Member Info for HereforHemo

scalability, costs, treatment centre concerns etc..really?

made scientific has over 100 staff and a 72,000 square foot manufacturing laboratory with a fully ai automated manufacturing process capable of running 5,000 batches per annum at full capacity, not to mention they are part of gc biopharma a multi billion dollar global corporation.

and md anderson, who by the way has a joint venture with the texas children’s hospital to specialise in pediatric treatment have over 300 staff dedicated just to pediatrics and between them have 47,000 employees! both by the way will be enrolling patients for the hg-ct-1 trial.

so the poster who continues to be a brainless imbecile will now be ignored. but if you are genuinely concerned then just **** off somewhere else. the rest of us will look at partners, former and current in pennsylvania university the world leaders in car-t, prevail, made scientific and the two leading cancer institutes in the world, md anderson and the texas children’s hospital and go…wow!

no wonder vlad says the future is “fantastic”

What some posters fail to realise, either through intent or basic stupidity is the competitive advantage HG-CT-1 has in treating r/r AML which lies in its highly specific targeting of the FLT3 receptor, which is expressed on the majority of Acute Myeloid Leukaemia (AML) blasts. Unlike standard chemotherapy, which broadly kills cells, HG-CT-1 is designed for precision and efficacy. A unique feature of HG-CT-1 is that it does not compete with the natural FLT3 ligand. This prevents a common issue where natural proteins block the therapy from binding to cancer cells, thereby maintaining high efficacy, demonstrated in the third patient showing no signs of AML even at the lowest dose.

Unlike any therapy currently approved it utilises third-generation CAR-T technology, which offers the same or enhanced efficacy as current treatments but with an enhanced safety profile.

Also, rather than having a bottleneck in manufacturing as well as cost constraints that other start ups have it has a partnership with Made Scientific, Hemogenyx has completed technology transfer to external GMP-ap

proved facilities, ensuring the therapy is ready for both clinical and commercial demand, a major benefit to partners.

With an imminent agreement being signed with Cellin in Estonia Hemogenyx can simply take the ‘plug and play’ process FDA approved at Made Scientific and generate early revenues across Europe from the exemption pathway and furthermore take this to Asia with another partner.

With dose escalation and pediatric treatment imminent as well as updates expected on both CDX and CBR, patience is certainly a virtue.

HL isn’t a problem on any device. Login via Google on your phone, go into your share account, click the action button with an envelope (third action blue button) then follow instructions.

Takes no more than 2 minutes.

I beg to differ:

https://madescientific.com/news/made-scientific-and-streamline-bio-announce-collaboration-to-accelerate-ai-driven-robotic-manufacturing-for-cell-therapies?hs_amp=true

Whilst GRex is a fantastic manufacturing process it’s important to realise it’s just a small part of the value Made Scientific and their partners bring to manufacturing HG-CT-1.

From our collaboration with Penn University, arguably the world leaders in CAR-T, the strategic partnership with Prevail to handle logistics, the clinical trials with MD Anderson, the leading cancer hospital in the world and now the highly advanced manufacturing environment at Made Scientific one would think..to quote Vlad:

“This is the real deal” and “the sky’s the limit”

Made Scientific, a leading clinical and commercial-enabling cell therapy contract development and manufacturing organization (CDMO), and Streamline Bio, a next-generation autonomous robotics company solving critical challenges in cell and gene therapy (CGT) manufacturing processes, today announced successful initial validation of Streamline Bio’s AI-driven precision robotics platform in a live cell therapy production environment.

With successful completion of initial validation work at Made Scientific’s Princeton, NJ facility, the companies are now advancing the path toward GMP integration, including the launch of early-adopter programs, and collaboration on deploying the fully robotic manufacturing solution for cell therapy innovators. Streamline Bio’s fully AI-driven platform addresses critical and bottlenecks in the CGT industry – including manufacturing complexity and the high cost and variable quality of cell therapies.

Unlike rigid, infrastructure-heavy siloed robotic automation solutions, Streamline Bio’s innovative platform is purpose-built to navigate the challenges of multi-step cell therapy production. The technology is designed to be flexible and immediately adaptable across diverse equipment and protocols, limiting requirements for process changes, additional change parts, or custom configurations. By automating manual, labor-intensive process steps, the platform reduces operator burden, mitigates the risk of human error, reduces costs, and enables skilled personnel to focus on higher-value process activities all while enabling full data traceability through its digital-first design.

As part of the next phase of their collaboration, Made Scientific and Streamline Bio are preparing the platform for GMP deployment utilizing Miltenyi CliniMACS Prodigy®, G-Rex®, and Fresenius-Kabi LOVO® systems. Streamline Bio’s fully robotic platform – now validated in a live manufacturing environment – will be integrated into Made Scientific’s GMP cleanrooms, demonstrating seamless orchestration of complex, multi-step workflows and setting the stage for commercial-scale implementations. Future studies will further verify additional unit operation and use cases including automated analytical and quality control testing workflows.

Let-it-roll I agree with all your sentiments as I believe a potential partner or indeed someone looking to acquire the company would want a commercially scalable ‘plug and play’ solution. I also believe it’ll be a non US company who Hemogenyx are in discussions with who would see tremendous value in a US manufacturing facility being tariff free.

I would point out however that we have no idea when HEMO and Made Scientific submitted the data to the FDA and as such when the 28 day window started for them to submit any objections. So it could be tomorrow or anytime really in April.

Either way the clock is very much ticking.

Yes obviously these will be different patients and the purpose of increasing the dose is that some patients might be kept alive on the lowest dose with HG-CT-1 treating their cancer but an increased dose may prove to be totally curative, ie with no cancer detected at all, as patient three has already demonstrated.

The FDA have 28 days to lodge any objections from when they received the data but it’s perfectly possible that was sent weeks ago. I’d also wager that the data wouldn’t have been sent through to the FDA if Made and Hemogenyx weren’t certain it was identical.

Having passed safety on the first cohort with no toxicity observed Adults will receive double the original dose, which should further increase efficacy although promising signs were observed even at the lowest dose. Pediatric patients will commence on the lowest dose and run in parallel with the adult trial.

An extremely important milestone has been passed today.

I’ve always believed there was more to the Made Scientific outsourcing than simply cost savings and scalability, although that alone is a major positive.

I’m sure most will not even be aware of the fact that Made are actually a subsidiary of a large multi billion dollar corporation in the far east, and it’s them that sanctioned the $12m GMP laboratory expansion in the US to enable commercial grade manufacturing

GC Biopharma owns Made Scientific and its peers Takeda and Astellas are currently forming massive alliances in the Asian market to secure precisely the type of "ready-to-go" cell therapy assets that Hemogenyx represents. Takeda and Astellas have officially formed a joint venture specifically to incubate early-stage drug discovery programs and they are actively looking for high-calibre startups and early-stage programs that can be "fast-tracked" into the global pharmaceutical market.

Made Scientific's parent, GC Biopharma, is independently building a massive "Asia-Pacific" moat through strategic partnerships and GC recently signed an MOU with the Thai Red Cross Society to transfer advanced manufacturing technologies across Southeast Asia. GC Biopharma also recently partnered with Kanaph Therapeutics to co-develop a bispecific antibody-drug conjugate (ADC) for solid tumors, proving their hunger for external oncology IP.

They have also launched a joint research project with NEX-I to identify novel therapeutic targets for cancer patients resistant to current immunotherapies.. These multi-billion dollar giants are currently in an "arms race" for cell therapy assets. Hemogenyx is uniquely positioned because:

Manufacturing is "In-House" (via Made Scientific): Since GC already owns the facility making the drug, an acquisition or "Asia-only" licensing deal with Takeda or Astellas would be operationally seamless.

Takeda recently established a major oncology partnership with Innovent Biologics for two late-stage medicines outside of Greater China. This "carving up" of regional rights is exactly how a small-cap like Hemogenyx could be monetised.

So perhaps the deal with Made Scientific is far more strategic than people realise?

Mr I, I think you’re being very conservative in your valuation.

Technology transfer completion alone is seen as a key binary-risk event, often tied to FDA approval or scale-up, especially when adhering to GMP standards and that can cause massive valuation swings on its own, sometimes 800%+, particularly if the market perceives a massive addressable audience which Hemogenyx will have.

Dose escalation and especially pediatrics will drive the price far higher than you anticipate, in my opinion.

Certain imbeciles may mock certain Hemogenyx share price projections, but they won’t be laughing soon.

Pumpky I have no problem people taking profit as the more cheap shares that are churned before news the better as far as I’m concerned.

The delay in patient enrolment due to the technology transfer has caused concern for some and opportunity for others, and being around 30% down over the last six months it’s fair to say there’s more of the former, especially when coupled with recent geopolitical events which undoubtedly make people more risk averse.

That being said my understanding is this. Firstly, the future of Hemogenyx looks fantastic. Secondly, the return on investment for Hemogenyx shareholders will be outstanding.

That’s in no way a signal to buy, it’s just what I think and believe to be the case. Only time will prove if I’m right.

Vlad stated on the 10th of February that Hemogenyx were in the final stages of the technology transfer, which would indicate to me it was just the operational and regulatory verification required to manufacture doses for the next phase of clinical trials to do. So perhaps documenting the specialised manufacturing protocols to produce HG-CT-1 for the upcoming second cohort of adult patients, and finalising the Chemistry, Manufacturing, and Controls (CMC) documentation for the FDA to review to ensure consistency and safety.

I’m guessing there was two maybe three weeks of work and if correct we must be very close to the 28 days the FDA would have to lodge any objections and I’m also guessing due to the professional nature and experience of Made Scientific there won’t be any.

My view, technology transfer is done and patient enrolment and treatment is imminent!

Not only are we on the verge of proving the curative potential in adults we also are on the verge of opening another $12bn market in the treatment of children. Furthermore, I believe the technology transfer is about far more than saving money.

A major pharma who wants to buy HEMO CAR-T can now do so without building their own lab, without having to employ their own staff, without having a delay whist doing their own technology transfer and without incurring any tariffs which alone adds substantial value to Hemogenyx, especially being scalable all the way to commercial levels.

So whether interest occurs straight after technology transfer is completed or after the first pediatric patient and the first dose escalation patient passes safety I’m not too bothered about.

Either way I think it’s a couple of months from here.

The only thing concerning here is how quickly posts become abusive, which demonstrate a complete lack of understanding of what’s going on.

What it’s true we’ve had a difficult week the recent sell-off and volatility is perfectly normal for early-stage biotech companies with ‘delays’, funding, warrants and recent geopolitical events all likely to have played a part but certainly it’s nothing to do with a failure in its clinical trials, or the technology transfer to Made Scientific (although I understand the impatience to see this completed)..

Do not forget the technology transfer competition is imminent and the underlying clinical milestones for HG-CT-1 remain intact, not least the treatment of the first pediatric patient which is a highly strategic milestone in itself and dose escalation could well secure it’s potential as a curative therapy.

Hemogenyx is still considered to be valued at a tenth of its peers even though they have substantially outperformed the market this year and once the news we all expect hits we’ll soon bridge that gap in my opinion.

Nothing goes up in a straight line so sit back, have some patience as we are very nearly there.

All in my opinion.

I could explain in great detail how much value the imminent completion of the technology transfer to Made Scientific would give to Hemogenyx and any potential suitors who would be purchasing a commercially scalable, highly efficient and cost effective manufacturing process, totally portable into new territories free from any delay and CAPEX or indeed tariffs.

I could also explain how a major could easily move early before further data is accrued on dose escalation and the first child as the price would only increase, or how pediatric treatment leads into early approvals and priority vouchers that could be valued at up to $200m alone allowing any major to recoup their initial investment.

I could explain how a typical early deal may well involve a payment of $100m up front with a total value of $1bn based on milestone payments and how just this initial deal would put £18 on the share price, ohh not to forget the 3 to 5 times ‘validation’ uplift on top of that.

I could go onto explain the extra value of unlimited patients revenue from Estonia or a fast track partner for CDX, or progress with CBR.

Or how with commercial success Hemogenyx could easily generate $1bn revenue or if partner led £150m royalties but then I’d have to explain how the share price could be approaching £400 a share.

And to be honest..I just can’t be bothered.

Socialist my personal view is that we'll ultimately spin off CBR and we won't sell CDX we'll arrange a joint venture where they will fund it into the clinic and we'll pay them a royalty upon commercialisation, similar but probably bigger than the Lilly arrangement.

When Spero announced a licensing deal with GSK for its antibiotic candidate.they received $66 million upfront and was eligible for $525 million in milestone payments , plus double-digit royalties. On the day of the announcement, their share price surged by over 160%. Then the stock surged another 245% in a single day after successful trial data.

If Hemogenyx, as I expect them to do, secured a similar deal with a leading institute or a big pharma for CDX, the market impact would likely follow a similar pattern:

A 100%–200% jump in a single day is common for small biotechs when a big name validates their science with cold hard cash. Not to mention that if an organisation provides a fast track road map into the clinic in another $12bn market, making Hemogenyx into a platform company, their valuation would increase exponentially and it becomes a ‘must have’ for majors.

The exciting thing isi expect something for CDX to be announced very soon, all in my opinion of course.

Socialist of course you’re right, but obviously it depends on how far Hemogenyx go it alone. If, as we expect Hemogenyx prove the curative nature of their CAR-T and CDX products than quite simply it becomes a must have for large pharmaceutical companies for the treatment of r/r AML, around a $4bn market for adults growing at approximately 12% and a $12bn market for children, growing at approximately 5%.

How much that is actually worth is anybody’s guess but personally I’d expect them to be sold sooner rather than later, hence my ‘conservative’ valuations.

I take your point but as far as I’m aware no other company in the world is targeting FLT3.