HERIndustries: Breast Cancer Therapeutic Development and Business Case

This project outlines HERIndustries' proposal for developing a breast cancer therapeutic, focusing on HER2-targeted antibody-drug conjugates. The company identifies breast cancer as a significant market opportunity, highlighting its prevalence and the current lack of a cure. The project details the business case for manufacturing the therapeutic, emphasizing the use of antibody-drug conjugates to target HER2-positive cancer cells, particularly in adjuvant treatment settings. The companion diagnostic choice is the HER2 gene, chosen for its proven ability to identify patients who would benefit from the therapy. The project also discusses the methodology, including the use of FDA-approved drugs, the consideration of side effects, and the results of the KATHERINE study. The company aims to reduce the mortality rate of breast cancer through the use of therapeutics, considering the market size and the potential for growth. The paper also references several research articles, including those discussing the use of antibody-drug conjugates and the KADCYLA therapy, to support its claims and methodology.

Here's some articles and websites on the paper we are going to write.
I'm going to start writing on the next page, you should read the materials and add where you feel
necessary.
https://www.biospace.com/article/releases/fda-approves-genentech-s-kadcyla-for-adjuvant-
treatment-of-people-with-her2-positive-early-breast-cancer-with-residual-invasive-disease-after-
neoadjuvant-treatment/
https://www.gene.com/media/news-features/fda-approves-new-treatment-option-for-adjuvant-
treatment-of-specific-type-of-early-breast-cancer
https://watermark.silverchair.com/mdz291.pdf?
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https://www.clinical-breast-cancer.com/article/S1526-8209(19)30653-6/fulltext

HERIndustries Proposal
The cancer that our company has been tirelessly fighting through the years is breast
cancer. Breast cancer is the most deadly cancer among women across the world, and despite the
number of women affected by this cancer, there is sadly no cure yet. However, at HERIndustries,
we are developing and implementing successful therapeutics that will make the fight against
breast cancer easier. That being said, we hope you will place your recovery in the hands of our
skilled researchers and scientists, and together we can make strides toward a cure for breast
cancer.
You may be wondering, what methodology does this company plan to use to eradicate
breast cancer? Through research, we have concluded that when you target the HER-2 gene
directly, the results that follow are very promising. We have been employing the use of antibody-
drug conjugates to target cancerous cells that are positive for HER-2. Due to the reactivity of
these drugs, and the fact that cancer cells may still remain in the body after tumor-removal
surgery, this class of drug is recommended to be taken after surgery. Most commonly, these
antibody-drug conjugates are used with one or two other drugs to achieve the best results, since
the cancer cells being targeted are already in metastasis, meaning they are much harder to
eliminate from the body since they have spread to secondary location. That is why using the
HER2 genes as a marker for where the drug should target works much better than other therapies
that we have experimented with. Along with this, this type of therapeutic regime has been
approved by the FDA, which further aids in our fight against breast cancer.After doing proper
researches, we came to the conclusion that this company can produce new products to reduce
breast cancer. When the HER- 2 gene are targeted directly, the results can be promising. The
cancer cells may remain within the human body after even the completion of the surgery

(Diamantis&Banerji, 2016). The HER2 targeted drugs are very reactive and it attack those
residual cancer cells. These drugs are generally provided along with other antibiotics. The
objective of treating the breast cancer at the early stages is to decrease the rate of the cancer to
come back. It has been experimentally proved that adjuvant treatments with Pejeta, Herceptin
and chemotherapy has reduced the risk of recurrence of breast cancer or death in comparison to
the Herceptin and chemotherapy alone. The FDA has also been able to do the conversion of the
perjeta based regimen which was already previously approved to full approval treatment through
surgery. The treatments are done to locally advanced cancers, inflammatory cells and the breast
cancer at the early stages (Fortune Business Insights, 2019). The side effects of the drugs are also
considered at the time of preparing the drugs. These are the reasons because of which HER2
genes are used as marker for making the drugs to work better than all other therapies.Our
company has considered the side effects of Perjeta when added along with Herceptin and
docetaxel. The most common side effects of using the combination of this are loss of hair,
diarrhea, decrease in the level of white blood cells, chances of vomiting and feeling tired. The
other side effects includes constipation, mouth blisters.
Antibody-drug conjugates (ADC) operate on the principle of a combined treatment.
These ADC’s target a gene specifically and are paired with a chemotherapeutic drug to eliminate
the cancer presenting cells [1]. This allows for a highly selective and highly cytotoxic treatment
plan all in one prescription, and with further research and implementation of these ADCs,
targeting the tumor stem cells and killing them before they can amount to a full tumor is a
possibility [1]. The specific antibody used in our company’s therapeutic is known as
trastuzumab. ADCs operate in conjugation with a chemotherapy linker, and the linker in our

therapeutic is DM1 [2]. This combination of drugs is the only FDA approved ADC that
successfully targets HER-2 positive cells [1][2]. Because of the therapeutic effects present in this
therapeutic some healthy cells may still be damaged, however, the target for HER-2 positive
cells greatly reduces the number of healthy cells that become affected by this drug. Due to the
research backed on the expression of HER-2 genes present in breast cancer, the HER-2 gene is
our companion diagnostic when deciding if our therapeutic is the correct choice for our patients.
Antibody-drug conjugates work on the principle of a combined treatment. The drugs treat the
cancer cells by combining with the chemotherapeutic agents. The incorporation of the HER2
blockade on the neoadjuvant therapy had shown to induce an increased rate of pathologic
complete response. Kadcyla was made available to the patients having residual invasive disease
after the adjuvant therapy was over and this proved to be very effective. The side effects of the
disease was also considered. The most important aspects of consideration were that kadcyla can
sometimes cause extreme liver problems including vomiting, eating disorders, jaundice and dark
urine (Genetech, 2019). The other side effects of using kadcyla is decrease in the platelet count
and increase in blood pressure. The other side effects includes pain in muscles, bleeding
decreased count of platelets, headaches and pain in the hand and feet. Our company takes into
consideration the results of the Katherine study. KATHERINE is an international, multi-center,
two-arm, randomized, open-label, Phase III study which evaluates the capability and safety of
Kadcyla versus Herceptin as an adjuvant therapy among the people with HER2-positive EBC
who are suffering from pathological invasive residual disease in the breast and the axillary lymph
nodes. This is followed by neo-adjuvant therapy which included Herceptin and taxane-based
chemotherapy. The principal endpoint of this study is iDFS, which can be defined as the time
from randomization free from the recurrence of the invasive breast cancer or from deaths from

any disease. Minor endpoints include iDFS consisting the second primary non-breast cancer,
disease-free survival and overall survival.
The market for therapeutics to treat breast cancer is large. The global market for breast
cancer therapeutics was at a staggering $17.8 million in 2018, and is expected to exceed double
that amount in the next 5 years [3]. Breast cancer has not been cured yet, however with the help
of different therapeutics, including ours, we hope to decrease the mortality rate of this aggressive
disease worldwide.
References
[1] Diamantis, N., &Banerji, U. (2016). Antibody-drug conjugates--an emerging class of cancer
treatment. British journal of cancer, 114(4), 362–367. doi:10.1038/bjc.2015.435
[2] Genetech. (2019). FDA Approves Genentech’s Kadcyla for Adjuvant Treatment of People
with HER2-Positive Early Breast Cancer with Residual Invasive Disease After
Neoadjuvant Treatment. Biospace. Retrieved from
https://www.biospace.com/article/releases/fda-approves-genentech-s-kadcyla-for-
adjuvant-treatment-of-people-with-her2-positive-early-breast-cancer-with-residual-
invasive-disease-after-neoadjuvant-treatment/
[3] Fortune Business Insights. (2019). Breast Cancer Therapeutics Market to Exhibit 10.2%
CAGR, Increasing R&D Investment to Boost Growth, says Fortune Business Insights.
Global News Wire. Retrieved from
https://www.globenewswire.com/news-release/2019/07/08/1879322/0/en/Breast-Cancer-
Therapeutics-Market-to-Exhibit-10-2-CAGR-Increasing-R-D-Investment-to-Boost-
Growth-says-Fortune-Business-Insights.html