The cancer therapeutics market is one of the largest segments of the biotechnology industry. According to the National Cancer Institute, roughly 1.8 million people were diagnosed with cancer in the United States in 2020 alone. However, the oncology and cancer drug market is expected to grow largely due to the surge in cancer research, the rise in the geriatric population worldwide, as well as the increase in collaboration between pharmaceutical companies. Moreover, the high market growth potential in developing nations, a rise in the number of pipeline products, and an upsurge in demand for personalized medicines are expected to create new opportunities for market players.
The National Cancer Institute notes that some of the most common cancer cases in the U.S. are bladder, lung, breast, colon and rectal, pancreatic, kidney and prostate. Specifically, the most common cancer in the U.S. is breast cancer, with 271,270 expected new cases in 2019. While breast cancer is one of the most common instances of cancer, the National Cancer Institute estimates that more death resulted from lung and pancreatic cancers. In fact, the breast cancer therapeutics market alone was worth USD 21.58 Billion in 2019 and is expected to grow at a CAGR of 13.1% according to Fortune Business Insights.
Sunshine Biopharma Inc. just announced breaking news that, “it has elucidated the mechanism of action of Adva-27a, the Company’s flagship anticancer drug candidate. Adva-27a has been found to have two activities: (i) evasion of P-glycoprotein, and (ii) inhibition of Topoisomerase II. P-glycoprotein is the most often encountered transmembrane efflux protein responsible for multidrug resistance in over 50% of all cancer types. By escaping the efflux pump of P-glycoprotein, Adva-27a is able to accumulate inside cancer cells and destroy them by inhibiting Topoisomerase II, a DNA unwinding enzyme preferentially used by cancer cells to multiply.
Multidrug resistance is by far the biggest challenge in cancer therapy and P-glycoprotein is the major culprit. A plethora of anticancer drugs that are central to chemotherapeutic regimes are susceptible to the P-glycoprotein efflux activity. Among these are the vinca alkaloids (vinblastine and vincristine), the taxanes (paclitaxel and docetaxel), the anthracyclines (doxorubicin and daunorubicin), the topoisomerase inhibitors (topotecan and etoposide), and the tyrosine kinase inhibitors (dasatinib and gefitinib). Sunshine Biopharma’s P-glycoprotein evading small molecule, Adva-27a, represents an effective alternative to all of these drugs.
In addition, it has been recognized that most cancers consist of a heterogeneous population of drug-sensitive and drug-resistant cells. During the course of current chemotherapy regiments, drug-sensitive cells are selectively destroyed and resistant cells become the dominant cancer cell population, leading to recurrence and metastasis. Unlike existing chemotherapy drugs, Adva-27a is able to destroy both populations of cancer cells resulting in more complete eradication of the cancer being treated.
‘The implications of this development are vast in the context of cancer therapy as a whole,’ said Dr. Steve Slilaty, CEO of Sunshine Biopharma. ‘We are excited to soon have a new drug available for cancer sufferers around the world,’ he added.”
Verastem, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of its investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. “Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with current therapies,” said Melissa Aucoin, CEO of the National Ovarian Cancer Coalition. “A Breakthrough Therapy designation in this disease is a significant step forward for the women who often, at a relatively young age, start a lengthy battle with this highly recurrent and impactful disease.”
Trillium Therapeutics Inc. announced last month that it has dosed the first multiple myeloma patient with TTI-622 (SIRPα-IgG4 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with the proteasome inhibitor carfilzomib and dexamethasone. TTI-622 is a fusion protein that is designed to block the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPα on macrophages and delivers a “don’t eat me” signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-622 exhibits anti-myeloma activity as a monotherapy that is enhanced when combined with proteasome inhibitors.
ImmunoGen, Inc. reported last week mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting, which is being held June 4-8, 2021. Two posters highlighting mirvetuximab combination regimens will also be presented by ImmunoGen’s collaborators during the meeting. “Due to the introduction of effective maintenance therapies, patients with recurrent ovarian cancer are living longer and comprise an increasing population in need of effective, well-tolerated non-platinum based regimens,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “With a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS, the combination of mirvetuximab plus bevacizumab shows compelling activity in patients with high FRα recurrent ovarian cancer. We are extremely pleased to present these data during an oral presentation at ASCO, as they build on previous findings and provide us with further evidence of mirvetuximab’s potential to become the combination agent of choice for ovarian cancer patients.”
Sorrento Therapeutics, Inc. announced last month its development partners have advanced into clinical development (Phase 1b through Phase 3 clinical trials) a number of fully human monoclonal antibodies (mAbs) for the treatment of COVID-19 and various cancers. Two independent anti-PD-L1 mAbs are now in Phase 2 and Phase 3 clinical studies. A PD-L1 mAb (STI-3031, also known as IMC-001) was licensed to ImmuneOncia Therapeutics, Inc. (“ImmuneOncia”), a joint venture between Sorrento and Seoul-based Yuhan Corporation. IMC-001 has completed a Phase 1b study in patients with metastatic or locally-advanced solid tumors and is nearing completion of a Phase 2, open-label, “Neo-Chance” study in patients with resectable gastric cancer, esophageal cancer and liver cancer. ImmuneOncia has also started to enroll patients in a Phase 2 study in relapsed or refractory extranodal NK/T cell lymphoma, nasal type. Sorrento has filed an IND in the U.S. and received clearance from the FDA to proceed with a Phase 2a study for STI-3031 for advanced urothelial carcinoma.