02 Apr Experimental Drugs offer hope for Breast Cancer Patients
Breast cancer is the most common form of cancer in women with an estimated one in eight women and one in 1,000 men being diagnosed with breast cancer during their lifetime. According to data made available by centers for disease control and prevention (CDC) over 237,000 cases of breast cancer are diagnosed in women and about 2,100 in men in the U.S alone. Approximately 41,000 women and 450 men in the U.S. succumb to this malady every year.
The breast cancer therapeutics industry is likely to reach US$16.21 billion by 2023 growing at a CAGR of 8.4% from 2015 to 2023 according to a report by Transparency Market Research. Lifestyle changes such as rise in age of childbearing, high intake of oral contraceptive pills, reduced breast-feeding, and undergoing estrogen modifying drug treatments are leading to increased incidences of breast cancer according to the report. The increasing spending on mergers and acquisition, strategic collaborations and the rise in research and development efforts to stay ahead of competitors will drive the growth in the market. Onslaught of generics could hamper the market from reaching its full growth potential though
The treatment plan for breast cancer consists of surgery such as mammaplasty, mastectomy, lumpectomy, radiation therapy, chemotherapy and oral medications. These come with their own set of limitations and side-effects. However, new advancements in technology are helping companies to develop novel therapeutics that with targeted delivery, improved efficacy, reduced side-effects and more positive patient outcomes. We take a look at companies that are developing potential treatment alternatives to conventional medications.
Athenex (NASDAQ: ATNX)
Market Cap: $821.04M; Current Share Price: 12.25 USD
Athenex is a biopharmaceutical company whose orascovery platform facilitates the administration of high potency oncology drugs in its continued efforts to develop and commercialize novel oncology-focused therapeutics. In addition, its SRC Kinase Inhibitiors are an improvement over Src inhibitors alone as they can bind to a novel site on tubulin heterodimers thereby broadening their anti-tumor activity. The company leverages it’s in depth understanding of human absorption biology and kinase inhibition to create drugs that can improve patient adherence and creation of therapies that can be used in combination with other immunotherapies hitherto considered unviable.
The company has received an Investigational New Drug (IND) Application, in October 2018 for an oral formulation of eribulin named Eribulin ORA, an anti-cancer agent indicated for the treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease, and to treat patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Its Oraxol Phase III clinical trial in metastatic breast cancer has been fully enrolled.
The company has a cGMP high potency API manufacturing unit for internal research as well as for sale to pharmaceutical entities worldwide. It has numerous subsidiaries such as Athenex Pharma Solutions, Polymed Therapeutics and CDE that support its operations in the U.S and china markets.
The company has made a strong network of strategic collaborations with companies such as Hanmi Pharmaceutical Co. Ltd. (KRX: 128940) from whom they have licensed their Orascovery technology, a licensing agreement with Xiangxue Pharmaceuticals Co. Ltd. (SHE: 300147) granting them exclusive rights to KX02 for all oncology indications, a licensing agreement with PharmaEssentia for rights to dual Src/pretubulin inhibitor KX01 ointment for treatment of certain dermatological conditions, and a collaboration with Eli Lilly (NYSE: LLY) and company for a Phase Ib study of Athenex’s Oraxol in combination with Eli Lilly and Company’s CYRAMZA® (ramucirumab), a vascular endothelial growth factor (VEGF) Receptor 2 antagonist, in patients with advanced gastric (stomach) and esophageal cancer.
In addition, it has research collaborations with Hong Kong Polytechnic University and McGill University for their patents and know-how on the development of a series of BCRP inhibitor and the Joint Development of Oral Topotecan to name a few.
As per its 2018 year-end financial results, the company had cash, cash equivalents and short-term investments amounting to $107.4 million as on December 31, 2018 as compared to $51.0 million as on December 31, 2017.
Atossa Genetics (NASDAQ: ATOS)
Market Cap: $19.88M; Current Share Price: 3.52 USD
The company is exclusively focused on the development of comprehensive breast cancer solutions starting from prevention to cure. It is developing an oral formulation of “Endoxifen”, a key tamoxifen metabolite that has shown to reduce the chances of future recurrence, along with a topical lotion that can reduce breast density. In addition, the company is developing a CAR-T delivery through microcatherers using the drug Fulvestrant to directly target diseased tissue. The company is currently enrolling patients for a Phase- 2 clinical study of its patented microcatheter technology.
Its “Endoxifen” offers an improvement over tamoxifen by directly delivering metabolite endoxifen to the body bypassing the need for metabolism by the liver. It also achieves a faster “steady-state” as compared to oral tamoxifen that can take up to 120 days. It is developing both oral and topical presentations of the drug. Additionally the company has also received a FDA approval permitting the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in pre-menopausal, estrogen-receptor positive (ER+) breast cancer patients.
Its topical application of Endoxifen has shown to reduce mammographic breast density (MBD) and prevent/reduce gynecomastia in prostate cancer patients starting androgen deprivation therapy.
The company received about $11.3 million from exercise of previously outstanding warrants in March 2019. As of December 31, 2018, the company had cash, cash equivalents and restricted cash of $10.5 million.
Clovis Oncology (NASDAQ: CLVS)
Market Cap: $1.31B; Current Share Price: 24.82 USD
Clovis is a commercial stage biotechnology company engaged in developing and commercializing oncology treatments worldwide. It develops diagnostic tools through its partners that can identify patients who will benefit most from its developmental programs that focus on targeting specific subsets of cancer. Its strategic collaborations allow it to choose the most appropriate technology for each indication along with its expertise in gaining regulatory approvals for its global commercialization paths.
Clovis is enrolling patients for a Genetech sponsored study of a combination of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in participants with Advanced Gynecologic Cancers and Triple-Negative Breast Cancer. The company has also entered into a clinical collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY) in July 2017, to evaluate the combination of Bristol-Myers Squibb’s immunotherapy nivolumab and Clovis Oncology’s rucaparib for treatment of treatment of prostate cancer.
It manufactures Rubraca (rucaparib), an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 for the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancers whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy. The company is conducting multiple clinical trials to study the efficacy of Rucaprib in the treatment of BRCA wild-type/LOH high Ovarian Cancer,Prostate Cancer and Bladder Cancer.
Its pipeline consists of Lucitanib, an investigational, oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3) indicated for treatment of ovarian cancer.
As per the companies 2018 operating results, (rucaparib) U.S. sales totaled $95.4 million. As of 31 December 2018, the company had $520.1 million in cash and cash equivalents.
GTx (NASDAQ: GTXI)
Market Cap: $28.86M; Current Share Price: 1.20 USD
It develops novel therapeutics based on hormone receptor targeting such as selective androgen receptor modulators (SARMs) and selective androgen receptor degraders (SARDs) for an array of disorders such as breast cancer, prostate cancer and stress urinary incontinence (SUI). The company believes that its small molecule technology has the ability to act as agonists, or antagonists based on tissue types. Since the pelvic floor and urinary sphincter are androgen receptor (AR) rich the company hopes to target these areas first using its novel modulators.
The company is conducting Phase 2 clinical trials for evaluating Enobosarm as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer and a Selective Androgen Receptor Degrader (SARD) technology for men with castration-resistant prostate cancer (CRPC).
In the pipeline is a candidate for SUI named G201002, an orally-administered enobosarm ((GTx-024, Ostarine®), 3 mg or 1 mg) for use in post-menopausal women with SUI. Enobosarm has shown to increase pelvic floor muscle mass thereby helping treat incontinence.
The company recently entered into a merger agreement with Oncternal Therapeutics, Inc., a clinical stage biotechnology company targeting cancer. The merged entities will be known as Oncternal Therapeutics, Inc. It aims to benefit from the Selective Androgen Receptor Degrader (SARD) program by leveraging it for developing its lead program cirmtuzumab, a novel first-in-class anti-ROR1 monoclonal antibody.
As per the companies Q3, 2018 financial results, cash and short-term investments were $38.1 million as of September 2018 as compared to $43.9 million as at December 31, 2017.
Immunomedics (NASDAQ: IMMU)
Market Cap: $3.67B; Current Share Price: 19.21 USD
Immunomedics develops advanced anti-body based immunotherapeutics for treatment of cancer and autoimmune diseases. It aims to become the leader in developing antibody drug conjugate (ADC) therapies for the global market. Its areas of expertise include antibody engineering using its proprietary CDR-grafting methods, antibody production and formulation, immunochemistry, molecular biology, antibody conjugation, peptide chemistry, synthetic organic chemistry, and protein engineering.
Each of its antibodies has the potential to be administered on their own or in combination with hemotherapeutics, therapeutic radioisotopes and cytokines to create targeted treatment options that can reduce damage to peripheral tissue on account of exposure. Its lead candidate for treatment of breast cancer is IMMU-132 (sacituzumab govitecan (anti-trop-2-SN-38 ADC)) for patients with metastatic triple-negative breast cancer (mTNBC). The company is preparing a response to the issues raised by the FDA in its Complete Response Letter (CRL) and intends to file a Biologics License Application (BLA) resubmission at the earliest.
The company’s pipeline of drugs consists of labetuzumab govitecan (IMMU-130) for the treatment of metastatic colorectal cancer, which is in Phase 2 trials currently and IMMU-140 (anti-HLA-DR-SN-38 ADC) for treatment of solid and liquid cancers. In addition, it is developing Epratuzumab (anti-CD22) for pediatric acute lymphoblastic leukaemia, veltuzumab (anti-CD20) for cancer and auto-immune diseases to name a few. It has an extensive portfolio in the areas of multivalent bispecific antibodies, F-18 labeling, DOCK-AND-LOCK™, antibody-drug conjugates, antibody-drug conjugate linker, and T-cell redirecting antibodies.
Its research efforts use a multi-pronged approach in areas such as ADC, Dock and Lock method or DNL that it is developing in collaboration with IBC Pharmaceuticals, Inc., Epratuzumab, an antibody which targets CD22, an antigen found on the surface of B-lymphocytes critical to the body’s immune function to name a few. It has collaboration with Algeta ASA, for the development of epratuzumab conjugated with Algeta’s proprietary thorium-227 alpha-pharmaceutical payload.
As of December 31, 2018, the company had $497.8 million in cash, cash equivalents, and marketable securities as per its 2018 year-end financial results.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.