expertise in drug development and scientific knowledge within the immunization realm. Notably, they co-developed a COVID-19 vaccine in collaboration with the University of Oxford. As many of you know, their vaccine has been successfully approved and holds an exclusive license worldwide with AstraZeneca.

What happened:

The one and only thing that happened today was Alliance Global Partners adding coverage of Vaccitech with a favourable buy recommendation.What’s truly eye-catching are the projections made, suggesting some pretty significant upside. The average one-year price target for Vaccitech is $12.24. Forecasts within this period have a bit of a spectrum, reaching from a low estimate of $7.07 to a high of $15.75. With that said, from today’s closing price that’s nearly 400% gain.

What’s The Big Deal?:

Alliance Global Partners giving the green light to cover Vaccitech is like a thumbs-up from a respected expert. It’s like a top-tier food critic saying, “This restaurant is a must-try.”

Think of it as Vaccitech stepping into the spotlight. It’s like a talented musician getting featured on a famous music blog—suddenly, more people start paying attention.

When a big player like Alliance Global Partners says, “Hey, this stock is a good buy,” it’s like a friend recommending a must-watch movie. You’re more likely to check it out based on that suggestion.

This kind of recommendation can also affect the stock price. It’s similar to when a popular influencer talks about a cool product—lots of people want to try it.

In a nutshell, this coverage is like a stamp of approval, making Vaccitech catch the attention of more potential investors and possibly giving the stock a boost. But it’s important to mention that just because a well established financial firm gives a price target, does not mean it’s accurate. In fact, tons of these projections are made daily with many being totally off the mark. Always do your own due diligence.

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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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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.

We will update you on ELUT when more details emerge, subscribe to Microcapdaily to follow along!

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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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