dcaf7
7月前
Abstracts for EHA presentations are available. Title of one of two Tuspetinib abstracts is "SAFETY AND EFFICACY OF TUSPETINIB AS MONOTHERAPY ANDCOMBINED WITH VENETOCLAX IN A PHASE 1/2 TRIAL OF PATIENTS WITHRELAPSED OR REFRACTORY (R/R) ACUTE MYELOID LEUKEMIA (AML)". From the abstract: Objective responses were observed (overall CRc=16.9%) in pts receiving 80 mg TUS/400 mg VEN: FLT3-WT(n=49, CRc:14.3%), FLT3-MUT (n=15, CRc: 26.7%) including pts with prior FLT3i treatment (n=12, CRc=33.3%),prior VEN treated (n=48, CRc=16.7%), VEN-naïve (n=17, CRc= 17.6%), RAS-mutated (n=11, CRc=9.1%), andTP53 mutated (n=17, CRc=17.6%) pts. No objective responses were observed at 40mg TUS with VEN,indicating a dose-related response.
dcaf7
7月前
A new corporate presentation has been issued. It has updated clinical data with Tus/Ven doublet obtained in 60 evaluable patients. Previous analysis presented at ASH was done in 36 patients. Interesting, they show only waterfall plot on slide 16, no tables with all nuances. I manually counted all CRc there and ended up with number 11. So, it gives a CRc rate of 11/60, or 18%. In ASH presentation it was 9/36, or 25%. I think 18% is too low for evaluable population. Looks like Tus is not so powerful drug to be used as a single agent or in combination with Ven in R/R patients. Therefore, Aptose has no other choice but to run a triplet trial hoping for more favorable results.
dcaf7
8月前
20% probability of success
Published 03/27/2024, 05:28 PM
On Wednesday, Jones Trading adjusted its outlook on Aptose Biosciences (NASDAQ:APTO), lowering the price target to $5 from the previous $12, while maintaining a Buy rating on the company's stock. The adjustment comes as Aptose Biosciences shifts its development focus towards a new drug combination for treating Acute Myeloid Leukemia (AML).
The firm highlighted that Aptose's immediate strategy will concentrate on a triplet combination therapy involving tuspetinib, venetoclax, and HMA for first-line AML treatment. A pilot study for this combination is slated to begin in the summer, with initial findings expected to be presented at the American Society of Hematology (ASH) conference.
Meanwhile, the development for relapsed/refractory AML has been paused to improve strategic positioning, with data to be shared at the European Hematology Association (EHA) 2024 conference.
Jones Trading noted that if Aptose demonstrates clear clinical benefits in the first-line setting, it may lead to enhanced business development opportunities as compared to the relapsed/refractory AML setting. Still, the firm also pointed out that a capital overhang is a significant pressure point for both the stock and its clinical development progress.
The company's current cash position stands at $18.6 million, which is expected to fund operations through August 2024. Jones Trading has updated its financial model to reflect the new strategic direction towards first-line AML treatment, estimating unadjusted peak sales of approximately $250 million, assuming a 20% probability of success and a 40% market penetration among patients unfit for intensive chemotherapy.
In light of these developments and other minor changes across the model, Jones Trading reiterated its Buy rating but reduced the price target for Aptose Biosciences to $5. The firm believes that despite the lowered target, the company's stock remains a positive investment opportunity.
https://www.investing.com/news/company-news/aptose-biosciences-target-cut-maintains-buy-rating-on-new-drug-development-93CH-3355850
dcaf7
10月前
Some thoughts on Rice.
Rice has an interesting career. “He served as Head of the Laboratory of Antiviral Drug Mechanisms and Manager of the HIV Clinical Interface Laboratory for the National Cancer Institute (NCI), National Institutes of Health from 1992 to 1998. In this position, Dr. Rice directed the activities of several projects targeting new ways to treat HIV and other infectious diseases. From 1989 to 1992, he was professor of Pediatric Hematology and Oncology at Emory University School of Medicine, where he built a program to identify new molecular structures as antiviral targets”. So, he was in hematology/oncology, but it was not related to oncology. Then, from Aug 1998 to Aug 2003 he worked as a CEO of Achillion Pharmaceuticals, an anti-infective pharmaceutical company. Under his leadership no drug was approved. From 2003 to 2013 he served as a CEO of Cylene Pharmaceuticals. The company was working on oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, or multiple myeloma. This drug is still in clinical trials, not even close to FDA approval. Their second drug was Quarfloxin, a selective binder for MYC GQ structure. Is it related to APTO-253? Anyway, later quarfloxin was discarded due to its poor bioavailability. Isn’t it a familiar theme? And from 2013 to the present, Rice has been a CEO of Lorus/Aptose Biosciences. The result of his work as a leader of Aptose is two failed drugs, APTO-253 and Luxeptinib. Point is that during his very long career in biotech industry as a CEO, Rice was not able to bring any drug to the market. I hope Tuspetinib is his last chance.
dcaf7
10月前
From latest 8-K. Very interesting. What is a Hanmi's purpose?
"Hanmi will have the right to designate for employment one or more individuals that are legally able to work in the United States or Canada (each, an “Hanmi Nominee”) to a position or positions within Aptose in applicable areas based on each Hanmi Nominee’s skills, education and experience. The parties agreed that the Hanmi Nominee shall be subject to Aptose’s usual employment rules, practices, policies, evaluation procedures, as amended from time to time and Aptose shall retain the right, in its sole discretion, to terminate such Hanmi Nominee’s appointment with Aptose for violations of Aptose’s employment rules, practices, policies and procedures. The parties also agreed that the Hanmi Nominee shall be entitled to salary, bonus, vacation, incentive payments and bonuses, expenses, allowances and any applicable benefits in amounts and to the extent consistent with employees of Aptose serving or having recently served in a similar capacity with Aptose with such amounts to be reimbursed to Aptose by Hanmi. In the event that a visa or other permit is required to be obtained to permit the Hanmi Nominee to work in the United States or Canada the parties agreed that Aptose would use its commercially reasonable efforts to assist the Hanmi Nominee with obtaining such visa or permit. The parties agreed that upon the nomination of the Hanmi Nominee that the parties would enter into a separate service agreement to outline the specific terms and conditions of the Hanmi Nominee’s appointment".
dcaf7
10月前
"We expect to revise our current development as follows. Assuming the net proceeds from this offering and our existing cash, cash equivalents and short-term investments, a net proceeds from the concurrent private placement offering, a committed equity facility, and ATM we plan to, (i) complete our ongoing APTIVATE clinical trial studying TUS and TUS/VEN, (ii) pause enrollment in the LUX G3 study and (iii) evaluate other costs reductions in general and administrative expenses."
Not a word about registrational trial?