Brain cancer trial update of Telix Pharmaceuticals

In the health care sector, clinical trials are an essential component of the development of innovative interventions and other tests that would help patients to aid in alleviating or treat the disease condition. Clinical studies benefit patients and are estimated to cost approximately $1 billion to the economy of Australia every year. The studies are conducted in a complex environment across various jurisdictions, and before commencing any clinical trial, there is a requirement of ethical as well as approval from the government.

International, as well as Australian research sponsors, can develop and support the highest quality clinical trials and benefit from the advantages of the Australian clinical trials environment, including popular facilities and researchers, well-organised review and regulatory frameworks and financial incentives.

Clinical trials in Australia are governed by national ethics guidelines and codes of conduct. Also, for unapproved devices and products, clinical studies must fulfil the requirements of the Therapeutic Goods Administration (TGA) and with international guidelines.

In this article, we are discussing one of the prominent Australian health care sector players, which is engaged in developing medicine for carcinoma and has recently planned its clinical trial study for Brain Cancer.

Let us zoom the lens on TLX-

Telix Pharmaceuticals Limited (ASX:TLX)

On 24 December 2019, the stock of TLX settled at $1.610, moving up by 6.977% from its last close, with outstanding market shares of approximately 253.28 million. The company has a market capitalisation of nearly $381.19 million, while the 52 weeks low and high price of the stock was noted at $0.620 and $1.950, respectively. TLX stock has delivered an excellent return of 131.54% on year to date basis and a positive return of 21.37% in last six months.

About the company

Melbourne headquartered clinical-stage biopharmaceutical company, Telix Pharmaceuticals Limited (ASX:TLX) is engaged in the development of therapeutic as well as diagnostic products using Molecularly Targeted Radiation (MTR). The company is into progressing a portfolio of clinical-stage oncology therapeutics to tackle the considerable unfulfilled medical requirement in renal, prostate, and brain cancer diseases.

MTR or Molecularly Targeted Radiation explained

For imaging and treating tumour, the company is developing a pipeline of Molecularly Targeted Radiation (MTR) products. In this therapy, a radionuclide is attached to a targeting moiety such as an antibody or small molecule. The targeting moiety binds to the cancerous cell and delivers a radioactive payload, which can be diagnostic, therapeutic or both, in a highly selective manner.

Many cancer cell-targeted therapies only destroy a subset of tumour in the microenvironment, but MTR therapies are intended to kill the tumour target plus adjacent tumour as well as supportive cells- this effect is known as “bystander effect.”

IPAX-1 Study Update

On 23 December 2019, the company updated the market with its IPAX-1 Study of TLX101 for brain cancer in ASX. The study aims for evaluation of safety and effectiveness of TLX101 in combination with external beam radiation therapy (EBRT) for the treatment of patients with recurrent glioblastoma (rGBM).

Telix has established a supply chain and manufacturing footprint for TLX101 that would support both further clinical studies and early commercialisation of the product. TLX101 is an innovative experimental therapeutic radiopharmaceutical which is under development for the treatment of GBM and known as 131I-IPA or 4-iodo-[131I]-phenylalanine. This study was aimed to perform two active treatment- a single or divided dose (three fractions of 131I-IPA and EBRT in 18 x 2 Gy fractions.

The main objective of this study is the evaluation of safety and efficacy of TLX101;

ü Identification of the maximum tolerated dose of 131I-IPA.

ü Evaluation of feasibility of divided doses of 131I-IPA administration.

ü Confirmation of biodistribution and absorbed doses to the rest of the body.

ü In the efficacy evaluation, the anti-tumor effect of 131I-IPA combined with external beam radiation therapy (EBRT) would be explored.

IPAX-1 study design-

This study is a multi-centre, open-label, single arm phase I/II clinical trial study and is conducted in European and Australian sites. All participants in this study receive a combination of TLX101 and EBRT. The study includes dose findings, and for this the dose is increased to find the most suitable dose for further study. After the establishment of safety, more patient would be enrolled to test the efficacy.

A total of six international sites are selected for IPAX-1 study that are leading neuro-oncology centres, in the Netherlands, Austria, Belgium as well as in Australia.

IPAX-1 Study progress-

The trial sites are recruiting the patients, and the regulatory approvals are granted in Belgian, Netherlands and Austria. The Australian clinical site is under process, and the study would start in early 2020, as both therapeutic good approval clinical trial notification and ethics approvals have been received. The highlights of study progress are-

ü Both single, as well as fractionated dose cohorts have recruited patients, so far disease stabilisation have been seen in all patients. The first patient enrolled in July is still clinically stable and have not progressed.

ü TLX101 is well tolerated, till now no serious adverse effects are reported without any evidence of hematologic toxicity.

ü From the preliminary data, it is concluded that the fractionated treatment might be more effective than single dose treatment.

ü Patients have generally been able to stay off corticosteroids.

ü The most widespread unfavourable consequences of TLX101 are Nausea, fatigue and such.

Study milestones- 2020

ü Completion of Phase I recruitment in the first quarter.

ü Determination of Phase II dose in second quarter of 2020.

ü Phase II initiation in third quarter of 2020.

ü Completion of recruitment for Phase II clinical study, in 4^th quarter of 2020.

ü In mid-2020, the company would present data from Phase I patients to FDA or EMA.

After clear targeting of TLX101 by SPECT imaging, it is observed that biodistribution of the drug is well tolerated with excellent dose targeting to the brain and brain is the dose limiting organ.

Beyond IPAX-1 study, in the United States, there is keen interest in TLX101 at major tertiary referral centres for GBM. With several leading cancer centres, the investigator-initiated trials (IIT) are under development and would be initiated after the recommendation of phase I clinical trial data. If planned Food and Drug Administration (FDA) consultation is favourable, there is a potential for expanded access program which has been planned for the end of the second quarter of 2020.

Multiple indication expansion opportunities in pediatric brain cancer, newly diagnosed GBM and other LAT-1 expressing cancers including brain and other cancer types.

Cancer Australia grant to Telix and Victorian Comprehensive (Vic) Cancer Centre-

On 19 December 2019, Telix Pharma announced that the collaborator of Telix Professor Frédéric Hollande from the Melbourne University, Centre for Cancer Research, VIC and colleagues have been successful in their Cancer Australia grant application entitled as “The Preclinical Validation of Radio-labelled Girentuximab as a Theranostic Agent in Metastatic Colorectal Cancer”. The grant was announced by Cancer successful grant application.

Girentuximab is the proprietary monoclonal antibody agent (TLX250) of Telix which targets the carbonic anhydrase IX (CAIX) antigen that is expressed in various cancers, including renal and colorectal cancer.

The research develops on a previous successful preclinical collaboration to determine the link between carbonic anhydrase IX and colorectal cancer in surgical tissue samples. This new research project would discover whether girentuximab has potential as an MTR agent for the imaging and treatment of metastatic (inoperable) colorectal cancer. The project would be undertaken for more than three years.

Disclaimer

This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.