BerGen Bio develops novel treatment for leukemia

Illustration oncology R&D

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Oslo Cancer Cluster member BerGenBio announce that preclinical studies on the agent BGB324 may be effective as new treatment for patients with drug resistant Chronic Myeloid Leukemia (CML). The data was presented in a poster at the Annual Meeting of the American Society of Hematology (ASH) early December.

It is estimated that CML accounts for approximately 10% of all new cases of leukemia. The disease originates from malignant stem cells in the bone marrow and ultimately spreads throughout the body developing into a rapidly progressive and almost uniformly fatal acute.

CML is now largely treated with targeted drugs called tyrosine kinase inhibitors (TKIs), which have led to improved long term survival rates and allow most patients to have a good quality of life when compared to the former chemotherapy drugs. Novartis’ Gleevec (imatinib) and Tasigna (nilotinib), and Bristol Myer Squibb’s Sprycel (dasatinib) are examples of these new targeted drugs.

Effective against drug resistance
However, long term therapy with the new treatment can result in the development of drug resistance and new mutations. BerGenBio’s preclinical in vivo studies shows that BGB324 may be effective as therapy taken alone, in leukemia and solid tumors, and is very effective in preventing and reversing acquired resistance to existing therapies.

The results are based on work conducted by Dr. Sonja Loges’ group at the University Comprehensive Cancer Center in Hamburg: “There is a significant unmet need for novel therapies that can address drug-induced resistant cancers”, comments Dr. Sonja Loges.

“The results of the preclinical studies support our belief that BGB324 could also offer a promising potential new treatment option for chronic myeloid leukemia, especially in patients that are resistant to the current standard of care.”

BerGenBio’s cancer drug BGB324 is the only selective Axl inhibitor in clinical development having recently completed a phase Ia clinical trial. Phase Ib clinical trials are planned in acute myeloid leukemia and non-small cell lung cancer in 2014.

Read the press release on BerGenBio’s website and the abstract in full on the American Society of haematology website.

About the Axl kinase receptor

Axl is a member of the Tyro3, Axl, Mer receptor (TAMR) tyrosine kinase family and is a fundamental receptor to cancer biology. It plays a crucial role in the epithelial-mesenchymal transition (EMT) which is a key driver of metastasis (cancer spread) and a mechanism of drug-resistance. The Axl receptor is regarded as one of the most promising new therapeutic targets for cancer drug development. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase.

About BerGenBio AS
BerGenBio AS is a biopharmaceutical company located in Bergen, Norway and member of Oslo Cancer Cluster. The company is committed to developing first in class therapeutics that inhibit EMT, preventing the formation of cancer stem cells and disrupting the important mechanisms of acquired cancer drug resistance. The
company is founded on proprietary platform technology called CellSelect™, which uses information
from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is
the first compound in BerGenBio’s pipeline to enter clinical trials, with additional compounds and drug
targets at different stages of preclinical development.

Helsemyggordning – financial instrument for health innovation

The Norwegian Parliament

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December 11th 2013, Oslo Cancer Cluster, Oslo Medtech and Nansen Neuroscience Network launched a proposal for a new financing mechanism to stimulate innovation from the health- and biotech industry.

The proposal was very well received among the politicians, industry, public organisations and investors at the debate meeting in conjunction to the launch. Conservative Member of Parliament Kristin Vinje viewed the scheme as an exciting proposition that it is worthwhile to investigate further.

The three health clusters have named the scheme “Helsemyggordning”, building on a similar financial instrument from the oil and gas industry that was established to encourage exploration and development activity among young and small petroleum companies.

To stimulate increased health innovation, the scheme “Helsemyggordning” would involve cash payments of tax deduction related to the cost of development and testing of health products and health technologies innovators who are not liable to tax. When the company gets profits and are liable to tax, they must repay the tax paid for the development and testing costs. The system thus acts as an interest-free capital loans from state to the health innovations.

Acting CEO in Oslo Cancer Cluster, Jónas Einarsson, says the scheme may  trigger the huge potential within Norwegian health R&D. “We are at a critical stage now, as the biotech projects coming out are more mature and in a need for early funding,” says Einarsson.

Menon Business Economics have analysed “Helsemyggordningen”. They conclude that it is easy to administrate, predictable, and targeted.

Please find more in debth information here:

Report on “Helsemyggordningen”

Presentation of Helsemyggordningen, by Erik Jacobsen, Menon Business Economics.

Marketing authorisation for Bayer/Algeta`s prostate cancer treatment

From the lab at Algeta

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Oslo Cancer Cluster member Bayer HealthCare announced Monday December 9th that they just received the marketing approval for Xofigo® (radium Ra 223 dichloride) by the Norwegian Medicines Agency. The approval came approximatelyone month after the European Commission granted marketing authorization in the EU for Xofigo® on November 15 2013.

Xofigo has been developed by Oslo Cancer Cluster member Algeta. In September 2009 Algeta signed an agreement with Bayer for the further development and commercialization of radium-223. Xofigo is produced in Norway at the Institute for Energy Technology (IFE) at Kjeller, just outside Oslo. The production plant opened in June 2013.

Bayer estimates that Xofigo will be available for Norwegian patients during the first months of 2014.

Xofigo was approved by the U.S. Food and Drug Administration in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

 


Ny radioaktiv behandling utviklet i Norge forlenger livet hos pasienter med prostatakreft med spredning

Statens legemiddelverk har 9. desember godkjent en helt ny type  behandling av kastrasjonsresistent prostatakreft med spredning til skjelettet. Studien som ligger til grunn for godkjenningen, viser livsforlengende effekt og færre uønskede plager med det nye legemidlet Xofigo, sammenlignet med placebo.

Behandlingen skjer ved at radioaktiv stråling med alfapartikler ødelegger kreftcellene i  skjelettet uten å skade vevet rundt. Xofigo er forsket frem i Norge.

Hvert år rammes omtrent 4500 norske menn av prostatakreft, som er den vanligste kreftformen i  Norge. I de aller fleste tilfeller er det det mannlige kjønnshormonet testosteron som gjør at  svulstene vokser og sprer seg videre. Standardbehandlingen på alle stadier av sykdommen er  ofte hormonbehandling for å stanse eller hemme testosteronproduksjonen (kirurgisk eller  medisinsk kastrering).

Når eller hvis hormonbehandlingen ikke lenger gir noen effekt, kalles tilstanden kastrasjonsresistent prostatakreft. Da forekommer spredning til skjelettet i 70 prosent av  alle tilfellene. I Norge oppstår hvert år 700-800 nye tilfeller av spredning til skjelettet som følge av prostatakreft.

Ødelegger kreftcellenes DNA
Det nye legemiddelet Xofigo (radium Ra 223 diklorid) er det første kreftlegemiddelet som avgir  radioaktiv stråling i form av alfapartikler. Alfapartiklene virker innenfor en kort radius. Det gjør at  de dreper kreftcellene effektivt, samtidig som de ikke skader vevet rundt i samme omfang.

Legemiddelet Xofigo injiseres intravenøst og det søker seg så til områdene rundt svulstene i  skjelettet. Alfapartiklene dreper deretter cellene gjennom å forårsake permanente skader på cellenes DNA. Xofigo gis som injeksjon på sykehus en gang hver fjerde uke i seks måneder. Pasienten kan forlate sykehuset etter hver av de seks enkelbehandlingene uten spesielle restriksjoner.

Åtte norske sykehus har deltatt i studien
Den kliniske fase III-studien, ALSYMPCA, som ligger til grunn for godkjenningen av Xofigo, viser  økt levetid på 3,6 måneder for de pasientene som fikk Xofigo i forhold til de som fikk placebo. I  tillegg viser studien færre komplikasjoner fra skjelettmetastaser, som beinbrudd og tverrsnittslammelser hos de patienter som fikk Xofigo.

Åtte norske sykehus deltok i fase 3-studien ALSYMPCA, deriblant de største norske kreftklinikkene.

– Like viktig som overlevelsesgevinsten er etter min menig at radium-223 evner å forsinke komplikasjoner fra skjelettmetastaser. Pasientene vi har behandlet hadde mindre behov for  smertelindrende strålebehandling, færre beinbrudd pga. spredningen og ikke minst færre tverrsnittslammelser, alt sammen hendelser som reduserer livskvaliteten betydelig når de inntreffer. Vi har altså ikke bare sett en overlevelsesgevinst, men en klinisk veldig viktig reduksjon i antall komplikasjoner. Det kan spare pasientene for store lidelser og helsevesenet for betydelige  ressurser som ellers ville bli brukt til å behandle disse, sier Daniel Heinrich, overlege ved  Kreftavdelingen på Akershus Universitetssykehus.

Heinrich har behandlet 52 norske pasienter under studiene som ligger til grunn for godkjennelsen  av middelet, og er en av de legene i verden som har størst erfaring i bruk av Xofigo. I alt har 138 norske pasienter deltatt i studien.

Xofigo ventes tilgjengelig på det norske markedet i løpet av de første månedene av 2014.

MNOK 50 subscribed in Lytix Biopharma

Doctor and nurse assessing the treatment of a cancer patient.

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Oslo Cancer Cluster member Lytix Biopharma AS has completed a successful issue that was subscribed shares of over 50 million NOK.

It was signed for in total 71,670 shares at a subscription price of NOK 700 per share. The company will, after the capital increase is registered in the ‘Business Register’, have 207 shareholders. CEO Unni Hjelmaas is delighted with Lytix Biopharma now having secured funding for the implementation of the company’s exciting plans within infection and cancer research through 2014.

“We are pleased with the interest the company has been shown in the challenging capital market”, says the chairman Knut Eidissen.

Lytix Biopharma’s board considers listing the company on the Oslo Stock Exchange, including the optimal time for this, and what type of listing which is most suitable.

Lytix Biopharma includes first patient in cancer study
The company recently started the recruitment of patients in a new clinical study of its cancer drug candidate LTX-315, targeting various kinds of cancerous tumors. The objective of the study is to demonstrate that LTX-315 is safe and activates the patient’s own immune system to kill cancer cells, a treatment called Immunotherapy. Up to 80 patients will be enrolled in the study, which is expected to be completed within 2015.

Lytix Biopharma’s CEO Unni Hjelmaas says, “This is a milestone in the development of the LTX-315. The study will demonstrate if the immunotherapy can be documented in cancer patients. We are pleased that the first patient is recruited at Oslo University Hospital – the Norwegian Radium Hospital”.

This study will include patients with different types of cancerous tumors located just under the skin. Four cancer hospitals in Europe are participating in the study – Oslo University Hospital – the Norwegian Radium Hospital (Norway), Jules Bordet and St. Luc (Belgium) and Guy’s Hospital (UK). The study is approved by the health authorities and ethics committees in the respective countries.

Lytix Biopharma’s cancer drug candidate has the potential to be a novel cancer immunotherapy. Immunotherapy is expected to induce the long-term survival due to the durable immune response. Preclinical data has shown that direct injections of LTX-315 into tumors mobilizes the immune system to kill cancer cells (see the video here) and prevent recurrence of cancer. Immune activation and shrinkage of treated tumors were observed in a first clinical study with LTX-315 in patients.

About Lytix Biopharma
Lytix Biopharma AS develops novel drugs for the treatment of resistant bacterial and fungal infections, as well as first-in-class oncology treatments. The Lytix anti-cancer drug is a mimetic of membrane-active host defence peptides and causes tumor necrosis and release of danger signals leading to an induction of anti-tumour immune responses. Lytix is developing synthetic peptides that take advantage of the characteristics of the innate immune system to produce an entirely new class of cancer therapeutics.

In the issue the following insiders have been allocated shares:
Picasso Kapital AS, controlled by chairman Knut Eidissen, 5760 shares
Steinar Hoeg, Director, 1,200 shares
Unni Hjelmaas, CEO 143 shares

Fazenda Securities has been the advisor and lead facilitator of this issue, and Sparebank1 Market has been co-facilitator.

Photo: Cancer Cell, Gerd Berge, UiT.