GlobeImmune | Presenting Phase II Data @ AASLD

GlobeImmune (Louisville, CO) a clinical-stage company focused on developing targeted immunogens for the treatment of cancer and infectious diseases, has had an abstract (“GI-5005 Therapeutic Vaccine Plus PEG-IFN/Ribavirin Improves End of Treatment Response at 48 Weeks Versus PEG-IFN/Ribavirin in Naïve Genotype 1 Chronic HCV Patients”) for their investigational hepatitis C virus product candidate accepted for presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (31 Oct. to 4 Nov. 2009 Boston, MA).

GlobeImmune will also present at AASLD end-of-treatment, 48-week data in interferon-naïve patients from a Phase II clinical study investigating the efficacy and safety of GI-5005 plus peg-interferon (peg- IFN) and ribavirin, the current standard of care, in patients with genotype 1 chronic HCV infection compared to patients receiving only SOC.

Chronic hepatitis C infection, a viral liver disease, is a major health epidemic worldwide. Currently, there are approximately 170 million people worldwide who are infected with the hepatitis C virus. Of these, 4 million live in the United States with an additional 5 million in Western Europe. Approximately 20-30% of all hepatitis C patients will face life threatening complications as a result of their disease. Hepatitis C accounts for 20% of cases of acute hepatitis, 70% of cases of chronic hepatitis, 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants in the United States. The incidence of new symptomatic infections of hepatitis C has been estimated to be 13 cases/100,000 persons annually. For every one person who is infected with the AIDS virus, there are more than four infected with hepatitis C. The Centers for Disease Control and Prevention estimate that there are up to 230,000 new hepatitis C infections in the U.S. every year. Currently, 8,000 to 10,000 deaths each year are attributed to hepatitis C.

The GI-5005 Tarmogen expresses a fusion protein encompassing sequences from both HCV NS3 and Core proteins. NS3 and Core are abundantly expressed in infected cells, are required for viral replication and contain targets that are recognized by both CD4+ "helper" and CD8+ "killer" T cells. Both the Core and NS3 proteins are highly conserved among HCV genotypes 1a and 1b, the HCV strains most prevalent in the U.S. In December 2007, GI-5005 initiated a multi-center, randomized, Phase 2 study in combination with standard of care (pegylated interferon plus ribavirin).

Tape-Delay from the RMLSIC | Part Deux

Continuing here with Part Deux of the Rocky Mountain Life Science Investor Conference presenting companies. Yesterday CLSDF posted the Diagnostic oriented entities, today we feature the biopharma folks.

ApopLogic – Aurora, CO-based AL is a biopharmaceutical company focused on the discovery, and development of therapeutic products that target apoptotic cell death pathways found in cancers, leukemias and lymphomas. The lead compound is Breceptin, a novel anti-cancer technology that antagonizes neuropeptide growth-factor receptors, targeting a broad range of cancers. The pipeline also includes Fasaret a proprietary therapy based on Fas ligand, an apoptotic cell death-inducing molecule with unique pro- inflammatory properties and Cytonil a proprietary combination of a cell-type specific growth factor and a cell signaling agonist to treat Sezary leukemia, cutaneous T cell lymphoma and psoriasis.

Allogenesis – Denver, CO-based AG is focused on pHPM, a ‘humanized’ purification of blood extracts for expansion of stem cells used for research & clinical applicications as well as wound healing in the dermal, orthopedic and additional soft tissue applications. The pHPM product is engineered to replace animal proteins in stem cell culture applications and augment existing in vitro culture media.

BioAmps – Aurora, CO-based BA is focused on focused on the discovery and development of proprietary antimicrobial peptide therapeutic solutions for the treatment of systemic infectious diseases, including methicillin-resistant Staphylococcus aureus (MRSA) and other resistant gram-negative and gram-positive bacteria. A rational design platform has produced a large portfolio of D-confirmation, alpha-helical antimocrobial peptides that are structurally manipulated to alter their hydrophobicity and amphipathicity properties. The charge substitutions and structure alterations on both the polar and non-polar faces of the peptides produce a unique “carpeted model” mechanism of action, broad spectrum of activity, and low level of toxicity to human cells.

GlobeImmune – Louisville, CO-based GI develops active immunotherapies called Tarmogens® for the treatment of cancer and infectious diseases. Tarmogens are recombinant yeast engineered to express disease antigens. Lead products include GI4000 and GI5005 both in Phase II for cancer and hepatitis C. The Tarmogen™ manufacturing process is simple and scalable with small molecule-like margins.

Inviragen – Ft. Collins, CO-based IV is focused on vaccines against emerging worldwide infectious diseases. Compounds queued up for clinical trials includes DENVax against dengue, HFMDVax against hand, foot and mouth disease and JEVax for Japanese encephalitis. In addition, are a number of ongoing vaccine research programs in chikungunya, HPV, influenza and plague vaccines.

LigoCyte Pharmaceuticals – Bozeman, MT-based LCP is a clinical-stage biologic drug development company focused on respiratory and gastrointestinal indications. The company’s virus-like particle (VLP) vaccine technologies support products that induce robust immune responses to prevent serious infections. The lead product is Norovirus VLP Vax in Phase I and the pipeline includes the biodefense vaccines against influenza and anthrax and the monoclonal antibodies Anti-CD103 partnered with Biogen Idec (NASDAQ: BIIB) and Anti-CD62 partnered with NIH.

miRagen – Boulder, CO-based MR is developing innovative microRNA (miRNA) based therapeutics for cardiovascular and muscle disease. The lead optimization pre-clinical pipeline candidates are focused on heart failure with indications of post-MI remodeling, chronic heart failure and refractory angina; broader cardiovascular disease including cardiac fibrosis, angioplasty/restenosis and arrhythmia; and, general fibrosis, muscular atrophy and amyotrophic lateral sclerosis.

Myocept – Lafayette, CO-based MC is a pre-clinical stage biopharmaceutical company focused on biotherapeutics designed to modulate signal transduction through subtypes of the cholinergic receptor family (AChR). The receptors targeted control contraction of skeletal and smooth muscle fibers, while other members of the AChR family are involved in angiogenesis, pain, additiction, down-regulation of inflammatory immune responses and progression of certain cancers.

Western States Biopharma – Aurora, CO-based WSB is a pre-clinical stage biopharmaceutical company developing novel therapies that selectively modulate adaptive immunity to treat inflammatory diseases while concurrently affecting the immune system’s natural ability to fight disease. Potential lead indications under consideration for WSBI19711A include rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis, and anklyosing spondylitis.

GlobeImmune is Fierce!

Congratulations to GlobeImmune for being named to Fierce Biotech’s 2008 Fierce 15 List (click HERE for a link to see the other 15 companies)! What makes it Fierce: GlobeImmune's third round of financing last fall was its biggest, $41.2M, bringing its total venture haul to north of $88M. Wexford capital led the round and Celgene, Boston Life Science Venture, Morgenthaler Ventures and Biogen Idec all participated. The money takes the company to a crucial inflection point: Phase II data that determines if the company's platform technology can deliver the kind of T-cell response it is looking for. GlobeImmune has three mid-stage studies underway to determine if its genetically modified recombinant yeast can induce T-cells to attack pancreatic cancer and hepatitis C.

GlobeImmune has been developing Tarmogens (Targeted Molecular Immunogens) based on scientific research in-licensed from the University of Colorado. And its development programs in divergent areas like hep C and cancer underscores just how broad a range the company could have. One successful program could lead to several more. Enrollment for the hepatitis C Phase II was wrapped in May. The study for pancreatic cancer is underway and a Phase IIa in non-small cell lung cancer--enrolling patients with a ras mutation--was launched in March. A successful mid-stage trial sets the stage for broadening the company's research activities, is likely to excite new partnership interest and also moves the company one step closer to evaluating its worth in a potential IPO.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

J. William Freytag, Ph.D. Appointed to GlobeImmune Board

It’s a GlobeImmune kind of day…How exciting to see Dr. Freytag join the GI Board of Directors. Dr. Freytag was President, Chief Executive Officer and Chairman of the Board of Aspreva Pharmaceuticals Company from July 2007 through December 2007 when Aspreva was acquired by Galenica for approximately $915 million. He held the same positions with Myogen, Inc. from July 1998 until November 2006 when Myogen was acquired by Gilead (NASDAQ: GILD) for approximately $2.5 billion. Dr. Freytag currently serves on the Board of Directors for Sierra Neuropharmaceuticals, ARCA Discovery, AlphaSniffer and Immunicon (Nasdaq:IMMC). Dr. Freytag has held senior executive roles in a number of capacities at companies such as Somatogen, a biopharmaceutical company where he was responsible for corporate and commercial development and at Boehringer Mannheim Corporation where he served as President of Research and Development. Dr. Freytag spent 10 years with DuPont Medical Products in various research and business positions. He earned his Ph.D. in biochemistry from the University of Kansas Medical Center.


*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

GlobeImmune Initiates Phase IIa GI-4000 NSCLC Study

GlobeImmune initiated a Phase IIa trial to evaluate their GI-4000 Tarmogen® for the treatment of non-small cell lung cancer (NSCLC) patients with tumors having mutations in the ras gene. NSCLC patients with tumors positive for mutated ras may have a worse survival compared to patients with other NSCLC types and therefore these patients may not benefit from treatment with selective tyrosine kinase inhibitors. This clinical trial will explore treatment with patients based on the results of a panel of molecular tests, including EGFR mutation status, ERCC1 expression levels, and ras mutation status. The GI-4000 trial is designed to study safety, immune responses, and clinical benefit, patients will receive GI-4000 for up to 3 years with the goal of delaying disease recurrence and prolonging survival.

GI-4000 is a Tarmogen® intended to generate an immune response to cells containing the seven most common mutations in the ras oncogene product. Mutations in ras are believed to be responsible for over 150,000 cases of cancer annually in the US, including pancreas, NSCLC, colorectal, ovarian and other cancers. In a Phase I study of advanced pancreas and colorectal cancer patients, GI-4000 was well-tolerated across the full range of doses tested. A multi-center, randomized, placebo-controlled Phase II trial of GI-4000 in combination with gemcitabine in resected pancreas cancer patients is ongoing.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

And the CLSDF Readers Have Spoken!

The winner of the CLSDF Reader’s Choice Company of the Year, 2007 goes to... GlobeImmune, Inc., who took home a commanding 43% of the vote. ARCA Discovery and ValveXchange came in tied for second place. Congratulations to President and CEO Tim Rodell, MD and the other 60+ folks in Louisville who are doing outstanding work.

For those of you who do not know: GlobeImmune is a biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of infectious diseases and cancer.

Tarmogens (Targeted Molecular Immunogens) are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein targets that stimulate the immune system against diseased cells. The whole heat-killed yeast, with the antigen expressed inside, is the product that is administered to the patient. Tarmogens program the cytotoxic T cells in the patient's immune system to eliminate diseased cells containing the antigen(s). GlobeImmune's patented Tarmogen platform has a number of advantages over current approaches because Tarmogens generate a potent T cell response, are not neutralized by the host immune system upon repeated administration, do not require a custom vaccine approach and are simple to manufacture.

The Company's lead product , GI-5005 a Tarmogen for the treatment of chronic hepatitis C infection has completed a placebo-controlled, dose-escalation Phase Ib clinical trial. A randomized, placebo controlled Phase II trial in combination with standard of care will begin is underway. GI-4000, a Tarmogen for the treatment of various mutated Ras-mediated cancers, is in a randomized, placebo-controlled, multi-center Phase II trial for the treatment of patients with resectable pancreas cancer in combination with adjuvant gemcitabine.

Interestingly too, the $41.6M Series C financing closed in 2007 ranked among the 20 largest venture rounds in the country. Here is the full list courtesy of the National Venture Capital Association:

1. Zogenix - $78.8M
2. Ception Therapeutics - $77.7M
3. Targanta Therapeutics - $70M
4. Portola Pharmaceuticals - $70M
5. AVEO Pharmaceuticals - $58.5M
6. Cogentus Pharmaceuticals - $55M
7. Phenomix Corporation - $55M
8. Sagent Pharmaceuticals - $53M
9. Microbia - $50M
10. Sangart - $50M
11. Ambit Biosciences - $49.3M
12. Spine Wave - $45M
13. Nereus Pharmaceuticals - $45M
14. QuatRx Pharmaceuticals - $44M
15. Novalar Pharmaceuticals - $42
    
16. MREVA Medical - $42M
17. Xcellerex - $41.84M
18. Deciphera Pharmaceuticals - $41.5M
19. Agensys - $41.31M
20. GlobeImmune - $41.16M
    

***NOTE*** Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

If you enjoyed this post get free email or RSS updates (here).

Tarmogens™ Transition to Phase II

GlobeImmune (Louisville) announced encouraging results from the higher dose cohorts of the randomized, placebo-controlled Phase Ib trial evaluating safety, immunogenicity and efficacy of GI-5005 in patients with chronic hepatitis C infection. The data yielded a favorable safety profile with the dose escalation to the highest planned dose without dose limiting toxicity; strong trends for a dose dependent response; viral load reductions in treated patients; viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy; biologic-immune activity by converting patients from an immune response profile associated with chronic infection to one similar to patients who clear the virus naturally during the acute phase; and, no placebo patients had near log10 reductions of viral load or demonstrated an immune response.

The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long term monotherapy.

A randomized Phase II study evaluating GI-5005 plus standard of care (pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone) is being initiated in 4Q07 at 50 centers in the US, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response or do not tolerate treatment in the pegylated interferon/ribavirin arm.

The recent $41.2MM Series C close should carry this trial through to its primary endpoints along with clinical advances in GI-4000 in the oncology program for respectable pancreatic cancer. Great news from GlobeImmune indeed and we are anticipating more great news as the Phase II trials progress!

Celgene Makes Ya Go Hmmm…

Just what I think to be an interesting observation…that is how deep New Jersey-based Celgene (NASDAQ: CELG) has penetrated into the Colorado bio-scape. The connection appears to have initiated back in 2001 on a licensing deal with Pharmion (NASDAQ: PHRM) for Thalomid® (BTW…take a listen to Pharmion’s UBS Global Life Sciences Conference presentation from today here). Celgene then most recently struck an alliance deal with Array Biopharma (NASDAQ: ARRY) and yesterday confirmed participation in GlobeImmune’s Series C financing. More big pharma recognizing the value being created here in Colorado!

GlobeImmune: Series C $41.2MM

GlobeImmune, Inc. closed a $41.2MM Series C financing. The round was led by Wexford Capital, other participants include Celgene (NASDAQ: CELG), Mellon Family Investment Company, Richard King Mellon Foundation, Eminent Venture Capital Corp., Boston Life Science Venture, and WRF Capital. Previous investors who participated in the round include HealthCare Ventures, Morgenthaler Ventures, Sequel Venture Partners, Lilly Ventures, Medica Venture Partners, Adams Street Partners, Biogen Idec (NASDAQ: BIIB), Pac-Link Bioventures, China Investment and Development, Yasuda Enterprise Development, Partners Healthcare, and GC&H Investments.

This financing should carry GlobeImmune through to primary endpoints of their Phase II trials of GI-5005 for chronic hepatitis C and GI-4000 for resectable pancreatic cancer. In addition, it may launch pre-clinical Tarmogen™ candidates into the clinic. The company has raised approximately $88MM to date and has attracted local, costal and international dollars from venture, corporate and foundation sources. Truly an incredible close and needless to say how excited we are to observe GI-4000 and 5005 move through the clinic.

GlobeImmune: Tarmogens On A Tear

GlobeImmune has announced positive interim data from their randomized, double-blinded placebo-controlled Phase Ib study of their GI-5005 Tarmogen in patients with hepatitis C virus (HCV). To date GI-5005 is well tolerated with no serious adverse events reported. The preliminary data has demonstrated that the treatment has converted subjects with a weak cellular immune response, typical of chronic HCV patients, to a strong cellular immune response, and the immune responses observed have shown statistically significant changes in ALT levels and viral load.

Tarmogens (Targeted Molecular Immunogens) are whole, heat-killed recombinant Saccharomyces cerevisiae yeast, genetically modified to express one or more protein targets that stimulate the immune system against diseased cells. The whole heat-killed yeast, with the antigen expressed inside is the product that is administered to the patient. Tarmogens program the cytotoxic T cells in the patient’s immune system to eliminate diseased cells containing the antigen.

Check out the June 2006 Red Herring Top 100 Startup Companies in North America: GlobeImmune article (here).

GlobeImmune Initiates Phase II Trial

GlobeImmune, Inc. announced the initiation of a Phase II clinical trial of GI-4000, for the treatment of early-stage pancreas cancer. GI-4000 is designed to activate the immune system against cancer cells containing a mutated protein called Ras that is found in 80-90% of pancreas tumors. In a recently completed Phase 1 study of end-stage pancreas and colorectal cancer patients, GI-4000 was generally well-tolerated across the full range of doses tested.

Read the Red Herring Top 100 Start-up Companies in America article on GlobeImmune here.

Parting Is Such Sweet Sorrow

Today GlobeImmune finished packing and said good bye to the Fitzsimons Redevelopment Authority. Early pre-clinical success, human Phase I clinical trials, multiple rounds of capital raising and hiring have culminated in the need for additional space that Fitzsimons, in its current state, was unable to provide to the accelerating start-up. Another way to look at the departure is the FRA met its expectations in incubating this once seed-stage endeavor and can consider the move a very successful graduation. Kudos to all. We look forward to monitoring the progress of GlobeImmune and their Tarmogen™ technology.