Medicenna Therapeutics extends period to exercise certain warrants » 07:1409/3009/30/22
Medicenna Therapeutics received conditional approval from the Toronto Stock Exchange to extend the expiry date of the common share purchase warrants of the Company originally issued on October 17, 2019. The Warrants, of which 1,549,052 are available to be extended, are exercisable for common shares of the Company at a price of $1.75 per Common Share and are set to expire on October 17, 2022. The Company has extended the expiry date of such Warrants by an additional nine months to July 17, 2023, with such extension being effective on October 17, 2022. All other terms of the Warrants, including the exercise price, remain unchanged. There are 1,661,552 Warrants remaining available for exercise including 112,500 Warrants held directly or indirectly by insiders of the Company which will not be extended.
|Over a week ago|
Medicenna confirmed response 'notable and not a fluke,' says Oppenheimer » 13:4709/2809/28/22
Oppenheimer analyst Matthew Biegler reiterates an Outperform rating on Medicenna Therapeutics with an $8 price target after the company announced that the partial responder in MDNA11's doseescalation trial now has a confirmed response. The "now confirmed evidence of single-agent activity against this usually tough-to-treat tumor type is notable and not a fluke," Biegler tells investors in a research note. The analyst continues to be "puzzled by the tepid investor reaction" since the partial response was first disclosed back in August, and believes the quality of clinical data that MDNA11 has put forth thus far "deserves more credit than it is currently getting."
Medicenna announces clinical data from Phase 1/2 ABILITY study of MDNA11 » 09:2809/2809/28/22
Medicenna Therapeutics announced new clinical data on anti-tumor activity from the Phase 1/2 ABILITY study of MDNA11, the Company's "beta-only" long-acting IL-2 super-agonist. These data include a confirmed partial response in a fourth-line metastatic pancreatic ductal adenocarcinoma patient that had previously failed chemo and checkpoint inhibitor therapies. The confirmatory scan for this patient continues to show further tumor reduction compared to prior scans, suggesting durable anti-cancer activity following MDNA11 monotherapy. Overall, five of fourteen evaluable patients in the ABILITY study's low and mid-stage dose escalation cohorts have achieved tumor control with MDNA11 monotherapy. The ABILITY study's dose escalation cohorts are evaluating MDNA11 monotherapy administered intravenously once every two weeks to patients with advanced solid tumors, with the primary objective of evaluating the safety and pharmacokinetics and determining the recommended Phase 2 dose. Once the RP2D has been established, a key secondary objective of the trial will be to evaluate the anti-tumor activity of MDNA11 alone and in combination with the checkpoint inhibitor KEYTRUDA in the trial's dose expansion phases. The ABILITY study's first three dose escalation cohorts evaluated MDNA11 at doses of 3,10 and 30 microgram/kg. Patients in the fourth and fifth dose escalation cohorts receive two 30 microgram/kg "priming" doses of MDNA11 before stepping up to receive fixed doses of 60 and 90 microgram/kg, respectively. The trial is currently enrolling patients in the fifth dose-escalation cohort, with no dose-limiting toxicities, dose interruptions, dose de-escalations, or treatment discontinuations due to safety issues observed to-date. Prior to enrolment in the ABILITY Study, patients in Cohorts 1 to 4 had failed up to four lines of systemic therapy. Prior to enrolment in the ABILITY Study, eleven of fourteen patients in Cohorts 1 to 4 had relapsed on, could not tolerate, or did not respond to at least one immunotherapy with a checkpoint inhibitor. Five of fourteen evaluable patients have achieved tumor control as defined in the study. One fourth-line metastatic PDAC patient that had previously failed chemo and checkpoint inhibitor therapies achieved a confirmed PR at the 60 microgram/kg dose. One 3L non-clear cell renal cell carcinoma patient at the 60 microgram/kg dose achieved SD. One 4L sarcoma patient receiving the 30 microgram/kg dose achieved SD. Two patients achieved SD at the 10 microgram/kg dose, with the metastatic melanoma patient maintaining SD for more than a year while escalating to the 60 microgram/kg dose. To date, MDNA11 has demonstrated a favorable tolerability profile in the monotherapy dose escalation segment of the ABILITY study. New data on MDNA11's safety, pharmacokinetic and pharmacodynamic profiles are expected to be presented at a major medical meeting in the fourth quarter of the calendar year.
Medicenna presents preclinical data on MDNA223, MDNA413 » 07:3609/2209/22/22
Medicenna Therapeutics announced presentation of data from two preclinical programs that demonstrate the anti-tumor activity of the Company's anti-PD1-IL-2 BiSKIT, aka MDNA223, and long-acting IL-4/IL-13 super-antagonist, aka MDNA413. The data are featured in two separate poster presentations at the 10th Annual Meeting of the International Cytokine & Interferon Society, which is taking place both virtually and in-person at the Hilton Waikoloa Village, in Big Island, Hawaii. Poster P110: "A Next Generation Bifunctional Superkine for Immunotherapy Encompassing the Combined Therapeutic Potency of IL-2 Super-Agonist and Anti-PD1." Poster P110 includes preclinical data from in vitro and in vivo studies of MDNA223, a next generation BiSKIT consisting of an anti-PD1 antibody linked to an IL-2 super-agonist. Anti-PD1 drugs, such as Keytruda, have been approved for a number of cancer indications. In vitro data presented at the meeting demonstrated MDNA223's potency against the PD1/PDL1 checkpoint was similar to that of a control anti-PD1 antibody while displaying increased affinity for IL-2 receptor beta and no binding to IL-2 receptor alpha. This enhanced IL-2Rbeta selectivity resulted in potent and preferential stimulation of anti-cancer CD8+ T cells over pro-tumor Treg cells. These data demonstrate the therapeutic synergy resulting from the BiSKIT's ability to concurrently target PD1 and the IL-2 receptor on the same immune cells. Poster P69: Fc-MDNA413 is a Novel Long-Acting IL-4/IL-13 Super-Antagonist that Suppresses M2a TAM Skewing and In Vivo Tumor Growth Including Synergy with an IL-2 Super-Agonist. Poster P69 includes preclinical data from in vitro and in vivo studies of Fc-MDNA413, a novel, long-acting IL-4/IL-13 Superkine. Fc-MDNA413 is designed to reverse the immunosuppressive tumor microenvironments of immunologically "cold" tumors by selectively binding to the IL-13 receptor alpha-1 with high affinity and blocking signaling via the Type II IL-4 receptor expressed on tumor associated macrophages and myeloid derived suppressor cells . It consists of an IL-4/IL-13 super-antagonist fused to the Fc domain for half-life extension. Data presented at Cytokines 2022 showed Fc-MDNA413 blocking the pathways that induce M2a TAMs and MDSCs to promote cancer growth and demonstrated its potential to treat cold tumors. In vitro analyses showed that the Superkine is 300-times more selective for IL-13Ralpha1 over IL-13Ralpha compared to a fusion protein consisting of Fc domain linked to wild type IL-13. This superior binding profile enabled Fc-MDNA413 to potently inhibit IL-4/IL-13 mediated functions as measured by pSTAT6 signaling, TF-1 cell proliferation, and M2a polarization of macrophages. In murine studies, Fc-MDNA413 demonstrated sustainable serum exposure at a dose that was well tolerated and inhibited tumor growth as a single agent in melanoma and colon cancer models.
Medicenna announces clinical collaboration with Merck on MDNA11 with KEYTRUDA » 07:1609/1309/13/22
Medicenna Therapeutics (MDNA) announced that it has entered into a clinical trial collaboration and supply agreement with Merck (MRK) to evaluate MDNA11, Medicenna's "beta-only" long-acting IL-2 super-agonist in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in the ongoing Phase 1/2 ABILITY Study. The ABILITY Study is a Phase 1/2 trial designed to assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of MDNA11 as a monotherapy and in combination with KEYTRUDA in patients with advanced/metastatic solid tumors. Under the terms of the clinical trial supply and collaboration agreement, Medicenna will sponsor the study and Merck will supply KEYTRUDA. The two companies will establish a Joint Development Committee to optimally advance the study's combination arm. "Entering into this agreement with Merck provides us with an opportunity to work with the world's leading immuno-oncology company," said Fahar Merchant, PhD, President and CEO of Medicenna. "Although we believe that MDNA11 has great potential as a single agent, combining it with KEYTRUDA may significantly enhance therapeutic benefit in different types of cancer, potentially maximizing the value of MDNA11. We are fortunate to have the opportunity to explore MDNA11 in combination with KEYTRUDA. MDNA11 is designed to selectively expand CD8 T and NK cells, as well as increase PD-1 expression on immune cells. With strong preclinical data demonstrating promising activity with anti-PD-1, we look forward to the opportunity to evaluate the efficacy of MDNA11 in combination with KEYTRUDA in various solid tumors," added Dr. Merchant.
|Over a month ago|
Medicenna Therapeutics announces upcoming milestones » 07:0508/1508/15/22
Additional anti-tumor activity data from the ABILITY study's fourth dose escalation cohort are expected in late September 2022. Initial safety, PK, PD and anti-tumor activity data from the ABILITY study's fifth dose escalation cohort are expected in the fourth quarter of calendar 2022. Anti-tumor activity data from the ABILITY study's single agent expansion phase are expected in the middle of calendar 2023. Top-line anti-tumor activity data from the ABILITY study's combination arm are expected in the second half of calendar 2023.
Medicenna Therapeutics expects cash to fund operations into 2024 » 07:0408/1508/15/22
Medicenna had cash, cash…
Medicenna had cash, cash equivalents, and marketable securities of $19.3 million at June 30, 2022, compared to $20.5 million at March 31, 2022. Subsequent to the quarter end Medicenna raised US$20 million by way of a public offering. Funds on hand as of June 30, 2022 plus those raised in the recent offering, we believe, are sufficient capital to execute the Company's operations into calendar 2024 and through important upcoming catalysts.
Medicenna Therapeutics reports Q1 EPS (7c), consensus (6c) » 07:0308/1508/15/22
"We are off to a…
"We are off to a solid start in fiscal 2023 with a stronger balance sheet and promising anti-tumor activity of MDNA11 monotherapy in the ABILITY study," said Dr. Fahar Merchant, President and CEO of Medicenna. "Whereas single agent activity with next-generation IL-2s has been elusive, we are encouraged with early signs of tumor control in patients with "immunologically cold" tumors including an unconfirmed partial response in a patient with advanced pancreatic cancer. These findings have accompanied desirable pharmacokinetic and pharmacodynamic characteristics, suggesting that MDNA11's rational design and 'beta-only' binding profile are facilitating selective stimulation of anti-cancer immune cells while avoiding the liabilities associated with native IL-2 and competing IL-2 programs. We look forward to building on these preliminary data as we continue to evaluate higher doses of MDNA11 as a single agent and plan to report new data from the ABILITY study during the coming weeks and months."
Medicenna Therapeutics 13.333M share Spot Secondary priced at $1.50 » 09:2508/0908/09/22
The deal range was…
The deal range was $1.45-$1.55. Guggenheim acted as lead book running manager for the offering.
Medicenna Therapeutics announces pricing of $20M public offering » 09:1708/0908/09/22
Medicenna Therapeutics announced that it has priced its previously-announced marketed underwritten public offering of 13,333,334 units of the Company in the Canada and in the United States at a price to the public of US$1.50 per Unit. The gross proceeds to the Company from the Offering are expected to be approximately $20 million, before deducting underwriting discounts and commission and other expenses. Each Unit will be comprised of one common share and one common share purchase warrant. Each Warrant entitles the holder thereof to purchase one common share at a price of US$1.85 per common share, subject to adjustment in certain events, during a period of 60 months following the date of the closing of the Offering. Guggenheim Securities, LLC is acting as sole book-running manager for the Offering. Bloom Burton Securities Inc. is acting as co-manager for the Offering. The Offering is expected to close on or around August 11, 2022, subject to the satisfaction of customary closing conditions, including the listing of the common shares issuable pursuant to the Offering on the Toronto Stock Exchange and the Nasdaq Stock Market and any approvals of each exchange. The Company plans to use the net proceeds of the Offering primarily to fund the clinical development of MDNA11, the pre-clinical development of a BiSKIT candidate, working capital and for general corporate purposes.