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Endless 1 februari 2021 15:52

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Arcus Biosciences: Highly Valued Even Without A Phase 3 Study

Jan. 17, 2021 9:28 AM ETArcus Biosciences, Inc. (RCUS)4 Comments5 Likes
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Summary

Arcus is founded by Terry Rosen, a successful biopharma entrepreneur.
It has novel programs in oncology, which have evinced considerable big pharma interest.
Current price is high, although it may be quite justified.
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Arcus Biosciences (RCUS), founded by Terry Rosen who we discussed briefly in a previous article, has a $2.4bn market cap based on a sophisticated pipeline of mid-stage cancer molecules, collaboration deals with Gilead (GILD) for 10 years, and AstraZeneca (AZN), and nearly $785mn in cash reserves that could be the envy of any biopharma, let alone one that began 5 years ago and does not even have a phase 3 trial. So what makes RCUS so highly valued by biopharma investors? Let’s find out.

Pipeline

Arcus has a wide and deep pipeline, meaning multiple novel molecules in multiple indications each. Here’s how it looks:

Source

The molecules are quite interesting. Listed randomly, these are:

Etrumadenant (Etruma) - Dual A2a/A2b Adenosine Receptor Antagonist Small Molecule

AB680 - CD73 Inhibitor Small Molecule - First small-molecule CD73 inhibitor to enter clinical development; both IV and oral formulations.

Domvanalimab (DOM) - Anti-tigit Antibody - A readout for a randomized interim-analysis for ARC-7 planned in 2Q21 in 1st line NSCLC with PD-L1 = 50%. The company is also advancing ARC-10 into a registrational trial to support both Dom + Zim and Zim approvals.

Zimberelimab (ZIM) - Anti-PD-1 Antibody inlicensed from WuXi Biologics

The Adenosine axis

Arcus is a leader in developing drugs targeting the adenosine axis. The adenosine axis plays a critical role in immunosuppression in the tumor microenvironment or TME. When a tumor cell dies especially through immunogenic chemotherapy, it releases extracellular ATP or adenosine triphosphate. CD39 and CD73 are two cell surface proteins that act as enzymes to catalyze ATP to AMP to adenosine. These are non-redundant proteins, meaning without CD73 the process is not complete. Now, this adenosine is a major immunosuppresor in the TME. It works by binding to A2a/A2b receptors expressed on many immune cells.

Arcus presently has two molecules that work in the adenosine axis. One is AB680, which blocks CD73 and stops it from converting ATP to adenosine. The other, Ertuma, works downstream of AB680. It blocks adenosine from binding to A2a/A2b, the two receptors that assist in immunosuppression by impairing of tumor-infiltrating lymphocytes (mainly T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by the A2a and A2b receptors, respectively. A2b is also upregulated in certain tumors, such as in KRAS-mutated cancers.

AB680 is a small molecule inhibitor of CD73 which offers several advantages over antibodies targeting CD73. The most advanced of these in terms of clinical development is AZN’s oleclumab and BMS-986179 from Bristol-Myers Squibb (NYSE:BMY). Adenosine is formed through the mediation of CD73 deep in the cells, and antibodies have a permeability issue when it comes to tumor tissue. However, a small molecule like AB680 is much more mobile. Antibodies are, therefore, not as effective against CD73, and especially against soluble CD73. One explanation, according to the company 10-K, for this difference in potency is that “small-molecule CD73 inhibitors bind in the active site of the CD73 enzyme with an affinity about ten million times greater than the affinity of its substrate, AMP, for CD73. In contrast, many anti-CD73 antibodies were not designed to inhibit the enzymatic activity of CD73 but to instead induce internalization of CD73 from the cell surface and therefore will be less effective at inhibiting soluble forms of CD73,” because large volumes of CD73 is shed from the cell surface and presents in soluble forms.

Endless 1 februari 2021 15:53

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AB680 has already established its safety profile as a single agent in healthy volunteers and in combination with chemo/anti-PD-1 in pancreatic cancer patients. The latest update from this latter indication came out just yesterday. Data was posted at ASCO. The data was as follows:

The ongoing, open-label, multi-centre trial is a Phase 1/1b study evaluating the safety profile and clinical activity of AB680 in combination with nab-paclitaxel plus gemcitabine (NP/Gem) and zimberelimab, an anti-PD-1 antibody, as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Across all four dose-escalation cohorts, no significant additive toxicity from AB680 combo was observed beyond that expected from NP/Gem plus anti-PD-1 combined, the company said.

41% objective response rate (7/17) was observed for the AB680 combination across all dose-escalation cohorts, including one patient who converted to a complete response for both target and non-target lesions.

This is preliminary data, but such ORR in this patient population is very competitive. PDAC is a devastating disease with a 5-year survival rate of just 9%. The last treatment approved for this disease was way back in 2013, which was Abraxane + gemcitabine, or Np/gem, on the basis of just 23% ORR. Here we already have 41% in an early trial, which is bound to improve. There are very few therapies in development, and PD-1 doesn’t work too well. In such a setting, AB680 could be a gamechanger - which is what makes big pharma interested in this company.

Source

AB680 has a half life of 4 days so it could be used once every 2 weeks according to the company. IV formulation has been tested, development of oral formulation is ongoing. The phase 1 preliminary data shows minimal toxicity added to chemo.

Other assets in the list are interesting, novel, but in early stages without data. They are interesting because, for example, the anti PD-1 antibody Zimberelimab has properties similar to pembrolizumab, or Keytruda, and Arcus’ effort is to combine molecules in its own pipeline to adequately address multiple pathways in a single indication.

Source

This keeps the company flexible while retaining its independence.

The collaborations

Arcus has a 10-year all-in collaboration with Gilead. The partnership provides for a 50/50 profit share in the US, but also lets Arcus retain strategic flexibility and maintain commercial rights over its entire pipeline. Key highlights of the deal are as follows:

- Immediate rights to co-develop and co-commercialize zim; option to exclusively license investigational products from each of Arcus’ other current and future programs over the 10-year collaboration term

- For each program, Arcus’ achievement of a designated development milestone will trigger an option window, and Gilead may exercise its option at any time up until the end of the option window

- Partnership provides additional opportunities to maximize value and bring potential benefits to broadest patient population possible (e.g., AstraZeneca PACIFIC-8 study)

Endless 1 februari 2021 15:54

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Under the terms of the deal, RCUS will receive $175M upfront plus a $200M equity investment (at $33.54/share) from GILD, up to $1.225B in opt-in and milestone payments and tiered high-teens-to-low-twenties royalties on GILD-licensed products ex-U.S.

Other major collaborations include a Roche/Genentech 50/50 co-development program in third-line metastatic colorectal cancer (CRC) and first-line metastatic pancreatic cancer.

Arcus also has a deal to collaborate with AstraZeneca on a potential registrational trial for domvanalimab, Arcus’ novel anti-tigit antibody, plus Imfinzi in stage 3 NSCLC. The trial will begin in 2021. Under the terms of the agreement, each company will retain existing rights to their respective molecules and any future commercialisation plans. AstraZeneca will conduct the trial, and each company will supply its respective anti-cancer agent to support the trial. The parties will share costs for the trial.

Financials

RCUS has a market cap of $2.4bn and a cash reserve of $785mn, more than enough to see multiple programs through approval. The stock is trading near its 52-week and all-time highs. The stock is largely institution owned. There is a healthy open market purchase of the stock from insiders:

Source

About their IP, the 10-K says:

As of February 1, 2020, we have issued U.S. patents directed to compositions of matter with respect to our adenosine receptor antagonist, CD73 inhibitor and anti- TIGIT antibody programs. As of February 1, 2020, our company-owned and licensed patent portfolio consists of 17 pending or issued U.S. patent applications, 8 pending Patent Cooperation Treaty (PCT) patent applications, and 133 pending or issued foreign patent applications directed to compositions of matter, methods of synthesis and methods of use. The term of any patents that issue will vary in accordance with the laws of each jurisdiction, but is typically 20 years from the earliest effective filing date. Our issued patents and any patents that may issue in the future from our company-owned or licensed pending applications are projected to expire between 2035 and 2040, absent any patent term adjustments or extensions.

Bottomline

Arcus is a very interesting company, just a little too overpriced right now. 2020 was an excellent year for the stock. The stock gained immensely following the Gilead deal. Its programs are early stage but have unique Mechanism of actions and promising early data from one program. The dilutions from last year and the collaboration payments have given them a cash moat of surprising proportions. Given all that, I will continue to watch the stock and look for an opportune price point to enter a position.

Endless 3 februari 2021 11:43

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twitter.com/kitepharma/status/1356875...

Endless 4 februari 2021 17:02

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Gilead Sciences Q4 2020 Earnings Preview

Feb. 03, 2021 5:35 PM ETGilead Sciences, Inc. (GILD)By: Gaurav Batavia, SA News Editor16 Comments
Gilead Sciences (NASDAQ:GILD) is scheduled to announce Q4 earnings results on Thursday, February 4th, after market close.
The consensus EPS Estimate is $2.15 (+65.4% Y/Y) and the consensus Revenue Estimate is $7.17B (+21.9% Y/Y).
Analyst expects R&D expense of $1.36B.
Over the last 2 years, GILD has beaten EPS estimates 63% of the time and has beaten revenue estimates 63% of the time.
Over the last 3 months, EPS estimates have seen 15 upward revisions and 1 downward. Revenue estimates have seen 12 upward revisions and 2 downward.

voda 5 februari 2021 06:22

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Gilead profiteert van coronabehandeling remdesivir

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Gilead Sciences Inc
$ 65,87 1,35 2,09 % NASDAQ
Gilead Sciences Inc (DE)
54,56 0,00 0,00 % Frankfurter Wertpapierbörse (Xetra)

(ABM FN-Dow Jones) Gilead Sciences profiteerde in het vierde kwartaal van 2020 van de opbrengsten van Veklury, zijn virusremmer die wordt ingezet bij coronapatiënten die in het ziekenhuis liggen. Dit meldde de Amerikaanse partner van Galapagos donderdag nabeurs bij het vrijgeven van de kwartaalcijfers.

In het kwartaal verdiende Gilead bijna 2 miljard dollar met Veklury, beter bekend als remdesivir.

De totale omzet van Gilead steeg van 5,88 miljard naar 7,42 miljard dollar. Analisten geraadpleegd door FactSet rekenden op 7,08 miljard dollar.

Onder de streep resteerde een nettowinst van 1,55 miljard dollar, tegenover circa 2,7 miljard dollar een jaar eerder. De winst per aandeel nam af van 2,12 tot 1,23 dollar.

De aangepaste winst per aandeel van 2,19 dollar was beter dan de 2,04 dollar die analisten voorspelden.

Na een plus van 2 procent in de reguliere handel op Wall Street steeg Gilead in de nabeurshandel donderdag nog eens 2 procent.

Door: ABM Financial News.
info@abmfn.nl
Redactie: +31(0)20 26 28 999

© Copyright ABM Financial News B.V. All rights reserved.

gamerule$ 5 februari 2021 20:45

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Eindelijk, de Filgotinib overhang is weg bij Gilead
Kan eindelijk flink stijgen

Endless 8 februari 2021 20:34

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Gilead Sciences: Still A Good Bet

Feb. 08, 2021 7:32 AM ETGilead Sciences, Inc. (GILD)4 Comments10 Likes
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Summary

Gilead Sciences has switched to acquisitions instead of share repurchases.
The company has made many deals which has saddled it with some debt, but should drive growth as well.
After a recent move higher, I still like the long term potential here at low valuations and potential for growth.
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Gilead Sciences (GILD) has seen quite an eventful 2020, a year in which it reverted from massive share repurchases to spending billions on multiple acquisitions. The operating business has stabilized and recently the stock has come to life as well.

Despite a recent 25% rally, valuations are not too demanding at 10 times earnings based on the 2020 numbers and the outlook for this year. The company has made a few big deals which should allow for growth, but there remain questions around the M&A as well, as the pressure is increasing after the company spent a lot of money on these deals.

An Eventful 2020
My last take on Gilead was in this premium article as I updated the investment thesis following the $21 billion Immunomedics deal. Following some pipeline setbacks, the company spent $21 billion to purchase Immunomedics in a deal which took place at a more than 100% premium.

With this deal, Gilead got its hands on Trodelvy, a Trop-2 antibody drug conjugate for which Immunomedics obtained FDA approval in April 2020 to treat adult patients with metastatic triple-negative breast cancer, with full approval seen in the final quarter of 2020. Note that both firms have high hopes for the same drug in bladder cancer as well, as multiple other studies are performed as well in monotherapy and combination therapy.

The actual deal pay-off requires some pipeline conversion, as the company sees accretion from 2023 onward, not a surprise given the $21 billion purchase price. Sales in the first two months after approval only came in at $20.1 million, and peak sales were estimated at around $3 billion.

That $21 billion deal was substantial as the M&A track record is mixed. The $11 billion purchase of Pharmasset is one of the best M&A moves in the pharmaceutical sphere in recent years, giving the company a very profitable and booming HCV franchise. The $12 billion deal for Kite Pharma, through which the company obtained Yescarta, has not lived up to its expectations yet. Furthermore, the company has invested multi-billion dollars into both Forty-Seven and Galapagos, with setbacks seen in some of these deals as well, certainly on the latter.

These deals were spurred by the observation that some real operational momentum was needed after the HCV franchise imploded by its own success, that of curing patients. While growth in the HIV business is applauded, it is potentially causing a similar dependency risk as well.

A group of other drugs, which contributed nicely over the past years, has seen a setback amidst some expirations. The other bright spots should be Yescarta, but that has been falling a bit short, as the company turned to Immunomedics to add a new potential growth engine. This and other deals meant that Gilead has spent roughly $40 billion on a few deals in just a few years time, which is equivalent to $32 per share. Given that shares recently traded at just $55 per share, that shows how large these deals have been, not necessarily on the near term revenue contribution, but certainly in terms of the costs.

Endless 8 februari 2021 20:34

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What Happened?
Since the announcement of the Immunomedics deal, which triggered a setback after which shares fell from the mid-sixties to the high-fifties, operational improvements arrived quickly. The company hiked the full year guidance in the third quarter. The company’s Covid-19 drug Veklury contributed $873 million in its debut quarter, being a major driver behind that hike.

In December, the company announced another EUR 1.1 billion deal for MYR Gmbh, as in the same month the company was able to report solid research results on Yescarta in treating non-Hodgkin lymphoma.

Early in 2021, the company hiked the 2020 guidance again. It furthermore hiked the quarterly dividend by more than 4% to $0.71 per share, while it reported very resilient 2020 numbers. Full year sales rose 10% to $24.4 billion after quite a few years of declining sales, actually thanks to Veklury. If not for this drug, sales would have been down around 2%. Veklury sales show real momentum, with fourth quarter product sales of $1.9 billion doubling compared to the debut quarter in the third quarter of 2020.

For 2021, the company sees sales at $23.7-$25.1 billion, or $24.4 billion at the midpoint of the guidance. This suggests flattish sales, based on a midpoint of $2.5 billion in sales of Veklury, actually downs slightly vs. the reported revenues at $2.8 billion in 2020.

The company reported adjusted earnings of $7.09 per share and guided for earnings at a midpoint of $7.10 per share in 2021, as GAAP earnings in 2020 only totaled ten cents. Much of the adjustment results from the written down acquired R&D of Galapagos and the declining share price with Gilead holding a substantial position in the equity as well. This certainly has had an impact on the balance sheet, now revealing a net debt load of around $30 billion, equivalent to about 2.5 times adjusted operating earnings.

The 2020 results reveal that reliance on HIV has been on the increase, yet this is expected to come down over time. HIV sales rose 3% to $16.9 billion in 2020 as HCV sales declined another third to $2.1 billion. Veklury sales have (temporarily) become the second largest product category with $2.8 billion in sales as the old-fashioned "other" products groups saw sales fall to $1.9 billion.

Other than Veklury, there are two growth engines. Cell therapy sales rose 33% to $607 million, almost all represented by Yescarta which has grown to more than half a billion, but still does not fully live upto the expectations. Of interest are sales of Trodelvy which was acquired of course with Gilead’s most expensive deal to date. After sales hit $20 million in the first two months following the launch, fourth quarter sales came in at $49 million. While the run rate of $200 million is not sufficient to justify the $22 billion price tag, momentum stills seems good.

A Final Take
Having been an avid holder who has continued to buy the dips, and including dividends has averaged all the way down to $61, I see shares now trading at $69 per share. This marks decent gains of 10-15%, yet it is evident that these gains have not been keeping up with the wider market.

Nonetheless, I like the more ambitious role of Gilead, and after the multi-billion dollars being spent on repurchases, it is time that real results are seen. While this could appear in 2021, product sales are essentially seen flat, yet I have real hopes that the company is being conservative in its guidance.

With shares trading at around 10 times trailing and guided earnings, the multiples look very reasonable as the company is essentially positing flattish sales and acquisitions have really fortified the growth profile. These acquisitions have led to Gilead incurring multi-billion dollars in debt and on a pro-forma basis adding just 2-3% of current revenues (talking Kite & Immunomedics here and not even all the smaller deals like Galapagos and Forty-Seven).

In the big picture, these deals still have to prove themselves, yet really have the potential to halt sales declines and actually allow for growth from here. After a decent 25% return from the recent lows, the fundamental appeal still remains there.

Endless 10 februari 2021 12:05

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KITE KONDIGT DE AMERIKAANSE FDA GOEDKEURING AAN VAN DE AANVRAAG VAN EEN NIEUWE DRUGS VOOR KITE-222, EEN ANTI-CLL-1 CAR T-CELL THERAPIE KANDIDAAT VOOR ACUTE MYELOÏDE LEUKEMIE

- Kite start multicenter klinische studie voor CAR T-celtherapie bij acute myeloïde leukemie -

Santa Monica, Californië - 9 februari 2021 - Kite, een Gilead Company, heeft vandaag aangekondigd dat de Amerikaanse Food and Drug Administration (FDA) haar Investigational New Drug (IND) aanvraag voor KITE-222 heeft goedgekeurd, de eerste chimere antigeenreceptor van het bedrijf (CAR) T-celtherapie gericht op C-type lectine-achtige molecule-1 (CLL-1). Kite is van plan om later dit jaar een multi-center Fase 1 klinische studie te starten ter evaluatie van KITE-222 bij recidiverende / refractaire acute myeloïde leukemie (AML).

"De goedkeuring van onze IND-aanvraag voor KITE-222 is een belangrijke mijlpaal tegen de ambitieuze en innovatieve doelstellingen van ons CAR T-ontwikkelingsprogramma", aldus Francesco Marincola, MD, Senior Vice President en Global Head of Cell Therapy Research van Kite. “Als leider op het gebied van celtherapie heeft Kite de allereerste CAR T-franchise van CD19-gerichte therapieën in de branche opgericht en we breiden onze onderzoeksaanpak uit met CLL-1 in AML, waar de ontwikkeling van CAR T historisch beperkt was vanwege het gebrek aan van een specifiek doelwit. We kijken ernaar uit om onze multicenter CAR T-studie te starten voor patiënten met AML die grote behoefte hebben aan nieuwe behandelmethoden. "

Over KITE-222

KITE-222 is een autologe T-celtherapie ontwikkeld met een CAR die specifiek gericht is op CLL-1. CLL-1-expressie is beperkt tot aan lijn gebonden myeloïde cellen en komt niet voor op gezonde hematopoëtische stamcellen. In preklinische studies heeft KITE-222 een robuuste antigeen-specifieke functie van CAR T-cellen aangetoond en het vermogen om AML-cellen te verwijderen in agressieve tumormodellen.

KITE-222 is onderzoekend en nergens wereldwijd goedgekeurd. De werkzaamheid en veiligheid zijn niet vastgesteld.

Over acute myeloïde leukemie (AML)

AML is de meest voorkomende vorm van acute leukemie bij volwassenen en vertegenwoordigt het grootste aantal jaarlijkse sterfgevallen door leukemie in de VS en Europa. AML begint in het beenmerg en kan zich snel verplaatsen naar het bloed en andere delen van het lichaam, inclusief de lymfeklieren, milt en het centrale zenuwstelsel. Elk jaar wordt bij ongeveer 30.000 mensen in de VS en Europa de diagnose AML gesteld, en het totale overlevingspercentage na vijf jaar bij volwassenen is slechts 24 procent. Bij patiënten met een recidiverende / refractaire ziekte is de behoefte het grootst, waar er momenteel geen standaardzorg is en de totale overleving ongeveer 3 tot 9 maanden bedraagt.

Over Kite

Kite, een Gilead Company, is een biofarmaceutisch bedrijf gevestigd in Santa Monica, Californië, met commerciële productieactiviteiten in Noord-Amerika en Europa. Kite houdt zich bezig met de ontwikkeling van innovatieve immunotherapieën tegen kanker. Het bedrijf richt zich op chimere antigeenreceptoren en door T-celreceptoren ontwikkelde celtherapieën. Ga voor meer informatie over Kite naar www.kitepharma.com.

Over Gilead Sciences

Endless 4 maart 2021 14:46

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twitter.com/gileadsciences/status/136...

Endless 4 maart 2021 14:48

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4 maart 2021

Gilead Sciences voltooit overname van MYR GmbH
FOSTER CITY, Californië - (BUSINESS WIRE) - Gilead Sciences, Inc. (Nasdaq: GILD) heeft vandaag de voltooiing aangekondigd van de eerder aangekondigde transactie om MYR GmbH over te nemen voor een totaalbedrag van ongeveer € 1,45 miljard in contanten. De overname levert Gilead Hepcludex® (bulevirtide) op, dat in juli 2020 voorwaardelijk werd goedgekeurd door het Europees Geneesmiddelenbureau voor de behandeling van chronisch hepatitis deltavirus (HDV) bij volwassenen met gecompenseerde leverziekte.

“Hepcludex is een belangrijke nieuwe toevoeging aan de Gilead-portefeuille. Met deze eersteklas therapie voor HDV, de meest ernstige vorm van virale hepatitis, hebben we de mogelijkheid om een ??gebied met een hoge onvervulde medische behoefte aan te pakken '', aldus Daniel O'Day, voorzitter en CEO van Gilead Sciences. “Gilead heeft bijna 20 jaar ervaring in het innoveren en verbeteren van therapieën voor virale hepatitis. We kunnen daar nu op voortbouwen met Hepcludex, in samenwerking met het MYR-team om het volledige potentieel van de therapie voor mensen met HDV wereldwijd te realiseren. "

Als gevolg van de voltooiing van de fusie is MYR een volledige dochteronderneming van Gilead geworden. Hepcludex is een onderzoeksmiddel en de veiligheid en werkzaamheid ervan zijn niet vastgesteld in de VS of in andere regio's waar het geen wettelijke goedkeuring heeft gekregen. Hepcludex, Gilead en het Gilead-logo zijn handelsmerken van Gilead Sciences, Inc. of aanverwante bedrijven.

Endless 6 maart 2021 05:16

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twitter.com/kitepharma/status/1368002...

March 05, 2021

U.S. FDA APPROVES YESCARTA® FOR RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

Endless 7 maart 2021 08:45

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Seeking alpha
Gilead wins FDA approval for Yescarta in follicular lymphoma

Mar. 06, 2021 9:09 PM ETGilead Sciences, Inc. (GILD)By: Dulan Lokuwithana, SA News Editor13 Comments
Kite, a unit of Gilead Sciences (NASDAQ:GILD), has announced that the FDA has granted approval for its T cell immunotherapy Yescarta (axicabtagene ciloleucel) for a certain category of adults with relapsed or refractory follicular lymphoma.
The approval allowing the Yescarta use in patients after two or more lines of systemic therapy was backed by ZUMA-5 study where 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta including 74% achieving continued remission at 18 months.
Yescarta, now approved for three indications, comes with a risk evaluation and mitigation strategy (“REMS”) due to risks such as neurological toxicities and has a boxed warning in the U.S. prescribing information.
In September, Kite announced the filing of the supplemental marketing application for Yescarta saying the approval could make it the first CAR T therapy indicated for patients with relapsed or refractory follicular lymphoma.

Endless 8 maart 2021 14:36

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Gilead announces new four year late-stage data for Biktarvy in HIV

Mar. 08, 2021 8:03 AM ETGilead Sciences, Inc. (GILD)By: Dulan Lokuwithana, SA News Editor4 Comments
Gilead Sciences (NASDAQ:GILD) has announced new long-term data from two ongoing Phase 3 studies (Studies 1489 and 1490) of Biktarvy for HIV-1 in treatment-naïve adults.
The data from open-label extensions (“OLE”) of the studies have indicated an undetected viral load in more than 98% of patients who initiated Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) and remained in the study.
The viral load (HIV-1 RNA <50 copies/mL) was maintained through four years of follow-up (n=235/237 for study 1489, n=241/243 for study 1490).
High efficacy and durable viral suppression were also detected in those who switched to Biktarvy, from a dolutegravir-containing triple therapy for the 48-week OLE periods (n=212 for study 1489, n=225 for study 1490), the company said.
No treatment-emergent resistance to any components of Biktarvy occurred in patients treated with Biktarvy.
In 2018, Biktarvy received FDA approval for the treatment of HIV-1 infection.

Endless 9 maart 2021 19:29

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twitter.com/gileadsciences/status/136...

Endless 11 maart 2021 09:53

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seekingalpha.com/article/4413054-gile...

Endless 15 maart 2021 11:52

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twitter.com/gileadsciences/status/137...

Endless 18 maart 2021 13:34

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FOSTER CITY, Californië & BAGSVÆRD, Denemarken - (BUSINESS WIRE) - Gilead Sciences, Inc. (Nasdaq: GILD) en Novo Nordisk A / S (Nasdaq Kopenhagen: NOVO B) hebben vandaag aangekondigd dat de bedrijven hun klinische samenwerking hebben uitgebreid bij niet-alcoholische steatohepatitis (NASH).

De bedrijven zullen een dubbelblinde, placebogecontroleerde fase 2b-studie uitvoeren om de veiligheid en werkzaamheid te onderzoeken van Novo Nordisk's semaglutide, een GLP-1-receptoragonist, en een vaste dosiscombinatie van Gilead's experimentele FXR-agonist cilofexor en experimentele ACC-remmer firsocostat , alleen en in combinatie bij mensen met gecompenseerde cirrose (F4) als gevolg van NASH. De vierarmige studie bij ongeveer 440 patiënten zal de impact van de behandelingen op de verbetering van leverfibrose en NASH-resolutie evalueren en zal in de tweede helft van 2021 beginnen met rekrutering.

Deze nieuwe fase 2b-studie bouwt voort op positieve resultaten van een fase 2a proof-of-concept-studie gepresenteerd op de Liver Meeting Digital Experience ™ in november 2020, waarin semaglutide, alleen en in combinatie met cilofexor en / of firsocostat, werd onderzocht bij 108 mensen met NASH en milde tot matige fibrose. De studie bereikte het primaire eindpunt en toonde aan dat alle regimes gedurende 24 weken goed werden verdragen. De meest voorkomende bijwerkingen waren gastro-intestinaal. In alle groepen stopte 5–14% van de mensen een proefbehandeling vanwege bijwerkingen.

Bovendien toonden post-hocanalyses van verkennende werkzaamheidseindpunten ter beoordeling van biomarkers van levergezondheid na 24 weken statistisch significante verbeteringen in hepatische steatose (gemeten door middel van magnetische resonantie beeldvorming protondichtheid vetfractie; MRI-PDFF) en leverschade (gemeten door serum alanine aminotransferase ; ALT) in de combinatiebehandelingsarmen versus semaglutide alleen. Leverstijfheid en de Enhanced Liver Fibrosis (ELF) -score daalden in alle groepen; statistisch significante verschillen tussen groepen werden echter niet waargenomen.

“NASH is een ziekte met een hoge onvervulde medische behoefte, aangezien er momenteel geen medicijnen zijn goedgekeurd om deze potentieel levensbedreigende aandoening te behandelen. Voortbouwend op de positieve resultaten van onze proof-of-concept-proef, hopen we samen met Gilead het potentieel van semaglutide met cilofexor en firsocostaat aan te tonen om mensen die met NASH leven te helpen, ”aldus Martin Holst Lange, Executive Vice President en Head of Development bij Novo Nordisk.

"Gilead is verheugd om onze samenwerking met Novo Nordisk uit te breiden en meer inzicht te verwerven in het potentieel voor combinatiebenaderingen bij de behandeling van mensen met cirrose als gevolg van NASH", aldus Mark Genovese, MD, Senior Vice President, Inflammation Clinical Development bij Gilead Sciences. "Deze studie is het nieuwste voorbeeld van onze aanhoudende focus op het stimuleren van innovatie om het leven van mensen met leveraandoeningen en fibrose te verbeteren."

Cilofexor en firsocostat zijn onderzoeksverbindingen en zijn niet goedgekeurd door de Amerikaanse Food & Drug Administration (FDA) of enige andere regelgevende instantie. Hun veiligheid en werkzaamheid zijn niet vastgesteld. Semaglutide is niet goedgekeurd door de FDA of een andere regelgevende instantie voor de behandeling van patiënten die leven met NASH, maar is goedgekeurd voor de behandeling van diabetes type 2.

Over NASH

NASH is een chronische en progressieve leverziekte die wordt gekenmerkt door vetophoping en ontsteking in de lever, wat kan leiden tot littekens of fibrose, die de leverfunctie aantasten. Het risico op progressie naar een gevorderde leverziekte, waaronder leverdecompensatie (verlies van leverfunctie) en leverkanker, is hoger bij mensen met NASH dan bij de algemene bevolking en NASH zou in de meeste landen de belangrijkste reden voor levertransplantaties kunnen worden. Momenteel is er wereldwijd geen farmacotherapie goedgekeurd voor de behandeling van NASH, en mensen met NASH hebben nog maar heel weinig behandelingsopties.

Endless 3 april 2021 09:28

0

De analisten hebben een strong buy afgegeven.

Kite dient aanvullende biologische licentieaanvraag in bij de Amerikaanse Food and Drug Administration voor Tecartus® bij volwassen patiënten met recidiverende of refractaire acute lymfatische leukemie
Do 1 april 2021, 22:15 uur?

- Indien goedgekeurd, zou Tecartus de eerste en enige CAR T-celtherapie zijn die is goedgekeurd voor volwassen patiënten (18 jaar en ouder) met recidiverende of refractaire B-cel precursor acute lymfoblastische leukemie -

Kite, een Gilead Company (Nasdaq: GILD), heeft vandaag aangekondigd dat het een aanvullende biologische licentieaanvraag (sBLA) heeft ingediend bij de Amerikaanse Food and Drug Administration (FDA) voor Tecartus ® (brexucabtagene autoleucel) voor de behandeling van volwassen patiënten met recidiverende of refractaire B-cel precursor acute lymfoblastische leukemie (ALL). De sBLA wordt ondersteund door gegevens uit de fase 1/2 ZUMA-3-studie, die ook worden ingediend voor presentatie op een aankomend wetenschappelijk congres.

In 2017 kreeg Tecartus de doorbraaktherapie-aanduiding van de FDA voor recidiverende of refractaire volwassen B-celprecursor ALL. Indien goedgekeurd, zou Tecartus de eerste en enige chimere antigeenreceptor (CAR) T-celtherapie worden die is goedgekeurd voor volwassenen (= 18 jaar oud) met recidiverende of refractaire ALL.

"Tecartus is al begonnen met het veranderen van de vooruitzichten voor veel patiënten met recidiverend of refractair mantelcellymfoom, en we worden aangemoedigd door de gegevens die we hebben gezien bij volwassen patiënten met recidiverende of refractaire ALL, aangezien de overlevingskansen bij deze patiënten slecht blijven met de meest gebruikte therapeutische middelen, ”aldus Frank Neumann, MD, PhD, Kite's Global Head of Clinical Development. "We werken nauw samen met de FDA om vooruitgang te boeken met onze aanvraag en om de voordelen van CAR T te bieden aan patiënten met deze bijzonder hardnekkige leukemie."

In juli 2020 werd Tecartus de eerste en enige CAR T-celtherapie die versnelde goedkeuring kreeg van de FDA voor de behandeling van recidiverend of refractair mantelcellymfoom, op basis van het algehele responspercentage en de duurzaamheid van de respons. De Tecartus US Prescribing Information heeft een Boxed Warning in het productlabel met betrekking tot de risico's van het cytokine release syndroom (CRS) en neurologische toxiciteiten, en Tecartus is goedgekeurd met een risico evaluatie en mitigatie strategie (REMS) vanwege deze risico's; zie hieronder voor indicaties en belangrijke veiligheidsinformatie.

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