dcaf7
3 days ago
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.
dcaf7
3 weeks ago
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.
dcaf7
2 months 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.
dcaf7
3 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
dcaf7
5 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
dcaf7
5 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.
dcaf7
9 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/
FACT-MASTER
10 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)