Xintela - senaste nytt

Länk till nyhetsbrevet & kommentar "Blockbuster"

Kommentar från Dr. Sven Kili, MD, specialist inom ortopedi och cell- och genterapi, och tidigare konsult och styrelseledamot i Xintela: ”Med de senaste kliniska resultaten med XSTEM har Xintelas team tydligt visat att det finns en säker och effektiv cellterapi för artros. Data från denna fas I/IIa studie har uppfyllt och överträffat sitt mål att påvisa säkerhet, men också att påvisa effekt. Vi har tidigare sett kliniska data från andra MSC-baserade terapier som visar på säkerhet, men varaktig effekt har saknats i hög grad, särskilt vid artros. Med denna studie visade Xintela inte bara effekt i form av smärtlindring, utan visade också starka initiala tecken på en DMOAD-effekt (Disease modifying Osteoarthritis Drug). Detta är verkligen den heliga graalen inom artrosforskning. Även om vi tidigare har sett terapier som ger smärtlindring, ofta kortvarigt, är möjligheten att visa en förbättring av objektiva indikatorer på artrosprogression, inklusive benkvalitet och bevarande av brosktjocklek, unik och extremt spännande. Naturligtvis kommer denna effekt att behöva upprepas i ytterligare studier för att få ett godkännande. Tillägget av 24-månadersuppföljningen i den pågående studien, kommer ge ytterligare indikation på hur länge förbättringen av leden kommer att pågå. Jag vill gratulera Evy och hela Xintela-teamet till att ha skapat en produkt som mer och mer ser ut som en potentiell blockbuster”. 

Min kommentar
Dr Sven Kili med bakgrund från GlaxoSmithKline har en imponerande bakgrund:

- Dr Sven Kili was the former VP and Development Head for the Cell and Gene Therapy division of GSK where he led the development of ex-vivo Gene Therapies for a variety of genetic disorders. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development and medical affairs activities culminating in the granting of the first combined ATMP approval in the EU for MACI®. His team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven worked for Geistlich Pharma where, in addition to leading the cell therapy medical activities, he oversaw all UK regulatory functions and was the QPPV for the EU. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada, a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA. Additionally he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.

Analys från Västra Hamnen Corporate Finance AB och Q&A med EQGen Biomedical

Q&A with EQGen Biomedical’s Executive Management Västra Hamnen contacted EQGen Biomedical’s founders Willem Scheele, MD, CMO, and CEO Grant Senner, MD, for a comment on the license and development agreement. 

 Dr. Scheele, could you tell us a little about EQGen Biomedical? 

- EQGen Biomedical was founded to deliver next-generation products in veterinary medicine and to optimise the health of animals globally. We are primarily focused on the great medical need to treat joint disease in horses. 

We have also recognised the possibility of expanding to dogs and other animals. 
- We have a management team with extensive experience and expertise in the field. 
Our CEO, Grant Senner, is a physician and entrepreneur with several leading positions in biotechnology and healthcare. 
Wendy Vaala, a renowned expert in equine and companion animals, is our Chief Veterinarian Officer. Wendy was formerly Director Strategic Development and Innovation - Companion Animal and Equine at Merck Animal Health. I am the company’s Chief Medical Officer and have over 30 years of experience in the bone and cartilage field and clinical drug development for human medicine. 

- We are very enthusiastic about this collaboration and see great potential in Xintela’s technology. 

How would EQSTEM change the situation for horses suffering from OA? 

- Today, veterinarians and horse owners are referred to symptom-relieving treatments, as there are no true DMOADs on the market. 
- Earlier studies with EQSTEM show reduced cartilage damage, bone sclerosis, and reduced pain. 

We aim to develop a cost-effective, off-the-shelf, true DMOAD for veterinarian medicine, without the need for blood or tissue harvest from patients and requiring no product preparation. This would radically change the situation for horses suffering from OA and other joint diseases. Our primary focus is on horses, but we have an ambition to expand our treatment to dogs and other animals. 

Could you quantify the potential of a successful DMOAD for horses?  

- In the US alone, there are around 10 million horses, and about 60 to 65 per cent develop lameness. 
Of these horses, approximately 55 percent have OA. If we could provide a treatment that stops the progression of a disease that causes many horses to retire from performance and other activities, I would say that the demand is large, regardless of geographical region. 

 Dr. Grant, what steps are required before launching EQSTEM? 

- Before launch, we need to achieve proof-of-concept. In dialogue with the regulatory entities, we will also plan for a pivotal study to achieve market approval. As a small company, we are open to partnerships for later-stage development. We have the competence and experience in-house to carry out such a study, and will assess the situation in due time. 

Could you tell us anything about EQGen’s financial situation? 

- EQGen is currently raising additional funds to accelerate program development. We believe that a critical inflexion point for company value exists concurrent with proof of concept studies, and we are actively working to maximise the chance of that technical and regulatory success.

What happens next in the collaboration? 

- We are currently discussing an appropriate plan for product development. Xintela will be assigned to initially manufacture EQSTEM in its GMP facility in Lund and assist with quality management. Eventually, we aim to carry out a technology transfer to manufacture EQSTEM in the US.

Min kommentar
Med utgångspunkt från "In the US alone, there are around 10 million horses, and about 60 to 65 per cent develop lameness. Of these horses, approximately 55 percent have OA." kan vi göra en halvhyfsad estimering av vad det innebär rent konkret. Vi utgår från 60% av 10 milj kusar = 6 milj st. Av dessa är uppskattningsvis 55% lämpliga för DMOAD (disease-modifying osteoarthritis drugs) som i detta fall exemplifieras av Xintelas EQstem. 

I rena siffror blir det 3,3 miljoner hästar och det enbart i USA. 

Vad kostar då en EQstem-behandling? Den informationen har vi ännu inte,men ponera att det lågt räknat handlar om $1000 US per kuse. I detta exempel skulle det bli $3,3 Miljarder US. Omräknat till ca 30 Miljarder Skr alltså. Tänker jag fel får någon korrigera mig. Om sen jänkarna utökar sin marknad till andra djur än hästar? Och går world wide och inte enbart USA? Man förstår då varför jänkarna är så excited över detta samarbete med Xintela.

I ett best case scenario blir det dessutom en hiskelig massa pengar som kommer rinna ner till Xintela i royalty. 

För den riskvillige med kapital över kan det vara en idé att spana in Xintelas aktie. 

Den håller fortfarande på att harva runt 40 öre, nedtyngd av aktuella TO3 med lösen på 30 öre. 

Potentialen är mer än hygglig om allt går Xintelas väg. Mvh the99