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Nektar Therapeutics (NKTR)

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  • G
    Groucho
    PIVOT-02 Melanoma Results at 2020 SITC:

    The first column is PIVOT-02 bemdivo. The second column is historical single-agent Opdivo.

    29.0. - 38.0 Median Time of Follow-Up (months)

    34% - 16% Complete Response

    53% - 44% Overall Response Rate

    30.9 - 6.9 Median Progression-Free Survival (months)

    47% - n/a 100% Reduction in Target Lesions

    71% - 52% 3 Year Landmark Overall Survival

    Not just better, far better.

    Opdivo is an approved checkpoint inhibitor. Keytruda is an approved checkpoint inhibitor.

    Immunotherapy drugs called immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the “off” signal from being sent, allowing the T cells to kill cancer cells.

    Opdivo & Keytruda - Apples & Apples

    Keytruda is the No.1 selling I/O drug in the world.

    Looking forward to the PROPEL bemtruda NSCLC data any day now.
  • G
    Gladpick
    FDA sends 2nd noncompliance notice for company failing to post trial results as crackdown ramps up
    Zachary Brennan
    Senior Editor
    The FDA is slowly but surely continuing its crackdown on drugmakers that fail to post their clinical trial results to a government database in a timely manner, this week going after Georgia-based Accuitis, which develops new treatments for skin disorders.

    Although the agency has previously outlined how it may take enforcement action and assess $10,000 per day fines against companies that fail to report their results, the agency has only sent two letters of noncompliance so far, and no fines have been issued to date.

    According to a FDAAA tracker from the University of Oxford, the government could have collected more than $21 billion in fines already because of the number of trial results that have not been reported in a timely manner.

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    In the most recent letter of noncompliance from this week, FDA pointed to Accuitis’ failure to post results for a Phase II trial in 36 participants from 2017 for the firm’s experimental treatment for moderate to severe acne rosacea. The company did not respond to a request for comment.

    Despite sending a prior letter to Accuitis in October 2020, the FDA said it also did not receive a response and said the company is not in compliance with the Food and Drug Administration Amendments Act of 2007’s results information submission requirements, which stipulate that trial results must be sent to the ClinicalTrials.gov databank no later than one year after the primary completion date of the applicable clinical trial.

    Back in April, FDA also sent a notice of noncompliance to Acceleron Pharma for its failure to post results from a cancer trial. The company posted the results in May. The trial in question flopped back in 2017 and the Cambridge, MA-based biotech halted its development of the drug at the time.
  • G
    Gladpick
    New Orleans EMS can't keep up with calls due to the Covid-19 surge as mayor restores a mask mandate
    By Aya Elamroussi, CNN 1 hr ago

    "Thanks to the Delta variant, the Covid pandemic is once again raging out of control," New Orleans Mayor LaToya Cantrell said at a news conference.

    "We have been here before; we've seen the movie. ... What was once unpreventable, today is preventable. And it's through our people getting vaccinated."
    Over the past week, the city saw more than 1,000 new Covid-19 cases, Cantrell said. And the daily case average also spiked to 272, up from 104 last week, she said.
    "This is a very dangerous number," she said. "Our children are dying. From two weeks old to two years old to four years old. You cannot make it up. Our children are dying."
    The mayor's mask mandate is effective immediately and applies to indoor settings and large outdoor crowds. The mayor is also requiring all city employees to get vaccinated.
    More than 71% of New Orleans city employees are vaccinated, but that is not good enough, Cantrell said.
    "You really need that mask on, period -- whether you are vaccinated and, of course, if you are unvaccinated," she said.
    As for the EMS, Cantrell said, "We currently do not have the capacity to respond to 911 calls that come from our community right now." ..........................
  • J
    JD
    Merck Conference Call this Morning. CEO states they are cash rich and are in the market to buy a company which will expand their pipeline. Will be more info in the Q&A
  • G
    Gladpick
    Delta variant raises fears of worsening mutations
    BY JUSTINE COLEMAN - 07/31/21 11:46 AM EDT 361

    The rapid spread of the delta variant is raising concerns among scientists that the coronavirus could mutate into more transmissible or deadlier strains.

    The fresh fears come as the U.S. vaccination rate has largely plateaued, and with much of the world still unvaccinated. Such a large amount of people without even one vaccine dose gives the virus more chances to spread, replicate and potentially develop mutations.

    Experts say that while mutations are not a certainty, the odds will remain high unless more vaccines are administered. And they warn that the highly transmissible delta variant, which came from mutations, could seem tame in comparison to future strains.

    In announcing the new mask guidance this week, Centers for Disease Control and Prevention Director Rochelle Walensky addressed the anxiety among public health experts over whether potential mutations might be able to bypass existing COVID-19 vaccines.

    “Right now, fortunately, we are not there,” Walensky said. “These vaccines operate really well in protecting us from severe disease and death.”

    “But the big concern is that the next variant of that might emerge, just a few mutations potentially away, could potentially evade our vaccines,” she added.

    When COVID-19 spreads, the virus replicates its genetic material to infect more cells. In the process, that material sometimes mutates from the original strain.

    Andrew Pekosz, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, said the virus mutates randomly but at a steady rate.

    Most changes do not help or inhibit the virus’s ability to spread, but “very, very infrequently” its genetic material alters to give it the upper hand, he said.......
  • G
    Guru
    Any ideas when Nektar will actually do anything meaningful with all of this technology? I am still holding onto quite a few shares but haven't followed the data for over three years.

    After 13 years as a shareholder, I am hoping I don't have to wait for another decade for another magical boost.

    Any insights on what is coming down the pipeline?

    Thanks,
    Guru.
  • G
    Groucho
    In November 2019 there were major changes to the PROPEL trial. One change was to add a Phase 2 with bemtruda for NSCLC. PROPEL was all good lot bempeg at this time.

    Then in 1H20 BMS decided not to pursue bemdivo for NSCLC. NKTR could now pursue a registrational trial with bemtruda for NSCLC.

    On the 3Q20, NKTR said;

    For PROPEL, our study in non-small cell lung cancer in combination with pembrolizumab, we've had great interest in the study from leading thoracic cancer centers in the U.S. and Europe. And consequently, we have surpassed our expected enrollment in the last few months. We now expect that we will have more data for each of the P less than 1%, 1% to 49% and 50% and greater PD-L1 from this study with data from approximately 30 patients who have had two scans or more available in the first part of 2021.

    On the 4Q20 CC, NKTR said:

    As we mentioned at the JPMorgan conference, enrollment in this trial came in well ahead of schedule with a high number of patients enrolled in November and December of last year. We plan to report the initial data from this study in the second half of this year. This will be data in approximately 60 patients spread across three separate PD-L1 expression cohorts.

    On the 1Q21 CC, NKTR said:

    As Howard stated, we expect to report initial data from the PROPEL non-small cell lung cancer study in the second half of this year. As we've said in the past, we are looking for a maturity of at least two scans or more for patients on treatment, so we can fully understand the potential clinical benefit of the doublet over time.

    ————

    My how quickly things change.
  • K
    Klaus
    Pembrolizumab Plus Chemo Significantly Improves OS in Metastatic TNBC With PD-L1 CPS ≥10
    July 27, 2021
    Kristi Rosa

    The addition of pembrolizumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial.
  • G
    Groucho
    262 may still be alive.

    This from SITC 2020:

    Abstract 368: "REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors", Diab, A., et al. (Combinatorial Therapies):
    Safety, pharmacokinetics (PK), pharmacodynamics (PD) and biomarker data supported selection of NKTR-262 3.84 mg Intra-Tumoral (IT) plus BEMPEG 0.006 mg IV q3w as the RP2D. A maximum-tolerated dose was not reached.
    Robust TLR 7/8 engagement was observed upon administration of NKTR-262 IT.
    NKTR-262 plus BEMPEG induced systemic activation of T cells and Natural Killer (NK) cells demonstrating engagement of the entire immune activation cascade required for systemic tumor clearance.
    Induction of TLR7/8-responsive genes significantly correlated with CD11c+ baseline density. CD11c+ target cells are significantly more abundant in baseline melanoma biopsies vs other tumor types.
    NKTR-262 IT, as monotherapy or in combination with BEMPEG, showed early signs of clinical activity and an acceptable safety profile in a highly relapsed/refractory, heavily pre-treated melanoma patient population.

    ————

    According to this the maximum tolerated dose was not reached as of November 2020 (9 months ago).

    JZ is most likely keeping tabs on mass quantities of biomarkers.

    It appears the majority of the financing is going towards bempeg and 255. It may be that 262 is simmering on low on the back burner while bempeg and 255 are cooking on high on the front burners.

    The REVEAL trial has been “active, not recruiting” since February, 2021. The trial description has all patients being relapsed/refractory.

    I am not expecting any news on REVEAL until after bempeg receives it’s first approval.
  • P
    Paul
    If I was a basher....
    I would be more concerned about my losses on CCL, INTC, ESPR, CLVS.... and post my grievances on those boards.
    Oh forgot, I don't own any of these stocks and am just a 25 cent paid poster.
  • K
    Klaus
    News
    Nektar to Announce Financial Results for the Second Quarter 2021 on Thursday, August 5, 2021, After Close of U.S.-Based Financial Markets
    SAN FRANCISCO, July 27, 2021 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) will announce its financial results for the second quarter 2021 on Thursday, August 5, 2021, after the close of U.S.-based financial markets. Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.
  • P
    Paul
    From the Daily Yeast....
    Even assuming that interest rates never again exceed 3 percent, this year’s spending spree alone would add $240 billion in interest costs to the federal budget every year, forever. That is $240 billion each year that could otherwise provide free public college, finance major climate initiatives, or significantly expand health care coverage. Instead, it will be spent on interest for bondholders.

    https://www.thedailybeast.com/kyrsten-sinemas-right-that-america-cant-afford-dems-free-trillions?source=articles&via=rss
  • G
    Groucho
    Data is coming -

    Data coming out in the middle of this year should be for the COVID-19 study.

    Data coming out this year should be Phase 2 PROPEL and early Phase 1/2 255. The Phase 3 melanoma should be out this year or early next year.

    Data coming out in 1H22 should be for three registrational studies: Phase 3 melanoma, Phase 3 RCC and Phase 2 accelerated approval UC.

    Data coming out in 2022 could be results from the 358 lupus trial.

    Interesting that there has been no mention of SITC, ASCO, or any other conference for presenting this data. Not in the 1Q21 CC or the 4Q20 CC.

    Stand alone dog-n-pony shows or separate PRs?

    This from the 1Q21 CC:

    We entered 2021 with a deep portfolio of candidates in immuno-oncology and immunology, spanning from Phase 1 to Phase 3 development, and we're looking forward to a steady cadence of key data readouts beginning later this year.

    We're planning our first formal data cut from the initial part of the study sometime in the second half of this year.

    We expect to have several initial data readouts for multiple studies, capturing single-agent NKTR-255 dose escalation and combination with at least one targeted antibody in the second half of this year.

    In liquid tumors, we're combining with rituximab and daratumumab. And in solid tumors, we're combining with cetuximab. We will have our first data in combination with these agents by the end of this year.

    Our first three registrational studies to read out in the first half of 2022 are . . . .

    Our early results are highly encouraging and this led to a large dose-ranging placebo-controlled study of NKTR-358 in these patients, which started in Q3 of last year. We anticipate results from this study could come in 2022.

    ————

    I need more coffee.
  • K
    Klaus
    Bristol Myers Squibb Co. BMY, -0.30% said Wednesday it swung to a profit of $1.055 billion, or 47 cents a share, in the second quarter, after a loss of $85 million, or 4 cents a share, in the year-earlier period. Adjusted per-share earnings came to $1.93, ahead of the $1.89 FactSet consensus. Revenue rose to $11.703 billion from $10.129 billion, also ahead of the $11.269 billion FactSet consensus. "We delivered a strong quarter across each of our four therapeutic areas, including building momentum for our new product portfolio and Opdivo returning to growth," Chief Executive Dr. Giovanni Caforio said in a statement. Opdivo was first approved by the Food and Drug Administration in 2014 as a treatment for melanoma and has since won approval for other indications. Sales of Opdivo rose 16% in the second quarter to $1.910 billion. Bristol Myers updated its full-year EPS guidance to a range of $2.77 to $2.97 from a prior range of $3.18 to $3.38. It still expects full-year adjusted EPS of $7.35 to $7.55. It expects worldwide revenues to grow in the high-single digits. Shares were flat premarket, but have gained 8.8% in the year to date, while the S&P 500 SPX, -0.47% has gained 17%.
  • K
    Klaus
    Johns Hopkins Dr. Marty Makary



    EXCERPT FROM WALL STREET JOURNAL



    The news about the U.S. Covid pandemic is even better than you’ve heard. Some 80% to 85% of American adults are immune to the virus: More than 64% have received at least one vaccine dose and, of those who haven’t, roughly half have natural immunity from prior infection. There’s ample scientific evidence that natural immunity is effective and durable, and public-health leaders should pay it heed.



    Only around 10% of Americans have had confirmed positive Covid tests, but four to six times as many have likely had the infection. A February study in Nature used antibody screenings in late summer 2020 to estimate there had been seven times as many actual cases as confirmed cases. A similar study, by the University of Albany and New York State Department of Health, revealed that by the end of March 2020—the first month of New York’s pandemic—23% of the city’s population had antibodies. That share necessarily increased as the pandemic spread.



    Natural immunity is durable. Researchers from Washington University in St. Louis reported last month that 11 months after a mild infection immune cells were still capable of producing protective antibodies. The authors concluded that prior Covid infection induces a “robust” and “long-lived humoral immune response,” leading some scientists to suggest that natural immunity is probably lifelong. Because infection began months earlier than vaccination, we have more follow-up data on the duration of natural immunity than on vaccinated immunity.



    Skeptics of natural immunity point to Manaus, capital of the Brazilian state of Amazonas, where reports in January suggested a wave of re-infections despite herd immunity. But the initial estimate of those infected was incorrect because it was based on antibody testing among those who donated convalescent plasma—an unrepresentative subgroup of the population. A follow-up study debunked the re-infection hypothesis and found only three confirmed re-infections in the entire state, whose population exceeds four million. Other studies have confirmed that re-infections are rare and usually asymptomatic or mild.



    Should the previously infected be vaccinated? My clinical advice to healthy patients with natural immunity is that one shot is sufficient, and maybe not even necessary, although it could increase the long-term durability of immunity. A University of Pennsylvania study of people previously infected with Covid found that a single vaccine dose triggered a strong immune response, with no increase in that response after a second dose. A separate study from New York’s Mount Sinai School of Medicine concluded that “the antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds the titers found in naïve”—never-infected—“individuals after the second dose.”
  • L
    Lobo
    Shortall boasted about buying Wynn at $130, said load up. It’s $99 and Vegas is headed for lock down. Macau is very iffy at this point also.
  • C
    Caffeinated Biochemist
    For cancer types treatable by Opdivo and Keytruda, only about 40% of tumors express enough PD-L1 to respond to treatment. We see a growing body of evidence that NKTR-214 paired with Opdivo or Keytruda can elicit responses, including CR’s, in the remaining 60% of tumors. The NSCLC data, coming this year, will be binned by PD-L1 expression level. If we see a significant increase in ORR and/or CR in the low expressers, as previous studies suggest we ought, I’d love to see what that does to the valuation. And that’s without considering 255, 358, and other assets.
    Bullish
  • S
    Saatradical
    Speculation: 4 years ago when Howard Robin announce NKTR 214 blow-out data in mouse-models that gradually led to a 100$ shareprice, do you think the very first thing that went through HR’s mind was ‘ wow I can game this w my options and have a 20 million$ windfall’, or did he think ‘ wow this is a huge breakthrough in oncology research and treatments for aggressive cancers!’. First thought….?
  • K
    Klaus
    Car-T 8 240 coming including BMY [CELG] BMY still building plants.

    Gilead Sciences Q2 Revenues Grow 21 Percent as CAR T-Cell Business Jumps 39 Percent
  • G
    Groucho
    The next five months -

    PROPEL data - this is bemtruda in NSCLC. This is bempeg with the NSCLC standard of care, which is Keytruda, which is the world’s No. 1 selling IO drug. This will most likely validate bempeg’s action as nothing converts PD-L1 negative to positive like bempeg does. And nothing heats up a tumor like bempeg. Share price shake-up and possible AA?

    Phase 3 melanoma data - The trial started Sept 2018 and BMS recently said data could be as early as late 2021. How can this be when the trial Primary Completion Date is April 25, 2022? Thanks to the Breakthrough Therapy Designation (BTD), which encompasses Fast Track, AA, Priority Review and Rolling Review, BMS has most likely been feeding the FDA early datasets. And since the majority of IO approvals include “in patients that expressed a high level of PD-L1”, there is a possibility that early AA based on specific PD-L1 expression could be granted? BTD is huge and low PD-L1 is an unmet need. Then there is the CR wildcard.

    Phase 2 UC data - The 110 or so low PD-L1 cisplatin ineligible folks have no other viable options. And 18 months ago there were 112 sites that ere recruiting. A large percentage of the 110 or so anticipated patients could now have 18-months of follow up. These folks have no other viable options. No other viable options, possible early AA?

    The first half of next year -

    Phase 3 melanoma Primary Outcome Measure data - If it does not come out in the next 5 months.

    Phase 2 UC Primary Outcome Measure data - If it does not come out in the next 5 months.

    Phase 3 RCC Primary Outcome Measure data - This trial started Dec 2018 and the Primary Completion Date is Dec 2021. Early PIVOT-02 RCC data had an ORR of 63% (5/8) for PD-L1 negative patients and an overall DCR of 79% (11/14). PIVOT-02 was combo lots of bempeg.

    The future with Keytruda -

    This from the 1Q21 CC:

    In terms of our strategy for BEMPEG plus pembro, our first priority is to focus on the largest settings where pembrolizumab is the gold standard of care, non-small cell lung cancer and head and neck cancer.

    ————

    It is looking like NKTR is planning additional bemtruda trials in the future. Or they are just baiting BMS. Or both.