Lead Product Candidates

Novelix has selected three lead product candidates for further development:

NVX-207 – A highly soluble betulinic acid derivative, this compound is active against a variety of human tumor types including lung, colon, liver, bladder and skin cancers. It carries great promise for the treatment of dermatological and dermato-oncological indications including actinic keratosis (AK), a $1.2 billion market in the US alone. A novel, small molecule, sterol analog, NVX-207 regulates caspase-9, a crucial factor in programmed cell death. It is well tolerated in a human case study and in studies with three animal species. This drug candidate has shown remarkable efficacy in clearing treatment-resistant, hyperkeratotic skin lesions in a human pilot. Additionally, clear evidence of efficacy, including complete remission, is demonstrable in treatment-resistant squamous cell carcinoma and sarcoma in canine patients. To gain benefit from high-value data-sets, Novelix is currently expanding clinical tests in canine patients. Licensing opportunities in companion animal health will only be pursued if strategically appropriate. NVX-207 for AK is currently the topic of alliance and licensing negotiations with potential partners including a major pharmaceutical company.
NVX-144 - A unique, orally bio-available, anti-cancer compound that potently induces the anti-cancer gene IL-24. This causes tumor cells to self-destruct while sparing normal tissues. NVX-144 is effective at nanomolar concentrations and exhibits ease of use and manufacturing characteristics that are expected to facilitate rapid clinical development. It has proven to be well tolerated in mice and has shown potent activity against a wide range of cancer types, including lung, colon, prostate and breast cancer as well as melanoma. These cancers are estimated to account for over 50% of all new cases. Importantly, NVX-144, also subject to big pharma alliance and licensing negotiations, markedly enhances the treatment effects of currently marketed anti-cancer agents and validates the company’s drug discovery and development platforms.
NVX-188 – A potent α_vβ₃ integrin inhibitor, showing activity at picomolar concentrations. α_vβ₃plays a central role in the proliferation and spread of highly invasive cancer cells making it an attractive target for therapeutic intervention. NVX-188 has potential applications as an inhibitor of tumor growth, of metastasis and of angiogenesis. Since α_vβ₃also plays a key role in non-neoplastic indications, NVX-188 is a highly attractive drug candidate for a variety of diseases beyond cancer including the large markets of osteoporosis and rheumatoid arthritis (RA). Novelix plans on evaluating NVX-188 in RA and other non-cancer indications through a recently incorporated European affiliate benefiting from substantial amounts of non-dilutive funding.

Novelix has worldwide, exclusive rights to these compounds and to about 300 other drug candidates through its own patent filings, through assignments from founders and through licenses for certain compounds from the University of Southern California (‘USC’). All of these compounds have been designed and developed by founders and team members. Most recently, Novelix also filed patent applications on NVX-412, a novel proprietary cancer compound designed in house that carries great potential through its unique mode of action in a number of large-market oncology indications as well as applications on combinatorial treatment strategies of targeted therapeutics.

Novelix is positioning its first two lead compounds for attractive preclinical deals. This strategy is fully aligned with our goal to prepare the company for a merger or acquisition scenario, management’s preferred exit strategy.

Lead Product Candidates Novelix has selected three lead product candidates for further development: NVX-207 – A highly soluble betulinic acid derivative, this compound is active against a variety of human tumor types including lung, colon, liver, bladder and skin cancers. It carries great promise for the treatment of dermatological and dermato-oncological indications including actinic keratosis (AK), a $1.2 billion market in the US alone. A novel, small molecule, sterol analog, NVX-207 regulates caspase-9, a crucial factor in programmed cell death. It is well tolerated in a human case study and in studies with three animal species. This drug candidate has shown remarkable efficacy in clearing treatment-resistant, hyperkeratotic skin lesions in a human pilot. Additionally, clear evidence of efficacy, including complete remission, is demonstrable in treatment-resistant squamous cell carcinoma and sarcoma in canine patients. To gain benefit from high-value data-sets, Novelix is currently expanding clinical tests in canine patients. Licensing opportunities in companion animal health will only be pursued if strategically appropriate. NVX-207 for AK is currently the topic of alliance and licensing negotiations with potential partners including a major pharmaceutical company. NVX-144 - A unique, orally bio-available, anti-cancer compound that potently induces the anti-cancer gene IL-24. This causes tumor cells to self-destruct while sparing normal tissues. NVX-144 is effective at nanomolar concentrations and exhibits ease of use and manufacturing characteristics that are expected to facilitate rapid clinical development. It has proven to be well tolerated in mice and has shown potent activity against a wide range of cancer types, including lung, colon, prostate and breast cancer as well as melanoma. These cancers are estimated to account for over 50% of all new cases. Importantly, NVX-144, also subject to big pharma alliance and licensing negotiations, markedly enhances the treatment effects of currently marketed anti-cancer agents and validates the company’s drug discovery and development platforms. NVX-188 – A potent α_vβ₃ integrin inhibitor, showing activity at picomolar concentrations. α_vβ₃plays a central role in the proliferation and spread of highly invasive cancer cells making it an attractive target for therapeutic intervention. NVX-188 has potential applications as an inhibitor of tumor growth, of metastasis and of angiogenesis. Since α_vβ₃also plays a key role in non-neoplastic indications, NVX-188 is a highly attractive drug candidate for a variety of diseases beyond cancer including the large markets of osteoporosis and rheumatoid arthritis (RA). Novelix plans on evaluating NVX-188 in RA and other non-cancer indications through a recently incorporated European affiliate benefiting from substantial amounts of non-dilutive funding. Novelix has worldwide, exclusive rights to these compounds and to about 300 other drug candidates through its own patent filings, through assignments from founders and through licenses for certain compounds from the University of Southern California (‘USC’). All of these compounds have been designed and developed by founders and team members. Most recently, Novelix also filed patent applications on NVX-412, a novel proprietary cancer compound designed in house that carries great potential through its unique mode of action in a number of large-market oncology indications as well as applications on combinatorial treatment strategies of targeted therapeutics. Novelix is positioning its first two lead compounds for attractive preclinical deals. This strategy is fully aligned with our goal to prepare the company for a merger or acquisition scenario, management’s preferred exit strategy.
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Lead Product Candidates

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