Black Diamond Therapeutics Inc (BDTX) Noticias

Good analysis of today released data.
https://www.oncologypipeline.com/apexonco/black-diamond-joins-arrivent-pacc-pack

Got to see the angles before they are played.
Great cancer plays wildly under valued BDTX and ICCM & SMMT
https://www.blackdiamondtherapeutics.com/pipeline-programs/pipeline

Black Diamond Therapeutics Announces Initial Phase 2 Data Demonstrating Robust Anti-tumor Activity of BDTX-1535 in Patients with Recurrent EGFRm NSCLC who Present with a Broad Spectrum of Classical, Non-classical, and C797S Resistance Mutations.

Black Diamond Therapeutics up over 140% since entry this year.

https://www.blackdiamondtherapeutics.com/about/our-vision

$BDTX

42% ORR, let’s go Dcaf!!!!

Black Diamond Therapeutics Announces Initial Phase 2 Data Demonstrating Robust Anti-tumor Activity of BDTX-1535 in Patients with Recurrent EGFRm NSCLC who Present with a Broad Spectrum of Classical, Non-classical, and C797S Resistance Mutations

In PR from Sep 14, Elizabeth Buck said,
“BDTX-1535 was designed to address a broad spectrum of EGFR mutations, with emphasis on non-classical mutations that extend beyond PACC mutations”. This phrase caught my attention. Why? Because of Arrivent data presented at WCLC meeting on Sep 9, 2024. Their drug, firmonertinib, demonstrated pretty strong efficacy in NSCLC patients with EGFR non-classical mutations in Phase 1b trial. Possibly, it's why BDTX share price has been down lately. The difference between Arrivent and BDTX trials is in patient populations. Arrivent is recruiting patients with PACC mutations with no prior TKI exposure as 1st or 2nd-line treatment. BDTX is enrolling all patients after osimertinib/other TKI in 2nd/3d line in cohorts 1 and 2, and TKI-naïve patients in cohort 3. Cohorts 1 and 3 recruit patients with all non-classical mutations, including PACC mutations. Data from cohorts 1 and 2 will be released by the end of Q3 and I don’t think we should compare them with firmonertinib results. But data from cohort 3, expected in Q1 2025 might show which drug is better to treat patients with PACC mutations.

The stock has been gyrating for months now, I think we’re going to get good news next week

The last paragraph in the PR is about NCM in newly diagnosed patients. Therefore, it makes sense to say about first line data first and second line data after it, even though expected data readout chronologically are in opposite order. But who knows. The recent share price decline looks suspicious.

Dcaf, any concern about the September 14th press release that kind of the left the end of September second / third line P2 data as an afterthought in the final sentence?

Abstract for poster presentation at ESMO 2024 was published.
Title: Real-world evidence of treatment practices and therapeutic outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations demonstrates high unmet medical need.
It is BDTX-sponsored study conducted by John Heymach lab. He is the first author of the abstract. They analyzed 11,434 sequenced cases of newly diagnosed and treatment naïve EGFRm NSCLC and found that 22% of patients have non-classical EGFR mutations (NCMs). They concluded that compared to NSCLC patients expressing classical EGFR mutations, patients expressing NCMs discontinue EGFR inhibitor treatment sooner, and chemotherapy remains the most common treatment, with poor patient outcomes. Moreover, the co-expression of osimertinib-resistant NCMs with L858R may contribute to inferior outcomes versus patients with L858R alone. These real-world data underscore the unmet medical need of patients expressing NCMs, and the opportunity for a 4th-generation TKI that potently inhibits NCMs in the newly diagnosed setting.

Raymond James initiated coverage of Black Diamond Therapeutics (BDTX) with an Outperform rating and $20 price target. The firm sees the potential for BDTX-1535 to potently target a broad spectrum of Estimated Glomerular Filtration Rate mutations in non-small cell lung cancer that are inadequately addressed by current standard of care, including non-classical EGFR mutations, osimertinib resistance mutations, and the L855R classical mutation, the firm tells investors in a research note.

BDTX under $7

On Thursday, Piper Sandler reiterated its Overweight rating on Black Diamond Therapeutics stock, maintaining a $12.00 price target.
The firm's confidence in the company remains steadfast following a recent investor lunch with BDTX management. The discussions emphasized the potential of BDTX-1535 in the treatment spectrum of EGFR NSCLC (non-small cell lung cancer).
The management of Black Diamond Therapeutics presented their development strategies, focusing on the role BDTX-1535 could play following the use of osimertinib. They highlighted an expected objective response rate (ORR) of 30-40% for the upcoming third-quarter 2024 readout as a positive indicator.
Additionally, the company sees a potential for BDTX-1535 after adjuvant osimertinib and as a first-line therapy for non-classical mutations, with an ORR of over 50% in this group indicating a clear path for development.
The discussions also touched upon the possibility of BDTX-1535 competing against osimertinib in patients with the L858R mutation. Piper Sandler expressed optimism about the broad mutational coverage of BDTX-1535, considering it a significant aspect of the drug's profile within the EGFR NSCLC market.
The anticipation of Phase II data for BDTX-1535 in 2L+ EGFR NSCLC expected this quarter has been noted as a potential turning point. Should the forthcoming data validate the drug's profile, it could mark a significant inflection point for the company. Piper Sandler's outlook suggests that the upcoming clinical readouts could reinforce BDTX-1535’s standing in the treatment landscape for EGFR NSCLC.

BDTX under $5

Piper Sandler maintains Overweight on Black Diamond stock.

On Wednesday, Piper Sandler reaffirmed its Overweight rating on Black Diamond Therapeutics (NASDAQ:BDTX) with a steady price target of $12.00. The firm's focus was on the upcoming initial Phase II data for BDTX-1535 in treating EGFR+ NSCLC. The analyst highlighted the importance of the response rate to platinum chemotherapy, which is a current standard, as a benchmark for BDTX-1535's success.

The assessment of BDTX-1535's clinical efficacy during the dose-escalation stage was revisited, with expectations set on what would constitute a positive and clinically meaningful outcome. The response rate to platinum chemotherapy, which stands at 27%, was cited as a significant comparator, suggesting that an Objective Response Rate (ORR) of 37% or higher, along with signs of durability, would be favorable. Such results could solidify the drug's position for further development and positive implications for future first-line non-classical readouts.

Black Diamond Therapeutics is in the spotlight as it prepares to release its Phase II data for BDTX-1535. This data could potentially establish the drug as a next-generation EGFR tyrosine kinase inhibitor (TKI). The firm's anticipation is based on the Phase I data, which has shown promising results across various analyses.

The steadfast Overweight rating by Piper Sandler indicates confidence in Black Diamond Therapeutics' prospects. The $12.00 price target remains unchanged, reflecting the firm's positive outlook on the company's ongoing clinical trials and the potential of BDTX-1535 to advance in the development pipeline.

BDTX 6.15 BREAK

BDTX HERE WE GO

Your awesome. Thanks!

BDTX...LOOKS LIKE 6.15 COMING UP

BULLISH ON THE WEEKLY BUT NOT ON THE 4 HOUR SO A TIGHT MENTAL STOP IS NEEDED

Thoughts here? As always, I appreciate your work and help! I love your posts as they make me laugh as there is so much idiocracy out there!

BDTX ON THE WEEKLY SET UP TO BREAK

An opinion of Dr. Lovly on BDTX-1535 in NSCLC with EGFR mutations.
https://www.onclive.com/view/dr-lovly-on-the-investigation-of-bdtx-1535-in-nsclc

Piper Sandler reaffirms overweight rating on Black Diamond Therapeutics stock.
Published 03/06/2024

On Monday, Piper Sandler sustained its Overweight rating on Black Diamond Therapeutics (NASDAQ:BDTX), with a steady price target of $12.00. The firm's assessment follows recent presentations at the American Society of Clinical Oncology (ASCO) where Black Diamond Therapeutics showcased early clinical results for its drug BDTX-1535, particularly in recurrent glioblastoma multiforme (GBM).

At ASCO, the company revealed two sets of data concerning BDTX-1535. The highlight was the drug's confirmed ability to penetrate the central nervous system (CNS). In a window of opportunity study, 8 out of 9 GBM patients demonstrated CNS exposure levels surpassing the predefined pharmacokinetic thresholds, which are five times higher than the IC50 against relevant EGFR alterations in GBM. This included 6 of 7 patients at a 200 mg once-daily dosage, which is also the dose currently under evaluation for non-small cell lung cancer (NSCLC).

While plans for BDTX-1535 in GBM treatment remain to be determined, the data presented are considered significant for assessing the drug's clinical potential in NSCLC, especially for its intracranial efficacy. The anticipation for BDTX-1535's utility is further heightened by the expected release of initial Phase II data in third-line or later treatment for EGFR-positive NSCLC, which is slated for the third quarter of 2024.

The positive outlook on BDTX-1535's CNS penetration is key because it supports the drug's potential effectiveness in treating intracranial diseases, a critical factor for NSCLC patients with EGFR mutations. The upcoming Phase II data release is seen as a pivotal event that could substantially impact Black Diamond Therapeutics' drug development trajectory.

The company's focus now shifts to the anticipated Phase II results, which could serve as a major catalyst for BDTX-1535, especially if the data aligns with the promising outcomes observed in the GBM studies. The maintained price target by Piper Sandler reflects confidence in the drug's prospects and Black Diamond Therapeutics' ability to navigate the next stages of clinical trials.

Both ASCO posters are available at BDTX website. In the abstract of phase 0-1/window of opportunity poster they say "a clinical readout is planned in Q4 2024". However, under Interim Conclusion you can see that "clinical readout is planned in Q3 2024". Not sure how to interpret PD data. Treatment with BDTX-1535 causes median decrease in pEGFR by 77%, but it has no effect on median pERK.

ASCO has released the abstracts for its upcoming meeting. Here is results from "window of opportunity" study. "A total of 7 patients with recurrent glioblastoma (Arm A) were enrolled in the Phase 0 component of the study. Two patients were excluded from PK analysis due to pseudoprogression. The mean unbound concentrations of BDTX-1535 in Gd-enhancing and nonenhancing tumor regions were 16.0 nM and 10.5 nM respectively. Four of five (80%) evaluable patients exceeded the PK threshold. The suppression of pEGFR and MIB1 was observed in 40% and 60% of patients, respectively. No serious adverse events were observed among patients in the Phase 1 component of the study and a clinical readout is planned in Q2 2024".
Are they going to present efficacy data at ASCO or later in June? It looks like concentration of BDTX-1535 in tumor is high enough to expect tumor shrinkage.
https://meetings.asco.org/abstracts-presentations/239008

I think, 1st line patient population with non-classical mutations is ~20,000. Not sure about cost. Osimertinib is ~$18,000/month.

DCAF— what’s the patient population for NSCLC with non-classical mutations. 10,000? And is it reasonable to assume the drug would sell for somewhere between 100k-200k?

Interesting, both BDTX-1535 and BDTX-4933 are listed as AI-discovered molecules (See Table S2).
https://ars.els-cdn.com/content/image/1-s2.0-S135964462400134X-mmc1.pdf
From paper https://www.sciencedirect.com/science/article/pii/S135964462400134X?via%3Dihub#s0040

BDTX new 52+ week high

Title of the second abstract, "Phase 1 study of BDTX-1535, an oral 4th generation covalent EGFR inhibitor, in patients with recurrent glioblastoma: Preliminary dose escalation results".

Titles of ASCO presentations are available.
Here is a title of BDTX-1535 presentation, "A phase 0/1 trigger trial of BDTX-1535 in patients with recurrent high-grade glioma (HGG) with EGFR alterations or fusions".

BDTX under $10

From today's presentation.
We don’t need to demonstrate activity on any single non-classical mutation to get a broad label. We need to cover a few mutations across certain subcategories of no-classical mutations shown in AACR presentation. These subcategories include L858R+non-classical, classical-like, PACC alone and complex, other non-classical, ecto- and juxtamembrane domain mutations.

We’ve got a winner 🫡

The prevalence of non-classical EGFR mutations is approximately four times higher than that of EGFR Exon 20 insertions.

On Monday, Wedbush, a financial services firm, increased its price target for Black Diamond Therapeutics (NASDAQ:BDTX) shares to $16.00, rising from the previous target of $10.00. The firm has maintained an Outperform rating on the stock.

This adjustment follows Black Diamond's presentation at the American Association for Cancer Research (AACR) which highlighted the potential market for its drug candidate BDTX-1535 in the treatment of non-classical EGFR mutations and osimertinib-resistance mutations in non-small cell lung cancer (NSCLC).

According to the analysis presented by Black Diamond, non-classical EGFR mutations are highly prevalent, found in 22-30% of first-line treatment-naïve EGFR-mutated NSCLC cases. This prevalence is approximately four times higher than that of EGFR Exon 20 insertions. The firm noted that patients with these non-classical mutations often have a poor response to existing EGFR inhibitors.

Additionally, the mutations, along with C797S, represent a significant mechanism of resistance to current EGFR inhibitors. Wedbush believes that BDTX-1535 could be a leading therapy for patients with non-classical and C797S mutations. The firm sees promising development opportunities for the drug in various treatment settings, including post-adjuvant, first-line (1L), and second-line (2L) post-osimertinib.

Black Diamond Therapeutics has recently begun a Phase 2 cohort study of BDTX-1535 in a first-line treatment setting following feedback from the FDA, with initial data expected in 2025.

The company is also anticipating Phase 2 data from second and third-line (2L/3L) cohorts for patients with C797S and/or non-classical mutations, and non-classical mutations alone, which are expected to be released in the third quarter of 2024.
https://www.investing.com/news/company-news/wedbush-raises-black-diamond-stock-target-on-drug-potential-93CH-3369858

Slides from AACR presentation are posted.
https://investors.blackdiamondtherapeutics.com/events-presentations#target-2
Look at slides 8-10. I counted more than 80 mutations on X-axis. Great contribution from Heymach lab, a lot of work. Most important is that BDTX-1535 works for all of them with minimal effect on wild type EGFR (slide 10). Although it is preclinical data, even not in mouse experiments, the drug shows strong antiproliferative effect and differentiated profile. Waiting for GBM data in 2ndQ and more clinical data in EGFRmut NSCLC in 3dQ.

BDTX under $10

Listened to Mark Velleca at Cowen Health Care Conference. One question to him was "What BDTX-1535 success looks like?" He said, in 2nd/3d line, ORR of 30%+ and mDoR of 6 mo. In 1st line with non-classical mutations, ORR of 50%+ and mDoR of 12 mo.

Expect GBM data at ASCO in June. As I understand, they will present data from phase 1 study where GBM is a separate cohort and from the second early phase 1 GBM study, called "Window of opportunity" where treatment is first line, EGFR status is confirmed and concentration of drug in tumor was measured. Second trial will provide more valuable information. If positive, BDTX will initiate a registrational trial in first line patients.

Is this GBM data readout in April potentially needle moving? I.e if the partial response rate is high enough does it imply 1535 can really help with GBM or does the nature of the P1 level mean we can’t read that much into it

It helps to understand why 1535 is a good drug after Osimertinib and why you may want to use it instead of Osimertinib in first line.

Is this suppose to be a good thing?

BDTX-1535 abstract for AACR presentation is released. There is no clinical data, it is about science. This study was conducted mostly by scientists from MD Anderson Cancer Center including John Heymach, who is an expert in EGFR/HER2 mutations in NSCLC. They discovered that treatment of two classical EGFR mutations, Exon 19 deletions and L858R, by Osimertinib results in two different resistance outcomes. Patients with Exon 19 deletions usually develop C797S resistance mutation whereas patients with L858R develop multiple non-classical resistance mutations. They also found that non-classical mutations often co-exist with L858R in first-line patients, making Osimertinib treatment less effective. For these patients BDTX-1535 should be a better option.
https://www.abstractsonline.com/pp8/#!/20272/presentation/8874

Thanks for the response. I agree 1535 looks promising. I plan to follow it closely. I am also interested in their RAF inhibitor (4933). I follow VSTM very closely. They are focused on RAS pathway inhibitors. Both VSTM and IKNA have RAF/MEK clamps in trials. VSTM is in the lead. It will be interesting to see how BDTX positions 4933 in the context of current RAF inhibitors and these new clamps.

Good to know, "if all goes well the drug could move into phase 3 in 2025, and hit the market in 2027".
https://www.pharmavoice.com/news/black-diamond-cancer-mutations-market-approval/709074/

So far, I like what I see. 1535 has a nice PK profile and it definitely has activity for non-classical mutations and C797S. Therefore, it potentially has a place in the market for post Osimertinib patients. First line non-classical also looks reasonably promising. I am not sure about GBM. Their “Window of Opportunity” trial is unusual by design. I've never heard of other drugs being tested that way, but I guess it is the only way to get a clear answer. We’ll see the data at ASCO. If positive, the company will be in a unique position to address unmet medical needs of patients with EGFR mutated GBM. Cannot say much about their second drug, BDTX-4933. Pre-clinical data looks good, but I won’t speculate on drug activity until I see at least early clinical data.

Cannot post. Something is wrong with iHUB.

Thanks for the link. Interesting. What's your current opinion of BDTX? TIA.

Good read on BDTX-1535 and EGFR mutations. Expect some data at AACR in April and ASCO in June. Note, "As such he’s happy to accept that BDTX-1535 has no activity on T790m". It is what I suspected reading and listening to last year company presentations. But it is OK with me. Drug looks good for non-classical and C797S mutations.
https://www.oncologypipeline.com/apexonco/black-diamond-picks-its-lung-cancer-battle

The stock has been heating up the past couple of weeks… it seems like the data readouts for 1535 since the latest equity raise have been positive, and the new CEO had real success getting FDA approval at CGI before selling to Gilead and later taking G1 to Phase 3 and an IPO. This guy seems to have robust (dare i say overqualified) commercialization experience for a tiny biotech with promising P1 assets for solidly sized patient populations with unmet needs— either I’m missing something here, or the stock trading below their latest funding valuation is a pretty attractive entry price no? I’ve been seriously looking into it and have appreciated reading through @dcaf and @Fact Checkers posts on here thanks guys