Vir Biotechnology Inc (VIR)

[DewDiligence]

VIR -45% on phase-2 failure in influenza:

https://finance.yahoo.com/news/vir-biotechnology-announces-topline-data-120000102.html

Vir Biotechnology…today announced that the Phase 2 PENINSULA trial evaluating VIR-2482 for the prevention of symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.

Why such a steep selloff? One reason is that VIR has tended to present itself to investors as all-powerful and all-knowing, which is perhaps a consequence of having George Scangos as (ex)CEO and having raised a huge amount of capital based on management’s reputation.

[DewDiligence]

VIR starts 4-drug phase-2 HBV trial:

https://www.globenewswire.com/news-release/2023/05/11/2666740/0/en/Vir-Biotechnology-Announces-First-Patient-Dosed-in-New-Phase-2-Chronic-Hepatitis-B-Virus-Trial-Evaluating-Combinations-of-VIR-2218-VIR-3434-PEG-IFN%CE%B1-and-an-NRTI.html

The four drugs are: VIR-2218, a siRNA; VIR-3434, a mAb; PEG-IFN; and a (generic) nucleoside.

A separate phase-2 trial (VIR calls it a “subprotocol”) will test VIR-3434 and a nuke, with and without VIR-2218, in patients who are chronic inactive carriers of the HBV virus. I'm unclear as to whether this second trial is for research purposes or for an addressable commercial market.

[DewDiligence]

48w VIR-2219 +peg-IFN—>31% HBs seroconverion:

https://www.globenewswire.com/news-release/2022/11/06/2549180/0/en/Vir-Biotechnology-Presents-New-Data-Evaluating-the-Potential-for-VIR-2218-and-VIR-3434-to-Achieve-a-Functional-Cure-for-Chronic-Hepatitis-B-Virus-HBV-Infection.html

The 31% figure is impressive insofar as peg-IFN by itself has a 48w seroconversion rate of only 5-10%. Of course, a 48w regimen of VIR-2219 + peg-IFN won’t be any easier to tolerate than 48w of peg-IFN monotherapy, so this regimen is still far from the ultimate answer for treating chronic HBV.

VIR has started testing the triple combination of VIR-2219 (siRNA) + VIR-3434 (mAb) + peg-IFN; initial data are expected in 2H23.

[DewDiligence]

VIR EASL presentations:

https://www.globenewswire.com/news-release/2022/06/25/2469082/0/en/Vir-Biotechnology-Announces-New-Clinical-Data-From-its-Broad-Hepatitis-B-Program.html

No CC.

[DewDiligence]

VIR HBV webcast slides:

https://investors.vir.bio/static-files/7ece44c3-0585-47af-81b4-2199889d6934

[DewDiligence]

VIR -14% on amended Sotrovimab EUA due to Omicron BA.2 variant:

https://finance.yahoo.com/news/us-food-drug-administration-revises-200400156.html

GlaxoSmithKline plc and Vir Biotechnology…today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody. The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant.

GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion.

This PR was issued after the close, but the market apparently got wind of the FDA decision about 3:45pm ET.

[DewDiligence]

VIR 4Q21 results:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html

As of December 31, 2021, excluding restricted cash, the Company had approximately $909.5 million in cash, cash equivalents, and investments. Excluding restricted cash and its equity investment in Brii Biosciences, the Company had approximately $766.4 million in cash, cash equivalents and investments.

[DewDiligence]

VIR’s 2022 HBV newsflow:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html

In 2022, the Company expects data readouts from multiple trials evaluating VIR-2218 and VIR-3434:

• Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, are expected in the first half of 2022.

• Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-alpha are expected in the first half of 2022.

• Additional data from the Phase 1 monotherapy trial of VIR-3434 are expected in the first half of 2022.

• The Company’s collaborator, Brii Biosciences, continues to lead the Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection. Initial data are expected in the second half of 2022.

Evidently, there will not be a 2022 readout from the phase-2 trial testing combinations of VIR-2218, GILD’s GS-9688, Vemlidy (TAF), and Opdivo (#msg-167061759, #msg-160854272, #msg-167063133).

[rwwest]

Up so far on another Biotech down day
Seems like a good omen.

[DewDiligence]

VIR slide set from JPM:

https://investors.vir.bio/static-files/7ecf45fb-6918-4cf8-9a02-b8c12183ca4f

[DewDiligence]

VIR/GILD start phase-2 trial testing quadruple regimen of VIR-2218; GS-9688; Opdivo; and Vemlidy (TAF) in (both nuc-suppressed and viremic) HBV patients:

https://finance.yahoo.com/news/vir-biotechnology-announces-initiation-phase-133000267.html

I’m not sure why it took almost a year for this trial to begin enrolling patients—the PR announcing the collaboration was issued on 1/12/21.

Please see #msg-160854272 for background.

[HokieHead]

Loaded again. After omicron news all weekend this will be the next MRNA biotech. $75+ by years end for starters imo.

[HokieHead]

In $46, omicron play.

[DewDiligence]

VIR starts HBV_combination_trial_of_ VIR-2218 and VIR-3434:

https://finance.yahoo.com/news/vir-biotechnology-initiates-phase-2-123000780.html

The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort.

…VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a therapeutic T cell vaccine against HBV.

See #msg-164593550, #msg-161217289, and #msg-164599741 for related info.

[DewDiligence]

VIR -6% on VIR-2218 and VIR-3434 monotherapy data presented at EASL:

https://finance.yahoo.com/news/vir-biotechnology-presents-clinical-data-125000851.html

CC to discuss these data with investment community at 11am ET.

[level42]

"profound efficacy." Vir Biotechnology and GSK plan to seek emergency use authorization for their experimental COVID-19 antibody therapy after interim data from a study showed 85% reduction in hospitalization and deaths among patients.


Based on these positive results, Vir and GlaxoSmithKline intend to request Emergency Use Authorization (EUA) for VIR-7831 from the U.S. Food and Drug Administration (FDA) and other international regulators.

"We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients," GlaxoSmithKline chief scientific officer Dr. Hal Barron said. "We look forward to the possibility of making VIR-7831 available to patients as soon as possible."

[interloper]

Too high too fast. Very typical price movement. I you think your gonna ride a rocket to the moon you better be ready when the booster fuel runs out.

[dealerschool2006]

why is VIR coming back down???

[rtrstock]

Huge disappointment.

This could go back to under 20.00 pps

Should have sold at 140.00

This stock price is just based on hype, the collapse is the reality of things.

[CatBirdSeat]

Two New Rockships Taking Off After VIR

Behold! FNMA & FMCC

Ka Ching ! Baby! $$$$

[rtrstock]

I Should have sold at 140.00

Now it's in a death spiral.

Robinhood shows this listing at a completely different price than ihub.

[Srhogan1984]

Full of crap haha

[ClayTrader]

* * $VIR Video Chart 01-26-2021 * *

Link to Video - click here to watch the technical chart video

[Srhogan1984]

Sounds like a short to me. You need a bog squeeze? Haha

[DewDiligence]

Today's move is somewhat scary in the context of #msg-160142077.

[DewDiligence]

VIR—(+40% undeservedly, IMO)—on_interim_phase-1_data_for VIR-3434_in_HBV:

https://www.globenewswire.com/news-release/2021/01/26/2164220/0/en/Initial-Data-from-Ongoing-Phase-1-Trial-of-VIR-3434-for-Chronic-Hepatitis-B-Virus-Infection-Demonstrates-Significant-and-Rapid-Reduction-in-Hepatitis-B-Surface-Antigen.html

The mean reduction in HBsAg (n=6) was 1.3 logs after 8 days. That’s not bad, but neither is it a knock-your-socks-off result. Monotherapy is unlikely to generate a functional cure in HBV, no matter how potent the agent may be against HBsAg.

VIR-3434 is a monoclonal antibody and is VIR’s second HBV agent in the clinic; the first is VIR-2218, an RNAi agent (#msg-155042587).

[DewDiligence]

Not really. It's just a phase-2 trial, not a full-fledged partnership.

[DewDiligence]

GILD, VIR collaborate on phase-2 HBV trial:

https://www.businesswire.com/news/home/20210112005578/en

The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.

Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial.

I.e., no cash is changing hands between the two companies.

[Srhogan1984]

Huge news!

[Srhogan1984]

What is happening here

[DewDiligence]

VIR starts phase-1 trial of VIR-3434:

https://www.globenewswire.com/news-release/2020/05/27/2039353/0/en/Vir-Biotechnology-Initiates-Phase-1-Clinical-Trial-of-VIR-3434-for-Chronic-Hepatitis-B-Virus-Infection.html

[ClayTrader]

* * $VIR Video Chart 05-18-2020 * *

Link to Video - click here to watch the technical chart video

[DewDiligence]

VIR 1Q20 results—3/31/20 cash=$361.8M:

https://www.globenewswire.com/news-release/2020/05/12/2032224/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-First-Quarter-2020-Financial-Results.html

[DewDiligence]

VIR reports interim phase-2 data in HBV:

https://finance.yahoo.com/news/vir-2218-demonstrates-dose-dependent-200110652.html

Vir Biotechnology today announced additional interim data from the ongoing Phase 2 trial… of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi) for the treatment of chronic hepatitis B virus (HBV) infection.

…In the ongoing Phase 2 trial, virally suppressed patients on nucleos(t)ide reverse transcriptase inhibitor therapy (n=24) received two subcutaneous 20, 50, 100, or 200 mg doses of VIR-2218 on Day 1 and Day 29. At Week 24, the mean change in HBsAg observed with 20, 50, 100, and 200 mg was -0.76 log10, -0.93 log10, -1.23 log10, and -1.43 log10, respectively [a nice dose response].

Of note, all patients who received the 200 mg dose level achieved a >=1 log10 reduction in HBsAg, with HBeAg- and HBeAg+ patients achieving similar mean declines. There has been no dose-related trend in the frequency of AEs observed during the trial, with the most common AE being headache (n=6; 25%). No patients discontinued the trial due to an AE.

…“Our next step will be to demonstrate whether knockdown of HbsAg can result in high rates of functional cure when VIR-2218 is given in combination with other agents, which is the goal of our next set of trials. We expect the first of those combination trials—combining VIR-2218 with a shortened course of pegylated interferon—to begin dosing patients in the second half of this year.”

VIR-2218 incorporates ALNY’s ESC+ siRNA technology, which VIR claims is a differentiating factor for VIR-2218 compared to other RNAi-based programs in HBV.

CC slides for the above data:
https://investors.vir.bio/static-files/48b8fe3c-79cb-4a80-85e9-ba1f14682abd

VIR is flattish in AH trading, but this doesn’t mean much vis-à-vis the HBV data presented above; lately, VIR has been trading as a COVID-19 play.

[Cornball69]

nobody pumping this here lol?

[DewDiligence]

Biocentury expounds on VIR-GSK hookup:

https://www.biocentury.com/article/304842

[Pugsieboy]

When Glaxo runs a deal with any company, run like hell. POS same f ing story every time with them.

[Rocket10]

When YOU post in any thread RUN LIKE HELL!

[crudeoil24]

Maybe VIR Ceo took the $250. and went shopping @ Costco.

[Pugsieboy]

Last time I saw a deal with Glaxo the stock tanked all day. Looks to be the same going on here.

[dinogreeves]

45 today most probably.

[crudeoil24]

VIR > GlaxoSmithKline To Make $250M Equity Investment In Vir
8:05 am ET April 6, 2020 (Benzinga) VIR up 29% 37.62
Companies will combine their unique scientific and technical expertise to combat COVID-19 and potential future coronavirus outbreaks


Promising antibody candidates for SARS-CoV-2 to be accelerated into phase 2 clinical trials within the next three to five months


GSK to make equity investment of $250 million in Vir
LONDON and SAN FRANCISCO, April 06, 2020 (GLOBE NEWSWIRE) -- LSE announcement -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.

[DewDiligence]

Link to Cowen webcast:

http://wsw.com/webcast/cowen57/vir/

[dinogreeves]

Conference call premarket tomorrow, this should spike before close.

[crudeoil24]

Up 7% in PM.

[eur06]

Incredibile.

[dinogreeves]

39 job openings

https://www.vir.bio/careers/jobs/

[dinogreeves]

Funded by Bill and Melinda Gates


https://www.vir.bio/pipeline/

[dinogreeves]

[dinogreeves]

https://www.nytimes.com/reuters/2020/02/28/world/asia/28reuters-china-health-biotechnology-scangos.html