Member Info for HereforHemo

Unfortunately many who have invested here, as well as those who haven’t have a complete lack of understanding of what’s going on, so let me explain once again.

On the 31st Hemogenyx announced the Technology Transfer to Made Scientific was completed AND comparability data had been sent to the FDA. The FDA then had to review that data for a minimum 28 days before ANY manufacturing could begin in case objections were lodged.

There were no objections so it was ‘approved’ but we were then at the end of April. So we are approximately 7 weeks into the “process”.

That’s 7 weeks to enroll a patient and check they meet the strict criteria, harvest their cells, transport them to Made Scientific, manufacture the CAR-T, test for sterility and bacterial infections, ship them back to MD Anderson and prepare the patient for the infusion. Even if everything was done in a speedy fashion the patient would have only been treated a week or so ago.

And here’s the thing. It is NOT announced immediately. All of Hemogenyx announcements have been Patient xx has been treated AND the treatment has been tolerated well. In layman’s terms this means the critical 14 days post treatment where toxicities are most likely and CAR-T cells expand most has been passed, and this virtually guarantees the patient will also pass the 28 safety as cohort 1 did.

So there is NO delay, everything is going according to plan and there’s major positive news ahead and soon.

All in my opinion if course.

There’s simply no getting away from the superb data of cohort 1. It’s an absolute fact:

Three adult patients have been enrolled and treated at the initial lowest dose level (7 × 10⁷ CAR+ cells).

Across these patients:

· CAR-T cell expansion and persistence were observed in all subjects, with peak levels typically occurring between 14 and 28 days post-infusion

· Reductions in blast burden were observed in peripheral blood and/or bone marrow

- Patient 3 showed no detectable AML

· No immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs) were reported

· Adverse events were generally low grade and manageable.

Patients will now be treated in parallel with adults on dose escalation and children and adolescents being treated on the initial dose.

What the initial cohort clearly demonstrated was that HG-CT-1 is doing actually what is was designed to do, rapidly kill AML in a precision fashion whilst not destroying healthy bone marrow, even at the lowest dose.

I believe it’ll continue its flawless safety profile whilst showing even greater curative potential. If it does then it’s very valuable and initial results from cohort 2 will be published next month, in my opinion.

The commercial problem with treating adult AML has always been age. This is because the median age of diagnosis for AML is roughly 68 years old, and because conditioning regimens and allogeneic transplants are highly toxic, older adults (who make up the vast majority of AML cases) are frequently ruled "ineligible" for a transplant. Their prognosis is notoriously poor.

A short-stay curative CAR-T like HG-CT-1 that preserves healthy stem cells removes the age bottleneck entirely. HG-CT-1 could theoretically treat frail, elderly adults who would otherwise be left to palliative care, effectively unlocking a market segment that represents over 60–70% of all adult AML diagnoses. And gaining a unique early approval from both the FDA and MD Anderson’s IRB is really something special as traditionally you’d have to wait until the end of phase 1 trials. While pediatric AML is rarer than adult AML, it represents an incredibly lucrative and high-priority sector for Hemogenyx due to severe unmet medical needs and specialised regulatory incentives. If Hemogenyx secures FDA approval for a pediatric indication under the Rare Pediatric Disease Designation, they would likely receive a Priority Review Voucher. These vouchers can be used to accelerate the FDA review time of a future drug by 4 months, or they can be sold to major pharma giants as bringing one of their blockbuster drugs forward could generate billions of dollars in additional revenue. As such, PRVs are sold on the open market with the last two going for $200 million to $205 million cash respectively. A pediatric AML approval also guarantees 7 years of market exclusivity in the US, shielding the therapy from competitors regardless of underlying patent timelines.

This total market approach from Hemogenyx would be worth a staggering $5bn a year. This is for one product candidate, it doesn’t include their CDX bi-specific antibody nor their CBR platform which uses highly advanced AI technology to target amongst others solid tumors and viruses (disease X).

So when investors think of an acquisition in the multi billion dollars, that the major pharmaceutical companies are already in discussions with Vlad, they’re not fantasists, they are just normal investors who think this company will shortly see exponential growth in the share price.

I wonder which big farmer with.a prospectic leg is interested in HEMO.

This board is priceless lol.

Mr Jinx, although we can rightly say it’s been around 11 months since the last patient was treated it’s unfair to highlight that as a delay.

The fact is Hemogenyx, for strategic reasons which have yet to become apparent to us, decided to outsource manufacturing to Made Scientific, in order to get commercial grade scalability. The highly complicated technology transfer (that usually takes between 12-18 months) was completed and announced on the 31st March.

The FDA then had 28 days to review the comparable data to either raise objections or to agree, and by the end of April that hadn’t raised any objections so in essence approved the manufacturing processes at Made.

So we’ve had around six weeks for MD Anderson to find, approve and enroll patients for both dose escalation and pediatrics and Made Scientific to manufacture and do one off extensive testing for both sterility and bacterial infections, all of which are time consuming.

Assuming MD Anderson moved very quickly and had patients enrolled within three weeks, with all the work Made had to do, I’d say patient injections would be taking place around now. So where you see a delay I’d beg to differ. But obviously you’re entitled to your view.

Well bearing in mind Hemogenyx have absolutely nothing to do with the trial now except pay the bill I’m not sure what ‘shady’ thing yoo suspect?

MD Anderson enroll the patients, Prevail Infoworks handle the management and logistics and Made Scientific manufacture the product.

When MD Anderson have successfully treated the patient/s they’ll inform Hemogenyx who in turn will RNS it to the market.

What’s complicated about you understanding?

Or maybe he has worked it out and thinks by constantly posting the same nonsense over and over again he’ll get the same responses over and over again, thus disrupting the board over and over again.

Just a thought.

Alde two scenarios with both feasible but both are wrong.

Maybe you’ll be right one day, so do keep trying.

So a bulletin board full of newly created previously banned posters and the normal imbeciles, with the rest of the posts endeavouring to justify and explain why said imbeciles were wrong.

Hardly an advertisement for any investor looking for information on the revolutionary science.

Who would have thought LSE could have managed to get worse? Perhaps this is one forum with no bottom.

It still amuses me that ‘investors’ state the only good thing about the investment case here is the science, which certainly is in my view is phenomenal and transformational for the treatment of AML.

Because the science alone is nothing without the 100% owned and retained Intellectual Property Rights that Hemogenyx have for all product candidates and platforms.

Furthermore, the FDA approved commercial grade scalability from Made Scientific and the commercial grade scalability now in place from the re-engineered CDX bi-specific antibody using the world renowned Lonza technology are also major assets.

Adding a second continent through Cellin Technologies in Europe, which brings both early commercial revenue around 7 years early coupled with Real World Data is alone transformative and the Master Service Agreement with the Estonian government is certain to be signed in the near future, with all hardware and infrastructure already in place and the technology transfer already underway.

Having Freedom To Operate already in place ensures no litigation and full legal protections for all Hemogenyx processes which again for any suitors is a major tick in the box.

For me, Vlad has one more tick it the box to achieve and that’s to secure a major to partner and fast track CDX into the clinic and we know he’s actively working on that as we speak.

So whilst some are critical of his management and communication skills, to me he is and has developed and executed the perfect business plan. He is in my mind a genius.

If either HG-CT-1 or the Lonza-engineered CDX proves to be truly standalone and curative, as we expect their commercial and strategic valuation is massive.

In the biotech sector, this is considered the "Holy Grail" of oncology development. Achieving a standalone cure for Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) without requiring a bone marrow transplant completely shifts the economics and logistics of leukemia treatment and would command an elite valuation:

Right now, the only real hope for a cure in chemo-refractory AML is an allogeneic bone marrow transplant. However, it is an option of last resort of which only 50% of patients survive. Also a vast number of aggressive AML patients are completely ineligible for a transplant due to advanced age, fragile health, or the inability to find a matched donor.

A target-specific, standalone curative option removes those barriers entirely. Hemogenyx would immediately capture the entire eligible patient population, including the massive, previously untreatable market segment that can never undergo a traditional transplant, as well as the whole pediatric population.

Be aware, bone marrow transplants are among the most expensive medical procedures on earth, often costing between $400,000 and $1 million per patient when factoring in intensive conditioning, weeks of isolation, and long-term treatment for severe complications like Graft-versus-Host Disease (GvHD). By offering a curative standalone cellular or bispecific therapy that eliminates the need for a transplant, Hemogenyx would save global healthcare systems hundreds of thousands of dollars/sterling/euros per patient. This gives the company immense premium pricing power. Insurance providers and state healthcare systems would readily pay top-tier pricing for a single, definitive curative therapy that bypasses the massive downstream financial drain of traditional transplant complications. A validated, standalone curative therapy for an aggressive blood cancer instantly turns a micro-cap biotech company like Hemogenyx into a high-priority target for cross-border mega-mergers.

In oncology, Big Pharma companies actively look to acquire advanced therapeutics that can dominate an entire indication. If the data from MD Anderson convincingly proves that patients achieve deep, durable, long-term remission with natural bone marrow recovery, and the first cohort gave every indication it will, Vlad wouldn't just be looking at a licensing milestone check. The company would be positioned for a multi-billion dollar acquisition or a massive, transformational co-commercialisation deal.

And it could come with a $3-5bn price tag!!

Bring on the next cohort of the now parallel trial with the first children, starting next week would be my guess.

I’m expecting some amazing results!! Good luck all.

Hemogenyx possesses an advisory and board framework that is extraordinarily for a micro-cap biopharmaceutical company. The team is a rare mix of pioneering biotech giants and younger, specialised clinical operators.

Dr. Vladislav Sandler is the scientific engine of the company. A former researcher at Albert Einstein College of Medicine and Cornell, his patented work on hematopoiesis (blood cell development) forms the intellectual property core of Hemogenyx. He has successfully navigated the company from an early-stage concept to an active, clinical-stage company.

Professor Sir Marc Feldmann is a literal titan of modern medicine. Sir Marc is famous for inventing anti-TNF therapy for rheumatoid arthritis, which led to the creation of Remicade (a multi-billion dollar drug that drove J&J’s $4.9 billion acquisition of Centocor). Having a scientist of his stature as Chairman gives Hemogenyx instant credibility with institutional investors and big pharma. 

Dr. H. Michael Shepard is another massive name in biotechnology. While at Genentech, Shepard discovered and developed Herceptin, a revolutionary targeted therapy for breast cancer (for which he won the prestigious Warren Alpert Prize from Harvard Medical School). Notably, Shepard and Marc Feldmann have a history of successful collaboration dating back decades.

Dr. Koen Van Besien bridges the gap from the lab to the clinic. Van Besien is a globally recognised hematologist and transplant specialist who previously directed transplant programs at the University of Chicago and faculty at MD Anderson (note the connection for the current trial). He is highly experienced in running the exact types of clinical trials Hemogenyx is undertaking. 

Hemogenyx has also punched well above its weight class in securing partnerships with elite institutions to advance its lead candidate, HG-CT-1 having an initial multi year collaboration with Pennsylvania University the world leaders in CAR-T therapy and now the MD Anderson Cancer Center, Hemogenyx’s primary clinical site. MD Anderson is widely ranked as the top cancer hospital in the world. They successfully cleared the assays and protocols to initiate the Phase I trials here, passed safety on cohort 1 and will shortly treat dose escalation and pediatric in parallel. Recognised as the birthplace of CAR-T therapy (via Dr. Carl June's historic work). Penn is slated as the secondary site to expand Hemogenyx's Phase I trials, providing a top-tier clinical environment. 

Cell and gene therapies live or die by their manufacturing capabilities and having both Made Scientific in the US and Cellin across two continents giving commercial grade scalable manufacturing is truly impressive, not to mention the real world data and early commercial revenue from Europe.

All in all a pretty exciting company.

Truffle, I’ve sent an instagram message across to her regarding the hospital exemption pathway in Estonia. This is exactly what providing HG-CT-1 for European patients is for.

Thanks Haywain. Must admit I never really knew what happened to SAFE HEMO Car-T but your explanation makes the science even more impressive.

CAR-T products traditionally celebrate persistence in the body but not the groundbreaking third generation HG-CT-1. It’s all about precision. If the drug works absolutely perfectly, the ultimate goal is that a bone marrow transplant wouldn't be needed. That is the "holy grail" of AML research.

Historically, cell therapies for AML were designed exclusively as a "bridge to transplant" because earlier generations of CAR-T couldn't separate the cancer cells from the healthy bone marrow cells, destroying both. 

However, the reason Hemogenyx’s trial is attracting so much attention from experts is that its engineering is aiming to challenge that requirement entirely. If it succeeds flawlessly, it fundamentally shifts how we treat the disease.

The ultimate target for Hemogenyx is to prove that HG-CT-1 can act as a standalone, curative therapy.  For this to happen without a transplant, the drug has to operate inside a highly precise "therapeutic window" It must aggressively hunt down and eliminate the FLT3-positive AML cancer cells. At the same time, it must leave enough healthy, lower-expressing FLT3 bone marrow stem cells intact so the patient's body can naturally regenerate its own blood system.

In fact, early chatter, observations and indeed results surrounding the trial's lowest dose cohort generated huge excitement precisely because no prolonged, DLTs or catastrophic cytopenias (severe drops in blood counts) were reported. If the drug can wipe out the cancer while allowing the bone marrow to recover on its own, the patient can completely bypass a transplant. 

Not having patients undergoing a bone marrow transplant is a massive benefit as bone marrow transplants (allogeneic HSCT) are incredibly brutal on the human body.

They require intense chemotherapy or full-body radiation to completely wipe out the patient's existing immune system beforehand. They carry massive risks, such as Graft-versus-Host Disease (GVHD), where the donor cells attack the patient's organs and many elderly or weakened AML patients simply are not physically strong enough to survive the transplant process.

If HG-CT-1 works perfectly as a standalone treatment, it opens up a cure to a massive population of fragile patients who currently have no viable options.

While a standalone cure is the dream, clinical trials move in conservative increments. Right now, the HG-CT-1 trial protocol still lists having an identified bone marrow donor as an eligibility requirement for patients entering the study.  This is used as a vital safety net. If the CAR-T cells do their job perfectly against the leukemia but accidentally suppress the bone marrow for too long, doctors can immediately step in, trigger the CAR-T "off-switch" to clear out the modified cells, and give the patient a donor transplant to save their life.

But, all the signs to date are that HG-CT-1 IS acting with precision and IS being curative without impacting on the healthy cells in the bone marrow. IMO.

“ We dosed our first three patients, generated the earliest signals of efficacy for HG-CT-1, secured regulatory clearance to expand into paediatrics, forged strategic partnerships in manufacturing, clinical operations and early commercialisation, and set the trial on a clear path to dose escalation.

These are the milestones that, taken together, define a clinical-stage company beginning to deliver”

Sir Marc Feldmann

Whilst not having the high intellect nor the ear of the company that some proclaim, it’s pretty simple logic to know what’s likely to come next.

Completing the manufacturing technology transfer to Made Scientific, Hemogenyx have the green light to recruit for both arms of HG-CT-1 simultaneously for Cohort 2. This means Patient 4 treated and Patient 4 safety passed milestones are what we can expect over the next 4-5 weeks on the adult side, while Pediatric Patient 1 treated and Pediatric Patient 1 safety passed will intertwine chronologically.

While the clinical trials for HG-CT-1 are the primary driver, management explicitly noted that they are continuing to advance the CDX and CBR candidates in the background, along with Estonia. So the signing of a Master Services Agreement (MSA) or a definitive partnership for CDX are the types of corporate updates that are likely to drop in between these clinical safety data windows. 

Once the initial safety gates (usually a 28-day window) are cleared for the first patients in these new cohorts, the trial opens up to the next participants and Patient 5 (adult cohort 2) and Pediatric Patient 2 represents the middle-to-late phase of this current trial expansion. Treating two patients a month going forward it’ll only be a couple of months before cohort 2 is completed.

So not too long before we have a total of 9 patients treated with both safety and efficacy known. With Estonian early revenue and real world data from a multitude of patients, any deal on CDX taking us to a true platform company could indeed be transformational for the share price.

Exciting times ahead, in my humble opinion anyway.

If you can’t handle basic English grammar and believe pharma starts with an ‘f’ I would think your IQ is probably on a par with Trump, and slightly under that of a shoelace.

i really don’t give a **** about what he says, when he says it, where he says it, why he says it or how he says it. he’s irrelevant.

for our wise lth’s i’d leave you with the words of william gibson

the future is already here — it's just not evenly distributed."

Kingpin we are all entitled to speculate and based upon the timeline you’re probably not far off with your predictions. However, I have to agree with Losta, your thread title is highly misleading as taken in isolation it comes across as fact..and it isn’t.