VANCOUVER – USA News Group – Researchers led by a scholar from City University of Hong Kong (CityU) have developed a novel artificial intelligence (AI) framework to make predictions on potential synergistic anti-cancer drug combinations for both therapeutic and toxic effects. Many of the biotech sector’s biggest wins of late have come through drug combinations, utilizing the strengths and downplaying the weaknesses of available therapies, including recent developments from Oncolytics Biotech Inc.(NASDAQ:ONCY) (TSX:ONC), Merck (NYSE:MRK), Amgen Inc. (NASDAQ:AMGN), Bristol-Myers Squibb Company (NYSE:BMY), and Mirati Therapeutics, Inc. (NASDAQ:MRTX).
For example, significant work is being done on behalf of women in America, where breast cancer is known to be the second leading cause of death from cancer—with an estimated 42,000 deaths in the US in 2020. The problem also persists in China, where breast cancer is now estimated to be the largest subtype of cancer among women, with over 416,000 cases and over 117,000 deaths in 2020.
As part of the fight against breast cancer, a multinational front is moving forward between US-based Oncolytics Biotech Inc.(NASDAQ:ONCY) (TSX:ONC) and Chinese multinational clinical-stage biopharma developers Adlai Nortye.
The aim is to work with Oncolytics’ promising immunotherapeutic agent pelareorep pelareorep for patients in China, after randomized phase 2 trials in North America already showed that treatment with pelareorep and paclitaxel led to a statistically significant increase in overall survival compared to treatment with paclitaxel alone.
This US-Chinese partnership has already initiated dosing in a bridging clinical trial for patients with advanced or metastatic breast cancer using a combination therapy of pelareorep with the chemotherapy drug, paclitaxel. Results from this newly initiated bridging trial should allow Adlai Nortye to include data from Oncolytics’ North American metastatic breast cancer trials in a future submission to Chinese regulators.
“Adlai’s bridging trial is an important step forward for pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second-largest in the world,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “We are very pleased that dosing in the trial has commenced and congratulate our partner on this notable achievement. Looking ahead, we are eager to continue our partnership with Adlai as we work to advance pelareorep towards registration in major global markets.”
Oncolytics’ second randomized phase 2 trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor.
So far there have been several potential suitors for pelareorep, including from Merck (NYSE:MRK), and Bristol-Myers Squibb Company (NYSE:BMY)—all of which make oncology drugs that are being evaluated in combination with pelareorep.
Merck (NYSE:MRK) recently had another drug combination win for its immunotherapy drug Keytruda, that’s administered intravenously and works by enhancing the immune system to help detect and combat tumor cells. This time it involved a collaboration with Mirati Therapeutics, Inc. (NASDAQ:MRTX)—makers of the experimental KRAS-blocking drug adagrasib. Mirati recently announced that more than 60% of patients with lung cancer showed confirmed tumor responses when its was added to Keytruda therapy.
Beyond Lumykras (known as Lumakras in the US) from Amgen Inc. (NASDAQ:AMGN)—which won U.S. approval earlier this year—Mirati’s adagrasib is now the most advanced experimental drug targeting a cancer-linked gene called KRAS that’s often mutated in tumors of the lung, colon and pancreas.
The data released at the beginning of November are the first from Mirati and give it a slight head start on Amgen, which doesn’t expect trial results for Lumakras and Merck’s Keytruda until the first half of next year.
Mirati expects to finish filing an application with the FDA for approval of adagrasib in patients with previously treated non-small cell lung cancer by the end of 2021.
Amgen recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending conditional marketing authorization for Lumyrkras, for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
Should the European Commission follow this recommendation for approval, Lumykras will be the first targeted therapy available in the EU for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.
Merck’s Keytruda recently garnered another win, this time gaining FDA approval for the adjuvant treatment of persons diagnosed with stage IIB or IIC melanoma following complete resection. Keytruda is already approved for multiple other indications, including NCSCLC, alongside pemetrexed and platinum chemotherapy, head and neck squamous cell cancer in combination with platinum and fluorouracil (FU), classical Hodgkin lymphoma, urothelial carcinoma and primary mediastinal large B-cell lymphoma, among other types of cancers.
Another cancer drug that’s being tested in combination with Oncolytics’ pelareorep and Mirati’s Sitravatinib, is Opdivo from Bristol-Myers Squibb Company (NYSE:BMY). Recently, the lung cancer drug Opdivo was shown to boost survival rates in patients with resectable NSCLC, when administered with chemotherapy in a recent phase 3 CheckMate 816 study.
“CheckMate -816 is the first Phase III trial with an immunotherapy-based combination to demonstrate a statistically significant and clinically meaningful benefit as a neoadjuvant treatment for patients with non-metastatic non-small cell lung cancer,” stated Abderrahim Oukessou, vice president, thoracic cancers development lead, BMS. “The combination of Opdivo plus chemotherapy first showed a statistically significant improvement in pathologic complete response rate without impacting surgical outcomes and has now extended the time patients live free of disease progression, recurrent or death. The event-free survival data from CheckMate -816 strengthen the evidence for the potential of Opdivo-based therapies to improve long-term clinical outcomes when used in the earlier stages of non-metastatic cancers.”
It’s yet to be seen what other advances will come from the anticipated use of AI for not only clinical decision-making, but also cancer diagnoses and more. AI may potentially have use in the treatment of cancer patients experiencing adverse effects as a result of their treatments, and provide the sector with several new combinations not yet being tried.
Article Source: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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