Member Info for Haywain

You are right spurious and puerile - Think I will stick to my opening thread:

Is it fair to say that Hemo are on the cusp of achieving something truly extraordinary? The development of an in-house 100% owned by Hemo anti-FLT3 CAR-T cell therapy, especially for a challenging indication like RR-AML, represents a significant advancement in the field . The approval of an Investigational New Drug (IND) application by the FDA represents a critical milestone that allows Hemo CAR-T to process to phase 1/2a clinical trial indicates a substantial level of confidence by FDA in the safety and proposed efficacy of Hemo CAR-T. In the pre-clincal development Hemo successfully demonstrated the efficacy in a chimeric mouse model with engrafted AML tissues which is a promising indication of success in humans.

Phase 1/2a trials often include initial efficacy assessments alongside safety evaluations. This provides early indications of whether the therapy is likely to be effective in the targeted condition. This should become clear relatively early in the trial with Prevails innovative approach to trial design and data reporting. Running a Phase 1/2a is also more resource efficient than separate trials for each phase which reduces the overall cost of achieving clinical proof of efficacy.

The combination of a novel therapeutic strategy, regulatory endorsement to proceed with human trials and the potential to address a significant unmet medical need does suggest that Hemo is at the threshold of a potentially transformative breakthrough in cancer therapy. To achieve this in spite of their tiny budget and the dubious financiers involved in the early days is what I would call remarkable and I would say that they are on the cusp of achieving something truly extraordinary. The market will catch up eventually.

Investors should believe the health authority that approved the IND. I do also remember your multiple warnings on this subject pre-IND approval. So it seems that FDA do not share your view.

Well I guess we will find out - but in the time being FDA approved hemo Autologous CAR-T for is use in Phase 1/2a clinical trials - So I will stick with the fact that FDA have reviewed Hemo CAR-T IND and deemed it safe to proceed with clinical studies.

Doesn't it give you a warm fuzzy feeling that in spite of FDA having buckets of safety data on autologous and allogenic CAR-T therapies and being in a perfect position to assess the safety and potential efficacy of Hemo CAR-T as it relates to R/R AML that they decided to give it the green light? No? well It does me.

In answering your question please consider that there is an inherent risk/benefit analysis applied to the assessment of all new therapies. If the FDA were concerned they would be blocking treatments - but instead they have responded by asking manufacturers to make an additional cautionary statement in the label. The risk for the stated oncogenic potential of autologous CAR-t associated with DNA integration from the viral vector is as much of a risk in autologous CAR-T as it is in allogenic CAR-T but with allogenic presenting additional challenges that must be addressed due to the fact that the cell is not isolated from the patient. The representative that they interviewed to say why allogenic T-cells were much safer was from a company specialising in allogenic-T cell manufacture. The fact remains that the potential benefits for autologous CAR-T's dramatically outweigh the risk for life threatening conditions especially in the case of RR AML. Additionally Hemo have an answer to the residency time should they need it during development. IMO

Is it fair to say that Hemo are on the cusp of achieving something truely extraordinary? The development of an in-house 100% owned by Hemo anti-FLT3 CAR-T cell therapy, especially for a challenging indication like RR-AML, represents a significant advancement in the field . The approval of an Investigational New Drug (IND) application by the FDA represents a critical milestone that allows Hemo CAR-T to process to phase 1/2a clinical trial indicates a substantial level of confidence by FDA in the safety and proposed efficacy of Hemo CAR-T. In the pre-clincal development Hemo successfully demonstrated the efficacy in a chimeric mouse model with engrafted AML tissues which is a promising indication of success in humans.

Phase 1/2a trials often include initial efficacy assessments alongside safety evaluations. This provides early indications of whether the therapy is likely to be effective in the targeted condition. This should become clear relatively early in the trial with Prevails innovative approach to trial design and data reporting. Running a Phase 1/2a is also more resource efficient than separate trials for each phase which reduces the overall cost of achieving clinical proof of efficacy.

The combination of a novel therapeutic strategy, regulatory endorsement to proceed with human trials and the potential to address a significant unmet medical need does suggest that Hemo is at the threshold of a potentially transformative breakthrough in cancer therapy. To achieve this in spite of their tiny budget and the dubious financiers involved in the early days is what I would call remarkable and I would say that they are on the cusp of achieving something truly extraordinary. The market will catch up eventually.

Thankyou. Indeed the information needed for others to research/verify/or challenge my statements is readily available. I welcome healthy debate; in fact I think it is essential, particularly given the complexity of the subject matter. While I have no control over the funding situation, I can further explore what Hemo is offering that could attract such funding whilst we all wait.

My perspective is that autologous CAR-T therapy, which uses the patient's own cells, is inherently safer than allogenic CAR-T therapy due to the reduced risk of immune reactions. Autologous therapy involves collecting and modifying the patient's own T cells, a process that, whilst complex, avoids the immunogenicity concerns associated with donor cells. On the other hand, allogenic CAR-T therapy offers a potential "off-the-shelf" solution, which is logistically appealing as it bypasses the need for individualised cell collection and processing. However, this approach requires additional genetic modifications to the donor T cells to reduce their immunogenicity and prevent them from being attacked by the recipient's immune system.

It's true that efforts are underway to enhance the safety of allogenic CAR-T therapies, addressing challenges such as minimizing the risk of graft-versus-host disease (GVHD) — a condition where donor cells attack the recipient's body. These efforts, however, introduce new complexities and potential risks- It is an evolving field.

In the context of Hemo-CAR-T, using autologous T cells negates concerns about GVHD since the therapy utilizes the patient's own cells. This approach is particularly advantageous for targeting specific subtypes of rare diseases, where the precision and safety of autologous therapy are paramount. While allogenic CAR-T therapy is promising for treating more common cancers due to its broader applicability and ease of use, Hemo's focus on a rare disease subset RR-AML justifies the preference for an autologous approach. Hemo's strategy is well-suited to its specific goals, leveraging the inherent advantages of autologous CAR-T therapy to address the unique challenges of treating RR-AML. IMO

Reg. I believe the majority who post here share the desire to see the funding issues resolved. I hope your comment about "paid company continuity insiders" wasn't directed at me? Having been invested for a long time my commitment is towards Hemo's success- most of my posting is born out of frustration. My intention in sharing information is solely to benefit shareholders, to start positive debate, rather than reading the swathes of conjecture/mistruth, moaning about poor share price performance etc and to improve collective knowledge in the absence of information being generated by the company. Reading through the discussions on this board can sometimes be disheartening so I try to direct a small portion of my time to share factual information about the company and its products for these purposes.

Stu - I could write a very long and essentially meaningless answer to your question because as you are aware the question has nothing to do with Hemo CAR-T. Do I see gene masking as a potential advancement in the future ? -possibly -In theory, such approaches could indeed offer an inherent advantage. The rationale behind using "masking" gene edits is to create a more sophisticated, perhaps even stealthier, CAR-T cell therapy that can evade the immune system's natural defenses or the cancer's resistance mechanisms longer than its predecessors. But personally I think this is some way off - What techniques were you thinking of specifically CRISPR -cas9 , Talens, zinc finger, RNAi, prime editing or synthetic biology gene circuit engineering? - Think I have heard you mention CRISPR before which ultimately in the fullness of time may offer direct solutions to aberrant gene functioning across may different disease states. What do you reckon?

I much prefer talking about science than shorters - but my previous post does accurately reflect my thoughts on the matter; especially when it comes to companies making potentially life saving treatments.

FLT3 is preferentially expressed on leukemic cells of myeloid lineage (including AML) making it an ideal target for CAR-T cell therapy. By focusing on a molecule that is abundant on leukemia cells but less so on normal cells hemo's anti-FLT3 CAR-T therapy aims to maximise tumor cell eradication while minimising damage to healthy tissue.

FLT3 plays a key role in the normal development of blood cells from hematopoietic stem cells. By designing the CAR-T cells to not compete with the natural FLT3 ligand hemo's CAR-T allows for the normal physiological signaling through FLT3 to continue in healthy cells. This means that while the CAR-T cells are efficiently targeting and killing leukemia cells the essential functions of FLT3 in supporting healthy blood cell development are preserved maintaining the balance necessary for normal hematopoiesis.

Given that approximately one-third of AML patients harbor FLT3 mutations that are associated with poor prognosis and the limitations of current treatments (e.g. resistance to small molecule inhibitors & toxicity of HSCT) there is a critical need for new therapeutic strategies. An anti-FLT3 CAR-T therapy directly addresses this gap- offering a novel treatment avenue for a difficult to treat patient population.

In essence Hemo's anti-FLT3 CAR-T therapy represents a more precise, potentially less toxic, and possibly more durable treatment option for patients with R/R AML who have limited responses to existing therapies. IMO ;)

Stu - maybe if you had lost someone to glioblastoma you would understand why my post was a little bit sickly for your taste

Navigating the intersection of financial markets and the development of life-saving cancer therapies presents a profound ethical dilemma. At the heart of this issue is a choice between prioritizing financial gain or valuing human life. Personally I hold the conviction that the advancement of medical treatments- particularly those with the potential to save lives should be elevated above monetary interests. I would willingly donate my shares to see this having the best chance of success.

Conversely, I recognize that the perspective of profiting from the challenges faced by companies striving to develop cancer therapies can be seen as deeply controversial if not morally reprehensible. To actively undermine or bet against the success of these endeavors for personal financial gain could be viewed as indirectly contributing to the loss of lives. In my view this borders on the unethical (at best) at worst- and I know this is controversial but I will caveat this with the general statement that forgives all "IMO" it is tantamount to manslaughter (ie causing the unintentional death of others - who could have otherwise received a beneficial treatment).

I believe that scientific advancements especially those with the power to cure diseases and save lives should be shielded from the volatility and the speculative nature of financial markets through short selling etc. I personally think there should be a moral imperative to support and protect the development of vital medical treatments from actions that could hinder their success. In short I would champion the pursuit of humanity over the pursuit of wealth.

Hopefully so - The work that Vlad has already done is up there in terms of the academic landscape - would be great to see some of the youngsters getting some of those accolades too - think Dr ben Jehhuda came up with the concept of cbr so why not

Hemo/Vlad is quite literally backed by titans of the industry and more specifically 2 men that are responsible 2 of all time top ten selling drugs - Enbrel and Herceptin - I think we are in relatively good hands https://www.fiercepharma.com/pharma/top-10-all-time-biggest-selling-drugs-by-2024

Dr. H. Michael Shepard is renowned for his pivotal role in the discovery and development of trastuzumab (Herceptin), a groundbreaking monoclonal antibody therapy for breast cancer. Herceptin specifically targets the HER2/neu receptor, which is overexpressed in a significant subset of breast cancers and is associated with aggressive disease and poor prognosis. Shepard's work on HER2 and the development of Herceptin has led to several key achievements and recognitions:

Discovery of HER2 as a Cancer Target: Shepard, along with his colleagues Dennis Slamon and Axel Ullrich, was instrumental in identifying the HER2 protein as a key factor in the growth of certain aggressive breast cancers. This discovery laid the groundwork for the development of targeted therapies for cancer.

Development of Herceptin: Shepard played a crucial role in the development of Herceptin, the first monoclonal antibody approved to target HER2-positive breast cancer. Herceptin has significantly improved survival rates for patients with HER2-positive breast cancer, transforming the treatment landscape for this aggressive form of cancer.

Lasker-DeBakey Clinical Medical Research Award: In 2019, Shepard, along with Dennis Slamon and Axel Ullrich, was awarded the prestigious Lasker-DeBakey Clinical Medical Research Award for their contributions to the invention of Herceptin. The Lasker Awards are among the most respected science prizes in the world, often referred to as "America's Nobels."

Impact on Patient Outcomes: The development of Herceptin has dramatically improved the outcomes for patients with HER2-positive breast cancer. Prior to Herceptin, HER2-positive breast cancer was considered very difficult to treat and had a poor prognosis. Herceptin has been shown to significantly reduce the risk of cancer recurrence and improve survival rates, especially when used in combination with chemotherapy.

Foundation for Further HER2 Targeted Therapies: Shepard's work has also paved the way for the development of additional targeted therapies for HER2-positive breast cancers, including lapatinib (Tykerb), pertuzumab (Perjeta), and ado-trastuzumab emtansine (Kadcyla), further expanding the treatment options for patients.

Advancements in Precision Medicine: The success of Herceptin has served as a model for the development of other targeted therapies, underscoring the importance of understanding the genetic and molecular underpinnings of cancer. This has helped to advance the field of precision medicine, where treatments can be tailored to the specific genetic characteristics of a patient's cancer.

Dr. H. Michael Shepard's contributions to cancer biology and the development of targeted therapies have had a lasting impact on the field of oncology, offering hope to millions of patients worldwide and shaping the future of cancer treatment.

Our chair man : Sir Marc Feldmann has made significant contributions to the field of immunology, particularly in the treatment of autoimmune diseases. His groundbreaking work includes:

Development of Anti-TNF Therapy: Feldmann, along with Sir Ravinder Maini, discovered anti-TNF therapy as an effective treatment for rheumatoid arthritis and other autoimmune diseases , transforming the approach to these conditions and impacting millions of patients worldwide. Never before had a monoclonal antibody been used as an approved therapeutic medicine. Therefore Sir Mark Feldmann was responsible for the first "biologic" and until recently the highest grossing therapeutic agent of all time. This discovery led to the development of several approved anti-TNF drugs, which are now the therapy of choice for various autoimmune diseases, including Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriasis, and psoriatic arthritis​​.

Awarded the 2020 Tang Prize: For his contributions to the development of cytokine-targeting biological therapies, Feldmann was awarded the 2020 Tang Prize in Biopharmaceutical Science​​.

Crafoord Prize and Other Honors: He and Maini were awarded the Crafoord Prize by the Royal Swedish Academy of Science for their identification of TNF blockade as an effective therapeutic principle in rheumatoid arthritis. Feldmann has also received the Albert Lasker Award for Clinical Medical Research, the Cameron Prize for Therapeutics from the University of Edinburgh, and the Dr. Paul Janssen Award for Biomedical Research, among others. He was recognized as the European Inventor of the Year in the Lifetime Achievement category by The European Patent Offices and awarded the Ernst Schering Prize​​​​.

Fellowships and Memberships: Feldmann is a fellow of several prestigious institutions, including the Royal Society of London, the Academy of Medical Sciences, and the Royal Society. He is also a Corresponding Member of the Australian Academy of Science and a Foreign Member of the National Academy of Sciences, USA. His fellowship at the Royal Society was elected in 2006​​.

Knighthood for Services to Medicine: In recognition of his services to medicine, particularly his work in developing treatments for autoimmune diseases, Feldmann was knighted in the 2010 Queen's Birthday Honours​​.

Over 600 Published Papers: Reflecting his commitment to advancing our understanding and treatment of inflammatory autoimmune diseases, Feldmann has authored more than 600 published papers. His research has primarily focused on cytokines, their role in autoimmune diseases, and therapeutic applications​​.

Sir Marc Feldmann's achievements have not only advanced scientific understanding but have also had a profound and practical impact on the treatment of autoimmune diseases, improving the quality of life for millions of patients around the world - Sir Marc chose to be a part of Hemogenyx because of the interesting work they were doin

Saint affimer conjugation would also be an option

I am pretty sure that material sciences will find a way to deliver CBR's to cancer wherever it resides: Lipid Nanoparticles (LNPs): Encapsulating mRNA in LNPs to protect it from degradation, facilitate cellular uptake, and enable endosomal escape. Polymeric Nanoparticles: Using biodegradable polymers (e.g., PLGA, PEI) to form nanoparticles for mRNA encapsulation and delivery. Protamine Complexes: Binding mRNA with protamine to form stable complexes that protect mRNA from degradation. I particularly like the idea of conjugating the CBR mRNA with an aptamer for targeted delivery ie you could select the cell type that the mRNA is delivered to and reduce the risk of unwanted off-target effects- the possibilities are endless