Cancer is among one of the leading causes of death around the globe; namely, in 2018, there were a total estimated 18.1 million new cases worldwide. The International Agency for Research on Cancer (IARC) projects that one-in-five men and one-in-six women will develop cancer over their lifetime. The agency also suggests that the rising number of cancer cases is correlated to a growing and aging population, in combination with exposure to risk factors associated with social and economic development. The most common types of cancer are lung, breast, and colorectal. The concern over the growing number of patients diagnosed with cancer is causing a demand for effective treatments to rise. As a result, biotechnology companies are developing various new treatments, drugs, and therapies to decelerate or eradicate cancer. According to data compiled by GBI Research, the global oncology market revenue is expected to grow to USD 241 Billion in 2023 from USD 118.6 Billion in 2016. It is also expected to grow at a CAGR of 10.66%. The oncology pipeline is large and very diverse, containing over 7,000 different products. However, the number of cases is still rising, which is responsible for the growing demand for new remedies. Q BioMed Inc. (OTC: QBIO), Celgene Corporation (NASDAQ: CELG), Seattle Genetics, Inc. (NASDAQ: SGEN), Incyte Corporation (NASDAQ: INCY), Nektar Therapeutics (NASDAQ: NKTR)
Throughout the process of cancer treatments, patients suffer from symptoms associated with cancer itself or the therapy. Common side effects include vomiting, inflammation, and pain, but companies involved in the oncology and immunotherapy industry have developed numerous palliative medications to aid with the symptoms. The medications most commonly used include analgesics, antiemetics, antidepressants, and steroids. Other variations of treatments, such as chemotherapy or radiotherapy, are intended to slow or control the spread of cancer rather than treating the associated symptoms or curing cancer itself. “Today new avenues for cancer diagnostics and therapeutics present themselves. The choices include specific diagnostics, such as the rapidly evolving use of liquid biopsies that analyze cells and molecules spawned by the tumor and found in bodily fluids such as blood or urine, a more focused analysis of non-responders, the financial implications of future therapies, and an advocacy for a return to basic scientific research. The result of exploring these options will be a wider range of treatment choices for oncologists and a more positive outcome for patients,” said Steve Brozak, President of WBB Securities, LLC, an investment bank and research firm that specializes in the biotechnology, specialty pharmaceutical and medical device sectors.
Q BioMed Inc. (OTCQB: QBIO) earlier last month provided the following update to its shareholders and investors, “Firstly, thank you for your support and interest in our company. We are committed to making QBIO a huge success. We believe we have built a solid and extremely valuable pipeline, and with the recent acquisition of the global brand Metastron from GE Healthcare, we are very well positioned to generate revenue in 2019 and beyond! Preliminary interest from larger pharma companies in our portfolio has also strengthened our conviction in the value we have built over these short three years. We have made great progress in each of the assets we are developing.
We are committed to growing and expanding the reach of our cancer palliation drugs. While Metastron is prescribed in 22 countries today as a non-opioid therapy for the debilitating pain associated with metastatic skeletal cancer, we believe Metastron has huge untapped potential in expanded cancer therapeutic indications. The opioid crisis is everywhere and as physicians curtail their use of opioids, Metastron is going to be more relevant than ever. It’s been proven safe and effective over many years of use. Furthermore, we believe that cancer palliation drugs like Metastron not only treat pain but can also improve survival when used in combination with other therapies, or even when used alone. Q BioMed plans to conduct supportive clinical trials to highlight what we believe are ignored clinically relevant datasets which may demonstrate improved survival. Stay tuned for more updates as we complete the market authorization transfers in the 22 countries where Metastron is approved. This drug is a substantial opportunity for Q BioMed. A very similar drug with a very narrow indication currently does almost $800 million a year in revenue!
Looking beyond our radiopharmaceutical oncology products, our pipeline chart includes a deep bench of drug candidates with significant value in large markets of underserved patients.
QBM-001 is a potential orphan drug treatment for young children and toddlers who are on the autism spectrum and are minimally verbal or non-verbal. Imagine the heartache and complications that arise from this condition for their families and in their surroundings. We are very hopeful that this therapy, comprised of very safe and well-known active ingredients, can make a huge difference for these desperate children and families. There is currently NO treatment for this subgroup of autistic children. We look forward to the completion of formulation and manufacturing by the end of Q2 2019 and a subsequent filing of an IND. The green light will allow us to commence a relatively short pivotal clinical trial of QBM-001 in Q3 2019. This trial is expected to take about a year to 18 months and we could have interim data reviewed by Q1 of 2020. Positive results from that readout could be a significant catalyst for a drug candidate that we hope to be a blockbuster billion-dollar asset! In a therapeutic space with no competition, this is a major orphan drug product candidate with multi-billion-dollar annual revenue potential starting in as little as 2 years from the initiation of the trial. Stay informed as we progress this to the clinic in 2019. We recently announced a strategic partnership with SRI International on this project. They are a leader in formulation and development in this space. There is more to come in the next few months.
Uttroside-B is our liver cancer orphan drug candidate. Liver cancer is the only cancer that has not seen an improvement in outcomes over recent years and incidence is expected to continue to grow until 2030. There are approximately 40,000 cases in the US and over a million worldwide. The prognosis is notoriously poor. Untreated patients in the US have a life expectancy under four months, while treated patients have a 2 year-survival rate of around 50%. We need better therapeutic options. Our early stage data suggests that this molecule could be very effective – potentially 10X more effective than current treatments. That’s why we are bringing this product closer to a proof of concept trial. Once demonstrated, we believe there will be a significant opportunity to realize a return on our investment in a partnership on this project. The current first line therapy is a drug with sales of a billion dollars per year. Our goal is to have the proof of concept completed in 2019. Again – stay tuned for developments on this important and valuable asset in our pipeline.
Our MAN-01 program, is our topical treatment (eye drop) for glaucoma. It reduces pressure build up in the eye by assisting with, and correcting, drainage problems in tiny vessels in the eye. It is the ONLY drug targeting these unique and extremely important vessels. Over 70 million people suffer from glaucoma around the world. Treating glaucoma in our MAN-01 program is a blockbuster opportunity on its own, however our research shows that the same drug action may ameliorate vessel damage in several other diseases such as: kidney disease (MAN-02), cardiovascular disease (MAN-03), and providing host-defense against infectious diseases (MAN-04) like the flu and even Ebola. We believe these programs comprise a multi-disease platform technology that has several multi-billion-dollar applications. We will be making more announcements about the MAN-01 program, and the platform, over the coming weeks and months.
We would be remiss if we didn’t address the performance of the stock in recent months. While we don’t like to comment on variables that are out of our control, our product offerings have expanded through the acquisition of Metastron and our portfolio value has increased as we approach some major milestones on each asset. We are committed to our plan and will continue to advance these drugs, thereby creating not only economic value, but real-world life altering opportunities for the patients that we are hoping to help.”
For our Exclusive Interview with CEO Denis Corin of Q BioMed Inc. Live from NASDAQ Marketsite please head over to: https://www.youtube.com/watch?v=ZsmRFGNBeI8
Celgene Corporation (NASDAQ: CELG), headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. Bristol-Myers Squibb Company and Celgene Corporation have recently announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately USD 74 billion. The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach. “For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company,” said Mark Alles, Chairman and Chief Executive Officer of Celgene. “Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together.”
Seattle Genetics, Inc. (NASDAQ: SGEN) is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited recently announced that data from the ECHELON-2 phase 3 clinical trial will be presented in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting. The data demonstrated that frontline treatment with ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) is effective in extending progression-free survival (PFS) and overall survival (OS) with a safety profile comparable to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), a current standard of care in patients with CD30-expressing peripheral T-cell lymphomas (PTCL). These data were also simultaneously published online in The Lancet. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. “This is the sixth FDA-approved indication for ADCETRIS in lymphoid malignancies and the second as a frontline treatment in combination with chemotherapy,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “The data presented today at ASH underscores that the ADCETRIS combination provides clinically meaningful benefit to patients with previously untreated PTCL and has the potential to be practice changing for these patients.”
Incyte Corporation (NASDAQ: INCY) is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. Incyte Corporation recently announced that the first patient has been treated in GRAVITAS-309, a pivotal Phase 3 trial for the first-line treatment of patients with chronic graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel and selective JAK1 inhibitor, in combination with corticosteroids compared to corticosteroids alone as a first-line treatment for moderate or severe chronic GVHD. Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD, and for the treatment of patients with non-small cell lung cancer in combination with osimertinib, an EGFR inhibitor. “Given the severity of chronic GVHD, we are pleased to announce the initiation of treatment for the first patient in the GRAVITAS-309 trial, as it represents a critical next step in our comprehensive development program aiming to bring important treatment options to market that address the significant unmet needs of GVHD patients across the spectrum of the disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte.
Nektar Therapeutics (NASDAQ: NKTR) is a research-based, development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. ImaginAb Inc., an immuno-oncology imaging company, recently announced that it has entered into a non-exclusive license and clinical trial collaboration with Nektar Therapeutics. Under the terms of the agreement, Nektar will use ImaginAb’s CD8 ImmunoPET technology to measure whole body and tumor CD8+ T cells’ density and distribution in cancer patients. The collaboration will provide important mechanistic insight into various candidates in Nektar’s immuno-oncology portfolio. “Novel PET biomarkers are essential to better understand and rationally develop next-generation immunotherapies, and ImaginAb’s CD8 ImmunoPET technology is designed to give us a non-invasive whole-body view of immune system activity,” said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar. “Through this partnership with ImaginAb, we now have access to a novel and important technology that can simultaneously measure CD8+ T cells in multiple tissues, including all target and non-target tumor lesions. Since the proliferation and tumor-infiltration of CD8+ T cells is a key mechanistic feature of our pipeline candidates, including NKTR-214, we have the potential to use this technology in future clinical trials to potentially expedite the development of our immuno-oncology pipeline therapies.”
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