Golden Age of Biotechnology
The biotechnology industry is experiencing an unprecedented period of scientific advancements in the fields of immune-oncology (e.g stimulating immune system to attack cancer) and gene therapy.
SJA, a division of Finalis Securities LLC Member FINRA/SIPC, works closely with promising early-stage biotechnology companies (Inomagen Therapeutics, ImmunoGenesis, Vidium Animal Health, Translational Genomics Research Institute – TGEN) evaluating strategic initiatives for advancing novel development programs. We would welcome the opportunity to schedule a call and discuss. Please click on the Calendly link to schedule https://calendly.com/sja930/zoom-call
Novel innate-oncology program focused on the STING (Stimulators of Interferon Genes) pathway
Stingray is developing potent and selective small molecule inhibitors of ENPP1, Ectonucleotide Pyrophosphatase / Phosphodiesterase1. ENPP1 is the direct negative regulator of the STING pathway which is essential for innate immune response. By targeting the negative regulator, we stimulate the pathway to its fullest biological capability without over-activating the immune system, which is a risk factor for direct STING agonism programs. Our inhibitor shows promise as a single agent and synergy with radiation therapy. We are continuing to generate in vivo data including additional combination studies and will begin toxicology in Fall 2020.
Use of ENPP1 inhibition to activate innate immunity is also important in many infections, such as Tuberculosis Avium, Coronavirus, and Hepatitis B. While our focus is primarily in oncology, we are working to generate data that explores our inhibitor's effect in other diseases.
ENPP1 inhibitors are the only known “Checkpoint” inhibitor in innate immunity and attractive to large phama as evidenced by AbbVie’s acquisition of MavuPharma in July of 2019 (terms undisclosed).
- ENPP1 is the only known “Checkpoint” inhibitor in innate-immunity offering a potential superior safety profile than 1st Gen approaches to drugging the STING pathway
- Stingray identified a clinical candidate, SR-8541A, with low nanomolar to picomolar activity, high selectivity, and favorable pK / ADME properties for oral tablet administration
- Generated compelling in-vivo data
- Activity as a single agent in CT26 colon cancer model: 57.8% decrease in tumor volume
- Demonstrated synergy with radiation and abscopal anti-tumor response in a MC38 model: 65% decrease in tumor volume and 38.5% anti-tumor response abscopal effect
- Stingray is evaluating the initiation of single agent (interferon / immune responsive tumors) and combination in-vivo studies
- Projected to file an Investigational New Drug (IND) application with the FDA in the 1Q2021
- Finish toxicology studies in the 4Q of 2022
- File IND in 1Q 2023
Next-generation checkpoint inhibitor and robust pipeline turning “cold” tumors to “Hot”
ImmunoGenesis was formed to develop products from the lab of Dr. Michael A. Curran, Associate Professor, Department of Immunology at MD Anderson Cancer Center. The focus of Dr. Curran’s lab is to develop strategies to overcome immune resistance in “cold” tumors which represent a majority of all cancers. Dr. Curran has been at the forefront of innovation in the immune-oncology (I/O) space since his time working closely with Nobel Laureate, Dr. James Allison. Dr. Curran’s name is on the patent for CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) inhibition and was the first to describe and drive early clinical research on the PD-1 / CTLA-4 combination approach, still the most effective clinical I/O combination.
ImmunoGenesis’ lead compound (IMGS-001) is a dual specific PD-L1 / PD-L2 antibody established to provide a superior foundation of PD-1 blockade through its ability to block all three PD-1 pathway inhibitory interactions (PD-L1:PD-1, PD-L1:PD-L2, B7-1:PD-L1) and has cytoreductive capability from effector function – the cytoreductive capability driving efficacy in “cold” tumors where current PD-1 inhibitors do not work. As a result, IMGS-001 demonstrated in pre-clinical models superior efficacy in “hot” and “cold” tumors versus existing checkpoint inhibitors. This stronger foundation will allow for a differentiated mechanism to drive combination and single agent efficacy in a market which is projected to generate $25 billion in revenues by 2024.
In addition to IMGS-001, ImmunoGenesis is developing other promising therapeutics catalyzing effective immune response in immunologically “cold” cancers such as prostate, colorectal, and pancreatic:
- IMGS-501 – STING Immune Stimulating Antibody Conjugate (ISAC) + PD-L1 / PD-L2 Dual-Specific Ab
- IMGS-401 – PD-L1 / PD-L2 + 4-1BB (Trifunctional Bispecific)
In August of 2020, ImmunoGenesis received $15.5M of non-dilutive capital from the Cancer Prevention Research Institute of Texas (CPRIT). Only 8% of all applicants win awards due to CPRIT’s stringent due diligence evaluation process. Proceeds from the CPRIT award will advance IMGS-001 though Phase 1 clinical and Evofosfamide through Phase 2 clinical studies.
Gene therapy for the treatment of Atrial Fibrillation
Inomagen Therapeutics is an early-stage company dedicated to developing and commercializing a biological (gene) therapy to improve the treatment of atrial fibrillation (AF) by targeting the underlying cause of the disease. AF is the most common sustained heart rhythm disorder affecting 6M people in the U.S. and 33M worldwide. Those suffering with AF have a ~6x higher risk of stroke leading to 750,000 hospitalizations and 130,000 deaths globally. AF incidence increases significantly with age, making the disease an epidemic in developed countries.
Unfortunately, current AF treatments have suboptimal efficacy. Drugs to control heart rhythm have <50% efficacy and can cause life threatening arrhythmias and significant side effects. For drug refractory patients, cardiac ablation is moderately successful (70%) treating early stage (paroxysmal) AF, however, often requires repeat procedures. Most troubling is cardiac ablation’s 30-50% success treating more advanced stage (persistent) AF representing the majority of symptomatic, drug refractory AF patients. Despite best efforts, improvements in ablation catheters and energy sources have led to only modest increases in ablation success.
Inomagen is developing a biological (gene) therapy targeting >70% efficacy for all AF patients including under-treated patients with advanced stage (persistent) AF. With the support of significant grant funding (>$6M), RTI identified fundamental molecular mechanisms in the creation of the AF disease state and major trans-genes to selectively target these mechanisms. In proof-of-concept studies, Inomagen’s gene therapy technology demonstrated a marked decrease in AF in clinically relevant, large animal models.
GENE THERAPY HAS POTENTIAL TO SURPASS CARDIAC ABLATION AS THE AF TREATMENT OF CHOICE
- Inomagen’s therapy directly targets the molecular mechanisms underlying AF and has potential to be more effective than current standard ion-channel blockers and ablation
- Inomagen’s gene therapy approach attenuates both electrical remodeling (assessed in the Rapid Atrial Pacing, RAP, mode) as well as fibrosis (Heart Failure Model) in large animals
- Potential to substantially reduce mortality, improve quality of life, and control healthcare costs
- Avoids creating destructive ablative lesions of heart tissue which do not have the capacity to regrow, and can limit future AF treatment options
- Uses a novel trans-venous delivery approach making the procedure comparable to or simpler than current AF ablation
- Simultaneous electroporation in atrial region using a commercially available electrophysiology mapping catheter achieved excellent atrial gene transfer
Vidium Animal Health
Vidium Animal Health, a molecular diagnostics company providing analysis and recommendations for veterinarians treating pets with cancer, would welcome the opportunity to meet with you during the Bio Partnering Forum.
Vidium has one of the industry's broadest animal health diagnostic platform including a best-in-class genomic diagnostic test - SearchLight DNA - leveraging the latest science available in order to better understand and treat cancer in dogs. SearchLight is a tumor-only test that determines all three types of mutations in the 120 most relevant cancer genes.
By informing veterinarians and pet parents about which mutations are causing their pet’s cancer to grow and spread, we intend to open up the use of precision medicine to combat canine cancer. In addition, Vidium will facilitate the use of these new, targeted therapies through consultations and easing access to oral medications compounded for use in dogs. Vidium's longer-term vision builds upon the company's market leading molecular diagnostic capabilities to include de-risking and expanding veterinary / human drug pipelines through "data" gathered from testing and treating dogs.
The animal health diagnostic marketplace is attractive to investors and strategic partners provided:
- There are 90 million dogs in the U.S. alone with 11 million added to households in 2020 (historic record)
- 4.2 million cancer diagnoses annually with 75% of families seeking diagnotic / treatment
- 10x higher annual cancer incidence in dogs compared to humans
- In 2019, U.S. pet spending totalled $95.7 billion of which $29.3 billion was spent in the Veterinary Care & Products Category including diagnostic testing
- 6% CAGR for Veterinary diagnostics with Veterinary cancer therapeutics growing even faster at 10.8% through 2024
Vidium has raised $7 million since inception including participation from a noted entrepreneur and investor, Ernest Garcia II, the founder of Carvana.