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Clovis Oncology, Inc. (CLVS)
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From today's PR- It's staring you straight in the eye: "...177Lu (EndolucinBeta®) ...has demonstrated significant anti-tumor effects in clinical and commercial use..."
FAP-2286 LUMIERE PI/II trial is open label and has started enrolling June'21. CLVS is already seeing efficacy and that's why it signed an initial(!) 5 year purchase agreement with ITM:
"""ITM’s n.c.a. 177Lu (EndolucinBeta®) is a high-purity version of the beta-emitting radioisotope Lutetium-177, that can be linked to a variety of tumor-specific targeting molecules for Targeted Radionuclide Therapy and has demonstrated significant anti-tumor effects in clinical and commercial use. ITM has developed a unique methodology to produce the highly pure form of Lutetium-177, without metastable Lutetium-177m, and manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing precision oncology pipeline."""
"""...The agreement covers an initial period of five years...."""
Report out: successful genomic testing in TRITON trial in metastatic CR prostate cancer patients identifies BRCA+ pts who respond to Rucaparib. Plasma, tissue and local testing were equally successful and represent a significant advance in the treatment of BRCA-mut mCRPC pts:
Clin Cancer Res . 2021 Oct 1;clincanres.2199.2021. doi: 10.1158/1078-0432.CCR-21-2199. Online ahead of print.
Response to rucaparib in BRCA-mutant metastatic castration-resistant prostate cancer identified by genomic testing in the TRITON2 study
Andrea Loehr 1, Akash Patnaik 2, David Campbell 3, Jeremy Shapiro 4, Alan H Bryce 5, Ray McDermott 6, Brieuc Sautois 7, Nicholas J Vogelzang 8, Richard M Bambury 9, Eric Voog 10, Jingsong Zhang 11, Josep Maria Piulats 12, Arif Hussain 13, Charles J Ryan 14, Axel S Merseburger 15, Gedske Daugaard 16, Axel Heidenreich 17, Karim Fizazi 18, Celestia S Higano 19, Laurence E Krieger 20, Cora Sternberg 21, Simon P Watkins 22, Darrin Despain 23, Andrew D Simmons 1, Melanie Dowson 24, Tony Golsorkhi 25, Simon Chowdhury 26, Wassim Abida 27
PMID: 34598946 DOI: 10.1158/1078-0432.CCR-21-2199
Full text linksCite
Purpose: The poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib is approved in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and a deleterious germline and/or somatic BRCA1 or BRCA2 (BRCA) alteration. While sequencing of tumor tissue is considered the standard for identifying patients with BRCA alterations (BRCA+), plasma profiling may provide a minimally invasive option to select patients for rucaparib treatment. Here, we report clinical efficacy in BRCA+ mCRPC patients identified through central plasma, central tissue, or local genomic testing and enrolled in TRITON2.
Experimental design: Patients had progressed after next-generation androgen receptor-directed and taxane-based therapies for mCRPC and had BRCA alterations identified by central sequencing of plasma and/or tissue samples or local genomic testing. Concordance of plasma/tissue BRCA status and objective response rate and prostate-specific antigen (PSA) response rates were summarized.
Results: TRITON2 enrolled 115 BRCA+ patients identified by central plasma (n = 34), central tissue (n = 37), or local (n = 44) testing. Plasma/tissue concordance was determined in 38 patients with paired samples and was 47% in 19 patients with a somatic BRCA alteration. No statistically significant differences were observed between objective and PSA response rates to rucaparib across the three assay groups. Patients unable to provide tissue samples and tested solely by plasma assay responded at rates no different to patients identified as BRCA+ by tissue testing.
Conclusion: Plasma, tissue, and local testing of mCRPC patients can be used to identify men with BRCA+ mCRPC who can benefit from treatment with the PARP inhibitor rucaparib.
Copyright ©2021, American Association for Cancer Research.
There was a question raised in the last Earnings Call by Paul Choi about lutetium supply issues. This 5 year agreement answered that question. Important move by Pat imo. Very positive.
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last quarter 13f filing shows some hedge funds aquire clvs around 4.50.... interesting. it may be long term play, nothing is coming soon other than miracle BO
no wonder one of the most shorted stocks on the planet has a bunch of bashers on this thread. Not a balanced thread. No one invested in the growth of CLVS would take the time to criticize the company they are invested on.
There are around 7,500 new ovarian cancer cases in the UK every year, that's 21 every day (2016-2018).
In females in the UK, ovarian cancer is the 6th most common cancer, with around 7,500 new cases every year (2016-2018).
Ovarian cancer accounts for 4% of all new cancer cases in females in the UK (2016-2018).
Ovarian cancer accounts for 2% of all new cancer cases in females and males combined in the UK (2016-2018).
Incidence rates for ovarian cancer in the UK are highest in females aged 75 to 79 (2016-2018).
Each year more than a quarter (28%) of all new ovarian cancer cases in the UK are diagnosed in females aged 75 and over (2016-2018).
Since the early 1990s, ovarian cancer incidence rates have remained stable in females in the UK (2016-2018).
Over the last decade, ovarian cancer incidence rates have decreased by a twentieth (5%) in females in the UK (2016-2018).
See our new Early Diagnosis Data Hub(link is external) for statistics on stage at diagnosis for ovarian cancer.
Incidence rates for ovarian cancer are projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035.
Ovarian cancer incidence rates in England in females are similar in the most deprived quintile compared with the least (2013-2017).
Ovarian cancer is more common in White women than Asian or Black women.
An estimated 41,000 women who had previously been diagnosed with ovarian cancer were alive in the UK at the end of 2010.
Clovis Oncology (NASDAQ:CLVS) Expected to Post Quarterly Sales of $38.38 Million
9. AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
10. CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES
11. PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9
10/12 Pharm Times: KOL's Dr. Morris and Dr. Shah on Rucaparib in ovarian cancer pts. Rucaparib testing in platinum-refractory ovarian cancer patients differentiates it from other PARPi. Preliminary results demonstrate efficacy in a subset of platinum-resistant OC patients:
"Patient Eligibility for the Use of PARP Inhibitors in Ovarian Cancer
October 12, 2021
sults show Ruca efficacy in PR patients but extrapolation to larger PR patient population
Bhavesh Shah, RPh, BCOP; and Thomasina Morris, RPh, MHA, BCOP, detail what makes a patient eligible to receive PARP inhibitors as second-line maintenance for the management of ovarian cancer.
Thomasina Morris, RPh, MHA, BCOP: Most of the data out there have been for platinum-sensitive. With the platinum sensitivity, it also shows that they have a better progression-free survival with a PARP inhibitor if they are BRCA mutated. Platinum resistance or refractory is a lot harder; in essence, they’re going to recur much quicker. You want to get them to a point where you can say they’re stable. You don’t want to switch them to something if it’s working; if you feel like you put them on another treatment and you haven’t exhausted what you’re already giving them, where are you truly giving them the benefit? The studies aren’t looking at platinum-refractory currently. They probably have small cohorts in the study, or supplemental material that says we looked at it, but the numbers are small. I think when we look at platinum-refractory, we don’t really think about PARP inhibitors as an option right now.
However, there’s an ARIEL4 study with rucaparib that also talks about giving platinum in platinum-sensitive patients, and paclitaxel in platinum-resistant patients, and doing a comparative in there. It’s coming, but it’s just not as fast as what we have seen with the platinum sensitivity. It’s interesting because when you talk about biomarkers, when patients with breast cancer are treated, they go through a number of biomarkers now, more so than they ever did in the past; everybody else is catching up. They’re trying to do as much as breast does, but breast has been doing it for a long time. With ovarian cancer, the GYN [gynecologist] oncologist is excited, saying, “We get to do more than just a CA 125 [cancer antigen 125].” They’re just thrilled that they can now look and talk to these patients and say, “I can give you more options at the time of diagnosis.” I think that’s what’s so important.
Bhavesh Shah, RPh, BCOP: I totally agree. There is subset analysis with a small number of patients, not recommending this, but in the Rubraca [rucaparib] trial, there was a small subset of platinum-refractory patients who were included. It’s hard to extrapolate the benefit in the general platinum-refractory patient population; based on the mechanism, it may not be as active as patients who are platinum-sensitive."
Position yourself for a Rally ~~ From Trading Nation:
Traders debate whether biotech is a buy after bounce
Biotechnology stocks could be headed for an even bigger bounce.
The iShares Biotechnology ETF (IBB) edged lower Friday after catching some momentary reprieve in Thursday’s trading session as the recent sell-off in speculative trades slowed.
There’s likely more upside in store, at least according to the ETF’s technical layout, Miller Tabak’s Matt Maley told CNBC’s “Trading Nation” on Thursday.
“When you see big downdrafts like we’ve just seen, that’s an opportunity where you can add to those positions,” the firm’s chief market strategist said.
The IBB’s relative strength index, a key momentum gauge, recently hit its most oversold level since 2018, which has only happened a handful of times in the last several years, Maley said.
“Each time, that’s resulted in a huge bounce in the group, anywhere from 18%-40%,” Maley said. “I think this is a great entry point. Even if you’re just a short-term trader, this is something that should allow you to get a nice rally into the end of the year.”
A similar momentum buildup is happening in shares of Moderna, which have lost nearly 30% in value over the last two weeks amid Merck’s antiviral Covid pill news and the broader growth sell-off, Maley said.
“Its RSI chart is down to a level that it’s only been down three other times in the last year,” he said.
“All three of those times, the thing has rallied anywhere from 28%-60% over the next several months,” Maley said. “I think this is a great entry point for long-term investors and even short-term ones who like to be a little bit more on the active trading side of things.”
Not only has the IBB outperformed the S&P 500 since its inception in 2001 — up more than 361% versus the S&P’s roughly 226% gain — but it could continue to do so, BK Asset Management’s Boris Schlossberg said in the same interview.
“Life sciences just generally as a sector is going to be one of the key sectors of the 21st century,” said Schlossberg, who is managing director of FX strategy at his firm.
“This is one of those types of sectors that you simply cannot ignore. It’s going to be a core holding for any investor,” he said. “Whatever sell-offs we have, whatever dips we have in this sector are very much temporary. You’ve got to just buy the dip here all the way through.”
The average cost of care for women with ovarian cancer in the first year after surgery is approximately $100,000. Patients bear approximately 3% of these costs in the form of out-of-pocket expenses.
potential buyer... ROCHE price $75 IMHO!!
Array BioPharma (ipatasertib), Clovis Oncology (rucaparib)
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase I clinical trial is evaluating ipatasertib with rucaparib (a small-molecule PARP inhibitor) for the treatment of metastatic castration-resistant prostate cancer and solid tumors.
Array BioPharma (ipatasertib), Clovis Oncology (rucaparib)
Based on the latest financial disclosure, Clovis Oncology has a Probability Of Bankruptcy of 76%. This is 75.56% higher than that of the Healthcare sector and 38.58% higher than that of the Biotechnology industry.
The realistic offer for this company would be something that contains a CVR attachment with offer of $12-15 . No reason to pay more for this company as it sits and it’s runway about to end .
Now lets see, who do you think is right, Vanguard or our resident shorts and Pat bashers? Biotech is all about where you buy it and where the company is in its life cycle, both of these have to match up. The goal is to minimize the risk while capturing the full reward and I think buying anywhere under $4.50 / $5 does just that.
You have $3 a share risk buying this today, failure of FAP-2286 will be meet with an avalanche of selling and
we will go under $2 post haste. Success and we will be bought out, that is all but certain. This FAP target could be the holy grail of this radio ligand therapy. Imagine being able to image pancreatic cancer while its
still treatable in its early stage, wall St would eat that stuff up.
Larry thinks copious amounts of FAP 2286 news will be coming in “weeks to months ahead”. Sounds like something the company wants you to think. But they had better plans to dilute $200M worth BEFORE such amazing pending news.
AJFAH Cancer Conference '21: Rucaparib featured by Dr. Kim Reiss-Binder in her presentation on targeted therapies for pancreatic cancer. Dr. Reiss-Binder described an "incurable" pancreatic cancer patient that she first treated in 2014 as part of a clinical trial. Today, 7 years later, the incurable PC patient is still in stable condition on Rucaparib maintenance treatment. Ruca relevant excerpts from a 10/7 synopsis of her presentation:
" ‘Tip of the Iceberg’: More Targeted Therapies for Pancreatic Cancer to Come
October 7, 2021
There’s a tremendous amount of interest in immunotherapy drugs given alongside targeted therapies for patients with pancreatic cancer, according to an expert.
For the longest time, there were no active therapy options for patients with pancreatic cancer and survival was “horrifyingly” short, according to Dr. Kim A. Reiss Binder.
However, that all changed in 2001 and has been steadily improving over the past two decades.
Binder, an assistant professor of medical oncology at the Abramson Cancer Center at the University of Pennsylvania, recently highlighted what’s new in the treatment of pancreatic cancer during the 12th Annual Joining FORCES Against Hereditary Cancer Conference. But before she discussed the newer developments in the treatment of the disease, Binder reviewed the history of platinum-based chemotherapies and how they have improved outcomes. Moreover, she discussed how the development of targeted therapies for the disease is just getting started.
To discuss this point further, she cited a personal experience with a patient in her clinic. The patient, according to Binder, was diagnosed with operable pancreatic cancer in 2012. He underwent surgery in June 2012 and then proceeded to receive six months of gemcitabine. Unfortunately, she noted, his disease returned near the end of that treatment. He was then started on FOLFIRINOX — which is a combination of leucovorin calcium (Folinic Acid), fluorouracil, irinotecan hydrochloride and oxaliplatin, and is still commonly used today, she said.
For incurable patients, Binder said, there’s a tremendous amount of interest looking into the continued role of immunotherapy and how it relates to patients with BRCA-related pancreatic cancer. She noted that several studies are looking further into PARP inhibitors, or PARP plus immunotherapy and PARP plus other drugs.
Moreover, she explained that patients with curable disease should continue to receive platinum-based therapy in the front-line setting.
She wrapped up her presentation by returning to the patient she had introduced to the audience earlier. She noted that he first enrolled in a clinical trial assessing Rubraca (rucaparib) in 2014. Now seven years later, she said, he remains on treatment with his metastatic disease.
“These are the people we need to figure out,” she concluded. “Why does he have this response? How can we get other people to that level?” "
Ready to sell off? Don`t - be patient $7.50 coming soon
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