Nereus Pharmaceuticals













Company Highlights

Nereus Pharmaceuticals is a pioneer in the use of marine microbial sources for the discovery and follow-on development of new therapeutics for cancer and inflammatory and infectious diseases. Nereus Pharmaceuticals has a clinical pipeline of two potentially best-in-class small molecule oncology drugs in clinical trials. The pre-clinical pipeline consists of several new chemical entities (NCEs) that are modulators of IKK activity for the treatment of cancer and/or inflammatory diseases and two NCE leads with novel pharmacophores that are broad spectrum antibiotics for infectious disease therapy.

Development Programs

The Company is currently advancing its emerging pipeline of new chemical entities into human clinical trials as shown in the pipeline chart below:

NPI-2358 is a potent, selective tumor vascular disrupting agent (VDA) with best-in-class pre-clinical characteristics that is being evaluated for the treatment of solid tumors and lymphomas in single agent and combination chemotherapy clinical trials. NPI-2358 was one of two hundred analogues that were produced after finding activity and novel chemistry from a marine fungal extract. NPI-2358 is made synthetically via a commercially viable process and in pre-clinical studies, the compound: 1) shows an excellent pre-clinical safety profile, 2) is active against multi-drug resistant human tumor cell lines, 3) has a longer duration of action on tumor blood flow, 4) has high specificity for tumor vasculature, and 5) strongly enhances the efficacy of most chemo- or radio- therapeutic regimens while maintaining excellent tolerability. A recommended Phase 2 dose was determined in a successful Phase 1 dose escalation clinical study. Extensive cardiac safety testing (ECGs, echocardiography and troponins) did not demonstrate an effect on cardiac function. Decreases in tumor blood flow were seen with DCE-MRI. NPI-2358 is being evaluated in a randomized Phase 1/2 study in combination with docetaxel in patients with NSCLC having failed prior therapy.

NPI-0052 is a highly potent potentially best in class proteasome inhibitor derived from a novel marine actinomycete and is being evaluated for the treatment of multiple myeloma, solid tumors, lymphomas and leukemias in three Phase 1 clinical trials. Due to the success of Velcade, the proteasome is a high interest drug target. In preclinical studies, NPI-0052 was superior to Velcade in demonstrating: 1) a proteasome inhibition profile that is broader (inhibits all three protease functions) 2) a significantly faster onset of action with a longer duration of action; 3) efficacy against Velcade, Revlimid, Thalomid and dexamethasone resistant tumor cells from multiple myeloma patients; 4) efficacy against a wider range of tumors, including many solid tumor models; 5) less cytotoxicity to normal cells; 6) a >6 fold higher in vivo potency; 7) potential for administration both orally and by intravenous injection on a once-a-week schedule; and 8) marked enhancement of efficacy when used in combination with biologics and chemotherapeutics such as Avastin, Erbitux, irinotecan, FOLFOX, FOLFIRI, HDAC inhibitors, and oxaliplatin.

Our IKK Series is a family of synthetic small molecule diterpene analogues that modulate IKK activity. Approximately 450 analogues were screened and many analogues are being evaluated that have cytotoxic activity on tumor but not normal cells and increased inhibition of cytokine synthesis. Modulation of IKK activity impacts the disease related activation of NF кB which has been implicated in the resistance of cancers to various therapies. Activation of NF-кB also promotes the expression of pro-inflammatory and pro-angiogenic activities such as TNF-α, IL-1, IL-6, IL-8 and VEGF. Several analogues have shown strong preclinical activity in models of inflammation and/or cancer and are being evaluated to determine the best candidates for graduation to IND candidate status.

Our anti-infectives are two novel pharmacophores with structures not previously described. They were identified in screens for broad spectrum antibacterial activity and activity against methicillin and vancomycin resistant strains. These interesting small molecule structures are still under evaluation by our research team.
 

Technology

Microbes from the ocean are proving to be an extraordinarily rich source of biologically active and diverse chemistry. Nereus has developed a highly productive discovery process that integrates microbiology, screening and natural products chemistry coupled to a robust suite of proprietary software tools. This platform combines extraction and fractionation with streamlined upfront sample dereplication to rapidly discover new, unique pharmaceutical agents. The unique requirements of marine microbiology make this approach inaccessible to companies relying on conventional microbial production and screening technology.

This pharmaceutical drug discovery platform is predictably scaleable with the potential to exceed the productivity of those based on terrestrial microbes, a proven paradigm that has delivered over 120 commercially relevant pharmaceuticals (including anti-infectives, anti-cancer agents, immunosuppressants, and statins for cholesterol reduction). The Company’s discovery platform provides one-of-a-kind access to novel pharmacophores, scaffolds and analogues that can be developed for therapeutic use. This platform and approach leads to strong composition of matter IP protection that can be expanded through proven pharmaceutical approaches. Nereus’ pipeline compounds have strong, global IP coverage.


Investors/Funding History

In July 2007 the Company closed a Series D-2 preferred stock financing in which it raised ~$45M led by BankInvest of Copenhagen. Additional new investors included Roche Venture Fund, Astellas Venture Management, Boston Life Science Venture Corp, Taiwan Global Biofund, and Eminent Venture Capital Corporation. Continuing principal investors include HBM BioVentures, Forward Ventures, Alta Partners, Advent International, GIMV, InterWest Partners, Pacific Venture Group, Novartis BioVenture Fund. The Company previously raised ~$80M in Series A, B, C and D rounds

Management

Kobi M. Sethna President & CEO, Co-Founder
(Parke-Davis/Warner Lambert, ICN, Pfizer, Lederle)
Charles T. White, Ph.D. Chief Business Officer
(DuPont, Medisorb Technologies International, Organon)
Donald J. Salz, CPA Vice President, Finance and Administration
(Arthur Andersen, FHP Healthcare)
G. Kenneth Lloyd, Ph.D. Senior Vice President, R & D and Chief Scientific Officer
(Synthélabo Recherche, Wyeth-Ayerst, SIBIA
Michael A. Palladino, Ph.D. Senior Vice President & Scientific Co-Founder
(Memorial Sloan-Kettering, Genentech, Ixsys)
Matthew A. Spear, M.D. Vice President and Chief Medical Officer
(UCSD Cancer Center, Pfizer)
Howard T. Holden, Ph.D. Senior Vice President, Regulatory Affairs and Compliance
(Parke-Davis/Warner Lambert, NCI, Ligand)
Ray Lam, Ph.D Vice President, Microbiology & Industrial Fermentation
(Bristol-Myers Squibb)
Barbara Potts, Ph.D. Vice President, Chemistry & Formulation Development
(Agouron, Pfizer)

Contact Information

Sandra Beach
Nereus Pharmaceuticals, Inc.
10480 Wateridge Circle
San Diego, CA 92121
USA
Phone: 858-200-8311
Website: www.nereuspharm.com
Email: sbeach@nereuspharm.com

 Number of employees - 33