Review on IO in metastatic uveal melanoma (plus my take on Glemba in metastatic UM and strategic approach to Glemba commercialization):
1. The review reports sobering facts regarding metUM: - mean OS of less than 6 months. - 80% death rate at 1 yr. - checkpoint inhibitors demonstrate an average 4% ORR (and that's considered an encouraging development in treating metUM).
2. Glemba PII mentioned as an ongoing immune-based clinical trial:
"...a phase II study of glembatumumab-vedotin, a monoclonal antibody-drug conjugate targeting glycoprotein NBM and conjugated to the cytotoxic agent monomethyl auristatin E (MMAE) (NCT02363283), are ongoing...."
3. We know the results of the first stage of the glemba/metUM PII trial as presented at ISOOB conf. 3/17: - ORR = 11% - stable disease = 68% - Disease control rate = 79% - these results are 3x better than checkpoint inhibitors, and as I posted previously warrant FDA approval due to severe unmet need.
4. Commercialization strategy: - at the 3/17 presentation one of the slides showed that they had 31 pts enrolled out of target of 34. - Dr. Patel indicated that the trial will be completed in 2Q'17. - CLDX needs to get on this like there is no tomorrow and focus major effort and resources on obtaining rapid FDA approval. - CLDX mngmnt should be preparing the groundwork by starting to spread the word (how about AM and TD having lunch with AF just like before...). - once Glemba is approved for metUM, the door is open to possible global approval based on GPNMB+ marker in a variety of cancers- the FDA has mentioned adopting this policy, and the other day delivered the first such approval for an IO drug.
Immunotherapy for the Treatment of Uveal Melanoma: Current Status and Emerging Therapies
Uveal melanoma is a distinct subset of melanoma with a biology and treatment approach that is unique from that of cutaneous melanoma. Here we will review the current data evaluating immunotherapies in
Uveal Melanoma trial was updated on clinical trials gov on May 24. Enrollment was increased from 34 to 35 and the protocol language was cleaned up.
Earliest time for NDA approval for MUM or Advanced Melanoma is end of 2018. Recurrent GBM through alternative submission pathways or priority review or breakthrough designation might speed things up.
The only thing to move the stock price now are the words "Submission", "NDA", and/or "partnership". We need to raise cash through partnership right now.
The fact that there was no layoff after Rindo nGBM failure, which is routine in R+D, is baffling. Kolltan acquisition is more baffling. His narrower focus of the pipelines is good. He finally understands Drug Development resourcing. His hire for an experienced Regulatory head is good. He now understands this is a critical position.
Clinical trials is just another battleground between companies.
Either Marucci is a complete idiot or he knows that drug approval is nearly certain. Right now, I am not certain of either.
Research: A+ Development: C+/B- Commercial: God help us.
CLDX key execs should not get their paychecks until their drugs approved by the FDA.. they got paid too much for accomplishing nothing.. it is time to put stop to this BS, over paid, over staffs, zero delivery. It is only fair to investors that CLDX execs must get no paychecks until producing an FDA approved drug or partnership that enhance investor values. Enough is enough already.. no more free meals for these non-productive execs.. time to drain the swamp NOW...
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomar
Does AD know what a revenue producing event is for stockholders or is it that he didn't know the timing? I hope I didn't miss it.
Anything someone says on yahoo post here has nothing to do with how much the share price moves so for you to talk about pumpers let them think they are pumping I've already bought long and probably going to purchase more. Remember not a single statement from anyone here is moving the price. Trust yourself
Glemba with 22% ORR with rash in cycle 1. This is good enough for approval in this refractory patient population. Someone in the board had hinted at this possibility in the past week or 2.
Do you think they poisoned the results of the Rintega trial? Can you prove that?
I found this bulletin that's almost a year old that provides more information about METRIC accrual than Celldex management has ever shared publicly. Of note is the slow pace of enrollment at that time and the references to Data Monitoring Committee meetings that recommend the trial proceed. I tried to find a more recent similar bulletin, but no luck.
Yeah...great news yesterday for CLDX. Already dropping on a measly 12000 shares. Ive said it before and ill say it again. CLDX burned their bridges with wall st on the Rintega scam
Head and Neck/Ovarian Should be exciting if we get to see the P1 Nivo/Varli results in HNSCC and ovarian Wednesday. Enrollment for both indications was bumped up dramatically from 18 to 54 versus original design. Both indications have seen CPI responses in the teens as mono therapy. I'm guessing RCC and colorectal indications were decent but not spectacular. But if the results are really strong Wednesday then 3379 in head and neck and 014 in ovarian would both lend themselves to combo therapy with varli in the not too distant future.
A phase II study of glembatumumab vedotin (GV), an antibody-drug conjugate (ADC) targeting gpNMB, in advanced melanoma. | 2017 ASCO Annual Meeting Abstracts
109 A phase II study of glembatumumab vedotin (GV), an antibody-drug conjugate (ADC) targeting gpNMB, in advanced melanoma. Patrick Alexander Ott, Anna C. Pavlick, Douglas Buckner Johnson, Lowell L. Hart, Jeffrey R. Infante, Jason John Luke, Jose Lut
Resident idiots....aka pumpers. CLDX is sitting at a measly $3. Please inform us again about how great Glemba and Varli are. We will all be eagerly awaiting your excuses.
Two questions from a relative newbie on this board.
1) Does CLDX management often post results without conducting a conference call with Q&A? 2) On April 18, 2016, there was a press release....Celldex Therapeutics Presents Favorable Safety Profile and Immune Response Data from Phase 1/2 Study of Varlilumab and Nivolumab at the AACR Annual Meeting 2016....my question is .....are the clinical results to be reported at ASCO the formal presentation of the April 18 profile numbers...hope this question makes sense....essentially I'm asking does it take a year plus to present what CLDX stated on April 18, 2016?....They stated positive results and now are just following up with the official numbers?
Abstract: 3007 - Phase 1 dose-escalation study of varlilumab and nivolumab in multiple solid tumors
"A total of 36 patients (21 CRC, 8 ovarian [OVA], 4 melanoma and 3 SCCHN) were enrolled."....I know they are still recruiting patients for the phase 2...from the year end call, " The Phase 2 study of varlilumab and Opdivo continues to enroll patients across multiple indications [colorectal cancer (n=18), ovarian cancer (n=54), head and neck squamous cell carcinoma (n=54), renal cell carcinoma (n=25), glioblastoma (n=20)]. "....so Bristol Meyers Squibb has ALOT more to enroll for phase 2.
Background: A phase 1 trial to assess the safety and immunological activity of the combination of varlilumab (V) and nivolumab (N), and recommend a dose of V for the phase 2 study was conducted. Methods: The study was performed using the approved dose of N (3 mg/kg Q2W) and escalating doses of V (0.1, 1, or 10 mg/kg Q2W) in anti-PD-(L)1 naïve patients with advanced cancer. Results: A total of 36 patients (21 CRC, 8 ovarian [OVA], 4 melanoma and 3 SCCHN) were enrolled. Toxicity was consistent with the safety profile of each agent individually; no unexpected toxicities were seen with the combination. No MTD was identified. An OVA cancer patient in the 10 mg/kg cohort had a DLT: hepatitis (G4) and acute kidney injury (G3). A CRC patient in the 10 mg/kg cohort had a drug-related SAE of mixed motor sensory neuropathy (G2) and a CRC patient in the 1 mg/kg cohort had rash (G3). No additional drug related SAEs or DLTs were reported. The majority of tumors were PD-L1 negative (24/27) by IHC at baseline. For patients with post treatment biopsies, PD-L1 expression was observed in 43.5% (10/23) and correlated with increases in CD8 T cell infiltration, consistent with the generation of anti-tumor immunity. Other treatment related biomarker changes included transient increases in serum chemokine levels, and a prominent decrease in circulating Tregs. Biomarker analysis did not clearly differentiate between dose levels, or delineate an optimal V dose. Three patients had objective PR by RECIST [CRC MSI-low (1 mg/kg V), SCCHN (10 mg/kg V) and OVA (10 mg/kg V, uPR)]. The response in the CRC patient is ongoing with a 94% decrease in target lesion diameter and a PFS of 19+ months. There were also 11 patients with SD. Phase 2 cohorts are ongoing in RCC, SCCHN, OVA, CRC and GBM. The Phase 2 portion includes exploration of different dose/regimens of V, including high and low exposure, to better characterize the optimal dosing strategy for V, in combination with a fixed dose of N (240 mg Q2W). Conclusions: The combination of V and N was well tolerated, associated with strong biological signals, and has evidence of clinical activity in subsets of patients with tumor types that are typically resistant to PD-1 inhibitor monotherapy. Clinical trial information: NCT02335918
pumpies started deleting their posts quickly to hide their stupidity.. they keep justifying every reason of why CLDX keeps going down and down. They thought the same BS abstracts and oral presentation at HCC would make a different, unfortunately investors have seen this movie before and they ain't buying it... Wake up.. this is another bio-scam ... this company's founders and top execs have no dog in this fight, they just milking the cash until it's running low, and then they bail.. time is running out... GL!!!!!!
A number of large investors have recently added to or reduced their stakes in CLDX. KLP Enterprises LLC purchased a new stake in Celldex Therapeutics during the fourth quarter worth $24,302,000. FMR LLC increased its stake in Celldex Therapeutics by 40.3% in the fourth quarter. FMR LLC now owns 19,327,111 shares of the biopharmaceutical company’s stock worth $68,418,000 after buying an additional 5,555,595 shares during the last quarter. Meditor Group Ltd purchased a new stake in Celldex Therapeutics during the first quarter worth $14,966,000. Columbia Wanger Asset Management LLC increased its stake in Celldex Therapeutics by 113.1% in the fourth quarter. Columbia Wanger Asset Management LLC now owns 6,195,855 shares of the biopharmaceutical company’s stock worth $21,933,000 after buying an additional 3,288,332 shares during the last quarter. Finally, Vanguard Group Inc. increased its stake in Celldex Therapeutics by 16.4% in the first quarter. Vanguard Group Inc. now owns 9,066,763 shares of the biopharmaceutical company’s stock worth $32,731,000 after buying an additional 1,278,206 shares during the last quarter. Institutional investors and hedge funds own 55.99% of the company’s sto
First day I've seen low volume and and in the green this is enticing coming into next week
From Street dot com Here's a quick summary of the overall response rates for epacadostat-Keytruda, parsed by tumor type: Urothelial (bladder) cancer: 35% (13/37), all partial responses. Renal (kidney) cancer: 30% (9/30), one complete response, eight partial responses. Head-and-neck cancer: 31% (11/36), two complete responses, nine partial responses. Non-small cell lung cancer 35% (14/40). all partial responses. [Melanoma data have been presented previously.] ASCO released a single abstract tonight describing preliminary ECHO-204 phase II data from epacadostat-Opdivo combination in a variety of tumor types. Here's a quick summary of the response rates: Head-and-neck cancer: 70% disease control rate, which combines objective tumor responses and stable disease. Melanoma: Lower dose ORR 75% (6/8), all partial responses. At higher dose, disease control rate of 64%. Ovarian cancer: 14% (4/29), all partial responses.
Abstract from CLDX is not bad data - wait for the update at their presentation.