Black Diamond Therapeutics Inc News - BDTX

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Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Results from Phase 1 dose escalation trial of BDTX-1535 in GBM patients demonstrated a favorable safety and...

Black Diamond Therapeutics to Participate in Jefferies Global Healthcare Conference

CAMBRIDGE, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a...

Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend]

Black Diamond Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Initial Phase 2 data of BDTX-1535 in 2L/3L EGFRm NSCLC patients on track for Q3 2024Enrollment ongoing in Phase...

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

Black Diamond Therapeutics Announces Presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a...

Black Diamond Therapeutics Announces Changes to Board of Directors

CAMBRIDGE, Mass., April 11, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a...

Black Diamond Therapeutics Presents Novel Real-World Evidence of the Evolving EGFR Mutation Landscape in NSCLC and the Opportunity for BDTX-1535 in an Oral Presentation at the 2024 American Association of Cancer Research Annual Meeting

Real-world data demonstrate non-classical mutations are present in 20-30% of all patients with EGFRm NSCLC...

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TrendTrade2016 2 weeks ago

BDTX HERE WE GO

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Tiger Money 2 weeks ago

Your awesome. Thanks!

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TrendTrade2016 2 weeks ago

BDTX...LOOKS LIKE 6.15 COMING UP

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TrendTrade2016 2 weeks ago

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

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Tiger Money 2 weeks ago

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!

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TrendTrade2016 2 weeks ago

BDTX ON THE WEEKLY SET UP TO BREAK

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dcaf7 3 weeks ago

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

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dcaf7 3 weeks ago

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.

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dcaf7 3 weeks ago

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.

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dcaf7 1 month ago

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

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dcaf7 1 month ago

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

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G. Angue 1 month ago

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?

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dcaf7 1 month ago

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

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Monksdream 2 months ago

BDTX new 52+ week high

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dcaf7 2 months ago

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".

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dcaf7 2 months ago

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".

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Monksdream 2 months ago

BDTX under $10

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dcaf7 2 months ago

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.

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G. Angue 2 months ago

We’ve got a winner 🫡

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dcaf7 2 months ago

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

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dcaf7 3 months ago

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.

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Monksdream 3 months ago

BDTX under $10

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dcaf7 3 months ago

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.

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dcaf7 4 months ago

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.

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G. Angue 4 months ago

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

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dcaf7 4 months ago

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.

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SlickNASDAQ 4 months ago

Is this suppose to be a good thing?

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dcaf7 4 months ago

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

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Tartiaboy 4 months ago

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.

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dcaf7 4 months ago

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/

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dcaf7 4 months ago

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.

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dcaf7 4 months ago

Cannot post. Something is wrong with iHUB.

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Tartiaboy 4 months ago

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

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dcaf7 4 months ago

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

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G. Angue 5 months ago

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

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dcaf7 7 months ago

Listened to yesterday fireside chat of Mark Velleca with Stifel analyst. It was first public appearance of Mark as a CEO of BDTX. I like how he answered analyst questions. He gave a clue to what we might expect from GBM part of BDTX-1535 study. He said that opportunity is in newly diagnosed patients where EGFR could be the major driver. My interpretation is that 1535 alone does not work well in recurrent GBM. However, combination of 1535 with Temozolamide in newly diagnosed GBM might work. He also talked a few minutes on a new study with BDTX-4933. Interestingly, he called this drug a Ras clamp. It clamps Ras in inactive conformation.

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dcaf7 8 months ago

From BB Biotech (BION), a Switzerland-based investment company,
"Notable recent transactions include an addition to the company’s holding in Black Diamond Therapeutics, a targeted oncology player. Promising clinical data on BDTX-1535, a treatment for lung cancer, allowed Black Diamond to undertake a capital raising. BION made an additional investment to maintain its 15% ownership stake in the company. Exposure to Black Diamond was raised further via open market transactions. The managers like this company in part due to its deployment of massive computational power and machine learning to deepen its understanding of disease processes and speed up the identification and development of new treatments".
https://www.edisongroup.com/research/a-cutting-edge-sector-and-a-high-dividend/32799/

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dcaf7 8 months ago

Correction, for $2.3/share.

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dcaf7 8 months ago

Biotech Growth bought 400,000 shares of BDTX for $2.3M.
https://investors.blackdiamondtherapeutics.com/static-files/95be4946-8d92-41b8-a8e6-247129c9cd56

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dcaf7 8 months ago

Oct. 16, 2023, 05:15 AM
Piper Sandler analyst Joseph Catanzaro maintained a Buy rating on Black Diamond Therapeutics (BDTX – Research Report) today and set a price target of $11.00.

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dcaf7 8 months ago

Maybe more important, PK is considered as a biomarker that would potentially increase chances for remission in patients with highest levels of BDTX-1535 in tumor.

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dcaf7 8 months ago

St. Joseph's Hospital and Medical Center in Phoenix is initiating a Phase 0 "Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions". The idea is to give patients BDTX-1535 prior to a planned resection. "During surgery, blood, tumor, and CSF samples will be collected to measure the amount of drug that is present in the samples. Participants with tumors demonstrating PK response will continue with once-daily BDTX-1535 treatment, continuously in 28-day cycles after surgery". Interesting. I guess it is the best way to study PK of drug in brain tumor.
https://classic.clinicaltrials.gov/ct2/show/NCT06072586?term=BDTX&draw=2&rank=3

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dcaf7 8 months ago

It looks like some PRs are durable. Question is what is median duration of response?
https://s3.us-east-1.amazonaws.com/black-diamond-assets.investeddigital.com/files/2023_BDTX-1535_NSCLC_Phase_1_Clinical_Poster.pdf

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FACT-MASTER 8 months ago

BDTX: New article

Top of the list here: (10-12-2023)

https://www.stockilluminati.com/bdtx/news.php

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FACT-MASTER 9 months ago

Thanks dc,

I'm not sure if David resigned though, it sounded more to me that he was removed by the BOD.

Could it be possible that the BOD ousted Epstein on account of finding out about his relationship with PairX?.. and to the extent of licensing ip!!

https://www.pairxbio.com/post/duke-nus-spinout-pairx-bio-launches-with-strong-biotech-credentials-venture-capital-backing

"“I am delighted that Duke-NUS, Esco Ventures, Avendesora and the PairX founding team are partnering to commercialise our platform and pipeline of novel cancer antigen–T cell pairs. This seed financing uniquely positions PairX to advance precision immunotherapies designed to treat cancer patients defined by shared mRNA splicing defects,”
- Adj Assoc Prof Epstein

Theory: BOD saw this
https://www.biospectrumasia.com/news/54/16545/pairx-bio-launches-venture-capital-backing-targeting-cancer-immunotherapies.html
contacted David - "your fired".

(imo though, PairX is cutting edge in the TCR-T category and Epstein sees the future of this)

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FACT-MASTER 9 months ago

BDTX: Black Diamond Therapeutics to Present Preclinical and Clinical Data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

https://finance.yahoo.com/news/black-diamond-therapeutics-present-preclinical-161400478.html

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dcaf7 9 months ago

As I can see, David Epstein is a CEO of PairX Bio since Sep 2023. He is also a founder of this company. It can explain why did he leave BDTX.
https://www.linkedin.com/in/david-m-epstein-8836593/

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dcaf7 9 months ago

I think, recent SP decline is related to three factors. 1. World Conference of Lung Cancer in September where several studies on drugs targeting EGFR mutations in lung cancer were presented, including 4th generation TKIs. It showed that market is relatively crowded. 2. Outcome of Janssen Landmark Phase 3 MARIPOSA Study where RYBREVANT plus lazertinib beat Osimertinib in 1st line EGFRmut NSCLC. It should affect BDTX strategy for 1535 development. Placing it post Osimertinib might became not so relevant. 3. CEO employment termination without cause.
Guess, all eyes are on data readout in GBM this quarter.

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FACT-MASTER 9 months ago

I don't think it is clinical data related, in this instance.

Done a bit of digging but need to verify some pieces of the puzzle.

Will send you a PM once i am sure of my dd.
( it's going to take me a while to check out a few things, limited time and swamped with my own work)

imo, this is not clinically related and believe BDTX is still on track with their excellent trials.

The replacement, Mark Valleca appears to be well experienced with medical development and the FDA.
This should bode well for BDTX as they move their clinical trials forward.

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Black Diamond Therapeutics Inc (BDTX)

Professional-Grade Tools, for Individual Investors.

BDTX News

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Black Diamond Therapeutics to Participate in Jefferies Global Healthcare Conference

Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend]

Black Diamond Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

Black Diamond Therapeutics Announces Presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Black Diamond Therapeutics Announces Changes to Board of Directors

Black Diamond Therapeutics Presents Novel Real-World Evidence of the Evolving EGFR Mutation Landscape in NSCLC and the Opportunity for BDTX-1535 in an Oral Presentation at the 2024 American Association of Cancer Research Annual Meeting

Black Diamond Therapeutics to Participate in Upcoming Investor Conferences

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]

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Professional-Grade Tools, for Individual Investors.

BDTX News

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Black Diamond Therapeutics to Participate in Jefferies Global Healthcare Conference

Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend]

Black Diamond Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

Black Diamond Therapeutics Announces Presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Black Diamond Therapeutics Announces Changes to Board of Directors

Black Diamond Therapeutics Presents Novel Real-World Evidence of the Evolving EGFR Mutation Landscape in NSCLC and the Opportunity for BDTX-1535 in an Oral Presentation at the 2024 American Association of Cancer Research Annual Meeting

Black Diamond Therapeutics to Participate in Upcoming Investor Conferences

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]

BDTX Discussion

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