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Legal Entity Type: C-Corp
Company Type: Biotechnology
Company Stage: Development
No. of Employees: 6
Desired Financial Amount: The financial planning schedule for funding rounds is the following: Seed Funding Year 1: $2.45M Seed funding for non-GLP toxicity study (1 large rodent species) Series A Funding Year 2: $13.5M Series A funding for CMC activities + GLP tox studies (2 large animal species) Series B Funding Year 3: $15.42M Series B funding for FIH clinical trial Phase 1 safety study
Background
Company Background
IllumaRas was founded in 2022 to pursue biomedical real-time imaging applications based on our sister company Tezcat Biosciences’ platform technology. Tezcat/IllumaRas scientific founders have been working on the technology since 2018.
Protein Carrier Technologies (PCT) are engineered protein scaffolds with useful binding specificities, mostly directed against targets of biomedical relevance. Our technology uses a metabolic protein carrier conjugated to a NIR (near infrared) dye molecule. Our entity has been successfully conjugated to different dyes including ICG and Cy5.
The inventors of the underlying technology are as follows: Craig Ramirez, Andrew Hauser, Nathan Beals, Dafna Bar-Sagi, Akiko Koide, and Shohei Koide. NYU owns applications using the protein carrier technology described above (PCT) , and has executed an exclusive, worldwide license agreement with Tezcat Biosciences with favorable terms for sublicenses. Tezcat Biosciences has put in place an Option to Sublicense to IllumaRas, which will be for exclusive, worldwide rights for biomedical imaging utilizing the technology.
IllumaRas is a C Corporation in Delaware and is registered to do business in Texas as of February 22, 2022.
Management
Our team of founders met over two years ago and have been actively collaborating to identify the most impactful indication for our technology. During this time, we’ve found that our diverse backgrounds and skills are complementary and will ultimately result in improving outcomes afflicted with cancer. From the CEO: The rich experience of the co-founders sparked my motivation to join IllumaRas as a pivotal part of helping advance this unique technology. What excites me are the values all cofounders share. One key resonating passion is to place patients front and center in everything we do – this shapes our character. Our technology offers surgeons, for the first time, the ability to visualize cancers (driven by the oncogene RAS) during surgery or screening. What a huge win for cancer patients suffering from poor outcome malignancies as is the case with aggressive pancreatic cancer, our leading indication.
One of our cofounders is an actively practicing oncology surgeon who embraces the promise of this technology and wants to use it immediately with all his patients. Our platform of personalized medicine will significantly impact not just surgical standard of care (SOC) for cancer patients, but also complement as well as elevate and empower other SOC modalities like chemotherapy and radiotherapy with regards to positive patient outcomes, longer survival rates, and better quality of life.
Enrique Gomez (MS) CEO, Founder
1. Executive in the biopharma industry with 25 years of experience. He served patients while collaborating with Bristol Myers Squibb, Shire Pharmaceuticals, and Takeda Pharmaceuticals.
2. His experience expanded from operational manufacturing and supply chain roles to strategic corporate responsibilities for M&A, due diligence, integration, and business continuity.
Craig Ramirez (PhD) Scientific Founder
1. Co-inventor of underlying technology while receiving PhD in Dr. Dafna Bar-Sagi’s lab @ NYU.
2. Received 2 NIH STTR awards and Johnson & Johnson QuickFire Challenge Award for therapeutic use of KRAS-specific technology.
Andy Hauser (PhD) Scientific Founder
1. Obtained a PhD from the Medical College of Wisconsin, in which my research utilized molecular and cellular biology to study the role of small GTPases in multiple cancer types.
2. Co-inventor of underlying technology while post-doc in the lab of Dr. Dafna Bar-Sagi at NYU.
Vance Sohn (MD) CMO, Founder
1. MD Anderson Cancer Center-trained surgical oncologist.
2. Practicing surgeon practicing the entire spectrum of General Surgery at different practice environments from critical access hospitals to quaternary level cancer centers.
3. Director of Medical Affairs for LumaBridge LLC, a Clinical Research Organization with a focus on oncology trials.
Elaine Lea-Chou (PhD) CSO, Founder
1. Biotech start-up consultant specializing in funding that bridges from proof-of-concept to SEED round fundraising. Responsible for raising $50M in non-dilutive funding in just 3 years for 6 discrete biotech start-ups.
2. Helped raise $30M total in non-dilutive CPRIT funds for OncoNano Medicine, a surgical imaging start-up based out of Dallas (UTSW) in 2019 and 2020.
Porfirio Ramirez (JD) CLO, Founder
1. JD from Harvard Law School.
2. Focus areas: private finance transactions, acquisitions, commercial transactions.
3. Previous firms: Arnold & Porter, Alston & Bird, Smith, Gambrell, & Russell
Board of directors
Craig Ramirez, Ph.D., Biomedical Research, Cellular and Molecular Biology
Andrew Hauser, Ph.D., Pharmacology and Toxicology
Enrique Gomez, M.Sc., Manufacturing Integrated Systems and Technology
Product / Service
disease area / application
IllumaRas is a biomedical imaging start-up with first-in-class precision technology to light up mutant (Ras) cancer cells in real-time in patients with either suspected or diagnosed oncological disease as they are undergoing routine screening, diagnosis/staging, or surgery with curative and/or palliative intent. This can occur in the doctors’ office or surgery in the operating room. Our platform is fluorescence-based real-time imaging where a doctor/clinician/surgeon can detect and delineate cancerous tumors in a patient during screening or on the operating table.
product / Service
Real time identification of tumors and tumor margins that dictate the extent of resection is a challenge faced during curative cancer surgery. There is a delicate balance between a microscopically negative excision and the preservation of unaffected healthy tissue. IllumaRas has developed a first-in-class precision technology to delineate and distinctly visualize tumors which enhances real-time and critical decision making in the operating room. IllumaRas technology is a protein-NIR dye conjugated molecule (to date has been linked to dyes like ICG and Cy5) that specifically targets and allows visualization of active tumor cells. Our foundational MOA is a tumor cell-enhanced metabolic process called macropinocytosis – the uptake of extracellular material by cells. Tumor cells with mutant RAS driver mutations (one third of all cancers) have increased activity – this increases uptake of our protein that is linked to a near infrared dye and thus illuminates cancer cells.
The process that allows real-time intra-operative visualization of Ras mutated malignancies enhances current surgical practice. Surgeons rely upon static imaging (CT, PET, MRI) to identify masses and to plan the appropriate procedure. Intra-operatively, anatomic familiarity based on imaging will identify the general area of the mass but a combination of visual confirmation, palpation, experience, and/or anatomic cues are considered to determine the extent of resection without certainty of the extent of cancer involvement. This task is made harder by inconsistency with how the disease presents – heterogeneity in cancers (not just by type but also between patients, as well as between organs) makes these methods quite challenging and often variable. By enhancing the ability of a surgeon to confidently: 1) see and confirm cancer, 2) identify unforeseen cancer or occult disease, and 3) see draining patterns of tumor with real time margin analysis to preserve non-affected tissue, our technology can significantly enhance patient outcomes and survival. Our capability has the potential to augment and easily integrate with existing workflows, as our current format for imaging detection and visualization is already compatible with existing surgical platforms widely in use. We anticipate straightforward assimilation and rapid adoption.
Our vision for the IllumaRas imaging platform is guided by the needs of cancer patients for personalized imaging. As they embark upon their treatment journey, imaging is dedicated to staging the extent of disease. Current modalities are non-specific to cancer and can lead to diagnostic uncertainty, additional tests, or biopsies. Then, after definitive treatment, all cancers undergo intense imaging surveillance for up to 5 years to evaluate for recurrence. Again, there are no tumor specific imaging modalities that exist- our technology ensures that Ras mutated cancers can be detected accurately and confidently.
technology / ip
Our technology is fluorescence-based imaging that allows real-time detection of tumors directly in patients during screening (endoscopic) or surgery (endoscopic, open, laparoscopic, robotic). A protein-NIR dye is administered via IV to the patient prior to the surgery, circulates through the body, specifically accumulates in cancer cells and tumors, and illuminates those areas. Excitation/emission and detection is done using approved surgical cameras and instrumentation systems (several manufacturers) are already in use in the surgical OR. Use of the technology for biomedical imaging has been rigorously validated in vivo for optimal biodistribution to mutant RAS tumors with favorable signal-to-noise readouts. We recently completed a key pilot study, suggested by Intuitive Surgical Inc. (an American-based company that is a worldwide leader in minimally invasive surgery) that validates the ability of our lead asset to identify tumor lesions in the pancreas after either: 1. standard-of-care (SOC) treatment (gemcitabine + nab-paclitaxel, aka Abraxane) or 2. surgical resection – with favorable signal-to-noise readouts and relevant sensitivity and specificity in both conditions.
As discussed above, for cancer detection surgeons currently rely upon static imaging (PET, MRI), real-time intraoperative visual examination, and/or real-time finger palpation. Our product combines the benefits of 1) fluorescence-guided surgery (FGS) for tumor delineation, and 2) a tumor-specific metabolic marker. Existing FDA-approved FGS biomarker predicates for cancer include Cytalux (ovarian, lung) and Cysview (bladder) but these are all based on biomarker expression/overexpression and are not always tumor-specific. Unlike these biomarkers, our tumor-specific marker is metabolic, and thus has greater specificity and more favorable signal-to-noise detection characteristics for more accurate and clearer tumor outlines that are easier to distinguish from surrounding normal tissue.
The foundational basis for our platform is licensed technology from Dr. Dafna Bar-Sagi’s lab (NYU Langone Health); Dr. Bar-Sagi is a leader in cancer research and macropinocytosis. Dr. Bar-Sagi along with Dr. Jason Lewis (Memorial Sloan Kettering) are working with our technology for PET imaging under a NYU/Tezcat license agreement that includes future work for 2 years. Our sister company Tezcat Biosciences has an exclusive, worldwide license agreement in place with NYU covering the PTC (protein carrier technology). In addition, Tezcat has filed a US provisional patent application broadening the protection of the core technology. Tezcat is pursuing the protein entity for therapeutic applications and has entered into an Option to Sublicense with IllumaRas specifically for human biomedical imaging.
distribution channels
Current and future customers are the end-user of our imaging platform – oncology and primary surgeons, hospitals, clinics, group practices and surgical/instrumentation/device entities and technology companies. IllumaRas is compatible with commonly used platforms including the minimally invasive Da Vinci surgical robot (Intuitive) and ICG laparoscopes (Karl Storz, Stryker, and Olympus) that are widely available and used in hospitals. Our go-to-market strategy is to establish a combination of direct and third-party distribution relationships.
market size
Our intended markets are patients undergoing routine screening and/or surgical imaging of primary (and potentially metastatic) cancers of various indications. Because our metabolic marker is pan-cancer, it can be applied to any cancer phenotype that has the RAS mutation (frequently mutated in many cancers). Mutant RAS is a driver mutation clearly linked to a dismal outcome and poor survival and is found in 20-30% of all cancers (American Cancer Society and MD Anderson, 2022 data). It has high prevalence in certain cancer types such as pancreatic (>90%; Witkiewicz et. al. Nature 2015), colon (40%) and lung (30%), and these are the first indications that we will pursue in that order of priority. Our initial indication is pancreatic cancer (PAC) patients who either have suspected or confirmed disease. PAC is one of the most fatal cancers globally and is the 12th most common cancer in the world (World Cancer Research Fund International, 2015). PAC in the US is expected to see the largest growth globally, from 48,110 cases (2016) to 61,469 cases (2026), at an Annual Growth Rate (AGR) of 2.28%. The general 5-year survival rate for people with pancreatic cancer in the United States is 11%.
We have conducted a market analysis for comparable market segments for existing FDA-approved imaging agents. Cytalux and Cysview are dye-based diagnostic imaging agents that are FDA-approved and used for niche cancer types and are both based on biomarker overexpression. On Target Laboratories commercializes Cytalux for two indications – ovarian and lung. Cytalux is positioned to be a blockbuster imaging agent by 2028. Photocure SAS commercializes Cysview for the single indication of bladder cancer. The average public price for Cysview is $1,283-1,500 per dose per patient (2022).
Lantheus commercializes Pylarify for the treatment of Prostate Cancer. This asset is a PSMA-targeting small molecule conjugated to a radionuclide fluorine-18. The conjugate can thus be visualized in vivo by scanning with positron-emission tomography (PET) scan. Pylarify price per unit dose is estimated at $5,146, and the U.S.A. market is 220,00 scans annually. Pylarify by the year 2028 will be a blockbuster brand reaching $1B in revenue.
Surgimab developed SGM-101 for the treatment of Colorectal Cancer and currently is in clinical trials. This asset is a CEA-targeting antibody conjugated to a near-infrared dye for use during fluorescence-guided surgery. Human carcinoembryonic antigen (CEA), a widely used tumor marker, is a member of a family of cell surface glycoproteins that are overexpressed in many carcinomas (Colorectal, Pancreas, Lung, Gastric), sometimes antigens are released into the bloodstream. We anticipate the price level for SGM-101 will be comparable to other molecules conjugated to a NIR dye.
We estimate the Global Total Addressable Market (TAM) for the three indications listed above is $27B, of which the USA market alone is valued at $18B. Our drug development plan is to first address the beachhead market in the USA for a pancreatic adenocarcinoma (PAC) indication (with a high prevalence of the RAS driver phenotype) representing a potential market value of $80-100MM. The follow-on indication is colon cancer (CC). Currently the US healthcare system standard procedure for CC diagnostic/surveillance is colonoscopy, where physicians perform 15M colonoscopy procedures annually; using a single dose of our optical imaging agent per patient translates to an estimated market value of $15-18B. The growth rate is anticipated to be 2.8% (PAC) and 1% (CC).
competition
For cancer detection, surgeons currently use static imaging (PET, MRI), real-time visual examination, and real-time finger palpation. Our product combines the benefits of: 1) fluorescence-guided surgery (FGS) for tumor delineation with 2) a tumor-specific metabolic protein linked to an NIR dye marker. Our diagnostic and staging capability has the potential to augment and easily integrate with existing workflows. Our current format for imaging detection and visualization is already compatible with existing surgical and endoscopic platforms widely in use, and anticipated easy assimilation into accepted workflows should greatly help with widespread adoption.
Existing FDA-approved predicates for use in FGS for cancer are Cytalux (ovarian, lung) and Cysview (bladder); both are based on biomarker expression/overexpression which can be problematic as they are not always tumor-specific and often are indication-specific. A few other companies using the same overexpression-based strategy that are chasing FDA approval are currently in clinical trials (SGM-101, BLZ-100, ONM-100). Unlike overexpression biomarkers, our tumor-specific metabolic marker allows for greater specificity and more favorable signal-to-noise detection characteristics to produce more accurate and clearer tumor outlines.
The metabolic FDG-glucose PET scan is widely used in industry, but is static, cannot be performed during screening/surgery, has minimum detection size limitations, and is radioactive. IllumaRas is dynamic, real-time optical imaging agent that can be used during screening/surgery and has the potential to detect tumors of all sizes without radioactivity.
Financials
Desired financial amount
The financial planning schedule for funding rounds is the following: Seed Funding Year 1: $2.45M Seed funding for non-GLP toxicity study (1 large rodent species) Series A Funding Year 2: $13.5M Series A funding for CMC activities + GLP tox studies (2 large animal species) Series B Funding Year 3: $15.42M Series B funding for FIH clinical trial Phase 1 safety study
previous funding
No outside capital has been raised.
current financials
IllumaRas is a biomedical imaging start-up in the pre-clinical and pre-revenue stage. IllumaRas is looking to obtain non-dilutive funding as well as Seed capital in the near future. We are fortunate to be able to benefit from advancements on and developments to the technology through the Tezcat/NYU partnership until we raise capital.
IllumaRas financial planning and estimated burn rate is as follows:
Year 1: $410K /month
Year 2: $1,131K /month
Year 3: $1,285K /month
financial use
The intended use for current SEED funding is to advance the asset in a de-risking plan, which targets the completion of the following milestones:
1) Expand indications $450K
2) Cell bank development $434K
3) Conduct pre-IND meeting with FDA $75K
4) Bioanalytical assay development $369K
5) non-GLP Toxicology (1 large rodent species) $284K
6) Operations $838K
Total $2,450K
revenue
The IllumaRas business model is to identify novel optical imaging agents, develop these assets through pre-clinical studies and clinical trials, achieve regulatory approval in the US and additional markets, and subsequently market these products at robust levels of reimbursement. Throughout the development lifecycle, we will aggressively explore opportunities to partner with biopharmaceutical, diagnostic, or imaging companies on joint-development programs, out-license or in-license assets or platform technologies, and/or engage in marketing and distribution partnerships.
Our primary strategy at this time is to advance our lead asset through IND application into first-in-human clinical trials for an oncology indication of current high unmet need. While we will explore licensing and partnerships for this lead program/indication, it is our current intention to maintain rights of this lead program through early clinical development. IllumaRas plans to enter into licensing arrangements or joint-development programs for the Company’s non-lead assets. These partnerships will provide not only non-dilutive financial resources to advance our lead program, but they will also enable us to develop compelling data, institutional relationships, and strategic optionality to bolster the Company’s long-term growth.
IllumaRas’ approach and platform chemistry has the potential to add new imaging agents with novel conjugations from existing approved imaging molecules. With a strong clinical data set and compelling health economics case, we are confident in our ability to secure favorable reimbursement levels, formulary placement, and regular selection as standard of care (SOC) for eligible patients. IllumaRas plans to pursue all pathways and designations available, which would expedite regulatory reviews and approvals.
IllumaRas will leverage existing reimbursement processes as directed by the Centers for Medicare & Medicaid Services (CMS). CMS has already set the foundation and updated coverage, coding, and payment information for imaging agents (radionuclide and FGS).
exit strategy
IllumaRas is actively exploring licensing and partnerships for our lead program/indication. The regulatory path for FDA approval for this class of molecules, which are for specific use in imaging applications, is to generate a clinical data package for safety readouts in humans. Our strategic and financial plan is structured to advance this asset through the drug development plan to FIH (First in Human) clinical trials (Phase 1a/b).
