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#pegilodecakin
reportstore · 2 years
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Riding Nektar’s wave: cytokine immunotherapies in oncology
Throughout the course of recent months, there has been tremendous attention on cytokines in oncology after Bristol-Myers Squibb (BMS) paid a dazzling $1.85B for rights to Nektar's lead investigational immuno-stimulatory asset, NKTR-214.
NKTR-214 is an engineered (pegylated) cytokine targeting the interleukin-2 (IL-2) receptor beta subunit, which can possibly turn "cold" tumors — tumors inadequately infiltrated with immune cells, and thus less responsive to immunotherapies — immunogenic. On account of this feature, IL-2-based therapies are touted as one of the most promising combinatorial methodologies with immune checkpoint barricade.
The sector is bustling with activity and various high-profile assets are in development. For instance, Immunservice's inhaled biomimetic IL-2 Pulmoleukin is in Phase II for lung metastases in renal cell carcinoma.
Likewise, Roche's RG7461, an IL-2 variant (IL-2v) linked to an anti-fibroblast activation protein (FAP) antibody, is in Phase II in combination with in-house modified death-ligand 1 (PD-L1) inhibitor Tecentriq (atezolizumab) for various solid tumors.
The biggest study is an ongoing pivotal trial testing Nektar's asset with BMS's Opdivo (nivolumab), a customized cell death protein-1 (PD-1) inhibitor, in 250 patients with various solid malignancies, as part of a collaboration wrote in 2016 between the two companies.
Although IL-2-based therapeutics are ahead with respect to clinical development, various other interleukin 1 receptor like 2 drugs development market projects in development are gaining traction, energized by the interest displayed in the sector following Nektar's prosperity.
Treading closely following IL-2 are IL-10 and IL-12, which have seen rekindled interest in oncology despite being previously tarnished by systemic toxicity, pharmacokinetic limitations, and an extremely thin therapeutic index.
A few different delivery mechanisms or plasmid vector technologies currently aim to address the limitations of these methodologies and have previously advanced into various oncology projects.
Armo Biosciences is in front of the load with pegilodecakin (AM0010), is a long-acting type of recombinant human IL-10. Attaching IL-10 to polyethylene glycol (PEG) drags out the presence of the particle in the circulation and within a tumor.
IL-10 stimulates the expansion and cytotoxic activity of CD8+ T-cells, which directly connect with and kill tumor cells. The readout of pegilodecakin's pivotal trial in pancreatic adenocarcinoma will be one of the main biotech events during this year's subsequent quarter.
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slimlastforskolins · 5 years
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Pegilodecakin with pembrolizumab and nivolumab shown to be safe in Phase 1B study -- ScienceDaily
Pegilodecakin with pembrolizumab and nivolumab shown to be safe in Phase 1B study — ScienceDaily
Pegilodecakin, a first-in-class drug currently in clinical trials, has shown positive safety results and may offer a potential new treatment avenue for patients with non-small cell lung cancer (NSCLC) and kidney cancer. The study, led by The University of Texas MD Anderson Cancer Center, demonstrated that the drug, in combination with two leading anti-PD-1 monoclonal antibodies, pembrolizumab and…
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pharmaphorumuk · 4 years
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Lilly swoops on Dermira to claim Dupixent rival
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Eli Lilly agreed on Friday to buy dermatology specialist Dermira for $1.1 billion and its lead drug, a competitor to Sanofi and Regeneron’s atopic dermatitis Dupixent.
The first major biopharma deal of 2020 – due to close before the first quarter is ended – will see Lilly pay $18.75 per share for Dermira, a 2% premium to its closing price the day before the takeover was announced but a sharp increase on its recent trading levels.
Lilly’s interest in Dermira lies mainly with interleukin-13 inhibitor lebrikizumab, which is in a pair of phase 3 trials in adult and adolescent patients with moderate-to-severe atopic dermatitis, after positive results in two phase 2b trials.
It’s also planning a third trial in combination with topical corticosteroids with readouts from all three studies due in 2021.
The acquisition also gives Lilly one marketed drug – Qbrexza (glycopyrronium) – which is a medicated dressing used to treat excessive underarm sweating or hyperhidrosis. Launched just over a year ago, sales of Qbrexza were $10 million in the third quarter, up 27% on the second quarter.
Lilly represents yet another change of owner for lebrikizumab, which was originated by Roche and was once considered one of the top prospects in its pipeline before the company opted to sell it to Dermira.
Roche divested the drug in 2017 after mixed results in asthma, its first targeted indication, in a deal valued at up to $1.4 billion including $80 million upfront. For Dermira, the acquisition plugged a pipeline hole left by the failure of its acne therapy olumacostat glasaretil in late-stage trials.
If the results from the phase 3 programme are positive lebrikizumab could be a challenger to IL-4 and IL-13 inhibitor Dupixent, which achieved blockbuster sales in atopic dermatitis in 2018, its first full-year on the market.
The product is still accelerating thanks to additional approvals in severe asthma and severe chronic rhinosinusitis with nasal polyposis, and Sanofi recorded sales of just under $1.4 billion for the drug in the first nine months of 2019.
The atopic dermatitis is however starting to look a little crowded in the late-stage pipeline, with Leo Pharma’s IL-4 and IL-13 inhibitor tralokinumab hitting the mark in its phase 3 programme towards the end of last year.
Meanwhile, oral JAK inhibitors like AbbVie’s Rinvoq (upadacitinib) – already approved for rheumatoid arthritis – and Pfizer’s abrocitinib have also shown efficacy in phase 3 trials. Lilly has also been testing its JAK inhibitor for arthritis Olumiant (baricitinib) in atopic dermatitis but that drug has been weighed down by safety issues.
Dermira’s chief development officer Luis Pena said recently he reckons lebrikizumab will be a strong rival to Dupixent thanks to its “broad efficacy, safety, and ease of use,” including once-monthly rather than biweekly injections for Sanofi and Regeneron’s drug.
The Dermira acquisition bucks something of a trend at Lilly of focusing its M&A activity in the oncology area.
Its largest deal last year was the $8 billion takeover of Loxo Oncology and its RET inhibitor selpercatinib, but it also acquired Armo Biosciences for $1.6 billion – adding pegilodecakin for solid tumours – and signed a $575 million partnership with AurKa for an Aurora kinase A inhibitor currently in phase 1 during 2019. It did however spend $1 billion licensing a non-opioid painkiller from Centrexion last May.
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healthsonar · 4 years
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Late-stage research of Eli Lilly's immunotherapy pegilodecakin in pancreatic most cancers fails to hit most important purpose of general survival https://www.firstwordpharma.com/node/1674210  $LLY
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raymondmccullers · 5 years
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Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer
Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer. Pegilodecakin with pembrolizumab and nivolumab shown to be safe in Phase 1B study. Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer syndicated from https://triviaqaweb.blogspot.com/
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jobsearchtips02 · 4 years
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FDA waves Epizyme’s $186K unusual cancer drug through to market– now prepare for the 2nd act
January 24, 2020 07: 09 AM EST
Amber Tong
FDA waves Epizyme’s $186 K rare cancer drug through to market– now prepare yourself for the 2nd act
Robert Bazemore
” Epithelioid sarcoma accounts for less than one percent of all soft tissue sarcomas,” Richard Pazdur, the powerful director of the FDA’s Oncology Center of Quality, mentioned.
Shefali Agarwal
SPONSORED
January20, 202007:00 AM EST
Blue Latitude Health
January24,202010:24 AM EST
John Carroll
Aymeric Le Chatelier, Ipsen
January24, 202008:30 AM EST Updated09:
17AM
John Carroll
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A$ 1B-plus drug stumbles into another huge PhIII problem– this time failing futility test– as FDA hold stays in effect for Ipsen
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David Meek
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At the time Ipsen stepped up in 2015 with more than a billion dollars in cash to purchase Clementia and a late-stage program for a rare bone illness that afflicts children, then CEO David Meek was confident that he had actually put the French biotech on a short path to a mid-2020 launch.
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Instead of prepping a launch, however, the company was hit with a hold on the FDA’s issues that a treatment designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might in fact stunt kids’s growth.
So they ordered a stop to any treatments for kids14 and under. Meek left soon after to run a start-up in Boston. And today the Paris-based biotech is grappling with the independent tracking committee’s choice that their Phase III had stopped working a futility test.
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Alex Karnal( Deerfield)
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January24,202009:53 AM EST
Amber Tong
Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a personal gene treatment startup, reshaping the company and bringing in new leaders to pave method for an IPO simply a year later on.
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January24,202009: 38 AM EST Upgraded10:00 AM
Natalie Grover
Various healing traits brandished by the 3 authorized treatments for sickle cell illness all extend life span, but their effect on lifestyle doubts and their long-lasting cost-effectiveness is not up to scratch according to the limits thought about reasonable by ICER, the non-profit concluded in a draft assistance report on Thursday.
Sickle cell disease( SCD ), which includes a group of inherited red blood cell disorders that usually affect those of African ancestry, impacts hemoglobin– and is identified by episodes of searing discomfort in addition to organ damage.
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January 24, 202006:
17 AM EST Upgraded06:42 AM
Natalie Grover
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Roche’s checkpoint player Tecentriq flops in another bladder cancer subset
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Simply weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer clients, Swiss rival Roche’s Tecentriq has failed in a pivotal bladder cancer research study.
The 809- patient trial– IMvigor010– evaluated the PD-L1 drug in clients with muscle-invasive urothelial cancer (MIUC) who had actually undergone surgery, and were at high risk for recurrence.
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January23,202010: 32 AM ESTUpgraded01:52 PM
John Carroll
UPGRADED: Eli Lilly’s $1.6 B cancer drug failed to spark even the tiniest favorable gain for patients in its first PhIII
Eli Lilly had high wish for its pegylated IL- 10 drug pegilodecakin when it bought Armo in 2015 for$ 1.6 billion in money But after reporting a few months ago that it had failed a Stage III in pancreatic cancer, without the data, its most likely value has plunged. And now we’re getting some precise information that underscore simply how little positive effect it had.
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January22,202006:04 AM EST Updated11:06 AM
John Carroll
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from Job Search Tips https://jobsearchtips.net/fda-waves-epizymes-186k-unusual-cancer-drug-through-to-market-now-prepare-for-the-2nd-act/
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scitechman · 5 years
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Investigational Drug with Immunotherapy May Provide New Therapeutic Opportunity for Patients Previously Treated for Kidney and Lung Cancer
Investigational Drug with Immunotherapy May Provide New Therapeutic Opportunity for Patients Previously Treated for Kidney and Lung Cancer
Pegilodecakin, a first-in-class drug currently in clinical trials, has shown positive safety results and may offer a potential new treatment avenue for patients with non-small cell lung cancer (NSCLC) and kidney cancer. The study, led by The University of Texas MD Anderson Cancer Center, demonstrated that the drug, in combination with two leading anti-PD-1 monoclonal antibodies, pembrolizumab and…
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desperatetlmes · 5 years
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Investigational drug may offer new treatment option for patients with lung and kidney cancer
Pegilodecakin, a first-in-class drug currently in clinical trials, has shown positive safety results and may offer a potential new treatment avenue for patients with non-small cell lung cancer (NSCLC) and kidney cancer. The study, led by The University of Texas ... from Google Alert - health https://ift.tt/2mLJBV6
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ruggerorespigo · 5 years
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Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer
Investigational drug with immunotherapy may provide new therapeutic opportunity for patients previously treated for kidney and lung cancer. Pegilodecakin with pembrolizumab and nivolumab shown to be safe in Phase 1B study. Latest Science News -- ScienceDaily https://www.sciencedaily.com/releases/2019/09/190925184946.htm
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azveille · 5 years
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Lilly dumps phase 2 cancer drugs that survived previous cull
A pair of Eli Lilly’s cancer prospects that made it through a pipeline cull in 2017 weren’t so lucky come 2019. The Big Pharma revealed in its first-quarter earnings presentation that it is dumping a PI3K/mTOR dual inhibitor it was developing for use in combinations and prexasertib, the CHK1 inhibitor it picked up from Array BioPharma.
Both the PI3K/mTOR drug, known as LY3023414, and prexasertib (LY2606368) were in phase 2 studies. The former was in a combination trial with Astellas and Medivation’s Xtandi (enzalutamide) for metastatic prostate cancer, and the latter in more than a dozen studies testing it alone and in combinations for a variety of solid tumors and blood cancers.
The drugs were among seven oncology programs Lilly prioritized in summer 2017—a list that included a PD-L1 antibody and the breast cancer med Verzenio (abemaciclib), which was already under FDA review at the time. The rest of the pipeline comprised partnered programs, three of which were already owned by third parties. Lilly sought to offload the remaining seven.
RELATED: Lilly puts two-thirds of midphase cancer pipeline up for sale in major shake-up of R&D priorities
The company made the cut to focus on candidates like prexasertib that it thought could become the next standard of care. “Lilly will pursue new standard-of-care changing therapies that target tumor dependencies in molecularly enriched populations, build rational combinations that overcome resistance and develop next-generation immunotherapies,” the company said at the time.
RELATED: Lilly's latest BACE setback embodies obstacles in Alzheimer's R&D
Since then, however, Lilly has been building its cancer pipeline through M&A, adding the late-stage pegilodecakin, a PEGylated form of the anti-inflammatory cytokine IL-10, in its $1.6 billion acquisition of Armo Biosciences. It also regained a phase 1 Aurora kinase A inhibitor dubbed AK-01 in its $110 million buyout of Aurka Pharma, a company set up by TVM Capital Life Science expressly to develop that asset. Lilly had sold AK-01 to TVM in 2016 after a "review of its clinical pipeline priorities.”
No other programs were removed in the first-quarter cull, which came after a larger cut in the third quarter of 2018 when Lilly dumped a BACE inhibitor that was being tested in Alzheimer’s disease in combination with a second drug, a monoclonal antibody that binds to amyloid deposits in the brain. That quarter also saw the Big Pharma drop a handful of phase 1 assets, including some immunology candidates, a CSF1R antibody that also survived the 2017 cut and another BACE 1 inhibitor for Alzheimer’s.
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thaimassagegreenock · 2 years
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Medicaid bought sex offenders' erectile dysfunction drugs
Selpercatinib is the first drug from Loxo's pipeline that Lilly has brought to market.
Prior to the acquisition, Loxo won approval of Vitrakvi, which targets a different genetic mutation and is sold by Bayer AG.
Education Secretary Miguel Cardona said Monday that Puerto Rico will receive nearly $4 billion in federal education pandemic relief funds to help boost the U.S.
territory´s fight against COVID-19. SAN JUAN, Puerto Rico (AP) - U.S.
Flashpoint Batley: Anti-racism protesters hold rally against... Flair also analysed dozens of open letters published by alumnae of private schools who complained last year about racist abuse they had endured in schools and a lack of black role models among teachers.
In the UK, the pandemic and a crackdown on immigration following Brexit contributed to unpredictable supplies of fruits, vegetables and prepared foods in stores and restaurant chains, said Shane Brennan, chief executive at the Cold Chain Federation.
"I encourage parents of teens in all states to talk to their teens and discourage them from sexting because even when sexting is consensual, those images are out of the control of the teens as soon as they have sent them," Davis said.
id="article-body" class="row" section="article-body"> We didn't see him unmasked until 77-year-old Sebastian Shaw portrayed him briefly in 1983's "Return of the Jedi." Of course, Anakin was given a fuller life story in the prequel trilogy, when Jake Lloyd played him as a boy and Hayden Christensen as a young adult.
Nicholas Hewlett, head of St Dunstan's College private school in southeast London, said staff were worried by a 'righteous generation' of children who were looking for their teachers to 'trip up' on even 'small, persistent slights'.
"This will be a significant cost saving for many of our urological patients with erectile dysfunction, including those experiencing side effects from diabetes or prostate cancer treatment," Dr Katz said in a statement on Thursday.
The MD is manufactured by B-ON, and the company asserts that the device can measure a user's electrocardiogram (EKG) activity, blood pressure, heart rate, blood oxygen levels and body temperature, at a 95 percent rate accuracy.
As detailed by Sportsmail last week, the FA were understood to have pointed Public Health England to the precedent of socially-distanced training set by the Premier League clubs ahead of Project Restart last summer, when players were initially only permitted to work in groups of five before resuming contact training after a fortnight.
Although the company will continue to pursue "higher-risk, high reward" drug candidates such as pegilodecakin, these will be a smaller part of the portfolio in the future, said Chief Scientific Officer Daniel Skovronsky.
It marks the first time the island has full access to those funds. If you have any type of concerns concerning where and ways to utilize where can i buy cialis on line, you could call us at our own web page. The announcement was made during Cardona´s official three-day trip to Puerto Rico, the first for a Biden administration Cabinet member.
Mr Hancock was today accused of 'sh**ging on the taxpayer' after it was revealed he took his mistress to the G7 summit and claims they may have started their affair a year ago with the shamed Tory who has abandoned his wife Martha and is said to have told friends: 'He loves her and wants to be with her.
The teams' former medic, who is currently facing a fit-to-practise tribunal, paints a stark picture of the gold-medal factory across 66 pages of eye-opening claims within his written defence, which was disclosed over the weekend.
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cancersfakianakis1 · 5 years
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Pegylated Interleukin-10: Clinical Development of an Immunoregulatory Cytokine for Use in Cancer Therapeutics
Abstract
Purpose of Review
Interleukin-10 (IL-10) is a cytokine with anti-inflammatory properties, which induces activation and proliferation of antigen-activated intratumoral CD8+ T cells. This review discusses the evolution of pegylated IL-10 (pegilodecakin) from preclinical investigation through first-in-human studies in oncology.
Recent Findings
Pegilodecakin was evaluated across multiple advanced solid tumors in a large phase 1/1b trial alone and in combination with chemotherapy or anti-PD-1 antibodies. Pegilodecakin monotherapy had immunologic and clinical activity in renal cell carcinoma (RCC) and uveal melanoma. In combination with anti-PD-1 inhibitors, pegilodecakin increased the responses in RCC and lung cancer with efficacy agnostic to PD-L1 status and tumor mutational burden. Pegilodecakin with FOLFOX had activity in pretreated pancreatic cancer, instructing the ongoing randomized phase III trial of the combination versus FOLFOX.
Summary
The increased half-life of pegilodecakin enabled compelling preclinical data for IL-10 which has now been confirmed by clinical activity in a variety of cancers. The ability of pegilodecakin to both exert anti-tumor immunity and inhibit tumor-associated inflammation characterizes the uniqueness of this cytokine therapy.
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pharmaphorumuk · 4 years
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Lilly claims another victory in Alimta patent defence
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Eli Lilly ended 2019 with a win in its long-running legal battle to prevent generics of its big-selling cancer drug Alimta from reaching the US market.
The ruling came in a dispute with Canadian generic drugmaker Apotex – being held in the US District Court for the Southern District of Indiana – and backed Lilly’s position that it has patent protection for Alimta through to May 2022.
Apotex is among several generic drugmakers who have secured FDA approval for generics of Alimta (pemetrexed), used to treat non-squamous non-small cell lung cancer (NSCLC) and mesothelioma, which brought in sales of $1.59 billion in the first nine months.
The drug is already in decline from a peak of $2.8 billion in 2014 as patent protection has fallen away in markets around the globe, but has enjoyed a new lease of life as a combination therapy with Merck & Co’s cancer immunotherapy Keytruda (pembrolizumab) in NSCLC.
Lilly is already seeing the impact of generics to the brand in Europe, but hoping to delay an expected steep decline in revenues once US generics arrive, buying it time to bring new drugs through its late-stage pipeline.
Lilly has aspirations to rebuild its position in oncology after losing ground to rivals like Merck & Co and Bristol-Myers Squibb who have benefited from a move into immuno-oncology but suffered some recent setbacks.
In October, for example, Lilly’s pegilodecakin added to the growing list of drugs that have failed to improve survival in pancreatic cancer although it’s still in testing for other indications including melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC).
Lilly has been successfully defending its Alimta patents in the US to date, winning an infringement lawsuit brought by Dr Reddy’s Laboratories and Hospira in June, and an appeal in August.
Like Apotex, the two generic drugmakers want to launch alternative salt versions of pemetrexed and have argued that they do not infringe on Lilly’s intellectual property for Alimta. Lilly has said it expects Apotex to appeal the latest verdict.
Mylan meanwhile – set to be joined with Pfizer’s Upjohn unit in a deal that will create a $9.5 billion generics giant – secured tentative FDA approval for its generic version of pemetrexed in August, setting up a launch in May 2022 after it too was defeated in the law courts after challenging the validity of Lilly’s patents.
In 2017, Eagle Pharma got a tentative FDA green light for its version of the drug, which it plans to sell as Pemfexy once Lilly’s exclusivity for its brand runs out.
The post Lilly claims another victory in Alimta patent defence appeared first on .
from https://pharmaphorum.com/news/lilly-claims-another-victory-in-alimta-patent-defence/
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healthsonar · 4 years
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Pegilodecakin Falls Quick in Part III Pancreatic Most cancers Trial
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vovamayskiy · 6 years
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Касторки нет ! Но вы держитесь ...
New Post has been published on http://kastorki.net/doktora-rekomenduyut/eli-lilly-pokypaet-kompaniu-armo-biosciences.html
Eli Lilly покупает компанию ARMO Biosciences
Американская фармацевтическая компания Eli Lilly & Co. объявила о приобретении разработчика иммуноонкологических препаратов ARMO Biosciences Inc., сообщает MarketWatch. Сумма сделки – около 1,6 млрд долл. (50 долл. за акцию).
Акции ARMO Biosciences выросли на 77,6%.
Ведущим продуктом ARMO является экспериментальный препарат pegilodecakin, проходящий завершающие стадии клинических исследований для лечения рака поджелудочной железы и ранние стадии КИ для лечения рака легкого, почечно-клеточного рака и других плотных опухолей.
Еще два экспериментальных препарата компании пока еще не исследуются на людях, а одни проходит доклинические испытания.
Завершение сделки запланировано на конец II квартала.
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party-hard-or-die · 6 years
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Lilly to buy Armo Biosciences for $1.6 billion to bolster cancer…
(Reuters) – Eli Lilly and Co said on Thursday it would buy Armo BioSciences Inc for about $1.6 billion to expand its portfolio of drugs that helps body’s immune system fight cancer as the U.S. drugmaker chases rivals in a lucrative market.
FILE PHOTO: The logo of Lilly is seen on a wall of the Lilly France company unit, part of the Eli Lilly and Co drugmaker group, in Fegersheim near Strasbourg, France, February 1, 2018. REUTERS/Vincent Kessler/File Photo
Lilly’s offer of $50 per share in cash represents a premium of 68 percent to Armo’s Wednesday close. Armo’s shares were trading close to the offer price at $49.73, while Lilly’s shares rose 1.2 percent to $80.22.
The deal comes just four months after Armo went public and would give Lilly access to the smaller drug developer’s lead candidate, pegilodecakin.
“This is one of the fastest post-IPO exits we’ve seen in a long time,” said Jefferies analyst Biren Amin, adding that the deal value looked fair considering that Armo has presented data for the drug in different types of cancer.
The treatment is being evaluated in pancreatic cancer patients in a late-stage study as well as in earlier stage trials for other forms of cancer.
Armo’s lead treatment is a naturally occurring immune growth factor called a pegylated interleukin-10 that stimulates the survival, expansion and killing potential of a particular type of white blood cell in the immune system.
Armo has several other drugs in various stages of pre-clinical development and that would give Lilly “a path and footing” in the immuno-oncology space, according to Guggenheim Securities analyst Tony Butler.
Immuno-oncology is one of the faster growing areas of cancer treatment with major players such as Merck & Co and Bristol-Myers Squibb closely competing for a bigger share of the market.
Last month, Lilly appointed the director of Thoracic Medical Oncology at New York University’s School of Medicine to lead its medical development in this area.
Lilly said it expected to close the deal by the end of the second quarter of 2018.
Credit Suisse was the exclusive financial adviser to Lilly and Wachtell, Lipton, Rosen & Katz its legal adviser.
Centerview Partners LLC was the lead financial adviser, while Jefferies LLC also advised Armo on the deal. Gunderson Dettmer was its legal adviser.
Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur
The post Lilly to buy Armo Biosciences for $1.6 billion to bolster cancer… appeared first on World The News.
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