CDX antibodies belong to a class of bi-specific antibodies that redirect patients’ own immune cells to eliminate HSC. In addition, CDX antibodies show promise in efficiently eliminating malignant cells belonging to a subset of leukemia. In sum, CDX antibodies have the potential to both eliminate malignant leukemic cells and increase the efficiency of conditioning while diminishing the side effects that accompany traditional methods of patient conditioning.
The Patent specifies that the antibody can be used to either treat or condition a patient requiring hematopoietic cell transplantation (Bone Marrow Transplant) with the following conditions listed
- Acute Myeloid Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Chronic Myeloid Leukemia (CLL)
- Peripheral T Cell Lymphoma
- Follicular Lymphoma
- Diffuse large B cell lymphoma
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
- Multiple Myeloma
- a non-malignant inherited and acquired marrow disorder selected from:
- Sickle Cell Anemia
- Beta-thalassemia major
- Refractory Diamond-Blackfan anemia
- Myelodysplastic syndrome
- Idiopathic severe aplastic anemia
- Paroxysmal nocturnal hemoglobinuria
- Pure red cell aplasia
- Fanconi anemia
- Congenital thrombocytopenia
Development of CDX Completed on 11th January 2021 with Dr Sandler stating:“We are extremely pleased with the outcome of our collaboration with GlobalCo, which has resulted in a CDX antibody that is ready to be developed for clinical trials. I am very proud of the Company’s team of scientists who, without a doubt, have proven that Hemogenyx Pharmaceuticals is capable of performing cutting edge research and development of the highest calibre. The completion of the development of the CDX antibody with GlobalCo is a key milestone on our path to creating an effective treatment for patients suffering from AML, and we look forward to entering into the next phase of negotiations with GlobalCo.”
Following successful completion of development of the CDX antibody it was necessary for either Hemogenyx to in-licence the IP of Global Co or Global Co to in-licence IP from Hemogenyx. On 14th April 2021, in a move that was seen by the company as red tape but by the market as a significant setback Global Co declined to in-licence Hemogenyx IP and Hemogneyx immediately decided to in-licence from Global Co. This should not have been as unexpected as it was as leading up to this point Dr Sandler made it clear that selling CDX at an early stage pre-clinical would be a betrayal of shareholders and would not realise true value, value that would be many times greater once clinical proof was achieved.
In this RNS and subsequent interviews Dr Sandler has confirmed that Hemogenyx continue to work closely with Global Co and its my understanding that the subsequent licencing agreement will demonstrate this ongoing commitment and interest in CDX by Global Co“We are pleased with the progress of our negotiations with GlobalCo and their continued interest in working with Hemogenyx Pharmaceuticals. We look forward to advancing our CDX antibody to clinical trials.”
Following the decision by Hemogenyx to in-licence IP from Global Co, both parties are now within a 6 month period to come to a licencing agreement. Following this Dr Sandler has made it clear that CDX will progress to clinical trials, given the nature of the CDX antibody its expected that Phase 1 and 2 will be combined as there is no “safe” or non-toxic dose for a healthy patient. As such early results are expected, as per a recent presentation at ASH 2020 results were seen in humanised mice being ready for Bone Marrow transplant after 2-3 weeks. Similar to the length of time taken for Chemotherapy.
As it stands we have no details about when IND Application will be filed or when Clinical trials will start, the first step to this process was protecting the IP with the patent which has now been granted and worldwide protection has been applied for. Provided IND enabling studies are now complete, at any point an IND application could be filed, this triggers a 30 day waiting period after which clinical trials can begin immediately. As is common with Hemogenyx shareholders are very much in the dark, the next CDX update is expected to clearly outline the next steps and provide a timeline. All indications from Hemogenyx including interviews with Dr Sandler are that the update will be extremely positive and a sharp contrast to the market reaction to the last CDX update.
Potential Market and Valuation
Difficult to estimate as the full scope of the CDX anti-body appears much larger than anticipated, whilst initially the primary indication to be treated was AML the recent patent clearly indicates that CDX may be a suitable alternative to Chemo or Radiotherapy for any condition requiring Bone Marrow Transplant. A study in the Stem Cells Journal put the cost of Chemotherapy at an average cost of $136,000 per patient. Each year, approximately 18,000 people, age 0 – 74 years, might benefit from a potentially life-saving bone marrow or umbilical cord blood transplant. With the current regime of chemotherapy and radiation many patients are just deemed unsuitable for BMT, therefore the actual pool of patients is potentially much larger and would allow treatment of much older people. Thus it should be apparent that Hemogenyx is targeting a multi billion dollar market in the US alone with a disruptive treatment.
Hemogenyx have been working with Global Co since May 2018 on CDX, in that time Global Co have provided Hemogenyx with Global Pharmaceutical scale Intellectual Property and resources free of charge, something that would cost millions. They did this on the understanding that they would have right of first refusal. This status quo continues today, despite a severe adverse market reaction to the “no deal” RNS Global Co have not walked away or ceased their assistance to Hemogenyx. As a Global Pharma the price of CDX is unlikely to be an influencing factor, they either want CDX and will pay for it when its proven or they don’t and they walk away and burn the costs to date. Other political and PR related considerations are likely to have played a much bigger part in the current arrangement, no PR risk for Global Co if CDX fails in clinical stages and much larger financial rewards for Hemogenyx if it succeeds. Nothing is guaranteed, Dr Sandler is a polarising character and an actual “no deal” is a possibility, but I would not bet against him!