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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...."""
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.
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.
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.
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.”
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 .
Ready to sell off? Don`t - be patient $7.50 coming soon
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.
SC1 - why do you care? 1201 reactions and counting. Why do you spend your time on a stock you don't like?
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?” "
Explorer, ARRAY got bought out for $11 billion, I was a shareholder. Took some of those proceeds and
built a nice position in CLVS.
How about a positive week for Clovis this week ?
(!) Report out: Updated review published on ATHENA trial testing Rucaparib as monotherapy (ATHENA-MONO) vs Ruca+ Nivo combo (ATHENA-COMBO) as frontline maintenance treatment in ovarian cancer pts. ATHENA-MONO primary results are expected in 1Q'22 while ATHENA-COMBO are expected to mature "at a later date"! Bottom line IMO: combo of Ruca+Nivo is working successfully and demonstrating improved efficacy vs Ruca alone:
Int J Gynecol Cancer. 2021 Sep 30;ijgc-2021-002933. doi: 10.1136/ijgc-2021-002933. Online ahead of print.
ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer
Bradley J Monk 1, Robert L Coleman 2, Keiichi Fujiwara 3, Michelle K Wilson 4, Amit M Oza 5, Ana Oaknin 6, David M O'Malley 7, Domenica Lorusso 8, Shannon N Westin 9, Tamar Safra 10, Thomas J Herzog 11, Frederik Marmé 12, Ramez N Eskander 13, Kevin K Lin 14, Danny Shih 15, Sandra Goble 16, Nikolay Grechko 17, Stephanie Hume 18, Lara Maloney 18, Iain A McNeish 19, Rebecca S Kristeleit 20
PMID: 34593565 DOI: 10.1136/ijgc-2021-002933
Full text linksCite
Background: The optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population.
Primary objectives: In women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA-MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)-blocking monoclonal antibody) versus rucaparib alone (ATHENA-COMBO).
Study hypothesis: (1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone.
Trial design: ATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA-MONO and ATHENA-COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA-MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA-COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA-MONO and ATHENA-COMBO share a common treatment arm (arm B) but each comparison is independently powered.
Major inclusion/exclusion criteria: Patients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted.
Primary endpoint: The primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1.
Sample size: Approximately 1000 patients have been enrolled and randomized.
Estimated dates for completing accrual and presenting results: The trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA-MONO are anticipated in early 2022 and results of ATHENA-COMBO are anticipated to mature at a later date.
Trial registration: This trial is registered at clinicaltrials.gov (NCT03522246).
Keywords: BRCA1 protein; BRCA2 protein; homologous recombination; ovarian neoplasms.
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