HERE’S WHY YOU SHOULD KEENLY WATCH GREENWICH LIFESCIENCES
14 JUL HERE’S WHY YOU SHOULD KEENLY WATCH GREENWICH LIFESCIENCES
Greenwich LifeSciences, Inc. (NASDAQ: GLSI), a clinical-stage pharmaceutical company, developing immunotherapy to prevent breast cancer recurrence in patients who previously underwent surgery, announced the removal of the clinical hold on the Phase III Flamingo-01 clinical trial by the U.S Food and Drug Administration (FDA).
The FDA had placed a clinical hold on Phase III Flamingo-01 Phase III clinical trial, citing manufacturing and pharmacy process issues. The Company was engaged in discussion with the FDA and submitted additional data from the testing of GP2 in the pharmacy process, thereby addressing concerns raised by the FDA. Greenwich will also undertake further testing of GP2 in the pharmacy process.
The Company has promptly begun site initiation visits and will provide further updates in the future as per a statement. Greenwich has completed negotiations of clinical trial contracts and budgets for three large hospital sites and the largest oncology network in the US and is now working on on-site initiation visits and site activation.
Market Cap: $156.27M; Current Share Price: $12.02
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The Company’s lead candidate is GP2, a novel peptide immunotherapy that is derived from the HER2/neu protein that is expressed in a variety of cancers. A highly elevated HER2/neu protein expression results in an increased chance of recurrence and a worse prognosis. GP2 immunotherapy enables a patient’s T cells to recognize and destroy HER2/neu-expressing cancer cells up on reoccurrence. GP2 is synergistic with Herceptin, a Genentech/Roche (OTC: RHHBY) monoclonal antibody treatment given in the first year after breast cancer surgery.
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GP2 peptide has demonstrated significant recognition of HER2/neu-expressing tumors. The candidate was well tolerated, with no severe adverse events reported. Most notably, in a Phase IIb clinical trial in the HER2/neu 3+ adjuvant setting, no breast cancer recurrences were observed after a median of five years of follow-up when the patient was fully immunized.
FLAMINGO-01 is a phase 3 clinical trial evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients with residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial will be conducted in the U.S and international clinical sites and will be led by Baylor College of Medicine.
The trial is designed to be double-blind and detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. The trial will have approximately 500 HLA-A*02 patients who will be randomized to receive GLSI-100 or a placebo. Another 100 patients of other HLA types will be administered GLSI-100 in a third arm. Once 14 out of 28 events occur, the Company plans to undertake an interim analysis for superiority and futility.
The Company had received a formal complete response letter from the FDA, which was preceded by an informal request to allow them to review an updated chemistry and manufacturing section on drug products before giving the go-ahead for initiating the Phase III trial. Greenwich’s manufacturing information for the final product was incomplete, leading to the FDA raising concerns about some manufacturing and pharmacy procedures. However, the Company promptly responded to the FDA and worked closely to resolve all issues.
HER2 (human epidermal growth factor receptor 2) is a gene that plays a crucial role in the healthy functioning, growth, and repair of breast cells. However, in about 25% of breast cancers, the HER2 gene multiplies uncontrollably. HER2 – positive breast cancer is likely to grow and spread more rapidly than HER-2 Negative cancers.
Breast cancer is the most common 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 the centers for disease control and prevention (CDC), over 237,000 breast cancer cases 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 disorder every year. The American Society of Clinical Oncology estimates that HER2/neu 3+ breast cancer patients comprise approximately 25% of all breast cancer patients.
The breast cancer therapeutics industry is likely to reach USD 38.4 billion by 2025, growing at a CAGR of 10.7%, according to a Grand View Research, Inc report. The increasing spending on mergers and acquisitions, strategic collaborations, and the rise in research and development efforts to stay ahead of competitors will drive growth in the market. Lifestyle changes such as a rise in the age of childbearing, high intake of oral contraceptive pills, reduced breastfeeding, and undergoing estrogen modifying drug treatments are causing increased incidences of breast cancer, according to the report. At the same time, the onslaught of generics could hamper the market from reaching its full growth potential.
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, technological advancements are helping companies develop novel therapeutics with targeted delivery, improved efficacy, reduced side effects, and more positive patient outcomes.
Clinical Trials are fraught with risk and uncertainty. There is a possibility that the candidates in the Company’s developmental pipeline may not be able to meet their clinical endpoints in trials. The Company may fail to receive regulatory approval for any other candidates, resulting in a setback for the other candidates in the pipeline.
However, a diverse pipeline will help mitigate the risk in case of adverse results or the failure to meet endpoints in any of its ongoing trials. The success of its clinical trials will allow the Company to advance its pipeline, but it should also be prepared to face any setbacks in case its ongoing attempts fail to meet its endpoints.
· GP2 is synergistic with Herceptin, a Genentech/Roche monoclonal antibody treatment given in the first year after breast cancer surgery. This provides an excellent opportunity to expand the market to include – HER2/neu 1-2+ patients with Herceptin, increasing the potential market share from m 25% to 75%. The Company is also exploring the possibility of expanding the drug in other HLA types from 40-50% up to 80% of all patients and in combination with 40-50% up to 80% of all patients and other HER2/neu cancers.
· The Company seeks to address a substantial unmet need in recurrent breast cancer patients who do not respond to Herceptin or Kadcyla. Greenwich wants to pursue the application of GP2 in a neoadjuvant setting and address the gap left by treatment options such as Perjeta or Nerlynx that have side effects such as diarrhea, nausea, and alopecia, fatigue, peripheral neuropathy, and vomiting, among others.
· GP2 enjoys patent protection through 2032 in the major markets (US, EU, Canada, Australia, & Japan), with ongoing efforts to build a robust patent portfolio in emerging markets.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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