For the past 6-months our team at MS Money Moves has been following the story of DelMar Pharmaceuticals (NASDAQ: DMPI) in an effort to educate and inform the investment community. During this time, we have been pleased by significant improvements in DelMar’s operational efficiency and its overall value proposition. Those of you less familiar with the company’s background should read my initial article.
The past 3-months have been tumultuous for the U.S economy due to the novel Coronavirus (COVID-19) outbreak which triggered a global pandemic and recession. Consequently, corporations big and small are being negatively impacted. In the biopharma industry many clinical-stage companies had to postpone or halt planned/ongoing studies due to stringent travel and social distancing restrictions. However, as I discussed in my last article DelMar has managed to forward all three arms (newly diagnosed, recurrent, adjuvant) of its two Phase 2 clinical studies evaluating VAL-083 as a therapy for patients with Glioblastoma Multiforme (GBM). Furthermore, last month the company announced full enrollment in the newly diagnosed arm and 90% in the adjuvant arm. Both the recurrent and adjuvant settings are on track for full enrollment this year.
The next data update is to be presented at the 2020 American Association for Cancer Research Virtual Annual Meeting II (AACR) June 22nd-24th. Despite the consistent and durable performance of VAL-083 across the GBM spectrum in MGMT unmethylated patients (an especially vulnerable GBM subtype) a path forward has remained unclear. Following two of the biggest announcements in DelMar’s history this is no longer the case. First on 6/4/20, DelMar announced the selection of VAL-083 by the Global Coalition for Adaptive Research (GCAR) as one of three drugs to be tested in its Glioblastoma Multiforme Adaptive Global Innovative Learning Environment (GBM AGILE) pivotal study. And secondly, a definitive merger agreement was announced on 6/10/20 in which DelMar will acquire Adgero Biopharmaceuticals Holdings in an all-stock transaction. In the rest of this article I will discuss the significance of these developments regarding the future of DelMar and how they impact our outlook for the company.
Inclusion in GCAR’s GBM AGILE Study Streamlines the Registrational Pathway For VAL-083
The Global Coalition for Adaptive Research (GCAR) is a non-profit organization comprising an interdisciplinary coalition of top-tier medical researchers and thought leaders with a shared goal; to expedite the review process of therapeutics for high unmet medical needs. Due to an extremely poor prognosis (only 3% of GBM patients survive 5-years), limited treatment options, and patient populations well defined by biomarkers, GCAR started with GBM. The fact that VAL-083 was selected as one of only three drug candidates for the study reaffirms an assertion made in my previous article that VAL-083 is a frontrunner in the GBM clinical landscape. Participation in the GCAR program should reduce the time to a New Drug Application (NDA) submission for GBM by at least 12 to18 months. Conducting VAL-083’s registrational study through GCAR connects DelMar with an elite network which includes 24-registered clinical sites with more coming online. Moreover, GCAR has been enrolling patients in the control group for over a year. Not only does this save time but also significantly curbs capital expenditures required to complete the registrational study.
How it Works?
GMB AGILE is designed as a seamless Phase 2 (efficacy & safety)/Phase 3 (confirmatory) trial allowing several therapies to be tested concurrently against a shared control arm. In addition to VAL-083, Bayer’s’ (OTCMKTS: BAYRY) kinase inhibitor regorafenib and Kazia Therapeutics’ (NASDAQ: KZIA) small molecule inhibitor of the PI3K/AKT/mTOR pathway (GDC-0084) are being investigated. For the control, the standard of care Temozolomide (TMZ, Temodar) will be used for newly-diagnosed patients, and Lomustine for recurrent patients. As patients enroll into the study they are stratified into their respective treatment (or control) groups based on biomarker subtypes. For instance, patients with an unmethylated MGMT gene would be in one group and those with a methylated genotype in another. As many of you know you DelMar selected the MGMT unmethylated population as its initial target due to VAL-083’s differentiated mechanism of action compared to TMZ. Unlike TMZ, VAL-083 makes double stranded DNA breaks that cannot be repaired by the MGMT protein. Additionally, with GBM AGILE VAL-083 has 3 shots on goal (newly-diagnosed methylated, newly-diagnosed unmethylated, and recurrent) to succeed.
In the Phase 2 portion of the study, increments of up to 150 patients will be administered VAL-083 and compared to a large control arm. Such a design enables a relatively speedy detection of a signal (or lack of) signifying a statistically significant therapeutic benefit. Assuming a signal is identified VAL-083 would be advanced to the Phase 3 confirmatory part of the trial. The anticipated timeframe to reach this point is approximately 18 to 24 months. DelMar stated in its press release that the first patients should start enrolling in 3Q20.
Acquisition of Adgero Biopharma Creates a Diversified Late-Stage Oncology Company with a Phase 3 Ready Assets
On 6/10/20 DelMar Pharmaceuticals and Adgero Biopharmaceuticals Holdings announced a definitive agreement for DelMar to acquire Adgero in an all-stock transaction. Completion of the merger would create a new entity (Kintara Therapeutics and new Nasdaq stock symbol “KTRA”) in which DelMar and Adgero shareholders would own 50.5% and 49.5% of the new company, respectively.
Adgero is a privately owned biopharma company focused on building out a pipeline based on its proprietary late stage photodynamic therapy (“PDT”) platform. In a nutshell, PDT utilizes light sensitive compounds (photosensitizers) that when exposed to certain wavelengths of light form reactive oxygen species (ROS) inducing localized tumor cell death. The lead PDT asset (REM-001) is being investigated as a treatment for cutaneous metastatic breast cancer (CMBC). In Phase 2/3 studies consisting of 148 patients, investigators observed compelling results in CMBC patients who previously failed radiation therapy. In approximately 80% of the evaluable tumor sites therapy with REM-001 achieved complete responses.
In addition to CMBC, there are several potential follow on indications for REM-001, with Recurrent Basal Cell Carcinoma Nevus Syndrome being ready for Phase 2 testing. Upon completion of the merger Kintara will be equipped with two Phase 3 assets and a strengthened cash position (the merger is contingent upon a $10M financing) and leadership team. DelMar President and CEO Saiid Zarrabian will maintain the role of President and CEO while Adgero’s interim CEO John Liatos will undertake the role of Senior Vice President of Business Development. Scott Praill, DelMar’s Chief Financial Officer, and Dennis Brown, DelMar’s Chief Scientific Officer will continue to serve in their same capacities.
In light of these new developments we are optimistic about the future of DelMar. For the first time since beginning coverage on DelMar a tangible and viable path forward has been revealed heading towards a potential FDA approval of VAL-083 for GBM, as well as REM-001 for other oncological indications starting with CMBC. Sure, DelMar may need to finance from time to time in order to see to completion its transforming into a commercial-stage company. However, as evident by news of a registration trial set to enroll next quarter and the merger agreement with Adgero, Saiid is hard at work behind the scenes making things happen. Who know what he will surprise us with next? On the heels of these positive developments we look forward to the updated Phase 2 data at AACR June 22nd-24th. In the last data update at the Society for Neuro-Oncology 2019 Annual Meeting (SNO) 47% (9/19), 42% (8/19), and 10% (2/19) of patients had complete responses, stable disease, and progressive disease, respectively, while 70% (16/23) of all patients were still alive. Furthermore, these results were on par with previous studies evaluating TMZ + radiation therapy (i.e. the standard of care).
I am/we are long DMPI. This article reflects the opinions of the author. MS Money Moves, nor the author, or any of its affiliates were compensated to write this article.