Product/Clinical Development
Product Development
Five products are in various development stages.

Clinical Development
Two products are currently in the clinical development stages.

Product Development

STAR™ Fusion Agents for Cancer

Altor has two products in clinical-stage and several others in research and preclinical development. Its lead product, STAR™ -Ck or ALT-801, an anti-cancer drug, has begun a Phase I clinical trial. The Company’s second clinical-stage product, a monoclonal antibody which prevents and treats staphylococcal infections in premature neonates, has been licensed to Biosynexus/GlaxoSmithKline. This product has completed Phase IIa clinical trials and is expected to soon begin later-stage trials. (more on the clinical trial...). Management believes the total U.S. market opportunity for all of Altor’s products and indications exceeds $13 billion.

The Company is also working with several clinical research institutes to develop the clinical protocol for clinical trials using ALT-801 in an adoptive cell therapy setting for treatment of cancer. Currently under such protocols, lymphocyte cells are obtained from a donor, activated in vitro with IL-2, and then transferred into a patient, where in some cases the donor cells react against the patient’s tumors. Altor believes that by replacing IL-2 with ALT-801, the fusion protein will be more capable of effectively targeting the donor lymphocyte cells against p53-positive tumors based on recognition activity of ALT-801’s TCR domain. These trials are expected to begin soon using currently available ALT-801 clinical material. The outcome of these studies may provide a rapid preliminary assessment comparing antitumor efficacy of ALT-801 targeted cellular therapy verses non-targeted approaches.

In addition, Altor is advancing its second STAR™ cancer product by conducting preclinical tumor efficacy studies with a molecule consisting of the anti-p53 reagent fused to antibody effector domains. Altor has found that these STAR™-Ig fusions not only have antitumor activity equivalent to therapeutic antibodies but are also capable of binding novel disease targets not typically seen by these antibodies. Should the STAR™-Ig fusion continue to show efficacy in current animal studies, the Company will advance this product (ALT-802) into clinical development.

STAR™ Fusion Agents for Viral Infections

Altor is developing STAR™ molecules against viral antigens from HIV, hepatitis C (HCV), and cytomegalovirus (CMV). These STAR™ molecules are being engineered into various formats as fusion proteins and drug or radioisotope conjugates to deliver viral therapies to diseased tissues. The Company intends to continue preclinical development of these STAR™ molecules and seek partnership opportunities for these and other targets.

Immunotherapeutics against Staphylococcal Infections

Altor has licensed its proprietary technology to prevent and treat staphylococcal infections to Biosynexus/GlaxoSmithKline in exchange for royalties on product sales.

STAR™-based Gene Therapy for Cancer

Altor has collaborated on an adoptive, human, T-cell gene therapy study using the p53 TCR with the National Cancer Institute.

STAR™ Multimers Reagents

Altor has launched an exciting new class of innovative products based on its proprietary STAR™ technology. These products enable the detection of novel disease targets presented on the surface of cells and tissues. Altor continues to expand the reagent product portfolio.

Current Product Development Status

Products
Status
Anti-Staph Therapeutic
(out-licensed)
Phase III
c264scTCR-IL2 (ALT-801)
(IV Bolus Injection)
Phase I/IIa
c264scTCR-IL2 (ALT-801)
(donor lymphocyte infusion)
Investigator Phase I/IIa
c264scTCR-Ig (ALT-802)
Preclinical
Antiviral TCR – Ck
Antiviral TCR – Ab
Preclinical
STAR™ Multimers
Portfolio Expansion
Anti-Tissue Factor Mab (ALT-836)
Phase IIb
See News...

Clinical Development

The Company currently has two products in clinical trials:

ALT-801, its targeted immunotherapeutic for cancer.

The Company’s long-term clinical objective is to develop ALT-801 as a targeted immunotherapeutic with better antitumor potency and a lower toxicity profile than that of human recombinant IL-2. Altor currently holds an active IND on ALT-801. Patient screening and enrollment in the Phase I trial is now underway.

The objectives of the Phase I trial are to:

  • Conduct a clinical trial in patients with metastatic or locally advanced cancers expressing the p53 antigen to examine the dose limiting toxicity, maximum tolerated dose (MTD), pharmacokinetics and antitumor response of treatment with ALT-801.
  • Expand the number of patients in the MTD cohort to further assess safety and anti-tumor response.

For more information on the Phase I trial, see: http://clinicaltrials.gov/ct/show/NCT00496860.

An out-licensed anti-staph therapeutic for neonatal sepsis.

A Phase IIa clinical trial has recently been completed for the lead compound, with later-stage trials anticipated to begin soon. The licensees bear all costs of clinical development of these products.

The Company is also working with several clinical research institutes to begin investigator-initiated clinical trials using ALT-801 in an adoptive cell therapy setting for treatment of cancer. These trials are expected to begin soon using currently available ALT-801 clinical material. The outcome of these studies may provide a rapid preliminary assessment comparing antitumor efficacy of ALT-801 targeted cellular therapy verses non-targeted approaches.

Literature and Publications...

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© Altor BioScience Corporation, 2007