BioEclipse Therapeutics™ is a clinical-stage oncology company that uses its proprietary platform technology to develop the next generation of immuno-oncology therapeutics. Our fundamental premise is that cancer has multiple causes and challenges that requires a multi-mechanistic approach.
We are continuously working to develop a new generation of precise, targeted, immunotherapies that bring hope to patients with advanced cancer who have few treatment options. Foundationally, we have harnessed a refined understanding of the human immune system, gaining insights into the reasons the body’s defense system so often turns a blind eye to the presence of cancerous cells and tumors.
- $13.8M raised to date
- 2 issued/licensed patents from Stanford University: (#10,064,893) & (#9,101,658)
- Projected $92.97B immuno-oncology drug market
- President & CEO, Pamela R. Contag, Ph.D., recognized by Goldman Sachs and Fortune Magazine, among many others
- Board of Directors made up of life science company investors, biopharmaceutical executives with product development and commercial expertise
- CRX100 clinical trials underway
Cancer is one of the leading causes of death around the world, and the number of incidences, especially those linked to social and economic developments in growing populations, are increasing at an alarming rate. Progress in understanding cancer biology and the immune system has fueled major advances in cancer treatments, but the current standard of care in oncology falls short for many patients with hard-to-treat cancers. Challenges persist due to:
- Drug resistance
- High toxicity to healthy cells
- Tumors can create signals that block drugs
- Disease recurrence
- Immune system’s anti-viral response
- Cell therapies challenged by solid tumors
The BioEclipse Approach
BioEclipse Therapeutics is working to improve cancer statistics for patients
The pioneering work underway at BioEclipse Therapeutics approaches cancer immunotherapy from not just one, but several directions. We believe that to defeat cancer, it requires a drug with multiple mechanisms of action (MOA) that work synergistically and systemically to:
- Target and kill cancer cells all over the body, at the same time
- Create a durable immune response that prepares the patient’s body to fight relapse and recurrence
Our Lead Therapeutic Candidate, CRX100
We have used an intellectual property portfolio, developed by the company’s founders and exclusively licensed from Stanford University, to create a first-in-class immunotherapy that pairs the power of an oncolytic virus with the tumor-locating ability of cytokine-induced killer (CIK) cells.
The result of this combination is a multi-mechanistic, targeted treatment that we believe will not only eradicate cancer cells, but also protect the patient from relapse and recurrence.
BioEclipse Therapeutics has demonstrated pre-clinical efficacy of their platform technology in multiple solid and liquid tumor types. BioEclipse’s lead drug candidate, CRX100, is now in Phase 1 Clinical Trials at Stanford, Moores Cancer Center at UCSD and Scottsdale’s HonorHealth. This clinical study is enrolling participants with the following tumor types:
- Epithelial Ovarian Cancer
- Gastric Cancer
- Hepatocellular Carcinoma
- Triple Negative Breast
BioEclipse is a venture-backed biotechnology company that has raised $13.8M to date. We have started our Phase 1 Clinical Trial for our lead drug candidate CRX100, which we intend to market in the US and globally. The global immuno-oncology drugs market is projected to reach $92 Billion by 2025.
Immuno-oncology is one of the fastest growing therapeutic areas due to the promise of eradicating cancer. We believe CRX100 has the ability to be produced at a lower cost and distributed globally. BioEclipse Therapeutics is striving to become a revenue producing company, and plans to continue numerous activities:
- Raise outside funding
- Write grants
- Conduct collaborations and strategic partnerships
- Out-license our patented technology
“The rise in the number of cancer cases across the globe is likely to contribute to the growth of the immune-oncology drugs market. According to the American Cancer Society, there were 1.7 million new cases and 0.6 million cancer deaths in 2019 in the USA. Therefore, the rise in cancer incidence rate globally is anticipated to boost the demand for the immune-oncology drugs market over the coming years” .
“The high cost of immuno-oncology therapies is a key factor hampering the growth of the market.” and ”Immunotherapy often costs an average annual price of more than $100,000 per patient and if the value of medical assistance is included then the price would reach $850,000 per patient” .
BioEclipse has focused our ongoing research and development on making our therapeutic both accessible and affordable. In the past year, we have discovered and developed a way to manufacture and ship our product at what we believe is a fraction of the cost associated with other cell and immunotherapies. The immunotherapy market was negatively impacted by Covid-19 due to the interruption in the supply chain. However, during the pandemic BioEclipse has been able to continue manufacturing, including scale up, for our Phase 1 clinical trial, and we have treated 4 patients as of October 2021.
Success To Date
- $13.8 M Raised to Date
- 2 issued/licensed Patents from Stanford University
- 2 Patent Applications Pending
- BioEclipse President & CEO, Pamela R. Contag, Ph.D., recognized as one of the 100 Most Intriguing Entrepreneurs of 2018 at the seventh annual Goldman Sachs Builders + Innovators Summit
- Recognized in the top 10 of the San Francisco Bay Area’s Women-Led most Funded Life Science Companies of 2020
- Named one of the “Top 25 Women in Small Business” by Fortune Magazine
- FDA allowed IND (April 2020)
- Enrollment Initiated for CRX100 Phase 1 Clinical Trial (Jan 2021)
- Opened 3 Clinical Trial Sites: Stanford, UCSD and HonorHealth
- Treated 4 Patients as of October 2021
- Prnewswire (March 5, 2021) - BioEclipse Therapeutics Announces First Patient Dosed in Phase 1 Dose-Escalation Clinical Trial of CRX100 in Refractory Solid Tumors
- The Bio Report (October 2020) - Designing Immunotherapies That Can Overcome Recurrence And Resistance
- Life Science Leader (September 25, 2020) - Accelerating Your Biopharma Startup's Path To The Clinic
- Prnewswire (April 28, 2020) - BioEclipse Receives FDA Clearance of Investigational New Drug Application for CRX100
- San Francisco Business Times (Feb 14, 2020) - Most Funded Bay Area Women Led Life Science Companies
- Nature - Dual biotherapy may deliver a curative treatment for cancer
Dr. Contag is an experienced senior executive who has served as the President and CEO for both public (Xenogen Corp., NASDAQ:XGEN), and private companies. Dr. Contag is currently the President and CEO of BioEclipse Therapeutics, and in this role she was ranked in the top 100 most intriguing entrepreneurs of 2018 by Goldman Sachs and was recognized in the top 10 of the San Francisco Bay Area’s Women-Led most Funded Life Science Companies of 2020. While CEO of Xenogen, the company twice received the R&D 100 award for achievements in Physics and Dr. Contag was named one of the "Top 25 Women in Small Business" by Fortune magazine. She was appointed by the White House to the Founding Board of the Startup America Partnership, and served as a National Director for Springboard Enterprises. She received her M.S. and Ph.D. from the University of Minnesota Medical School in Microbiology and Immunology and completed her Postdoctoral Fellowship at Stanford University School of Medicine.
Sohn is an experienced Biopharmaceutical executive, Chairman of BioEclipse Therapeutics, a privately held, clinical-stage immuno-oncology company and is an independent Director on the Board of Directors of Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Rubius Therapeutics (NASDAQ: RUBY), Axcella Health (NASDAQ: AXLA), Maze Therapeutics (privately held) and Landec Corp (NASDAQ: LNDC). Additionally Sohn particularly enjoys engaging with students as Adjunct Professor at UCSF and serving on the Advisory Board of the Drexel LeBow Raj & Kamla Gupta Governance Institute. She has broad expertise across strategy, strategic product development, business development, commercialization of new medicines and vaccines, partnering, M&A, and preIPO and public company governance.
Gregory Schiffman is a CPA and an accomplished senior finance executive with more than 25 years of strategic and operational finance, treasury, and corporate development, manufacturing and logistics experience. Mr. Schiffman has served as CFO at Lion Biotechnologies, Inc., which has since been renamed Iovance Biotherapeutics, Inc., and served as Executive Vice President and CFO at StemCells, Inc., Dendreon Corp. and Affymetrix. Notably, during his tenure at Dendreon, the company secured marketing authorization from the FDA and the European Commission for the world’s first cell-based, autologous immunotherapy for prostate cancer. Prior to these roles, Mr. Schiffman was Vice President and Controller at Applied BioSystems where he managed global financial operations and headed up a variety of global assignments at Hewlett Packard, including international finance projects in Europe and Asia, and a U.S. manufacturing operation. Mr. Schiffman received an M.B.A. from Northwestern University’s Kellogg School of Management and holds a bachelor’s degree in accounting from De Paul University.
Mark Frohlich, M.D., is an experienced biotechnology executive and medical oncologist who has been involved in the development of cellular immunotherapies for cancer for 20 years. He previously served as Executive VP of Portfolio Strategy at Juno Therapeutics prior to its acquisition by Celgene, and as Executive VP of Research and Development and Chief Medical Officer of Dendreon Corporation, where he led the clinical team responsible for the approval of the first cellular immunotherapy in the U.S. and Europe (Provenge®). Dr. Frohlich graduated Summa Cum Laude from Yale College with a B.S. in Economics and Electrical Engineering, and earned an M.D. from Harvard Medical School. He continued his training at UCSF, where he completed an internal medicine residency, served as Chief Medical Resident, and subsequently completed an oncology fellowship program.
Biao He, Ph.D., is a Partner at Tsingyuan Ventures, where he has led the firm’s biomedical investments since 2017. Before arriving at Tsingyuan, Dr. He was a Partner at TEEC Angel Fund from 2012 to 2017 where he led their biomedical investment portfolio. Dr. He is also a Co-Founder of ACCB Biotech and Pinpoint Genomics. ACCB Biotech is one of the leading companies in the space of precision medicine for oncology in China. As a co-founder of Pinpoint Genomics, he led the development of the first lung cancer molecular prognostic test, prior to its acquisition by Life Technologies in 2012. Dr. He was a Professor in the Department of Surgery at the Cancer Research Center at the University of California, San Francisco (UCSF). He earned a Ph.D. in Molecular Genetics from the University of Virginia and received a bachelor’s degree and a master’s degree in Biochemistry from Tsinghua University in Beijing.
Stephen is a highly experienced CFO (COO and CEO positions also held). He has 25+ years in public and soon to be public life science companies, including significant experience in managing IPO's. Broad industry experience, including specialty pharma, med device, healthcare technology and healthcare services. Experience in late stage (including commercial and product launch) as well as clinical stage companies.
A New Class in Combination Immunotherapy Cancer Treatments
- Activated innate immune cells protect and deliver an oncolytic virus to the target
- Intravenous, not intra-tumoral delivery
- Safety and tolerability of each therapeutic component confirmed in humans
- Viral particles are delivered directly to the tumor within a patient’s own expanded immune cells, where they replicate and kill millions of cancer cells to debulk large tumors
- Multi-mechanistic; application in multiple indications
- Durable immune response prevents recurrence, and is potentially curative
- Compelling animal data presented and published to support pursuit of development in humans
— CRX100 is both precise and systemic. It targets tumor cells and avoids healthy cells, and it has the ability to reach tumors all over the body. This means the compound holds promise for metastatic disease treatment with limited toxicity. Because our therapy uses a patient’s own immune cells, expanded and activated outside the body, a patient does not have to undergo depletion of their circulating cells by a specific drug or receive highly toxic cytokines during treatment, which may increase safety.
The Scientific Foundation
Current cancer therapies, including immunotherapies, have several major shortcomings. We address these by combining activated cytokine-induced killer cells (CIK) and an oncolytic virus that have been thoroughly tested in humans with excellent safety profiles but which if taken as individual therapies have limited efficacy. When combined, the two agents work synergistically to find and kill cancer cells, creating a powerful, next-generation cancer immunotherapy. Importantly, this combination therapy specifically targets solid and liquid tumors, attacking them on multiple fronts by releasing the oncolytic virus from an expanded/enriched population of CIK cells that have the ability to specifically traffic to and bind to tumor cells. The benefits of this approach include:
- The compound acts as both a protector and carrier, activating the patient’s immune cells and enabling them to deliver a cancer-killing virus payload
- Eradicates malignant cells and creates a long-term (durable) immune response that prevents new cancer growth (relapse or recurrence)
- High effector-to-target ratio (1 million:1) allows for the debulking of large tumors; kills metastatic tumors
- Can be made safely from the patient’s own CIK cells or from donor cells
- Donor cells are not rejected by host, so repeat treatments are possible, if needed
Patient-derived killer cells are treated ex-vivo with cytokines to create activated CIK cells, which are innate immune cells programmed to seek out, find and then kill cancer cells. The CIK cells are then infected with vvDD (vaccinia virus, double deletion). The virus hides inside the CIK cells until reaching the cancer cell, where the virus harnesses the cancer cell’s RAS oncogene pathway to explode and kill the cancer cell.
The antitumor effect of the combination of cytokine-induced killer (CIK) cells and attenuated vaccinia virus show that our CIK cells carry the oncolytic virus to the tumor bed in about 48-72 hours, after which a rapid burst of viral replication kills the tumor cells. When the virus is carried by CIK cells, it can reach tumors away from the vasculature. This produces more uniform distribution of viral infection within the tumor, which contributes to sustained viral gene expression and increased tumor destruction in-vivo.
Studies have demonstrated that there is a synergy between the cytotoxic effect of CIK cells and the oncolytic effect of the virus against tumor cells. The key attributes of this synergy are the protection of the virus by the CIK cells from immune system destruction, and the ability of the CIK cells to activate the immune response in the tumor microenvironment, thereby increasing the potency CRX100 significantly compared to using cells or virus alone.
Problem #1: Drug Resistance
— Resistant tumor cells grow in the presence of most cancer drugs. For instance, more than 70% of ovarian cancer patients have progressive tumors that are resistant to standard-of-care therapies.
BioEclipse Solution: A combination therapy with multiple mechanisms of action
— CIK cells naturally locate, infiltrate and destroy tumor cells. This allows CIK cells to carry and deliver our oncolytic virus directly into the tumor bed where the virus and the immune cells work separately, but systematically, to attack cancer cells.
Problem #2: High Toxicity to Healthy Cells
— Most tumor-killing agents also attack normal cells and cause toxicity and other side effects.
BioEclipse Solution: Our therapy is designed to be selective in killing tumor cells.
— CIK cells are the natural immune surveillance and killing mechanism for abnormal cells, including infected and cancerous cells. CIK cells bind to and kill cancer cells while releasing the oncolytic virus directly in the tumor. Also, our oncolytic vaccinia virus is highly attenuated to allow replication in tumor cells, but not in healthy cells.
Problem #3: Tumors Can Create Signals That Block Drugs
— Tumors use a variety of tricks to evade the immune system. Tumor cells can hide by changing their cell surface to become invisible to immunotherapies.
BioEclipse Solution: Our therapy attacks tumors on multiple fronts
— CIK cells can carry the oncolytic virus across the vasculature and breach the tumor’s protective environment, where it then attaches to tumor cells. The virus is released, infects the tumor and works to kills cells and make the tumor more susceptible to our immunotherapy. Viral infection of the tumor causes an increase in expression of stress ligands on the cell surface which signals the immune system to attack the tumor. Viral destruction of tumor cells also makes tumor antigens highly visible to the immune system.
Problem #4: Disease Recurrence
— Drug resistance and tumor immune evasion can leave behind metastatic or residual disease after treatment with standard therapies, leading to recurrence.
BioEclipse Solution: Durable immune response against multiple tumor antigens
— CIK cells produce chemicals that attract the other cells in the adaptive immune system, including antigen presenting cells, cytotoxic T-cell and T-helper cells. Together these cells generate a response against tumor antigens from lysed tumor cells. This is a memory immune response that allows the adaptive immune system to continue identifying and destroying cancerous cells after the initial treatment.
Problem #5: The Immune System’s Anti-Viral Response
— Injection of oncolytic viruses directly into the tumor is an inefficient method to kill tumors throughout the body. Oncolytic viruses delivered through the blood leaves the virus open to attack by the neutralizing anti-viral responses of a patient’s immune system, which kills the virus before it can reach the tumors. This prevents the virus from reaching the tumor and hinders repeat treatment.
BioEclipse Solution: Our platform delivers the oncolytic virus inside the CIK cells
— CIK cells camouflage the virus in the blood and ferry the virus to tumor cells allowing the virus to reach the tumors unassaulted by the immune system. The CIK cells can deliver the virus directly to the sites of metastatic disease. Cancerous cells act as viral production factories which allows the virus to replicate and destroy many more cancer cells. Our therapy uses immune cells expanded and activated outside of the body which means they do not continue to replicate after reinfusion and thus have reduced side effects.
Problem #6: Cell Therapies Don’t Work On Solid Tumors
— CAR-T and other engineered T-cell therapies face unique challenges finding, entering and surviving in solid tumors. So, while these therapies have shown encouraging results in hematologic cancers, efficacy against solid tumors has proved elusive.
BioEclipse Solution: CIK cells bring the virus in close proximity to the tumor cells which allows tumor lysis by the virus
— CIK cells are specifically and innately designed to travel to tumor cells to eradicate the abnormal cells without requiring the identification of specific tumor antigens. CIK cells can overcome the immunosuppressive tumor microenvironment and with the multi-faceted MOAs can induce an anti-tumor response from within the tumor bed. Once inside the tumor cell, the virus begins replication and increases stress ligands on the tumor cell surface to elevate the tumor visibility to the immune system.
Use of Proceeds
If the offering's maximum amount of $1,069,998 is raised:
|Use||Value||% of Proceeds|
|Compensation for BioEclipse Employees||$166,000||15.5%|
|Contract Research Organizations||$317,000||29.6%|
|Direct Costs Associated With Patient Infusion||$346,020||32.3%|
This is an offering of Class B Common Stock, under registration exemption 4(a)(6), in BioEclipse Therapeutics, Inc.. This offering must raise at least $10,000 by April 19, 2022 at 10:59pm ET. If this offering doesn’t reach its target, then your money will be refunded. BioEclipse Therapeutics may issue additional securities to raise up to $1,069,998, the offering’s maximum.
If the offering is successful at raising the maximum amount, then the company’s implied valuation after the offering (sometimes called its post-money valuation) will be:
These financial statements have been reviewed by an independent Certified Public Accountant.
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemption 4(a)(6) of the Securities Act of 1933.
We’re also required to share links to each of the SEC filings related to this offering with investors.
Understand the Risks
Be sure to understand the risks of this type of investment. No regulatory body (not the SEC, not any state regulator) has passed upon the merits of or given its approval to the securities, the terms of the offering, or the accuracy or completeness of any offering materials or information posted herein. That’s typical for Regulation CF offerings like this one.
Neither Netcapital nor any of its directors, officers, employees, representatives, affiliates, or agents shall have any liability whatsoever arising from any error or incompleteness of fact or opinion in, or lack of care in the preparation or publication of, the materials and communication herein or the terms or valuation of any securities offering.
The information contained herein includes forward-looking statements. These statements relate to future events or to future financial performance, and involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
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