26 Jul 22 - A combination comprised of selinexor (Xpovio) and ruxolitinib (Jakafi) induced rapid spleen responses at week 12 and showcased a manageable toxicity profile in patients with treatment-naïve myelofibrosis.
The combination of selinexor and ruxolitinib has been well tolerated and with a manageable [adverse] effect [AE] profile,” lead study author, Haris Ali, MD, an associate professor in the Department of Hematology and Hematopoietic Cell Transplantation, of the Division of Leukemia, at City of Hope Comprehensive Cancer Center, and colleagues, wrote in a poster on the data. “No dose-limiting toxicities [DLTs] were observed in patients with treatment-naïve myelofibrosis who received once weekly oral selinexor at 40 mg or 60 mg in combination with standard-dose ruxolitinib.”
#selinexor saves lives. Excellent safety profile. Thanks Dr. Haris Ali @harisali_md. Well done.
Don't let the sucker Aaron Goodman @AaronGoodman33 and hedge funds who are short #KPTI find out. #oncology #Xpovio #ruxolitinib #Jakafi #myelofibrosis
When Aaron Goodman bashes KPTI you know it's time to buy. There's evidence of link between him and an agency hedge funds use to retain "consultant" doctors. Is Goodman a paid shill? We can't prove it but he looks like one.
Fact is #selinexor has an excellent safety profile and is well managed by a huge number of doctors and the drug saves lives and works wonders. Just a bunch of fringe bozos on Twitter get a kick out of trash talking a life saving drug. And some have been linked to hedge funds.
There's evidence that links Aaron Goodman to an agency that hedge funds use to hire "consultant" doctors.
It's well known the shorts hire doctors to trash talk a drug they're short on. I was in elevator and heard conversation of one hedge fund manager with a puppet medical doctor. I also had exchanges with Shkreli (convicted criminal hedge fund manager) who paid doctors to trash talk stocks. If they hired Goodman or not we don't know but it happens.
Their goal is to weaken sales and dissuade doctors and ultimately debilitate the company. They especially do this to companies they know have no teeth or a weak legal department.
21 July 2022 - Big News is out. This approval will boost revenues, makes Karyopharm even a more attractive buyout candidate, and changes valuation models. Analysts upgrades should come soon. Current valuation is ridiculously low. Last year an analyst assigned a $60 buyout price target. Things have only gotten better since then. A big victim of stock price manipulation, KPTI is set to rebound strongly in the months ahead as revenues increase and buyout prospects get better and better. I am critical of the CFO and Legal Counsel and think those departments can significantly improve with better leadership, but am very optimistic overall. Do your own research. Congrats to Richard Paulson and Karyopharm team for this important approval which seemed like Mission Impossible a few months ago.
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
– Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication –
– Approval Follows Positive Opinion by European Committee for Medicinal Products for Human Use (CHMP) in May 2022 –
NEWTON, Mass. and FLORENCE, Italy, July 21, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. With this approval for the extension of NEXPOVIO®'s indication in the European Union (EU), the conditional marketing authorisation is now converted to a full approval. The marketing authorisation, which marks the second indication for NEXPOVIO®, is valid in all 27 member states of the EU as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Stemline Therapeutics B.V., a wholly owned subsidiary of the Menarini Group, will be responsible for all commercialization activities in Europe.
The approval follows a positive opinion granted in May 2022 by the CHMP based on results from the Phase 3 BOSTON study that demonstrated once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death compared to standard twice-weekly bortezomib plus dexamethasone (Vd) regimen. The results from the BOSTON study were published in The Lancet (Grosicki, et al.) in November 2020.
"The European Commission's approval of an expanded use of NEXPOVIO® provides another option for patients with multiple myeloma who have relapsed, or become resistant to current treatment regimens," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize NEXPOVIO® in Europe."
"The approval of NEXPOVIO® marks an important step forward for patients in Europe where nearly 51,000 new cases of multiple myeloma are diagnosed each year and therapeutic options are limited," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "We are committed to offering patients and physicians a valuable new treatment option and are working hard to make NEXPOVIO® available in different European countries as quickly as possible."
About the BOSTON study
The Marketing Authorisation is based upon the Phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study, which was a multi-center, randomized study (NCT03110562) that evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly SVd versus twice-weekly Vd. The primary endpoint of the study was progression-free survival and key secondary endpoints included overall response rate, rate of peripheral neuropathy, and others. To learn more about this study, please refer to Karyopharm and Menarini's press release on the positive CHMP opinion issued on May 20, 2022.
About Multiple Myeloma in Europe
Multiple myeloma is an incurable cancer with significant morbidity and the second most common hematologic malignancy. According to the World Health Organization, in 2020, there were approximately 51,000 new cases and 32,000 deaths from multiple myeloma in Europe1. While the treatment of multiple myeloma has improved over the last 20 years, and overall survival has increased considerably, the disease remains incurable, and nearly all patients will eventually relapse and develop disease that is refractory to all approved anti-myeloma therapies. Therefore, there continues to be a high unmet medical need for new therapies, particularly those with novel mechanisms of action.
About NEXPOVIO® (selinexor)
NEXPOVIO®, which is marketed as XPOVIO® in the U.S., has been approved in the following oncology indications by the European Commission: (i) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy; and (ii) in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy.
The expanded NEXPOVIO® indication now allows adult patients with multiple myeloma to be treated in earlier lines of therapy. The indication for NEXPOVIO® is valid in the EU Member States as well as Iceland, Liechtenstein, Norway, and Northern Ireland. NEXPOVIO® is also approved in the UK under a Conditional Marketing Authorisation. The extension of indication in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy is currently under review by Medicines and Healthcare Products Regulatory Agency.
NEXPOVIO® is a first-in-class, oral exportin 1 (XPO1) inhibitor. NEXPOVIO® functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). NEXPOVIO® blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.
European approval seems to be shoe in
7.19.2022 - DL/2022/5395 - C(2022) 5253 - COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "NEXPOVIO - selinexor", a medicinal product for human use and repealing Decision C(2021)2299(final). Waiting for C(2022) 5253 Decision details to be published. But "granting" sounds positive., supposing it is replacing Decision C(2021)2299.
Karyopharm Granted Regulatory Designations for Eltanexor for the Treatment of Myelodysplastic Syndromes
– FDA Fast Track Designation and European Commission Orphan Medicinal Product Designation Underscore the Significant Need for New Treatment Options for MDS –
NEWTON, Mass., July 20, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced new regulatory designations for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) investigational compound being studied for the treatment of myelodysplastic syndromes (MDS): (i) the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk MDS; (ii) the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion to designate eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU). Karyopharm also received orphan drug designation from the FDA in January 2022. MDS are a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function with a risk of progression to acute myeloid leukemia.
Karyopharm is currently investigating eltanexor in an ongoing open-label Phase 1/2 study in patients with relapsed/refractory MDS. Previously, Karyopharm reported initial data from the Phase 1 portion of this study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS.
Approximately 15,000 people in the U.S.1 and 14,000 people in the EU2 are expected to be diagnosed with intermediate-to-high risk MDS in 2022. HMAs are the current standard of care for newly diagnosed, higher-risk MDS patients. However, only 40-60% of patients respond, with these responses typically lasting less than two years.3 The prognosis in HMA-refractory disease is poor, with a median overall survival of four to six months.4,5 There are currently no approved therapies for HMA- refractory MDS.
"These recent designations from the FDA and EC reinforce eltanexor's potential to improve clinical outcomes for patients with relapsed/refractory MDS," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are dedicated to advancing our ongoing clinical trials and remain committed to bringing eltanexor to these patients and their families as a new treatment option."
Fast track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process.
Orphan Medicinal Product Designation is granted by the EC to promote the development of drugs that target rare (less than 5 in 100,000 people across the EU), seriously debilitating and/or life-threatening diseases, and are expected to provide a significant benefit over existing authorized treatments. Orphan designation qualifies a company for certain incentives that apply across all stages of drug development, including the potential for ten years of market exclusivity following marketing approval, fee reductions, and eligibility for orphan drug grants.
Locking Leukemia’s Cellular Escape Hatch
“Wood and team found that a combination of Selinexor and an AKT inhibitor work much better than chemotherapy, which is the current standard of care for otherwise healthy patients.”
P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia
CEO Richard Paulson beneficially owns about 660,000 shares. At a $30 buyout price he'll cash in $20 million. At $50 he'll cash in $33 million. But they urgently need a new CFO, in my view.
I think CFO Mike Mason is too caught in the wasteful cost structure paradigm of Mike Kauffman (a great scientist but terrible ex-CEO) to bring meaningful change and cut the fat. That's one of his weaknesses, in my opinion.
Mason is also unfortunately running IR (head of IR, Elhan Webb reports to him) which effectively means he filters communication to Richard Paulson. So if you want to reach out to the CEO, going through IR is not a good idea. Write to him via letter 85 Wells Ave. Newton MA 02459 or richard.paulson @ karyopharm.com/
The stock is sick because in my opinion we have a terrible CFO / head of IR, Mike Mason and terrible Legal Counsel, Mike Mano carrying on the investor-unfriendly lame culture of terrible ex-CEO Mike Kauffman who hired both of them. Both these roles are absolutely critical to building of shareholder value which this culture has been terrible at so far. Same mentality, same people doing same things expecting different results. It's time for new blood. These guys should resign and follow Mike Kauffman out the door.
An investor wrote: "I know “Mike” people too, and call them “Артём” but that’s a long story. Fortunately, for them and us, the science will prevail, especially with combos that outperform main line treatments and support from “precision medicine” (genetic biomarkers)."
Very bullish sign when bashers are resorting to outright lies to try to disparage the company. If the company. One such lowlife with a new ID and no prior posts wrote today that Sohanya sold all her shares. She just sold a few bucks worth out of her around 90,000 shares to pay taxes on options which is very normal. I wish the company's legal arm had some balls to go after these bashers but Michael Kauffman hired average, passive people who were below him. Ace CEOs hire people better than themselves. C minus CEOs hire D people.
So let's see Richard shake up the company into a lean and mean place instead of being a punching bag for Wall Street crooks.
Yesterday, 7 July 2022, I had a 40 minute call with Karyopharm's IR director and their legal council.
I asked them things, I gave them tips / ideas which they said they appreciated.
I am not fond of their legal council.
Unfortunately the IR VP is reporting into the CFO.
The CFO and the legal council were hired by Mike Kauffman - and they're both called Mike. Dr.Kauffman was lousy CEO whom some people think I was instrumental in helping oust him. D-CEOs hire people below them. Ace CEOs hire people who are better than them.
Both Mikes are weak links in my view, and still embody the weak management of Kauffman and the culture he set in.
I questioned them on the Delphi transaction. Upon scrutiny and analysis on my part and their statements, bottom line is they claim they didn't tell the Board on June 7 or June 8 when they got the notice from Biogen. How inept is that?! And Delphi's transaction the next day was therefore just a coincidence! Right! Mano got defensive and asked if I'm thinking he's a lying that Delphi didn't know. I don't know the facts but never assumed he was lying. I remained puzzled and didn't conclude "oh he must be lying". Something doesn't add up. SEC may investigate Delphi. Till will tell.
And then it took KPTI 8 days to release a PR. Mano said we're working on improving out timing! What?! They haven't even gotten timing of PRs handled? Why did it take 8 days?
All this seems to fall in Mike Mano's department -- he was somewhat defensive which further confirms that. It's sloppy at best, IMO.
In my view, this screams of mismanagement. Great science but the IR/Legal side of the company still appears weak, and guess who's in charge of them: the two Mikes.
Elhan, the IR director is a nice, decent lady. Mano is also a nice guy and three of us had a good contact. I even played her a Turkish song on the guitar at the end of the call (we talked about guitar earlier), which they liked. She even understood the words, though I sang them with Azeri accent.
She kept answering me with "investor calls" -- I gave her tips about a lot that can happen outside investor calls.
Argot is in the picture with a reduced role (good). Gave them some tips I got from other CFOs about need to actively manage these thin-spread external IR firms.
We established a reliable channel of communication (me emailing Elhan). Although I could choose to write to Richard directly esp. given Mike Mason is Elhan's boss and I don't believe he's been investor friendly. And I'm not happy with the cost structure and I have no confidence in him as CFO, esp. regarding him calling shorts on ATM (I relayed a message to him that use of ATM at these prices would be utterly irresponsible). But I'm not selling my shares because of that. I'm holding till buyout.
Regarding countering disparagement by short cartel, their hired doctors (consultants) - I don't see it in Mano's profile any "teeth".
At the end Mano was like this is a talk between me, Mike Mano and you (trying to persuade me not to relay anything to public). I reminded them these are formal discussions between the company and the public and there's no need for them to be confidential - since nothing private was told to me. Hello!
Also told Elhan about history / founder's syndrome - she hadn't heard about it. And that she needs to be disruptive to inherited status quo. But given she reports to Mason I'm not holding my breath.
Mano wanted more info on my statement that Kauffman was a terrible CEO in my view. I elaborated some reasons.
It felt I had to reiterate some basics for them: that public company's management is hired by shareholders to build shareholder value, and detailed the factors that go into it, e.g. confidence on demand channel - marketing of the security - etc. etc.
And other topics, like BP manipulating share price; notes on buyout prospects and what the founders told me on the two zoom calls I had with them.
It was more of a learning experience for them than for me. They got to tap into the intensity of the challenge they're faced and that us shareholders hold them accountable.
I will keep my shares till buyout.
Company is still bogged down by repercussions of Michael Kauffman's mismanagement, in particular a couple of people he hired, Mike Mason as CFO and Mike Mano as Legal Counsel. In my view, based on a number of observations. Shorts have upped their stake probably knowing the company's weakness in these areas (CFO and Legal). Great science, great medicine, in hands of people who have proven to be incapable of building shareholder value. But I'm still not selling my shares. If you want to contact the management contact me for their email addresses off contact page of https://www.rezamusic.com/various/kpti
6/7 $KPTI gets news from partner. No big deal, not part of valuation – but shorts would abuse it to pound the stock.
6/8 Delphi/Deepa sells a lot of shares. Saves $1.3m in opp loss.
6/10 Delphi files S4.
6/15 Finally, KPTI makes public disclosure.
Stock tanked from June 8 onwards and Delphi got a great price. Deepika as Director should have been informed on 6/7.
KPTI's lawyer, Mano, told me the Board was not informed of the news prior to D’s sale. Why not?! He forgot to tell them?!
Was 6/8 sale totally random? True D was long term venture cap but still, timing is very fishy. Did D find out in another way than formally by Mano/co? Possibly.
Mike Mano was hired by Mike Kauffman who was a terrible CEO. Mano told me they’re trying to improve their PR timing. Seriously? After all this time and money they still can't get that right? Insider sale + legal dept screwup? I won’t be surprised SEC investigates Delphi’s sale. I’m not selling my shares till buyout, regardless.
Buyout Spree in Second Half of 2022
M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says
Price Jolt Two Week Cycle
An experienced investor said when there are jolts it takes 2 weeks for it to settle.I agree. KPTI broke down after a non-event deal cancellation on something that was not even in the valuation picture, coupled by a director (hedge fund) selling a small fraction of her holding which some speculated may have been related to crypto crash. Neither of these were justification for the price breakdown, so I'm on the side of those who think some market makers are manipulating KPTI. In that scenario, the stock falling under $5 triggered margin calls at some brokers. I know as a fact some brokers don't even let self-directed accounts to buy stocks under $5 and some major brokers don't provide margin buying power for stocks under $5. So these 3 factors created a jolt. I don't think there were any real, big sellers. But games including naked shorting by MMs. But these have a short cycle of about 2 weeks for dust to settle and start of buys that historically have caused sudden rebound.
PS -- Add to the manipulation mix end of quarter window dressing by hedge fund shorts to maximize their performance and fees.
UPDATE: 5 Jul 2022: First day of new quarter and the stock rallied hard. Supports my theory that hedge fund shorts manipulated it to cook their books. But we also need Michael Mason, the CFO, to steo uo to the plate and STOP the use of ATM. Jefferies might be leaking it to Wall Street and it's used against the company. Karyopharm should not sell any shares using ATM, under $10. To sell in the $5's is a grand sin!
Mount Sinai looked at the genomics of your super responders, found that cancers that don't respond to chemotherapy +- radiation respond to Selinexor with deep and durable responses.
Straight out of small biotech playbook. Next step: Buyout.
$ARNA was taken out of retail hand and sold to Pfizer ($PFE). I’ve seen many examples of biotechs where retail holds majority shares and supports the company for years, then professional investors get involved and play their tricks and get retail to sell and they get majority of the shares then the company gets sold for a big premium. ARNA was $15 before reverse split after their lousy Founder/CEO was fired by the board which many believe was due to our efforts (and me specifically as active investor group). That $15 share was bought by Pfizer for $100 a few years later. $KPTI (Karyopharm)’s founder/CEO was fired last year (again many think our/my efforts was the catalyst) – and institutional interest has been rising. Next in the play book is a buyout for a rich premium, in my opinion. So I just hold my shares. Heavy manipulation is expected as another 10% of the company is in retail hands and needs to shift to institutions. So games are played abundantly. I just hold and smile and wait it out. Experts believe 2nd half of 2022 will see many bio-pharma M&A's. KPTI was on top of Barclay's M&A list for $60 a share last year. Nothing has changed except manipulation to shift wealth from retail to institutional hands. Retails who hang in there win. In my opinion; not an investment advice.
Antengene Announces Clinical Trial Collaboration with BeiGene to Evaluate Selinexor in Combination with Tislelizumab in T and NK-Cell Lymphoma
Excellent New Presentation at Jefferies / Sales on track
Management reiterated guidance for the year. Sales are on track, despite efforts of the hedge fund doctor puppets to derail sales.
is Approved in 38 Countries
38 countries! More approvals coming.
Canada Approved Selinexor
FORUS Therapeutics Inc ("FORUS") Announces XPOVIO® (selinexor) Is Authorized for Sale by Health Canada
Selinexor and an AKT inhibitor work much better than chemotherapy
Locking Leukemia’s Cellular Escape Hatch
“Wood and team found that a combination of Selinexor and an AKT inhibitor work much better than chemotherapy, which is the current standard of care for otherwise healthy patients.” P2RY2-AKT activation is a therapeutically actionable consequence of XPO1 inhibition in acute myeloid leukemia
Q&A with Karyopharm Therapeutics
The stock has been on a roller coaster along with XBI.
Institutional interest is almost 90% again (89.19%). I really like this metric because it shows level of conviction of institutions who generally do a lot of due diligence before buying a stock.
KPT Is more sensitive to XBI these days because also XBI increased its holding.
The company's founders should be rolling off the management page on the website any day. That's a good thing.
ASCO meeting starts this Friday. Karyopharm will be presenting new Selinexor data.
Short interest is at 14.5 million shares. They rise in short interest corresponds with latest price drop but it is artificial supply given institutional interest has been going up, so that could increase chance of short squeeze.
The company's presenting at Jefferies' in NY on June 9.
The company is presenting at EHA in Austria on June 9-12.
Phase 3 trials are cool. They put the company one step closer to more revenue. A P3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma has started and it's paid for by a MM coalition. Can't beat that.
EU approval will likely be granted this month. Menarini Group is ready to hit the ground running.
KPTI's investment thesis right now, in my book, is valuation, valuation, valuation. Any way I look at it the company ought to be three times current value currently. It'll get there, in my opinion.
Buyout written all over this stock. The ex-founder told me it's effectively a matter of when not if. I can wait. Amgen and Pfizer are on top of my list.
Revamped my KPTI info page: https://www.rezamusic.com/various/kpti
Karyopharm to Present New Selinexor Data at the 2022 American Society of Clinical Oncology Annual Meeting
– Encouraging Initial Data Observed in Phase 1/2 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Favorable Tolerability with No Dose Limiting Toxicities and 75% of Evaluable Patients Demonstrating ≥35% Spleen Volume Reduction (SVR 35) at Week 12 –
– FDA Grants Orphan Drug Designation for Selinexor for the Treatment of Myelofibrosis –
– Exploratory Subgroup Analyses from SIENDO Trial in Patients with Endometrial Cancer Treated with Selinexor as Maintenance Therapy Identified p53 Wild-type as a Potentially Important Predictor of Efficacy, with 10-month PFS Improvement over Placebo; No Benefit Was Seen in Patients with p53 Mutant Tumors –
GREAT NEWS: Another Phase 3 trial and good phase 2 data and paid by an expert group!! The European Myeloma Network and Karyopharm Announce Dosing of First Patient in Collaborative EMN29/XPORT-MM-031 Study
- Phase 3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma -
FULL EMA SECOND APPROVAL COULD COME BY END OF JUNE
Full EMA approval could come before end of June. Kimmtrak was approved by EMA 38 days after CHMP approval. On 25 Feb Kimmtrak was recommended by CHMP. It was approved on April 4. 60 days is max. 38 days for Karyopharm means 26 June.
POSITIVE CHMP OPINION FOR SECOND LINE PLUS - EU APPROVAL EXPECTED BY 19 JULY 2022 - "The Chinese goes straight to first relapse showing the considerable operating latitude Antengene has in APAC. It would not surprise me if APAC does greater sales than US and EU combined." Dr. DD based on:
Dr. Kevin Lynch, Antengene’s Chief Medical Officer added, “Antengene is especially pleased for the use of selinexor to be recommended from the first relapse or multiple relapses. We understand that cancer care is complex and that having effective treatment options for the first relapse that offers the potential for durable disease control is especially important to patients and their families. We look forward to bringing this important therapy to patients in China and other Asia Pacific geographies.”
And now we know that will be the case. CHMP said YES!
Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma
̶ European Commission Decision Anticipated within Approximately 60 Days –
NEWTON, Mass. and FLORENCE, Italy, May 20, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received one to three prior lines of therapy.
The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC) makes a decision on Karyopharm's NEXPOVIO application. The EC's decision is expected within approximately 60 days following the CHMP recommendation. In December 2021, Karyopharm and Menarini Group entered into an exclusive license agreement to commercialize NEXPOVIO® (selinexor) in Europe.
"Despite therapeutic advances, multiple myeloma remains an incurable disease that is difficult to treat," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Today's positive CHMP opinion brings us one step closer to our goal of making NEXPOVIO available to patients globally who may benefit from its novel mechanism of action. We are pleased to have Menarini as a partner in this effort given its commercialization expertise as well as strong heritage and footprint in Europe."
"We are thrilled with the CHMP's recommendation in favor of NEXPOVIO and what it represents for multiple myeloma patients in need of new and innovative treatment options," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "Pending potential marketing authorization from the EC, we will work closely with appropriate authorities to ensure this important treatment can be made available to patients in Europe."
Karyopharm's application is supported by data from the Phase 3 BOSTON study, which evaluated the SVd triplet regimen in patients with relapsed or refractory multiple myeloma and were published in The Lancet (Grosicki, et al.) in November 2020. This CHMP opinion follows the approval of XPOVIO® (selinexor) by the U.S. Food and Drug Administration in December 2020 in the SVd combination in patients with multiple myeloma after at least one prior therapy.
Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the European Hematology Association 2022 Hybrid Congress
Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that initial data from a Phase 1 portion of the Ph 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis has been selected for a poster presentation at the European Hematology Association (EHA) 2022 Hybrid Congress taking place June 9-12, 2022, in Vienna, Austria. The data are also being presented in a poster session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 4th.
The company is presenting at EHA in Vienna on June 9-12.
"We are to be sharing initial selinexor data in treatment-naïve patients with myelofibrosis at both EHA and ASCO," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "JAK inhibitors remain the only class of approved therapies for myelofibrosis and there is a critical need for novel class of treatments that improve the hallmarks of this devastating blood disease including reductions in spleen size, as well as improvements in constitutional symptoms, quality of life, and anemia response. We look forward to sharing our findings and further exploring selinexor in this patient population."
17 May 2022: Excellent presentation at RBC CAPITAL
https://www.veracast.com/webcasts/rbc/healthcare2022/j34239.cfm -- Management came across as extremely confident.
Board Member Change Hints At Buyout
"I do not see often times where a C-suite board member of one company is replaced by a former C-suite of the same exact company and was chosen by the departing board member. Note in the press release Mikael specifically chose Peter. The reason to leave the board was super weak too (too much work, yet has not started any new appointments or positions. "On behalf of the entire Board, I would like to thank Mikael for his dedicated service to Karyopharm and for his help in identifying his successor." Potential Partners:
Amgen (for MM Kyprolis and Paruvutamab - INV) is obviously at play here given the extensive history Richard has with them, and the fact that recent data has shown that Kyprolis (carfilzomib) + Selinexor (XKd regimen) kicks ass in heavily pre-treated MM patients (Seriously listen to this presentation).
For those that don’t understand, MM is a disease that will likely come back over and over. If the cancer comes back within 60 days that’s refractory, if cancer comes back after 60 days that’s relapsed. Triple refractory means that the top 3 class of drugs for MM failed within 60 days following treatment
Proteasome inhibitors: Bortezimib/Velcade (generic available, and declining brand sales at $720MM in 2020) and Carfilzomob/Kyprolis (2020 sales $1.065BN) mainly, but also oral Ixazomib/Ninlaro
Immunomodulatory agents - lenalidomide, thalidomide, pomalidomide, and lenalidomide
Anti-CD38 Monoclonal Antibodies - Daratumumab / Darzalex (2020 sales ~$4.2BN)
Selinexor has a unique mechanism of action and does not seem to have any cross resistance to these classes of drugs and works with high-risk cytogenetics.
Back to XKd -- How does Selinexor / Xpovio perform in this patient population in combination with Kyprolis?
Look at Refractory Patients
Now look at the results especially look at high risk cytogenetics and triple refractory patients
This data was so compelling even with 32 patients that this regimen has been submitted to NCCN. If I was Amgen I would be taking a very close look at a partnership.
Pfizer also is looking to get into the MM game with Elranatamab and has a deep history with Richard Paulson.
I would also add BMS to this list now (Pomalyst + Selinexor has had some great data and an additional Phase 3 coming).
Biopharma has to do M&A because there is growth at all costs. This problem is becoming larger and larger with VC and evaluations at IPO. If a company believes that they can make money from a buyout, they pull that trigger because sales always drastically increase with the extremely large sales force that Big Pharma has (Kyprolis ~75% increase first quarter for example).
Antengene Announces Commercial Availability of XPOVIO® (Selinexor), for the Treatment of Relapsed/Refractory Multiple Myeloma, Prescribed for the First Time Across Mainland China
-Distribution channels in place to streamline/facilitate patient access.
-XPOVIO® will be available in 600 hospitals and 105 DTPs (across China including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong)
Antengene announces that its first commercialized product, the oral XPO1 inhibitor XPOVIO® (selinexor) approved for the treatment of relapsed/refractory multiple myeloma (R/R MM), has officially entered multiple hospitals, online-hospitals, and direct-to-patient (DTP) pharmacies in mainland China and widely prescribed in the country for the first time at Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai Jiaotong University School of Medicine Renji Hospital, Tongji Hospital of Tongji University, Shanghai Sixth People's Hospital, Shanghai Jiaotong School of Medicine St. Luke's Hospital, and the PLA Naval Medical Center. By the end of May, selinexor will be expeditiously rolled out to approximately 600 hospitals and 105 DTPs in over 30 provinces, autonomous regions, and municipalities including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong, providing Chinese MM patients across the country with an easy to access to this new treatment option.
Antengene Announces XPOVIO® (selinexor) Data to be Presented at the Upcoming 2022 European Hematology Association Hybrid Congress
LATEST CORPORATE PRESENTATION
HIGH PROFILE DOCTOR JOINS THE TEAM
9 MAY 2022
Karyopharm is pleased to give a warm welcome to Dr. Tomer Mark as our Senior Vice President of Medical Strategy! We are confident that his deep expertise within the hematology space will be invaluable as we continue to develop our core programs.
We got some top notch sales reps
e.g.Tanya Rivers Granados
'New paper is published "A Case Report of a 58-Year-Old Woman with a Diagnosis of High-Risk Myeloma Refractory to Multiple Line of Therapy and Treated with Selinexor, Bortezomib, and Dexamethasone Prior
to Allogeneic Stem Cell Transplantation."
In this paper, a case of a 58-year-old woman with high-risk MM who had received 8 prior treatment lines, and whose disease was refractory to ixazomib, bortezomib, and all immunomodulatory agents, is described. After everything stopped working, this patient was treated with selinexor, bortezomib, and dexamethasone (XVd). After 1 cycle of XVd, she achieved a partial response, and after 4 cycles, a very good partial response (VGPR). Therefore, stem cell transplantation was performed. She remained relapse-free for 13 months after initiating XVd. Good to see that Selinexor works well in patients which have no other options.'
KPTI Titles for Selinexor presentations at ASCO in June:
1. Phase Ib trial of selinexor (SEL) in combination with nivolumab (NIVO) alone or nivolumab plus ipilimumab (NIVO+IPI) in patients (pts) with advanced malignancies: The renal cell carcinoma (RCC) experience.
2. Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS).
3. Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT-EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification.
4. A phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis.
5. Phase Ib study of selinexor and eribulin combination in advanced solid tumors and triple-negative breast cancer.
Karyopharm Announces Selinexor Data to be Presented at the 2022 American Society of Clinical Oncology Annual Meeting
Title: Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT - EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification
Presenter: Vicky Makker, Memorial Sloan Kettering Cancer Center
Abstract #: 5511
Date and time: Tuesday, June 7, 2022, 8:00 a.m. – 9:30 a.m. CDT
Session: Clinical Science Symposium/Molecular-Based Treatment for Endometrial Cancer
Title: A phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis
Presenter: Haris Ali, City of Hope
Abstract #: 7060
Date and time: Saturday, June 4, 2022, 8:00 a.m. – 11:00 a.m. CDT
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Title: Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS)
Presenter: Abdulazeez Salawu, University Health Network
Abstract #: 11563
Date and time: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT
Title: Digital monitoring and assessments in patients with glioblastoma
Presenter: Yasaman Damestani, Karyopharm Therapeutics, Inc.
Abstract #: 2045
Date and time: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT
Session: Central Nervous System Tumors
CEO Richard Paulson has a very impressive background. Solid business and sales and management experience unlike the last CEO who was just a good doctor/scientist and ran the company into the ground by mismanagement. Turnaround in progress. https://www.linkedin.com/in/richard-paulson-462536/
Details of KPTI Presentations at American Association For Cancer Research April 8 to 13 (company's IR is asleep on the wheel as usual - several of these involve KPTI employees so why not PR it?)
· 4067 / 21 - Combination venetoclax and selinexor effective in relapsed refractory multiple myeloma with translocation t(11;14) https://www.abstractsonline.com/pp8/#!/10517/presentation/15278
· 5455 - Nuclear export inhibitor selinexor synergizes with proteasome inhibitor marizomib in preclinical models of glioblastoma https://www.abstractsonline.com/pp8/#!/10517/presentation/17686
· 1122 / 12 - Selinexor synergizes with IL-12 to inhibit tumor growth in syngeneic mouse models of melanoma https://www.abstractsonline.com/pp8/#!/10517/presentation/16291
· 6022 - Synergistic anti-cancer effects of selinexor and bevacizumab in mouse xenograft models of glioblastoma https://www.abstractsonline.com/pp8/#!/10517/presentation/17979
· 6023 - Selinexor synergizes with temozolomide in preclinical models of glioblastoma independent of MGMT promoter methylation https://www.abstractsonline.com/pp8/#!/10517/presentation/17980
· 6025 - Baseline cytokine profiling in naïve and tumor-bearing Balb/c and C57BL/6 Charles River mice https://www.abstractsonline.com/pp8/#!/10517/presentation/17982
· 5832 - Utilizing small noncoding RNAs as biomarkers for selinexor treatment in gastric cancer https://www.abstractsonline.com/pp8/#!/10517/presentation/18815
· 4195 / 3 - Evaluation of the anti-myeloma effects of high and metronomic selinexor alone and in combination with duvelisib in vitro and in vivo https://www.abstractsonline.com/pp8/#!/10517/presentation/16809
· 5519 - Selinexor synergizes with anti-PD-1 antibody and inhibits tumor growth and metastasis in syngeneic mouse models of KRAS mutant colorectal cancer https://www.abstractsonline.com/pp8/#!/10517/presentation/17738
· 5536 - Selinexor inhibits lymphoma-leukemia tumor progression directly and through activation of anti-cancer immune response https://www.abstractsonline.com/pp8/#!/10517/presentation/17755
· 5314 - Selinexor, a selective inhibitor of nuclear export (SINE) compound, enhances the anti-tumor activity of Eribulin in leiomyosarcoma https://www.abstractsonline.com/pp8/#!/10517/presentation/18544
· 5330 - Nuclear protein export inhibitor selinexor chemotherapy combination for pancreatic cancer therapy https://www.abstractsonline.com/pp8/#!/10517/presentation/18560
Numerous Presentations at American Association For Cancer Research April 8 to 13.
Company's IR is asleep behind the wheel as usual.
20 presentations with Selinexor at AACR meeting in April / "99% inhibition of tumor growth with two mice cured sounds remarkable"
"From the abstract 5519, "Selinexor synergizes with anti-PD-1 antibody and inhibits tumor growth and metastasis in syngeneic mouse models of KRAS mutant colorectal cancer."
"We performed preclinical studies to evaluate the effectiveness of selinexor and the anti-PD-1 antibody RMP1-14 in syngeneic mouse models of KRAS mutant CRC. Both selinexor and RMP1-14 demonstrated single agent activity against KRAS mutant CRC in the two mouse models relative to controls. In the metastasis model, tumor growth inhibition (TGI) at Day 21 was 63.5% (p=0.0001) for selinexor and 68.9% (p<0.0001) for RMP1-14. The combination of selinexor and RMP1-14 significantly inhibited tumor growth and metastasis with a TGI of 98.9% (p<0.0001). No tumors were detected in two mice from the combination group at the end of the study.
Conclusions: Synergistic anti-cancer activity of selinexor and anti-PD-1 antibody in KRAS mutant CRC mouse models warrants further clinical investigation."
So, 99% inhibition of tumor growth with two mice cured sounds remarkable.'
Top expert is a big fan of KPTI's science
Robert L. Coleman, M.D., FACOG, FACS
Sarah Connors joined the company as Vice President, Head of Corporate Communications.
Excellent background. MBA. Over 10 years at Sanofi...
GOOD NEWS: MERCK KEYTRUDA BLOCKBUSTER EXECUTIVE JOINS KARYOPHARM AS CHIEF MEDICAL OFFICER
For the nagging nancies, fake longs, shorts, idiots who are disparaging our new hotshot CMO, Dr. Rangwala who was previously executive clinical director at Merck, where she was involved in the clinical development of the blockbuster immunotherapy Keytruda. https://www.fiercebiotech.com/biotech/karyopharm-taps-former-merck-executive-serve-chief-medical-officer
New CMO left her job to join Karyopharm: https://www.linkedin.com/in/reshma-rangwala-70421a84
I am very impressed with her profile. She has all the right experience. Dr. Rangwala has a very impressive background with a MD and PhD degrees and a blockbuster under her belt -- and very strong regulatory background which is what KPTI needs -- a pragmatic CMO.
WHICH BIG PHARMA WILL BE THE PROUD OWNER OF KARYOPHARM?
Dr. Due Diligence:
"Amgen talking about wanting to buy more companies in their Growth Strategy through 2030.
Top tier Pfizer, Amgen with Amgen getting the edge given the employee composition at Karyopharm. These have always been the top two and wrote about that 7 months ago.
Second Tier BMS MM and Solid Tumor including Glioblastoma and $16+ Billion Cash on Hand. Pomalyst Trial cannablizes Empliciti (Pom and Empliciti are both BMS products).
Much lower Tier JNJ - established in MM (Daratumumab), WT p53 huge potential for Prostate Cancer (their bread and butter), and potentially in urothelial and lung. They do not have an established MDS pipeline, but seem to have some trials in this space (MDS/AML).
5th is a wildcard company I'm looking more at their structure, and seeing what's possible."
"Well said! SIENDO2 will be a slam dunk! No question asked! If I am the CEO of a BP, I would be very motivated to buy this now with a almost guaranteed approval with potential of billion dollars peak sales in 24 months. The questions are: Will the buyer willing to give "can't refuse price"? Will the board willing to take the risk and time and not willing to sell now and wait?"
Karyopharm Names New Head of Investor Relations
– Elhan Webb, CFA, Formerly of Rubius Therapeutics and Radius Health, Appointed as Senior Vice President of Investor Relations –
– Webb Brings More than 20 Years of Diverse International Experience Across Investor Relations, Business Development, Investment Analysis and Portfolio Management in the Healthcare and Biotechnology Fields –
SIENDO Conference Call 3/17/2022 & Happy St. Patrick's Day!
5 March - NEW SELINEXOR APPROVAL. Many more to come.
APPROVAL OF NDA BY THE SINGAPORE HSA FOR XPOVIO (SELINEXOR) FOR THE TREATMENT OF RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND DIFFUSE LARGE B-CELL LYMPHOMA IN THREE INDICATIONS
"I remember what Pfizer CEO said about buyouts. He wants to identify gems before they are fully developed, to maximise their investment return. Siendo is essentially that. Now is the time to buy for its potential in other solid tumors. Not later. Just a thought about the possibility of an imminent buyout."
Older posts are regularly archived. Sign up for mailing list.
Also see: Doctors With Questionable Affiliations: Vinay Prasad, Aaron Goodman, Al-Ola A Abdallah, Maha Hussain, Howard Scher
Do your own research. This is not an investment advice.
Donations appreciated: www.paypal.me/rezaganjavi
To be removed reply with "Remove".