We are ready to enter clinical trials with our proprietary drug-eluting implant which will prevent post-surgical lung cancer recurrence without toxicity
Cook Biomedical is a codevelopment and supply partner. Preclinical large animal testing awaits Series B and GMP product is will be ready for clinical testing Q3 2020. Large medical device companies have expressed significant interest in adopting our solution into their thoracic oncology franchises.
>$2-3B market opportunity for ABC103 alone. The majority of early-stage NSCLC patients (68%) undergo surgery, including 16% who also receive fuitile chemotherapy and/or radiation therapy. ABC103 is non toxic and can be used in all lung cancer surgeries. Therefore, thoracic surgical oncology market size is about $1.1B worldwide Breast cancer lumpectomy is $1B worldwide Abdominal oncology $1B Primary malignant brain tumor $130M
Additional applications for ABC drug delivery technology have been tested and can be developed into clinical projects rapidly.
Problem or Opportunity
2 million new cases of lung cancer per year worldwide with 5-year survival of 15-18%. About 250,000 of these are early stage patients who undergo surgery. Even with the best available care, their 5-year survival is a dismal 14-49%. Post-surgical recurrence of 40-70% is the cause for treatment failure. Failure is as a result of untreated, or under treated residual tumor burden left behind after surgery. Systemic IV chemotherapy and radiation therapy have proven ineffective in treating this residual disease due to: 1) poor tumor targeting (<1% of IV chemotherapy is delivered to the tumor), 2) short duration of therapeutic concentration (<20 hours), and 3) dose-limiting toxicity (limiting treatment to administration of 1-3 weeks between chemo allows for the development of resistance).
Solution (product or service)
"ABC103" is our proprietary drug-eluting surgical staple line buttress administered at the time of surgery. Many follow-on drug-delivery applications possible including using ABC103 non-toxic adjuvant coadministered with immunoncology drugs.
ABC103 is comprised of an approved drug (Taxol-paclitaxel), biocompatible/biodegradable polymers coated onto currently approved staple line buttress. ABC103 has been engineered to overcome all three drawbacks of current therapy i.e. targeting to tumor, sustained duration of therapeutic administration of paclitaxel treatment for >100 days with NO evidence of toxicity. ABC103 has been designed to enable surgeons to use the same procedures, devices and drugs they currently. Surgeons have expressed strong interest in adopting ABC103 to enable them to safely prevent post-surgical lung cancer recurrence.
ABC103 has been designated by FDA as an "Orphan Drug and reviewed under 505(b)(2)" which allows for rapid and cost effective path to approval with US approval driving WW approvals. FDA has indicated, at pre-IND, that only a single Phase I/II and single Phase III are required to approval. Orphan Drug designation confirmed by FDA brings 7 years of market exclusivity, confers market dominance and sustains premium pricing on top of assured profitable DRG fee share, clinical data drives rapid approvals, opinion leader advocacy drives adoption. Please refer to our website www.acuitybio.com which has a useful 60" explainer video
Existing standard of care surgery and chemoradiotherapy which is ineffective.
Advantages or differentiators
Orphan Drug Designation in hand with rapid path to clinical approval established. Experienced management, Advisors, Clinical sites selected, CMO/CDMO's in place
Fits directly into standard of care procedures and medical devices Validated $5,000 surgical treatment reimbursement under existing DRG as a fee share with hospital/ACO. Reimbursement equal to one round of systemic chemotherapy/ brachytherapy. ABC103 is jointly a high value for medicine and high margin product. Anticipated gross margins >$4000 per patient direct to AcuityBio with DRG reimbursement alone. Drug pricing "upcharge" can be achieved through CMS "278" code and will be supported by Orphan Drug/ Breakthrough Product designation.
AcuityBio will be an M&A target, or partner with Cook Biomedical/Cook Medical as the channel for sales and marketing of ABC103. AcuityBio will either be acquired by a large medical device manufacturer like Jn, or Medtronic. After acquisition, ABC103 would be adopted into their lung cancer franchise and marketed as part of their product offerings using their established channel. Alternatively, AcuityBio can partner with Cook Biomedical and Cook Medical for sales, marketing and distribution of ABC103 worldwide. Major medical device companies and Cook have expressed interest in these models.
Money will be spent on
Completion of preclinical testing, GMP manufacture and Phase I/II clinical trial
Offer for investor
If less than $1M we are offering investors a SAFE with 20% discount Series B. If greater than $1M, then terms for Series B to be negotiated