Business Development
Lorus is open to discussing all types of partnering arrangements, including the following:
In-Licensing
We are actively seeking to in-license novel and promising drug candidates that would complement our existing product portfolio in oncology. Our criteria for evaluating in-licensing opportunities are as follows:
- Therapeutic area: Oncology (solid and hematological)
- Development stage: preclinical to early clinical (P1/P2a)
- Technologies
- Small molecules
- Monoclonal antibodies
- Peptides
- Therapeutic vaccines
- Immunomodulators
- Target: Sufficient scientific support for novel target and anticancer mechanism, and clear demonstration of target driven efficacy
- Good therapeutic window
- Demonstration of single agent activity in clinic (preferable)
- Composition patent filed on or after year 2000
Out-Licensing/Partnering
In accordance with our corporate development strategy, our mandate is to advance programs up to the clinical proof-of-concept stage. We strive to find suitable partners for our programs at any stage of development based on inflection points that maximize value to out stakeholders but certainly prior to initiation of late-stage registration trials. Lorus is committed to providing continuing support, guidance and expertise to facilitate optimal progress in the development of its partnered programs.
Lorus has the following programs available for partnering
LOR-2040: Phase III-ready for R/R AML
LOR-2040 is an antisense ribonucleotide reductase (R2) synthesis inhibitor in development for treatment of acute myeloid leukemia as its most advanced indication. Lorus has completed the safety and efficacy studies for proof-of-concept and has designed a Phase III program for a licensing partner.
The cellular target or LOR-2040 is R2, also known as RRM2, a subunit of R2 that is essential for DNA synthesis and repair in all cells, but when elevated in cancer cells is a malignant determinant and is associated with resistance to many chemotherapeutic drugs.
LOR-2040 Attributes for Potential Partnership
- Target: R2 (subunit of RNR) - downregulation correlated with clinical response
- Oligonucleotide backbone provides rapid intracellular uptake in target tumor
- Strong rationale and evidence for synergy with cytarabine in AML
- Lead indication: AML
- Hard to treat patient population with high unmet medical need
- Fastest path to approval
- Combination with HiDAC in refractory & relapsed patients < 60 yrs
- Phase Ib & II completed; Phase III ready
- Favorable risk-matched efficacy results justify large trial to support registration
- Phase III protocol and adaptive statistical plan available
- Alternative regional Phase IIb protocol also available
- Orphan drug status from FDA for AML
- Development strategy for additional indications and life cycle management
- Robust broad spectrum preclinical efficacy
- Clinical experience in range of cancer indications and combination regimens
- Lorus is committed to ongoing knowledge transfer in support of licensing
Lorus is seeking global or regional partner(s) to advance the clinical development of LOR-2040 through the registration study and eventual commercialization.
LOR-220: Novel, First-in-class small molecule in preclinical stage for drug-resistant bacterial infections
LOR-220 is a novel small molecule that targets a class of novel bacterial serine/threonine kinases, which has recently emerged as critical signaling molecules in bacteria. LOR-220 is active against multi-drug resistant Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and other infections produced by important emerging pathogens. In preclinical studies, LOR-220 has demonstrated strong antimicrobial activity in animal models of sepsis without significant toxicity. A field study conducted with hundreds of clinical bacterial isolates demonstrated higher antimicrobial activity of LOR-220 compared with approved first line antimicrobial drugs.
LOR-220 is currently in preclinical development and Lorus is seeking a suitable partner to advance development into the clinic and beyond.
The following program has been out-licensed
Virulizin: Out-licensed to Zor Pharmaceuticals
Immunotherapy is a promising therapeutic method that harnesses the power of the immune system to fight cancer. Virulizin® is a novel immunotherapy agent that stimulates the body’s immune system through several mechanisms, including the activation of macrophages and the infiltration of natural killer cells into tumors. Virulizin® also induces the expression of several cytokine proteins such as IL-12 and IL-17E, which act as chemical messengers to boost the cellular immune response against cancer. These combined activities have significant antitumor effects, while showing a high margin of safety.
Preclinical and clinical studies
In preclinical studies, Virulizin® has demonstrated antitumor activity against a wide range of cancer indications, including breast, ovarian, and pancreatic cancers. Virulizin® has been evaluated in hundreds of cancer patients and has demonstrated an excellent safety profile with only a small number of mild adverse events. Virulizin® has completed three Phase I/II clinical studies in solid tumors and pancreatic cancers. Virulizin® has also completed a randomized placebo-controlled Phase III trial for the first line treatment of pancreatic cancer in combination with gemcitabine. Top-line results from the trial did not demonstrate statistical significance in median overall survival but exploratory analysis showed promising trends in specific patient populations. As in earlier clinical trials, Virulizin® treatment was well tolerated with no major side effects.
Current status
Virulizin is licensed to Zor Pharmaceuticals for North, Central, and South America, Europe, and Israel. The holder of the Virulizin intellectual property portfolio, The Erin Mills Investment Corporation (TEMIC) holds the license for territories not covered under the Zor license agreement.
Virulizin was approved in Mexico in September 2011 for the treatment of malignant melanoma and Zor Pharmaceuticals is actively pursuing commercialization throughout Latin America. Zor is also currently planning for additional clinical studies to confirm the survival benefit associated with Virulizin® in a predefined subpopulation of pancreatic cancer patients. These clinical trials will be designed to support approval of Virulizin® in jurisdictions covered the Zor license agreement.
Lorus is seeking regional partners to develop and commercialize Virulizin in territories not covered under the Zor license agreement (ex-North, Central, and South America, Europe, and Israel).
Business Development Contact
For any business development enquiries, please contact our Business Development Department:
Theresa O'Connell
Manager, BD
Telephone +1.416.798.1200 x394
Email: toconnell@lorusthera.com