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Still lining their FDA ducks up:
Cellectar Biosciences Gets Orphan Drug Designation for Lymphona Treatment
BY Dow Jones & Company, Inc.
— 8:46 AM ET 01/06/2020
Cellectar Biosciences Inc. (CLRB) said Monday the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation to CLR 131 in lymphoplasmacytic lymphoma.
The company said CLR 131 is its lead Phospholipid Drug Conjugate product candidate currently in a Phase 2 clinical study in relapsed or refractory select B-cell lymphomas, including lymphoplasmacytic lymphoma.
Cellectar said CLR 131 has previously been granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission and Rare Pediatric Disease and Orphan Drug designations for the treatments of neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing's sarcoma.
Cellectar shares were up 9% to $2.50 premarket.
January promised data release? January 13-15, 2020?
Cellectar Biosciences to Present at Biotech Showcase 2020
BY GlobeNewswire
— 8:00 AM ET 12/19/2019
FLORHAM PARK, N.J., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences ( CLRB
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), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that James Caruso, president and chief executive officer of Cellectar Biosciences ( CLRB) will present a company overview at the Biotech Showcase on Monday, January 13, 2020 at 10:30 am Pacific Time. The conference will be held at the Hilton San Francisco Union Square on January 13-15, 2020.
A live and archived webcast of Mr. Caruso’s presentation will be available in the Investors section of the company’s website.
20 people in clinical trial and to more than double:
“Cellectar Announces Data From 20 Patients Receiving a Single 25mCi/M2 Bolus Dose of CLR 131 in the Phase 2 CLOVER-1 Study
BY GlobeNewswire
— 8:00 AM ET 12/16/2019
30% overall response rate seen with an average progression free survival of 4.5 months and an acceptable and expected safety profile
Additional data in patients receiving higher fractionated doses of CLR 131 anticipated in January
FLORHAM PARK, N.J., Dec. 16, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences ( CLRB
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), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced summary data from 20 patients receiving a single dose of CLR 131 in its Phase 2 CLOVER-1 trial in select relapsed/refractory (RR) B-cell malignancies. The company had previously announced data from 10 multiple myeloma patients receiving a single dose of CLR 131 in February 2019, which showed a 30% overall response rate (ORR).
The Phase 2 CLOVER-1 study is designed to identify a safe and efficacious dose and regimen to be used in a pivotal study for select hematologic indications. The 20 evaluated patients, included 10 subjects with relapsed/refractory multiple myeloma, and 10 with relapsed/refractory B-cell lymphoma. The median age was 71 (range 52-82), including 7 females and 13 males, with a median of 6 prior systemic therapies for multiple myeloma and 4 for patients with lymphoma. Eight patients had prior autologous stem cell transplant therapy. Data from these 20 patients showed a 30% ORR, a 75% clinical benefit rate, an average progression free survival of 4.5 months and an acceptable and expected safety profile.
“The 30% ORR seen suggests that CLR 131 treatment at the single 25 mCi/m2 bolus dose may have activity in these heavily pre-treated patients,” said James Caruso, president and CEO of Cellectar Biosciences ( CLRB
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). “We recently presented data at ASH on 19 patients with relapsed, refractory multiple myeloma, which showed improved efficacy and safety with fractionated doses vs. the single bolus dose, and patients receiving a fractionated dose of 37.5mCi showed a 50% ORR. As background, recently approved drugs for this indication have demonstrated approximate ORRs of 25% in a similar patient population and up to 29% as a third line treatment. We plan to provide additional data in patients who are receiving higher fractionated doses of CLR 131 in January.”
The primary adverse events (AEs) seen were cytopenias, including thrombocytopenia, anemia, neutropenia, and decreased white blood cell count. The hematologic AEs were expected, manageable and followed a predictable timeline to nadir (average 49 days) and subsequent recovery (average 16 days post nadir). Patients with disease in the bone marrow experienced more cytopenias than did patients with no detectable disease in the bone marrow. All patients recovered from the cytopenias.”
Fresh Good News:
“...Hepion Pharmaceuticals: CRV431 Testing to Advance to Next Higher Dose >HEPA
BY Dow Jones & Company, Inc.
— 4:40 PM ET 12/10/2019
Hepion Pharmaceuticals Inc. (HEPA) said Tuesday that its testing of liver disease drug CRV431 can advance to the next higher dose.
The Phase 1 study began in the third quarter of 2019 to assess the safety and tolerability of CRV431 in healthy volunteers. The study is examining doses of 75 mg, 150 mg, 225 mg and 300 mg, with the potential to assess higher doses, where CRV431 is administered orally once daily for 28 days.
The team's review of the 75 mg data showed this dosing level to be safe and well tolerated, which authorized escalation to the next dosing level of 150 mg.
CRV431 is Hepion's lead drug candidate, aimed at reducing liver fibrosis and hepatocellular carcinoma tumor burden in liver disease arising from non-alcoholic steatohepatitis.
TWO PEOPLE??
Sunofwolf, you need to research more as studies and trials progress. The news release below mentions dozens and dozens of patients in past and near future clinical trials and the clearly stated prospect of HIGH dosing of CLR131 which can safely lead to much higher “overall response rates” (ORR).
Price has been creeping up the last few weeks in anticipation of more favorable data promised below in coming weeks:
“...FLORHAM PARK, N.J., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences (CLRB), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the presentation of fractionated dosing data in 19 patients with relapsed/refractory multiple myeloma. Dr. Sikander Ailawadhi, M.D., Associate Professor, Division of Hematology/Oncology at Mayo Clinic Florida, presented the data in an oral presentation at the 61st Annual American Society of Hematology (ASH) meeting.
Dr. Ailawadhi’s presentation highlighted results from 19 patients with relapsed/refractory multiple myeloma from Cellectar’s Phase 1 and Phase 2 CLOVER-1 trial collected prior to July 30, 2019. The data from the oral presentation support prior literature and preclinical data showing that fractionated dosing provides an enhancement of efficacy and safety while reducing adverse events. The patients presented received one of 3 dose levels: a single bolus dose of 31.25 mCi/m2 or a fractionated dose of 31.25 mCi/m2 or a higher fractionated dose of 37.5 mCi/m2 of CLR 131. The fractionated 37.5 mCi/m2 dose of CLR 131 represents the greatest amount of drug administered to date in the Phase 2 CLOVER-1 trial.
The overall response rate (ORR) for all multiple myeloma patients across the 3 dose cohorts was 31.3% and a 100% disease control rate. Patients receiving the higher fractionated 37.5 mCi/m2 dose demonstrated a 50% ORR with the remaining 50% having minimal responses (greater than a 25% reduction in the surrogate marker of efficacy).
The patients presented had received a median of 4 prior systemic therapies (range 2-13), had a median age of 69 (range 51-83), including 8 females and 11 males and 80% of the patients in the 37.5 mCi/m2 cohort were either quad or penta-refractory, and all were refractory to [img]daratumumab.
These data showing a 50% overall response rate in a cohort of heavily pretreated multiple myeloma patients and a 31.3% overall response rate in all dose levels presented is impressive,” said Dr. Ailawadhi. “CLR 131 continued to demonstrate a good safety profile with limited off-target effects and the fractionated dosing of CLR 131 showed improved tolerability versus single bolus dosing. While these doses demonstrate beneficial activity, there is the potential that a second cycle or further fractionation could further enhance both efficacy and tolerability.”
The primary adverse events (AEs) at all dosing levels were cytopenias and included thrombocytopenia, anemia, and neutropenia. The hematologic AEs were expected, manageable and followed a predictable timeline to nadir (average 40 days) and subsequent recovery (average 17 days post nadir). The demonstrated recovery post nadir for CLR 131 compared favorably to other similar radiotherapeutic drugs, such as Bexxar, which requires on average 90 days for recovery post nadir.
“These results showed excellent safety with limited off-target effects and improved tolerability compared to our single bolus dosing. With the overall activity observed with CLR 131 to date and efficacy signals across all doses and especially at the fractionated dosing level of 37.5 mCi/m2, we remain optimistic about the potential for continued enhancement of efficacy and safety with fractionated dosing,” said Jim Caruso, president and CEO of Cellectar. “We anticipate announcing additional data in the coming weeks in patients receiving single bolus and fractionated dosing from our Phase 2 CLOVER-1 trial, in which we have enrolled approximately 50 patients. ”
A copy of the presentation deck can be accessed on the Posters and Publications section of the Cellectar website.
About the Phase 2 CLOVER-1 Trial
CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).
The study will enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated dose of 37.5mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131 administered on day 1 and day 7 (± 1), with the option for a second dose cycle approximately 75-180 days later. The company expects to report topline data in 2019.
Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.
About the Phase 1 R/R MM Trial
The Phase 1 multicenter, open-label, dose-escalation study is designed to evaluate the safety and tolerability of CLR 131 administered as a 30-minute IV infusion, either as a single bolus dose or as two fractionated doses, in patients with R/R MM. All doses to date have been deemed safe and well tolerated by an independent Data Monitoring Committee (DMC). Based on the data and the recommendation of the DMC, the Company is enrolling a Cohort 7 where patients will receive 40mCi/m2 fractionated dose of CLR 131.
About CLR 131
CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate™ (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission, and was granted U.S. Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.
About Cellectar Biosciences, Inc. (CLRB)
Cellectar Biosciences (CLRB) is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development (R&D) collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug ConjugateTM (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations.
The company’s lead PDC therapeutic, CLR 131, is currently in three clinical studies – a Phase 2 study, and two Phase 1 studies. The Phase 2 clinical study (CLOVER-1) is in relapsed/refractory (R/R) B-cell malignancies, including multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL). The company is also conducting a Phase 1 dose escalation study in patients with R/R multiple myeloma (MM) and a Phase 1 study in pediatric solid tumors and lymphoma.
The company’s product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
Contacts
Investors:
Monique Kosse
Managing Director
LifeSci Advisors
212-915-3820
monique@lifesciadvisors.com
Image: CLRLB.png
Source: Cellectar Biosciences (CLRB)
MORE CLRB NEWS
Will be interesting here next week
Now that the market has digested the vast near term potential is this company.
Please note the 12/10/19 live HEPA broadcast at JPM CONFERENCE as specified in the link below:
https://old.nasdaq.com/press-release/hepion-pharmaceuticals-to-present-at-the-first-annual-biotuesdays-prejpm-virtual-conference-20191203-00445
https://biotuesdays.com/events/
Slow appreciation of price,
after the irrational exuberance- or was it rational?
CLRB ASH Presentation 12/7/19 Abstract:
As posted by ASH:
...Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma: Therapy, excluding Transplantation: New Approaches in the Treatment of Relapsed/Refractory Plasma Cell Discrasias
Hematology Disease Topics & Pathways:
Adult, B-Cell Lymphoma, Technology and Procedures, Study Population, radiation
Saturday, December 7, 2019: 10:45 AM
Hall E1, Level 2 (Orange County Convention Center)
Sikander Ailawadhi, MD1, Patrick J. Stiff, MD2, Emad Ibrahim, MBBCh, MD3, Anusha Vallurupalli, MBBS4, Elizabeth H. Cull, MD5, Damian J. Green, MD6, Kate Oliver, BS7* and Jarrod Longcor8*
1Division of Hematology/Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL
2Loyola University Chicago Stritch School of Medicine, Maywood, IL
3Redlands Community Hospital, Redlands, CA
4University of Kansas Cancer Center, Westwood, KS
5Cancer Institute, Prisma Health, Piedmont, SC
6Fred Hutchinson Cancer Research Center, Seattle, WA
7Cellectar Biosciences, Madison, WI
8Cellectar Biosciences, Florham Park, NJ
Background: CLR 131 is a novel targeted radiotherapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Based on initial preclinical and clinical experience and the radiosensitivity of MM, fractionated dosing of CLR 131 is being examined in RRMM in a Phase 1 trial (NCT02278315) and a Phase 2 trial, CLOVER-1 (NCT02952508).
Methods: Both the Phase 1 and Phase 2 trials of CLR 131 aim to determine efficacy and safety in RRMM. Eligibility criteria include progressive or relapsed MM that is refractory to at least 1 proteasome inhibitor (PI) and 1 immunomodulatory (IMiD) drug with no upper limit to the number of prior lines of therapy. Prior autologous stem cell transplant (ASCT) and external beam radiation therapy are allowed (< 20% of total marrow irradiated). The Phase 1 trial was a single and fractionated ascending dose escalation safety study and the Phase 2 trial is evaluating 3 doses: a bolus dose and 2 fractionated doses. The fractionated doses of CLR 131 included infusion of either 31.25 mCi/m2 CLR 131 or 37.5 mCi/m2 CLR 131 (administered as 15.625 mCi/m2 or 18.75 mCi/m2, respectively, on day 1 and day 7 (± 1 day)) administered as a 30-minute intravenous infusion is reported here. Adverse events (AEs) are graded by NCI-CTCAE v4.03. Responses were determined using IMWG criteria as assessed by the investigator.
Results: As of 30Jul2019, 10 subjects have received fractionated 31.25 mCi/m2 and 6 subjects fractionated 37.5 mCi/m2 CLR 131. In addition, 1 subject was scheduled to receive fractionated 37.5 mCi/m2 CLR 131 but died due to progressive disease prior to administration of the second dose; this subject is not included in the analyses below as they did not receive both fractionated doses. There is no upper age limit for enrollment and the median age for the 16 RRMM patients was 71 (range 51-83), including 6 females and 10 males with a median of 4 prior therapies (range 2 to 13). Seven patients had prior ASCT.
CLR 131 demonstrated 100% disease control rate in subjects receiving either fractionated dose of CLR 131. The overall response rate (ORR) in the fractionated 37.5 mCi/m2 cohort is 50%. Three subjects in the cohort experienced a partial responses (PR), median time to response 43 days, and the other three had minimal responses (MR) with an average 39% reduction in m-protein. In this cohort, 80% of the subjects were either quad- or penta-refractory; all 80% were refractory to daratumumab. There were two subjects in the 31.25 mCi/m2 cohort with non-secretory disease and their status was followed by FDG-PET imaging. Both have been excluded from the evaluation of efficacy as their disease does not meet with IMWG criteria for response. No patients in this cohort achieved a PR or better however a majority of the subjects experienced a minimal response. The primary AEs include thrombocytopenia, anemia, neutropenia, and fatigue (Table 2). The hematologic AEs were expected, manageable and followed a predictable timeline to nadir (average. 40 days) and subsequent recovery (average 17 days post nadir).
Conclusions: CLR 131 is a unique, first in class targeted radiotherapeutic for RRMM. Preliminary data for CLR 131 administered as a fractionated dose shows an acceptable and expected safety profile in this patient population. Fractionated dosing at 37.5 mCi/m2 has shown an efficacy signal and has been adopted as the standard for CLR 131 dosing in ongoing and future trials. Dose escalation to determine the highest tolerated dose is ongoing in the Phase 1 study and is currently examining a fractionated infusion of 40 mCi/m2 administered as 20 mCi/m2 CLR 131 on day 1 and day 7 (± 1 day). [/] Based upon these data enrollment to the fractionated 37.5 mCi/m2 cohort of the Phase 2 trial continues...”
Link: https://ash.confex.com/ash/2019/webprogram/Paper131014.html
ROFLMAO
NICE RELOAD
Above $2 where I belongs
For now but where is the promised Q4 data on clinical trials at higher CLR131 dosing?
Clay: wedge formation or flag,
...Either way your calm words of wisdom are appreciated.
Indeed, Monday will be interesting.
Cheers!
*********************
As they say:
“...Flag Chart Patterns - Final Word and Cautions
Flags are created by a sharp price move, followed by a consolidation which runs between—or close to—parallel lines. Look to trade breakouts of the consolidation. A breakout can be in the opposite direction of the sharp move, or in the same direction.
Set a stop loss just outside the flag on the opposite side of the breakout. Use one of two targets or both. One is based on the height of the flag and one is based on the height of the pole...”
THE QUESTION BECOMES: What interval price chart to apply to the above charting advice from the “experts”?
Today’s flag or wedge? Or a 2 day or 5 day chart to measure the whole pattern?
Here comes $2.00 per share,
...Regardless of the negative know nothings with unsubstantiated assertions.
I thought THIS news was imminent,
referring to the 3rd and 4th paragraphs below from a September 2019 CLRB press release.
But yes this week was too soon:
“... The poster, entitled: “CLR 131 Demonstrates High Rate of Activity in a Phase 1, Dose Escalation Study in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)” highlights data from 4 subjects in Cohort 6 who received a fractionated dose of 37.5 mCi/m2. Subjects in this cohort achieved a 50% overall response rate, with two subjects achieving a partial response and two subjects achieving minimal responses (39% and 48% reduction in M protein). CLR 131 was deemed safe and tolerated in all subjects with cytopenias being the only reported treatment emergent adverse events of grade 3 or higher. The majority (75%) of the subjects had high risk cytogenetics where median bone marrow plasma cell involvement was 25%. Patients’ median age was 72.5 and averaged 5 prior systemic therapies, with one patient being dual class refractory, one being quad-refractory, and two being penta-refractory.
The Phase 1 study employs the International Myeloma Working Group (IMWG) criteria for measuring responses. The IMWG defines a partial response as a 50% reduction in the marker of disease and a minimal response as a 25% to 49.9% reduction.
“Cohort 6’s overall response rate of 50% with 100% disease control in highly chemo-refractory elderly patients highlights CLR 131’s potential as a first-in-class targeted radiotherapeutic for relapsed or refractory multiple myeloma. We saw an encouraging dose response compared to prior cohorts and CLR 131 continues to demonstrate a favorable safety profile,” said James Caruso, president and CEO of Cellectar. “We have progressed to a higher 40 mCi/m2 fractionated dose Cohort 7 with data expected in Q4 2019.
Additionally, based on the positive results from Cohort 6, we are now allowed to use the 37.5 mCi/m2 dosing level in our ongoing Phase 2 (CLOVER-1) study evaluating CLR 131 in patients with relapsed/refractory (R/R) B-cell malignancies and expect data from the Phase 2 trial in Q4 2019.”
IT WILL BE MOST INTERESTING TO SEE IF THE ORR IS CLOSER TO 75% WITH THE HIGHER DOSING. IF SO, CLRB AND CLRBZ WILL SKY ROCKET UP, UP AND AWAY!
Whale was getting full,
So I sold all my CLRB common shares.
No press release to support the spike.
We have a big whale buyer,
and once again you have to ask WHY. Why are deep pockets interested in this previously lackluster stock/company?
Unless we have a press release soon from CLRB, there are only two explanations:
1. Market price manipulation by the company or 3rd party to screw legitimate investors/traders;
2. A fund thinks that based what is already on the table, i.e. publicly disclosed, this company is undervalued and CLRB IS about to prove it.
A POSITIVE PRESS RELEASE TODAY OR TOMORROW FROM CLRB WOULD ALSO EXPLAIN THE PRICE APPRECIATION OF THIS MISERABLE PERFORMER OVER THE LAST YEAR.
SO WHAT IS THE EXPLANATION?????
A close in the $1.60’s would be validation,
With volume over a million shares.
A close in the $1.20’s would be Wolf food. LOL
Selling the spike has stopped for now,
Interesting. Weak hands waiting to know if good news is imminent before taking it down to $1.10.
Time will tell... but nice Fibonacci retrace so far:
Back down (this morning) 38.2 % more or less.
Ok, Mr. Negative,
Verifiably prove there are only two people in CLR 131 clinical trials.
Put up, or shut up the defamatory libel.
Sun, have you been to the the NJ office? Have you gone inside?
Bubble, bubble, toil & trouble,
https://ih.advfn.com/stock-market/NASDAQ/cellectar-biosciences-CLRB/stock-news/81029249/current-report-filing-8-k#TM1921486D1_EX99-1_HTM
One of these days, “Wolfe”, one of these days: to the moon sonny.
ROFLMAO...all so true. Factual & refreshing!
This company is not a joke nothing will ever
stop its progress, all be it slow and deliberate like any good biotech.
https://www.cellectar.com/product-pipeline
The stock is another issue in the meantime.
People seem to forget that common stock’s purpose, for the company, is to raise revenue to build its business after start-up. When a company succeeds making profits, common stock’s purpose for shareholders is to make money as owners. The younger generations seem to think if it is not a microwave oven, it is not an oven.
Warren Buffett prefers old fashioned ovens for good food...that or cheese burgers and coke.
I Today’s 9/30/19 CLRB stock price says
that the weekend’s European presentation was “underwhelming” as compared to expectations.
Now I need to wait and see how TWO IV doses at higher CLR 131 levels in the Phase 2 Clover study helps DLBCL patients as distinguished from these results revealed over the weekend:
“...The oral presentation, entitled: “Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients (R/R DLBCL),” featured data from 6 subjects who received a single 30-minute intravenous (IV) dose of 25mCi/m2 of CLR 131. Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR). All patients enrolled in the study received an average of 3 prior lines of systemic therapy, 5 of 6 patients were refractory to at least one prior line of therapy. Importantly, CLR 131 showed activity against both germinal center and activated DLBCL. In a patient for whom cytogenetics was available, CLR 131 showed activity against c-Myc and BCL-2 mutation (single & dual-hit) positive patients. As required by the Lugano Criteria for Response, the patient who experienced a CR had a total reduction in tumor volume of greater than 99% and continues to be a CR at 510+ days post dosing. This patient was refractory to two prior treatment lines, which included the combination regimen RICE.
Analysis of dosing showed that the disease control rate and progression free survival were markedly improved in patients receiving a dosing ratio of 1.2% or greater (drug to tumor volume) versus those receiving below a 1.2% dosing ratio. Finally, the most frequent adverse events (AE) in DLBCL patients were consistent with prior studies of CLR 131; the majority of AEs being hematologic in nature and predominately Grades 1 and 2.
“The data presented show an encouraging overall response rate including a complete response at the time of the interim assessment after a single 30-minute IV dose of 25mCi/m2 of CLR 131. We remain optimistic that CLR 131 has the potential to provide a meaningful treatment option for a variety of lymphoma patients and look forward to reporting additional data from this Phase 2 CLOVER-1 study in 2019,” said James Caruso, president and CEO of Cellectar. “The study remains ongoing and, based on this cohort and additional data from an ongoing dose escalation Phase 1 study, patients in the Phase 2 CLOVER-1 study are now receiving a higher 37.50 mCi/m2 fractionated dose administered in two 30-minute infusions of 18.75mCi/m2.”
CLRB NEEDS A MUCH HIGHER OVER ALL RESPONSE RATE (ORR), AGAINST ALL THE CANCER TYPES, OR A FEW OF THEM, BEFORE THE STOCK PRICE CAN HIT $5+ or $10+ price per share AND PATIENTS CAN TRULY BENEFIT!
TO BE CLEAR, AN ORR OF OVER 50% will be needed! I prefer 75%.
I stand corrected, staccani,
I misread the summary below which has accompanied the last few PR’s.
It says there are “three” clinical studies, one a phase 2 and two in phase 1, there are no phase 3 trials that have started. Sorry to post an inaccuracy.
PR SUMMARY LANGUAGE:
“...The company’s lead PDC therapeutic, CLR 131, is currently in three clinical studies – a Phase 2 study, and two Phase 1 studies. The Phase 2 clinical study (CLOVER-1) is in relapsed/refractory (R/R) B-cell malignancies, including multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL). The company is also conducting a Phase 1 dose escalation study in patients with R/R multiple myeloma (MM) and a Phase 1 study in pediatric solid tumors and lymphoma...”
Maybe, but the REAL NEWS in a few days
should be about non-Hodgkin lymphoma (DLBCL) results in the PHASE 3 clinical trials of CLRB’s CLR-131:
Diffuse large B-cell lymphoma is a cancer of B cells, a type of white blood cell responsible for producing antibodies. It is the most common type of non-Hodgkin lymphoma among adults,[1] with an annual incidence of 7–8 cases per 100,000 people per year in the USA and the UK.[2][3] This cancer occurs primarily in older individuals, with a median age of diagnosis at approximately 70 years of age,[3] though it can also occur in children and young adults in rare cases.[4] DLBCL is an aggressive tumor which can arise in virtually any part of the body,[5] and the first sign of this illness is typically the observation of a rapidly growing mass, sometimes associated with B symptoms—fever, weight loss, and night sweats.[6]
This weekend could be the stage for news, after today’s announcement that CLR-131 was granted orphan drug designation by the European Commission:
Cellectar Announces Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2019
BY GlobeNewswire
— 8:00 AM ET 09/10/2019
FLORHAM PARK, N.J., Sept. 10, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences (CLRB), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced an oral presentation at the upcoming European Society for Medical Oncology ESMO Congress 2019 being held in Barcelona, Spain from September 27 – October 1, 2019.
The presentation will focus on the nature of the patient population and the activity of CLR 131 in these heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
I hope to post CLRB NEWS...
7 or 8 days from now, regarding Phase 3 Clinical Trial data on CLR 131 in relapsed/refractory DLBCL.
Staccani: there was this:
FLORHAM PARK, N.J., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences (CLRB), Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced Mr. Jarrod Longcor, chief business officer of Cellectar presented data from Cohort 6 of its Phase 1 dose escalation study of CLR 131 in relapsed or refractory multiple myeloma (R/R MM), in a late breaker poster at the 17th International Myeloma Workshop being held in Boston, MA from September 12-15, 2019.
The poster, entitled: “CLR 131 Demonstrates High Rate of Activity in a Phase 1, Dose Escalation Study in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)” highlights data from 4 subjects in Cohort 6 who received a fractionated dose of 37.5 mCi/m2. Subjects in this cohort achieved a 50% overall response rate, with two subjects achieving a partial response and two subjects achieving minimal responses (39% and 48% reduction in M protein). CLR 131 was deemed safe and tolerated in all subjects with cytopenias being the only reported treatment emergent adverse events of grade 3 or higher. The majority (75%) of the subjects had high risk cytogenetics where median bone marrow plasma cell involvement was 25%. Patients’ median age was 72.5 and averaged 5 prior systemic therapies, with one patient being dual class refractory, one being quad-refractory, and two being penta-refractory.
The Phase 1 study employs the International Myeloma Working Group (IMWG) criteria for measuring responses. The IMWG defines a partial response as a 50% reduction in the marker of disease and a minimal response as a 25% to 49.9% reduction.
“Cohort 6’s overall response rate of 50% with 100% disease control in highly chemo-refractory elderly patients highlights CLR 131’s potential as a first-in-class targeted radiotherapeutic for relapsed or refractory multiple myeloma. We saw an encouraging dose response compared to prior cohorts and CLR 131 continues to demonstrate a favorable safety profile,” said James Caruso, president and CEO of Cellectar. “We have progressed to a higher 40 mCi/m2 fractionated dose Cohort 7, with data expected in Q4 2019. Additionally, based on the positive results from Cohort 6, we are now allowed to use the 37.5 mCi/m2 dosing level in our ongoing Phase 2 (CLOVER-1) study evaluating CLR 131 in patients with relapsed/refractory (R/R) B-cell malignancies and expect data from the Phase 2 trial in Q4 2019.”
https://ih.advfn.com/stock-market/NASDAQ/cellectar-biosciences-CLRB/stock-news/80737952/current-report-filing-8-k#TV529504_EX99-1_HTM
Yes, it is hard betting against The House.
I have sell orders GTC in place just incase the next spike is ridiculous.
Good luck.
17th IMW workshop in Boston for tomorrow has published abstracts:
Poster SP305 by CLRB, at page 555 (public document linked below):
“...Conclusions: CLR 131 represents a first in class targeted radiotherapeutic for RRMM. These data suggest that RRMM including high-risk patients can experience meaningful clinical benefit from treatment with CLR 131 with an acceptable and expected safety profile in the fractionated dose cohorts. Based upon this encouraging activity in late line RRMM patients, this dose of CLR 131 is being Standardized...”
https://files.aievolution.com/imw1901/docs/17th_IMW_Abstract_Book_FINAL_V2.pdf
Rymankoly: Remember this reply
To your May 2019 post:
Crusader:
“Yes, typical, sell the CLRB news,
LEARNED BEHAVIOR UNTIL THE BEAR TRAP IS SPRUNG,
LATER THIS YEAR...October??? “.
You also correctly wrote in another post around that same time: “People are not learning.”
WELL NOW, IT IS ALMOST OCTOBER! Will things ever change? Tomorrow groundhog day or not?
Today’s strong price action (again)
I think is is because of tomorrow’s planned data release:
International Myeloma Workshop, Boston (4 days). Cellectar Biosciences (NASDAQ:CLRB): Phase 1 data on CLR 131 in MM.
THESE CONFERENCE PRESENTATIONS USUALLY RESULT IN A DOWNWARD CORRECTION OF ALMOST 3%, BUT MAYBE THIS TIME WILL BE DIFFERENT WITH HARD CLINICAL TRIAL NUMBERS RELEASED AND NOT JUST FLUFF!
$27 break out on price would
...End this nightmare.
Solid price action today,
it convinced me to buy six figures more common shares.
Perhaps we expect too much/ too soon from the upcoming conference presentation by CLRB.
Time will tell in a week or so.
Clobbered today, after beat by five cents on EPS.
TOO BAD IT WAS A NEGATIVE .10 loss...
Sure enough, they are selling this kind of news,
Load the truck while you
can afford to do it!!!
Of course “they” will sell this news, but not the FDA news in a couple months or sooner.
It will not just be clinical trial news. Buy-out news seems likely...try selling that news...NOT!
SEC filing on new 9% owner of CLRB stock:
https://ih.advfn.com/stock-market/NASDAQ/cellectar-biosciences-inc-CLRB/stock-news/80236068/statement-of-ownership-sc-13g
Text from link:
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 13G
Under the Securities Exchange Act of 1934
(Amendment No. )*
Cellectar Biosciences, Inc.
(Name of Issuer)
Common Stock, par value $0.00001 per share
(Title of Class of Securities)
15117F500
(CUSIP Number)
June 20, 2019
(Date of Event which Requires Filing of this Statement)
Check the appropriate box to designate the rule pursuant to which this Schedule is filed.
?
Rule 13d-1(b)
?
Rule 13d-1(c)
?
Rule 13d-1(d)
*The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.
The information required on the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).
CUSIP No. 15117F500
SCHEDULE 13G
Page 2 of 8
1
NAME OF REPORTING PERSON OR
I.R.S. IDENTIFICATION NO. OF ABOVE PERSON
North Sound Management, Inc.
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a) o
(b) o
3
SEC USE ONLY
4
CITIZENSHIP OR PLACE OF ORGANIZATION
Delaware
NUMBER OF
SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON
WITH
5
SOLE VOTING POWER
850,000
6
SHARED VOTING POWER
0
7
SOLE DISPOSITIVE POWER
850,000
8
SHARED DISPOSITIVE POWER
0
9
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
850,000
10
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
o
11
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
9.0%
12
TYPE OF REPORTING PERSON
CO
CUSIP No. 15117F500
SCHEDULE 13G
Page 3 of 8
1
NAME OF REPORTING PERSON OR
I.R.S. IDENTIFICATION NO. OF ABOVE PERSON
Brian Miller
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a) o
(b) o
3
SEC USE ONLY
4
CITIZENSHIP OR PLACE OF ORGANIZATION
United States of America
NUMBER OF
SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON
WITH
5
SOLE VOTING POWER
850,000
6
SHARED VOTING POWER
0
7
SOLE DISPOSITIVE POWER
850,000
8
SHARED DISPOSITIVE POWER
0
9
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
850,000
10
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
o
11
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
9.0%
12
TYPE OF REPORTING PERSON
IN
CUSIP No. 15117F500
SCHEDULE 13G
Page 4 of 8
1
NAME OF REPORTING PERSON OR
I.R.S. IDENTIFICATION NO. OF ABOVE PERSON
North Sound Trading, LP
2
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(a) o
(b) o
3
SEC USE ONLY
4
CITIZENSHIP OR PLACE OF ORGANIZATION
Delaware
NUMBER OF
SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON
WITH
5
SOLE VOTING POWER
850,000
6
SHARED VOTING POWER
0
7
SOLE DISPOSITIVE POWER
850,000
8
SHARED DISPOSITIVE POWER
0
9
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
850,000
10
CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
o
11
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)
9.0%
12
TYPE OF REPORTING PERSON
PN
CUSIP No. 15117F500
SCHEDULE 13G
Page 5 of 8
ITEM 1.
(a)
Name of Issuer:
Cellectar Biosciences, Inc. (the “Issuer”)
(b)
Address of Issuer’s Principal Executive Offices:
100 Campus Drive
Florham Park, New Jersey 07932
ITEM 2.
(a)
Name of Person Filing:
This statement is being filed on behalf of each of the following persons (each, a “Reporting Person” and, collectively, the “Reporting Persons”):
(1) North Sound Management, Inc.
(2) Brian Miller
(3) North Sound Trading, LP
Mr. Miller is the sole shareholder of North Sound Management, Inc., the general partner of North Sound Trading, LP.
(b)
Address of Principal Business Office, or if none, Residence:
The principal business address for each of the Reporting Persons is:
c/o North Sound Management, Inc.
115 East Putnam Avenue
Greenwich, CT 06830
(c)
Citizenship:
See row 4 of the cover page of each Reporting Person.
(d)
Title of Class of Securities:
See cover page.
(e)
CUSIP Number:
See cover page.
ITEM 3.
IF THIS STATEMENT IS FILED PURSUANT TO §240.13D-1(B) OR 240.13D-2(B) OR (C), CHECK WHETHER THE PERSON FILING IS A:
Not applicable.
ITEM 4.
OWNERSHIP.
(a)
Amount beneficially owned:
See row 9 of the cover page of each Reporting Person
(b)
Percent of class:
Each of the Reporting Persons may be deemed to be the beneficial owner of 9.0% of the outstanding shares of the Issuer’s common stock, par value $0.00001 per share (“Common Stock”).
The calculations of beneficial ownership percentage is based on 9,396,036 shares of Common Stock issued and outstanding as of May 30, 2019, as reported in the Issuer’s Form S-1 filed with the Securities and Exchange Commission on May 31, 2019.