PxRadia Inc. United States

PxRadia is applying its HD-mAb technology platform to provide increased therapeutic potency to biosimiliar monoclonal antibodies. These antibodies are directed to validated targets such as Her-2, CD-20 and PD-1/PD-L.  We and our partners will share new IP and rights and differentiation from current products in the marketplace.

Website:
www. pxradia.com
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
HD-mAb Technology Platform Potentiates Therapeutic Efficacy of Monoclonal Antibodies
Alliance & Collaborations
Pending
Current Financing Needs
$2M
Current Investors
LH Financial, NYC
IP Status
Files
Recent Milestones
Seed Round Financing
Management Team Highlights
Alton C. Morgan, Serial Entrepreneur & world renown Expert in Monoclonal Antibodies
Ms Gail Thurston
VP Corporate Development 
Dr Alton C Morgan
President and CEO 

Quintessence Bioscience United States

Quintessence Biosciences, Inc. is a private, clinical stage biopharmaceutical company developing novel anti-cancer compounds based on our patented EVade™ Ribonuclease technology. The lead candidate, called QBI-139, completed a first in human dose escalation Phase I clinical trial in patients with solid tumors. Quintessence is looking for funding for a proof of concept clinical trial (Phase Ib/IIa) with a defined patient population.

Biotech Subsector
Biotech Phase of Development
Technology Overview
EVade™ Ribonucleases (RNases) are the only proteins under development to target the RNA in cancer cells. These RNases are based on naturally occurring human RNases, which have a few amino acid substitutions to evade their natural inhibitor inside cells. The lead candidate, QBI-139, is 95% identical to human RNase I. The EVade™ RNases are taken up by endocytosis. Relative selectivity has been demonstrated with a good therapeutic window in xenograft models. QBI-139 has a strong therapeutic window against a variety of in vivo xenograft models including: colon, non-small cell lung, ovarian, pancreatic and prostate cancer.
Alliance & Collaborations
The Phase I trial of QBI-139 was done at MD Anderson Cancer Center and University of Wisconsin-Madison.
Supporting Metrics or Evidence
Dose escalation of QBI-139 in a Phase I trial has recently been completed. The drug showed a distinct safety profile relative to already approved drugs. The exposure profile in patients was similar to animal models. Based on encouraging indications of efficacy, an expansion cohort in a defined patient population is being planned. Based on pre-clinical and clinical results as well as market and regulatory considerations, the company is particularly interested potential expansion cohorts in: - Second or third line non-small cell lung cancer regardless of mutation status in combination with a platinum doublet, - Second line platinum refractory/resistant ovarian cancer in combination with a platinum doublet or - Post-androgen receptor antagonist in hormone resistant prostate cancer (HRPC) in combination with a SOC agent.
Current Financing Needs
Quintessence is looking for $8M to fund a proof of concept (Phase Ib/IIa) clinical trial.
Current Timeline
Once funding is available, QBI-139 can be advanced to manufacturing for the next clinical trial.
Current Investors
Quintessence has been funded by individual investors as well as some support from NCI SBIR grants.
IP Status
The company has a strong portfolio of intellectual property related to the use of human RNases as therapeutic agents, including composition of matter patents running through 2029.
Recent Milestones
QBI-139 has completed a first-in-human, dose escalation Phase I clinical trial in patients with solid tumors.
Management Team Highlights
Ralph Kauten, CEO, has been founder or senior management at a variety of successful biotech companies, including Promega, PanVera (now part of ThermoFisher), and Mirus Bio (now part of Arrowhead Research). Laura Strong is a scientist by training and overseen advancement of the RNase from discovery to end of Phase I clinical, including managing the communications with FDA.
Laura  Strong
Laura Strong
LinkedIn logo President & COO 

RDD Pharma Israel

RDD Pharma, a clinical stage company with programs in:
1. Fecal incontinence (Phase 2a)
2. Chronic anal fissure (Phase 3 ready).
3. Pruritus Ani - preclinical development
4. Radiation Colitis - animal studies

- All rograms utilize a 505(b)2 strategy .
- Anal Fissure IP goes out to 2030.
Year Founded
2009
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

Company focused on ano-rectal diseases

Experienced management team

Lead product targets $600M market with poorly
addressed needs

Follow on product targets a $3B US market

Pipeline - Three clinical stage products:

  • PHASE III READY – ANAL FISSURE
  • PHASE IIa – FECAL INCONTINENCE ONGOING
  • PHASE II READY – PRURITUS ANI

De-risked 505(b)2 regulatory path

Supporting Metrics or Evidence

Fecal Incontinence - P1 Proof of Concecpt + Phase 2a Ongoing

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Current Financing Needs

OrbiMed Israel (invested $4M in 2012) is a lead investor and has committed to $3M of a $15M Series B.

Current Timeline

Anal Fissure  - Phase 3 to commence 1Q2015

Fecal Incontinence - Phase 2a data read March/April 2015

Current Investors

OrbiMed

Ofakim Hi-Tech Ventures

Corporate Finance Holding GmbH

Mor Research

IP Status

Nifedipine Capository™ - Device for Treating the Anal Sphincter

–      Japan                         Granted (new)

–      Australia                   Granted

–      Korea          Allowed (new)

–      Israel           Allowed (new)

–      USA            Granted

–      Canada                     Allowed

Fecal Incontinence

–      US – National Phase

Radiation Colitis

–      Methods for Treating and Ameliorating Radiation-induced Gastrointestinal Tract Injury

Pruritus Ani

–      Method of Treating Anal Pruritus and Other Perianal Disorders

–      USA-issued patent: April 1, 2014

Recent Milestones

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Management Team Highlights

Jason Laufer CEO 

•       Over 25 years in healthcare clinical and commercial operations

•       Global BD & Licensing at URL Pharma (acquired by Takeda for $800M), Managing Director at CELLGRO® (acquired by Corning , and CEO at Elutex

Nir Barak, MD CMO and Founder

•       More than 10 years as internal medicine physician

•       Career integrating R&D and clinical medicine

•       Formerly CSO/Founder of OBEcure Ltd.

 

Robert Niecestro PhD Regulatory Affairs

  • Over 25 years of experience in the healthcare industry
  • Managing Director of Accelapharm, VP Reg. of Axsome Rx and EVP of Clinical & Reg. Affairs at TG Rx
  • VP Clinical & Reg. Affairs at Keryx Biopharma

 

Monil Shah, PharmD MBA Clinical Advisor

  • VP, Clinical Affairs at Ventrus Biosciences
  • Over 15 years in clinical management roles at BMS, Celgene, Amgen, and Novartis

Jason Laufer
CEO 

Recardio Austria

RECARDIO is a virtual, private, clinical stage life science company founded in 2011 focusing on drug based regenerative therapeutic modalities for the treatment of cardiovascular diseases.

The company started product development mid-stage by taking advantage of >$100m of previously invested capital in the licensed lead compound, Dutogliptin. Safety has been established in more than 1000 subjects and all non-clinical studies have been completed to the highest standards, including 2 year carcinogenicity, resulting in a de-risked clinical development program from the safety perspective and overall reduction in total program costs.

 After completion of limited preclinical studies clinical trials will commence in early 2015 in patients with acute myocardial infarction.



After establishing proof-of-principle in vivo and completion of the preclinical development, it has entered clinical stage and is developing multiple therapeutic leads as the future regenerative medication for patients with various cardiovascular diseases, with the potential of improving their cardiac function, quality of life and survival.

Website:
www.recardio.eu
Year Founded
2011
Biotech Subsector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Current Financing Needs
Series A in process
Current Timeline
Phase 2b starting in 2015
Current Investors
Private
IP Status
Issued use and composition of matter patents
Recent Milestones
Positive FDA advice in 12.2014
Roman Schenk
CEO 

Recursion Pharmaceuticals United States

The Problem: Pharmaceutical development has traditionally focused on intense study of an explicit molecular target related to a specific disease of interest. This strategy is costly and inefficient.

 

The Solution: We have developed technology that can be scaled to quickly, precisely, reliably, and simultaneously model thousands of genetic diseases in human cells and evaluate the effect of thousands of individual drugs on those disease models. We've built a computational platform that recognizes structural changes in millions of diseased cells and then identifies drugs that return those diseased cells to a healthy state.

 

Proof of Concept: We have already used an early version of this platform to discover a potential treatment for one genetic disease. We have IP for this drug, and have already been approached about licensing.  We are scaling our platform now to enable us to achieve our goal of discovering and partnering to bring to market treatments for at least 100 genetic diseases in 10 years.

Dr Chris Gibson
LinkedIn logo CEO, Recursion Pharmaceuticals 

Rhamnopharma, Inc. United States

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Current Financing Needs
Initial
IP Status
Issued US patents
Recent Milestones
Identification of novel MOA
Management Team Highlights
Founder experienced in drug development
Anton Leighton
CEO 

SAJE Pharma United States

Regulating Nitrosylation for Multi-Disease Therapies

SAJE Pharma’s S‑nitrosoglutathione reductase (GSNOR) inhibition technology regulates nitric oxide signal transduction pathways that are critical for multiple therapeutic benefits.  SAJE’s small molecule drugs regulate nitrosylation by inhibiting GSNOR.  Many biologists consider that “Nitrosylation is the new phosphorylation”, meaning that nitrosylation regulates cell pathways as directly as does phosphorylation.  The big advantage for SAJE is that there is only one human GSNOR to inhibit as compared to 100’s of phosphorylation targets, making it a much more “druggable” target with less possibility for off-target toxicity.  SAJE and its collaborators have discovered that GSNOR inhibition reduces: inflammation, oxidant damage, fibrosis, mucus accumulation, and bronchoconstriction.  Such multiple therapeutic efficacies by inhibiting only one enzyme with small molecules is unprecedented in pharmacology.  SAJE is focused on idiopathic pulmonary fibrosis and asthma as its first clinical applications, although there is animal data for efficacy in other diseases including cardiovascular, metabolic, inflammatory, liver, kidney, and other respiratory.  One GSNOR inhibitor has shown Clinical Proof of Concept for GSNOR as a target in a Phase IIa trial in asthma.

SAJE Pharma’s executive team consists of experienced drug development scientists and serial entrepreneurs whose backgrounds include FDA, large pharma, start-up companies, and the CRO industry.

SAJE has licensed one patent app that is nearing issuance in the EU and the US.  It protects SPL-334, SAJE’s lead molecule, and other related molecules.  In addition, SAJE is close to filing 3 more patent apps on its novel compositions that inhibit GSNOR.  A clear advantage for our drugs compared to many novel therapies  is the cost of goods.  Our drugs will cost pennies per dose.

SAJE would like to raise $15 MM to take SPL-334 through a Phase IIa trial in IPF.  The drug is ready for IND-enabling studies.  The company’s exit strategy is to out-license each of its drugs and their accompanying data set, one at a time, for different diseases in different categories.

Year Founded
2011
Biotech Subsector
Biotech Phase of Development
Technology Overview
Regulating Nitrosylation for Multi-Disease Therapies SAJE Pharma’s S nitrosoglutathione reductase (GSNOR) inhibition technology regulates nitric oxide signal transduction pathways that are critical for multiple therapeutic benefits. SAJE’s small molecule drugs regulate nitrosylation by inhibiting GSNOR. Many biologists consider that “Nitrosylation is the new phosphorylation”, meaning that nitrosylation regulates cell pathways as directly as does phosphorylation. The big advantage for SAJE is that there is only one human GSNOR to inhibit as compared to 100’s of phosphorylation targets, making it a much more “druggable” target with less possibility for off-target toxicity. SAJE and its collaborators have discovered that GSNOR inhibition reduces: inflammation, oxidant damage, fibrosis, mucus accumulation, and bronchoconstriction. Such multiple therapeutic efficacies by inhibiting only one enzyme with small molecules is unprecedented in pharmacology. SAJE is focused on idiopathic pulmonary fibrosis and asthma as its first clinical applications, although there is animal data for efficacy in other diseases including cardiovascular, metabolic, inflammatory, liver, kidney, and other respiratory. One GSNOR inhibitor has shown Clinical Proof of Concept for GSNOR as a target in a Phase IIa trial in asthma.
Alliance & Collaborations
Eight universities, NIH, CROs
Supporting Metrics or Evidence
Ferrini ME, Simons BJ, Bassett DJP, Bradley MO, Roberts K, et al. (2013) S-Nitrosoglutathione Reductase Inhibition Regulates Allergen-Induced Lung Inflammation and Airway Hyperreactivity. PLoS ONE 8(7): e70351. doi:10.1371/journal.pone.0070351. Kinetic and Cellular Characterization of Novel Inhibitors of S-Nitrosoglutathione Reductase. Paresh C. Sanghani, Wilhelmina I. Davis, Sharry L. Fears, Scheri-Lyn Green, Lanmin Zhai, Yaoping Tang, Emil Martin, Nathan S. Bryan, and Sonal P. Sanghani. THE JOURNAL OF BIOLOGICAL CHEMISTRY VOL. 284, NO. 36, pp. 24354–24362, September 4, 2009.
Current Financing Needs
$15 MM
Current Timeline
One drug ready for IND-enabling studies, other drugs in research for various diseases
Current Investors
Private, Grants
IP Status
One patent application nearing issuance in US and EU. Three more apps nearing submission on novel compositions of GSNOR inhibitors
Recent Milestones
Michael J. Fox grant, private financing, new collaborations, Positive IPF and metabolic data
Management Team Highlights
Licensed technology, invented new technology, many grants including Michael J, Fox, private financing, IND ready project
Matthews Bradley
Founder President Chairman & CTO 

Siragen Pharmaceuticals, LLC United States

Siragen Pharmaceuticals is a drug discovery and development company, focused on novel approaches to treat Aging and Neurodegenerative Disorders such as Alzheimer’s Disease. Siragen is developing a group of small lead molecules that tackles Alzheimer’s Disease and aging neurons by novel strategy different from current unsuccessful approaches.   Siragen Pharmaceuticals, based in San Diego, California, was incorporated in May 2014, and is a spin off of Neurogeneration Inc. Siragen's products will be for the brain what cholesterol agents are for the heart.

Website:
www.siragen.com
Year Founded
2014
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Technology Overview

Sira-9 targets a specific pathway of the stress response due to oligomer toxicity. Siragen has identified targets within this pathway that prevents the synapse loss induced by synaptic dysfunction and synaptotoxicity. Siragen has also identified another target, which alleviates age-associated phenotypes and extends the life span of neurons by reducing inflammation. These small molecules are specific and can be easily delivered as a pro-drug.

Alliance & Collaborations
UCSD, Duke University, UCLA, Salk Institute
Current Financing Needs

$5M

Current Timeline

Siragen’s development programs are focused on 1) target identification 2) target validation 3) hit to lead identification and optimization 4) in vivo studies and 5) begin clinical trials on identified compounds. The Company aims to develop its pipeline of novel molecules to clinical proof of concept and partner with industry leaders for late stage development and commercialization

Current Investors

Private

IP Status

•  expanding IP portfolio

Recent Milestones

• Target identified and validated for drug discovery in Alzheimer’s disease • Successful assay development for hits • Lead candidate Sira-9 currently in development for Alzheimer’s disease

Management Team Highlights

The team consists of CEO and Founder: Michel Levesque, MD, entrepreneur and neuroscientist, CSO and Co-Founder: Mohamedi Kagalwala, neurochemist and neurobiologist. Scientific advisory board consists of prominent scientist Dr. Eliezer Masliah (neuropathologist and neurodegenerative disorders expert, UCSD), Dr. Kalpana Merchant (Ex CSO, Translation Science at Eli Lilly Pharmaceuticals) and Dr. Anthony Means (pharmacologist, Baylor College of Medicine)

Dr Michel Levesque
Founder 

Sitka Biopharma Inc. Canada

Sitka Biopharma is a preclinical stage company focused on developing a breakthrough nanoparticle platform technology designed to increase absorption of drugs in difficult-to-penetrate tissues. Initially targeting oncology indications, we are developing our lead candidate to address the absorption challenge of intravesical chemotherapy for bladder cancer, and later intraperitoneal delivery for ovarian cancer.

We have demonstrated preclinical proof-of-concept for our lead candidate using in vivo and ex vivo models for bladder cancer.
Our goal is to complete our IND in 2015 and begin a Phase 1/2a Proof-of-Concept clinical trial in nonmuscle-invasive bladder cancer in 2016.

Partnership Opportunities for Platform Technology:

Our nanoparticle platform technology offers unique benefits over other nano-delivery systems and has the potential to be combined with a variety of different drugs to improve absorption for therapeutic uses in both humans and animals.

Benefits of Sitka's HPG nanoparticle platform include:

  • unimolecular structure
  • small size (8-10 nm)
  • tailored for a high degree of localized drug bioavailability in large surface applications
  • potential utility with a wide variety of drugs and indications

We welcome opportunities to collaborate with biopharmaceutical companies that wish to take advantage of our platform technology.

Year Founded
2013
Biotech Phase of Development
Technology Overview
Our nanoparticle platform technology offers unique benefits over other nano-delivery systems and has the potential to be combined with a variety of different drugs to improve absorption for therapeutic uses in both humans and animals. Benefits of Sitka's HPG nanoparticle platform include: unimolecular structure; small size (8-10 nm) and low viscosity; tailored for a high degree of localized drug bioavailability in large surface applications; potential utility with a wide variety of drugs and indications
Current Financing Needs
Seed private investment of $500,000; can be leveraged 2:1 up to $1.5M via partnership with CVI founded Accel-Rx (www.accel-rx.com)
Current Timeline
IND/Entry into clinic in early 2016
Current Investors
CDRD Ventures Inc (www.cdrdventures.com)
Michael Parr
President & Chief Scientific Officer 

SynDevRx Inc. United States

SynDevRx develops new and effective treatments for metabolic-related diseases including pre-diabetes, diabetes, obesity, dyslipidemia and fatty liver disease as well as treatments for cancer.  Our treatments are best-in-class MetAP2 inhibitors of the fumagillin drug class.  SynDevRx lead compound, SDX-7320, is a polymer conjugate of a novel fumagillol derivative which releases the pharmacologically active drug in vivo.  Our approach improves both the efficacy and safety of low molecular weight drugs while reducing systemic drug exposure compared to the small molecule drug alone.

Website:
www.syndevrx.com
Year Founded
2007
Biotech Subsector
Biotech Phase of Development
James Shanahan
VP Business Development