RAADYSAN BIOTECH, INC: Drug Development for Triple Negative Breast Cancer

by RAKHEE GUPTE

We are developing the first targeted therapy for the treatment of Triple Negative Breast Cancer which will also treat all types of breast cancers as well as other gynecological cancers.
FISHKILL, NY United States Breast Cancer Drug Development Biotech Equity Raise MedStartr Ventures challenge

All Team Company Patients Physicians Hospital Partners Mission Innovation Details Investor Info Due Diligence Docs Supporters Comments Updates

About our project

The problem we solve: There are currently no targeted therapies available for the treatment of Triple-Negative Breast Cancer. It is the most aggressive type of breast cancer with high incidence and poor survival rates. Since cells of this type of breast cancer do not express hormonal receptors, they are resistant to currently available receptor-based therapies. This has created an unmet need for the identification of molecular targets that are non-receptor based and that are directly involved in cell proliferation.

About our solution: Our anti-cancer therapeutics will be the first targeted therapy for Triple Negative Breast Cancer, which will selectively target only the cancer cells, leaving the normal cells intact. It will be hormone and growth receptor independent and directly target DNA replication/cell proliferation machinery, leaving no room for a roundabout. It will not directly damage the DNA, thus minimizing cell toxicity and improving patient survival rates.

Progress to date:

(A) Novel Molecular target: Identified and validated

(B) RNAi Therapies:

  • Developed
  • In vivo validation done
  • In discussion with RNAi companies for commercialization

(C) Small Molecule Entities (SMEs):

  • Proof-of-concept validated
  • Custom SMEs have been designed
  • In-vitro testing in progress for second-generation drug candidates

(D) Intellectual Property: Three U.S. patents issued and one PCT pending

 

About Our Team

Creator: RAKHEE GUPTE

Location: New York

Bio: Dr. Gupte has over 20 years of academic and pharmaceutical experience in oncology and cardiology. She received her Master’s in Microbiology & Immunology from Bombay, India. She was employed as a Senior Scientific Officer in Neo-Pharma, Bombay, India, for 3 years, and has industrial expertise in quality assurance/control, product management, training medical representatives and liaison with medical fraternity. She received her Ph.D. in Biochemistry & Molecular Biology from the New York Medical College (NYMC), Valhalla, NY, and also did her post-doctoral fellowship and became Research Associate in the department of Physiology, NYMC. She was appointed as Assistant Professor at University of South Alabama, Mobile, AL. Currently, she is appointed as a Visiting Scientist in the Department of Pharmacology, NYMC, Valhalla, NY.

Title: Drug Development for Triple Negative Breast Cancer

Advanced Degree(s): MS, PHD

About Team Members

RODERIKE POHL
VICE PRESIDENT - RESEARCH, PHD
Biography: Dr. Pohl received her Ph.D. in Pharmaceutics from the University of Connecticut, Storrs, CT, and has over 18 years of pharmaceutical experience in the fields of pharmaceutics, bio-pharmaceutics and preclinical research. Dr. Pohl was a co-founder and the Vice President of Research at Biodel Inc. She previously worked for Mannkind Corp. as Vice President of Preclinical Research, and for Pharmaceutical Discovery Corp. as Director of Biopharmaceutics and Preclinical Research.
Title: VICE PRESIDENT - RESEARCH
Advanced Degree(s): PHD
LinkedIn: https://www.linkedin.com/in/roderike-pohl-7b384921/

STEVEN TAYLOR
GROUP LEADER - DRUG DISCOVERY, BSc, PHD
Biography: Dr. Taylor has 15 years of experience in drug discovery and development. He received his Bachelor’s degree and PhD in Chemistry from the University of Sheffield, UK. Dr. Taylor served as the Group Leader at Evotec; and as VP Chemistry in Midatech Pharma. He has expertise in all aspects of medicinal chemistry including structure based drug design, high-throughput screening (HTS), fast follower approaches, GMP manufacturing, quality, formulation, analytical chemistry and regulatory development. Dr Taylor has authored/co-authored 15 patent applications and 9 publications.
Title: GROUP LEADER - DRUG DISCOVERY
Advanced Degree(s): BSc, PHD
LinkedIn: https://www.linkedin.com/in/steve-taylor-9912799/

VIJAY BHISE
VICE PRESIDENT - BUSINESS DEVELOPMENT, BE, Eng. Sc. D
Biography: Dr. Bhise received his B. Tech (Chemical Eng.) from I.I.T, Delhi, India, and Eng. Sc. D, (Chemical Eng.) from Columbia University, New York. He has over 35 years of industry experience in technology and business development and holds eight U.S. patents. Dr. Bhise was the Vice President at Scientific Design Company, where he made key contributions in research and development, sales and business development.
Title: VICE PRESIDENT - BUSINESS DEVELOPMENT
Advanced Degree(s): BE, Eng. Sc. D
LinkedIn: https://www.linkedin.com/in/vijay-bhise-ba180720/

PAUL MIEYAL
STRATEGIC ADVISOR, PHD, CFA
Biography: Dr. Mieyal received his Ph.D. in pharmacology from New York Medical College, a B.A. in chemistry and psychology from Case Western Reserve University, and is a Chartered Financial Analyst. He is a Vice President and the Director of Life Sciences Investments of Wexford Capital and has over 15 years of experience investing in healthcare. He serves as a director of Nephros (NEPH), and several private companies, including Optiscan Biomedical, ElMindA Ltd., and Microbiogen.
Title: STRATEGIC ADVISOR
Advanced Degree(s): PHD, CFA
LinkedIn: https://www.linkedin.com/in/paul-mieyal-ph-d-cfa-9a0a2754/

About Our Company

RAADYSAN BIOTECH, INC

Location: 9 HAWTHORN COURT
FISHKILL, NY 12524

Founded: 2012

Website: http://raadysanbiotech.com

Product Stage: Prototype/MVP

YTD Sales: Working on it

Employees: 3-5

How We Help Patients

We would like to reach out to all the patients that are suffering from Triple Negative Breast Cancer and their family and friends. Although our drug discovery is at its early stage of development, our drug will be the first targeted therapy for Triple Negative Breast Cancer. We envisage that our drug will be successful not only in combating the disease but also minimizing or eliminating the need for Chemotherapy and/or radiation altogether. We sincerely urge family members to give traction to our drug development so that it reaches the patients sooner rather than later.

How We Help Physicians

Problem: As physicians you are already aware that, early diagnosis and treatment of breast cancer could play a monumental role in reducing deaths. Most of the drugs available for the treatment of breast cancers target either the endocrine (estrogen; ER) or growth factor (ErbB-1, ErbB-2 [human epidermal growth factor receptor 2; HER2], ErbB-3 and ErbB-4) receptors for therapy. However, emerging resistance to endocrine and HER2 receptors targeted therapies has created a dire need for identification of molecular targets that are non-receptor based, specifically for Triple Negative Breast Cancer which is devoid of all these receptors.

Unmet Market Demand: Dr. James Watson, co-discoverer of the DNA double helix in 1953, told Reuters in January 2013 that almost none of the existing treatments available for cancer cures cancer, because the cancer cells find a work-around for existing drug therapies. If one biochemical pathway for growth is blocked, says cancer biologist Robert Weinberg of MIT, the cancer cells activate a different, equally effective pathway. That is why Watson advocates a different approach: targeting features that all cancer cells, especially those in metastatic cancers, have in common and which are directly involved in proliferation of the cancer cells.

Our Solution: Our anti-cancer drug entities will offer the following benefits over the currently existing anti-cancer therapies, specifically for Triple Negative Breast Cancer treatment:

  • It is endocrine and growth receptor independent.
  • Directly targets DNA replication/cell proliferation machinery in all kinds of cancer cells, leaving no room for circumvention.
  • Does not directly damage the DNA, as observed with other conventional anti-cancer drugs, thus minimizing cell toxicity and improving patient survival rates.
  • Functions as a universal MT for global anti-cancer therapy.
  • Selectively targets only cancer cells

 

 

How We Help Hospitals

Although we are a pre-clinical company, we would like to keep our options open to proceed to the stage of IND filing and Phase I clinical trials. We would want the hospitals and cancer centers to be aware of our drug development efforts, to tap a future possibility to conduct Phase I clinical trials in their institute.

How We Help Partners

Investor: Our Company is developing revolutionary therapies for breast cancer and we believe that our drug entities will be able to capture the global anti-cancer drug therapy markets and fetch revenues of $10-15 billion in sales annually. On a conservative basis, preliminary estimate of the revenues that will be generated through licensing or sale of the technology for the development of pharmaceutical products would be $500 million to $1 billion, depending upon the stage at which the technology will be acquired by the pharmaceutical company.

 

Challenge Mission

Key Milestones Achieved and Planned

By 2020, we are confident that we will be able to license or sell our anti-breast cancer therapeutics to larger pharmaceutical companies. We plan to expand and accelerate our R&D capabilities by employing skilled scientists to engage in testing and validation of our small molecule drug candidates for other gynecological cancers such as ovarian, cervical and uterine.

Our Competitive Advantages

For drug development companies in the oncology space, partnership transactions and acquisitions are common at early stages.  Small companies, such as ours, typically license their drug(s) to larger pharmaceutical partners in exchange for a large upfront payment, additional milestone payments and royalties which are contingent upon the continued successful development of the licensed drug.  We intend to pursue this strategy to monetize our intellectual property and drug assets.

Barriers to Entry

The major players in the targeted cancer therapies market today include:  (i) RNAi/miRNA therapeutic companies such asIonis Pharmaceuticals, Alnylam Pharmaceuticals, Regulus Therapeutics, et al; and (ii) Traditional pharmaceutical companies such as Pfizer, Novartis, Roche/Genentech, Merck, Bristol-Myers Squibb et al. We believe that the market opportunities are significant and offer excellent chances for success. We are confident that we will be able to secure business relationships with key players due to the uniqueness of our novel anti-cancer molecular target and drug entities and innovative approach for developing targeted therapies.

Traction, Funding and Partners

We have had preliminary discussions with two potential pharmaceutical partners.  They have each expressed an interest in pursuing deeper discussions once we have generated additional data for our products (which is the intended use of this fundraising).  We continue to explore potential opportunities with additional potential partners and licensees on an ongoing basis.

Innovation Details

Intellectual Property Summary

A. US

  • Therapeutics - 2 issued

Patent No. US 9,193,970 & Patent No. US 9,546,366

  • Diagnostics (To be issued in December 2017)

Application# 15/405,632

B. PCT

  1. Pending PCT Patent (Therapeutics)

Application# PCT/US 15/62118

  • Pending PCT Patent (Diagnostics)

Application# PCT/US 15/62118

We have obtained three US patents for our technology and a PCT patent is pending. The international search report (for PCT) has deemed our technology as novel, inventive, with industrial applicability.

Clinical Information

NOT APPLICABLE

Regulatory Status

Our project is characterized as “pre-clinical” which means that we have, so far, identified our novel cancer target and validated our approach in cancer cells as well as in animals, but not yet in human clinical trials. We have identified two means to inhibit our novel anti-cancer target: one which we are seeking to partner with a larger company and one which we are developing ourselves.

How we will use the funds raised

Funding will be utilized for:

  1. R & D expenses - Optimization of our lead Small Molecule Entities (SMEs) for Triple Negative breast Cancer and additional validation studies
  2. G & A expenses - US and International IP protection; personnel hiring.

 

Thank You

Battling breast cancer is a long and painful journey. Although, there has been encouraging progress made for the treatment of some types of breast cancer, there is no targeted therapy for Triple Negative Breast Cancer. We have identified a new way to treat this type of breast cancer. We need your help to fund our R & D efforts, at this early stage, to fast track our drug development process so that it will available to the patients sooner rather than later.

We firmly believe in the phrase that, “The hand that rocks the cradle, rules the world”. That hand may belong to a man or a woman, as breast cancer affects them both. Our mission is to see that this hand is there to rock their baby’s cradle, hold their hand when they take their first step, clap for their graduation, give away the bride and once again rock their grandchild’s cradle. We sincerely hope that you all will help us fulfill our mission.

Investor Info

Market Size

Prevalence rates for breast cancer in seven major markets (France, Germany, Italy, Spain, UK, US and Japan) grew to just over 2.14 million in 2016. The global anti-breast-cancer therapeutics market is projected to be approximately $13.38 billion in 2018 and $18.2 billion in 2023.Globally, the anti-cancer therapeutics market is approximately $100 billion and is estimated to reach $147 billion in 2018.

Source: IMS Health (12/2014); IMs Health Market Prognosis (3/2015)

Projected 3 Year Growth

By 2020, we are confident that we will be able to license or sell our anti-breast cancer therapeutics to larger pharmaceutical companies. We plan to expand and accelerate our R&D capabilities by employing skilled scientists to engage in testing and validation of our small molecule drug candidates for other gynecological cancers such as ovarian, cervical and uterine.

Revenue Model

For drug development companies in the oncology space, partnership transactions and acquisitions are common at early stages.  Small companies, such as ours, typically license their drug(s) to larger pharmaceutical partners in exchange for a large upfront payment, additional milestone payments and royalties which are contingent upon the continued successful development of the licensed drug.  We intend to pursue this strategy to monetize our intellectual property and drug assets.

Competitors

The major players in the targeted cancer therapies market today include:  (i) RNAi/miRNA therapeutic companies such asIonis Pharmaceuticals, Alnylam Pharmaceuticals, Regulus Therapeutics, et al; and (ii) Traditional pharmaceutical companies such as Pfizer, Novartis, Roche/Genentech, Merck, Bristol-Myers Squibb et al. We believe that the market opportunities are significant and offer excellent chances for success. We are confident that we will be able to secure business relationships with key players due to the uniqueness of our novel anti-cancer molecular target and drug entities and innovative approach for developing targeted therapies.

Traction

We have had preliminary discussions with two potential pharmaceutical partners.  They have each expressed an interest in pursuing deeper discussions once we have generated additional data for our products (which is the intended use of this fundraising).  We continue to explore potential opportunities with additional potential partners and licensees on an ongoing basis.

Due Diligence Docs

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RAKHEE GUPTE
Drug Development for Triple Negative Breast Cancer

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