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Another 1M shares are purchased by Biotech Growth N V.
https://investors.blackdiamondtherapeutics.com/static-files/825570ab-52f3-4b2a-b862-78d94a857b59
BTW, Biotech Growth NV is a private equity fund managed by BB Biotech which is located in Switzerland.
Several EGFR TKIs received BTD based on Ph1/2 data. For example, CLN-081, Sunvozertinib, Mobocertinib.
Stifel upgraded Black Diamond Therapeutics (BDTX) to Buy from Hold with a price target of $10, up from $2, following the company's BDTX-1535 phase 1 data released this week. Compared to novel developments that have modest monotherapy efficacy in 2L post-Tagrisso and are forced into combinations or lengthy randomized trials, the BDTX-1535 effect size may potentially allow for rapid monotherapy regulatory paths, the firm says.
HC Wainwright upgraded shares of Black Diamond Therapeutics from a neutral rating to a buy rating in a research report sent to investors on Wednesday. The brokerage currently has $11.00 target price on the stock.
What I learned from yesterday's presentation:
1. Drug demonstrated dose linear PK. It allows for greater predictability in drug response, simplifies the dosing process, reduces risk of dose-related toxicity, and makes drug development process easier.
2. Manageable EGFR TKI safety profile. In fact, at the proposed 200 mg QD dose, safety profile of BDTX-1535 is similar to Osimertinib.
3. Drug is active. ORR of 50% in patients progressed on Osimertinib, although it is true for evaluable population.
4. Clear anti-tumor activity in CNS. One comment from invited KOL was that many patients have CNS only resistance. Very high unmet medical need.
5. Robust reduction of ctDNA carrying mutant alleles. In a few cases, mutant clones were eliminated completely after 1535 treatment.
6. Activity against acquired and intrinsic mutations in this study. Preclinical studies indicate that drug is active for more than 50 different EGFR mutations.
7. Plan to initiate dose expansion cohorts in newly diagnosed patients with intrinsic driver mutations as well as in 2nd line Osimertinib R/R patients. One cohort will study patients with CNS mets.
8. First pivotal trial may be a single arm trial with ORR as a primary endpoint for accelerated approval. I expect a BTD designation.
9. Patient population in NSCLC in the US only: 4000 patients with intrinsic driver mutations and 6000 patients with acquired resistance mutations, including C797S and a number of complex mutations. It is 10,000 not even counting GBM patients.
Jun. 27, 2023
Wedbush has upgraded Black Diamond Therapeutics (NASDAQ:BDTX) to outperform from neutral after the biotech reported positive phase 1 data on lead asset BDTX-1535 for lung cancer.
The firm also boosted its target price to $10 from $3 (~443% return based on Monday's close).
Analyst Robert Driscoll said that based on the results in non-small cell lung cancer, he believes BDTX-1535 has potential in patients with a wide range of EGFR mutations, including as a first-line treatment for intrinsic (non-classical) such mutations.
Encouraging data. BDTX-1535 looks like a real deal.
Interesting update from Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER) on 06/16/2023 (SUPPL-2). Additions and/or revisions underlined:
If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your Rolvedon for information on how to prepare and inject a dose of Rolvedon.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?DrugNameID=2769&event=searchdetail.page&utm_medium=utm_source
For some patients, there is no need to go the hospital next day after chemo. No need in same day injection.
Not related to Aptose. Was searching information about a drug called Sotagliflozin. Found a video with detailed analysis of this molecule in terms of chemical structure, potency, PK, etc. It looks like a chemist view, adjusted to non chemist person. Would like see a video like that for Lux and Tusp. That would help to understand what kind of advantages/disadvantages both drugs might have and what to expect from them.
They don't need to worry about cash now. Company's future depends on Ph1 data.
Good analysis of ASRT and Spectrum acquisition.
https://seekingalpha.com/article/4611296-assertio-close-to-completing-an-unlikely-turnaround
Single agent Tusp is a fastest and least expensive way to bring Tusp to the market. It is a big hurdle, but in the end it would help a lot for future approvals in combinations. One example is manufacturing. Everybody, including big pharma knows that. Don't underestimate it. Single agent approval would be a huge win for Aptose, good for SP and will increase chances for buyout. You are a big fan of Rice, but he cannot deliver. What he is good at is switching your focus after each failure or misstep.
Yeah, after guiding many months that two single arm registrational trials will start this year, it suddenly became a "waste of time". And of course, everybody should forget it. Now you need to focus on combinations. It will take only 1-2 years to start a registrational trial, 2 years to run it, 1 year to submit and NDA and 1 year to get approval. In the year 2028, Tusp will be on the market. 3-4 more dilutions, possibly another R/S and everybody is happy. But wait, it is a only a doublet. In a couple years, we might discover that a doublet is a waste of time and only triplet combination makes sense. And THAT will be the breakthrough. Be patient, drug development is not easy.
They didn't say how phase 1 data will be presented. Primary endpoint of dose-escalation part of their study was finding a RP2D. They said it was done.
Usually, it is a red flag for drug perspectives. Aptose explained it saying that 80 mg dose was partially studied by Hanmi ~3 years ago and patients in 2nd+ line had less options than they have now. Therefore, they were less pre-treated. I guess, FDA was not satisfied by this argument. I think, they are right, because you can bring other explanations which don't look good for Tusp. Not good at all. Therefore, stick to your data.
In general, today's presentation was not positive. They had an EOP1 meeting with FDA. As a result, FDA told them not to use 120 mg as a RP2D and to stick with 80 mg. It is consistent with the results of dose-escalation study, but it is not what Aptose wanted. The meeting didn't bring any clarity on what ORR and mDoR they need to beat in their single arm study. They need to conduct a natural history study and to find out it by themselves. Rice said it is difficult. I guess it is easier to do for Flt3i failures but not for TP53mut and other patient populations. As an alterative, they are thinking about Tusp vs Tusp/Ven trial, where Tusp arm is a control. Not a bad idea but trial will be more expensive and possibly will require preliminary dose-finding. Finally, initiation of a single arm registrational study disappeared from their timeline slide. This is the most annoying thing to learn. Delay after delay after delay. Typical for Aptose. Some hope is on slide 35 where you can find "Large Biotech/Pharma Type Agent". Give it to large pharma.
In today's presentation, David Epstein said that they have completed dose-escalation part of Phase 1, identified a RP2D and will open dose-expansion cohorts later this summer.
"For example, we’ve considered an alternative pegylated filgrastim (such as Spectrum’s eflapegrastim, marketed under the brand name Rolvedon) as a biobetter of Neulasta (pegfilgrastim)".
https://www.primetherapeutics.com/news/biobetters-wait-what-im-just-figuring-out-biosimilars-part-4/
Possibly, no solid ground for lawsuits. Rice didn't deceive anyone. Didn't make false statements.
Preclinical drug formulation is different from clinical. To me, it looks like they didn't analyze solubility of G1 formulation in GI tract environment although it is a simple test. I call it negligence which resulted in waste of time and resources. Had they done this test, they wouldn't have "reasonable expectations". Combinations at the beginning with precipitating drug? Not sure it is a good strategy.
This is an open label dose escalation study. They need to collect data for current dose, present it to FDA and get a green light to start a higher dose. They don't need to report it in 8-K. They can present these data at conferences when they feel the number of patients is adequate to discuss safety and potential efficacy. Most of oncology meetings have a policy prohibiting disclosure of your data before the abstracts are published or before actual meeting presentation.
A couple of quotes. "Precipitation of orally administered drugs in the gastrointestinal (GI) tract is an undesirable process which often can be observed upon the entry of solutes containing poorly soluble weak bases into the small intestine. Precipitation can be a result of a sharp pH change, the dilution of the formulation with GI fluids, or the digestion of solubilizing agents in the formulations."
"In the pharmaceutical industry, various high-throughput methods are applied to determine the kinetic or thermodynamic (equilibrium) solubility of drug candidates. Kinetic solubility is often determined by first dissolving the drug in a polar aprotic organic solvent such as dimethyl sulfoxide and then adding this
drug solution to a buffer in a 96-well plate. The solution is then allowed to equilibrate for a predetermined time in which the drug may precipitate. After filtration, the drug remaining in solution is measured using an UV plate reader".
My question is, why it had not be done before initiation of dose escalation study?
Lux paper is published, "Concomitant targeting of FLT3 and BTK overcomes FLT3 inhibitor resistance in acute myeloid leukemia through the inhibition of autophagy".
https://pubmed.ncbi.nlm.nih.gov/36226489/
Hanmi is presenting Rolontis at ASCO. Wonder why Rolvedon is not presented by Spectrum there?
https://www.koreabiomed.com/news/articleView.html?idxno=21266
If they want to present both NSCLC and GBM data at same meeting, I think "AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS" is more appropriate. Meeting dates: October 11-15, 2023. I am sure they will be asked about it on Friday at Jefferies.
https://www.aacr.org/meeting/aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics-2/
I don't expect major news at Jefferies. Wonder when 1535 data will be presented? They guided 2H 2023, possibly at some meeting. Thinking about WCLC in September.
Mono is a fastest way to the market. By the way this company is operated you cannot ignore this opportunity. As for SL, it might be true only for one or two mutated clones of certain cell line. BTW, no mechanism is offered. If they are serious about it, they should start a new Ven r/r cohort in their combo arm.
Most important is what FDA told them about registrational trial(s). New responses in mono and combo arms of APTIVATE trial could be helpful. Unfortunately, R/S could mute any good news from Tusp program. Unless ORR in combo arm is 100%.
No Lux updates at EHA. Nothing to report?
https://www.aptose.com/news-media/press-releases/detail/265/aptose-to-hold-interim-clinical-update-webcast-on-saturday
HC Wainwright issued their Q3 2023 earnings per share estimates for Spectrum Pharmaceuticals in a research note issued on Friday, May 26th. HC Wainwright analyst E. White expects that the biotechnology company will earn $0.01 per share for the quarter. So, in Q3 they will be profitable but won't exist as an independent company.
Japan's Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations. It can be approved by FDA in same indications by Jul 24, 2023. This approval certainly will affect a design of Tusp registrational study. Big uncertainty is that we don't know whether Tusp works after Quiz in Flt3 mut patients or not.
Unfortunately, any strong data will be viewed as precursor of dilution. Therefore, no decent jump of SP. At best, Aptose is ~2 years away from the results of pivotal Ph2 study. Very long wait. Meanwhile, you will need to have expenses higher. They spent two valuable years and critically needed cash on Lux and APTO-253 but failed to deliver. Keep in mind that it was under favorable market conditions which you don't have here now. Second attempt will be much more painful. Pretty trivial story for a small biotech company. I am also not sure that Rice is a right CEO for challenging times that lie ahead. I can see only one good scenario, it is to be acquired.
What is next? Dilution? Any reason to buy new shares before dilution?
Rice is just the magical ingredient that never fails to bring precipitation in stomach of every investor.
It is why EOP1 meeting is so important. They should gain clarity on drug dose, registrational trial design and patient population, on what FDA wants in terms of outcome, ORR, mDoR, mPFS, how to define mDoR and mPFS for patients bridged to HSCT, etc. I hope, they will become more focused after this meeting.
A few notes from today's RBC presentation.
1. In a couple of weeks, we do have a meeting established. Have a couple of goals for that, one is to establish a RP2D, another is ancillary studies, need healthy volunteer studies, food, fasted, that you can combine drugs, you have to do 13-weeks chronic tox studies, those are ongoing (is it in rats?). And also, to get an idea of registrational path we want to do and some agreements on the terms, what is response rate needed in different categories, r/r, 2nd, 1st line.
2. More data with doublet in October at ESH meeting.
3. Commercial opportunity for Flt3i failures, patients with TP53 mut, Ras mut, each is about $15M (or $50M? not clear).
4. Lux. We don't have money we need to support Lux studies but it is still in clinic. We expect to enroll back, especially patients with B-cell malignancies, DLBCL, MCL, FL, also move into inflammation models.
https://www.veracast.com/webcasts/rbc/healthcare2023/T5xwmm.cfm
I don't believe in CVRs. Based on my experience, they end up worthless.
New Rolvedon sales forecast. "Spectrum Pharmaceuticals' five analysts are now forecasting revenues of US$67m in 2023. Before this consensus update, the analysts had been forecasting revenues of US$55m". But after merger with ASRT who cares.
https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-sppi/spectrum-pharmaceuticals/news/analysts-just-made-a-huge-upgrade-to-their-spectrum-pharmace
They started "A Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation-Positive Cancers"
https://clinicaltrials.gov/ct2/show/NCT05786924?term=NCT05786924&draw=2&rank=1
Good read on Nimbus. Unfortunately it is non publicly traded company. Their approach and structure remind me Cullinan Oncology (CGEM). Besides, CGEM also has HPK1 targeting program.
https://cullinanoncology.com/programs/