Enanta Pharmaceuticals Inc (ENTA) News

From BIOWORLD -

Infection
Enanta Pharmaceuticals describes new PL-pro
July 22, 2024

Enanta Pharmaceuticals Inc. has patented compounds acting as nonstructural protein 3 (nsp3, PL-pro; SARS-CoV-2) inhibitors reported to be useful for the treatment of asthma, SARS-CoV-2 infection (COVID-19), rhinovirus, norovirus and lung infections. [Subscription needed]

https://www.bioworld.com/articles/710689-enanta-pharmaceuticals-describes-new-pl-pro?v=preview

FWIW -

Friday, July 19, 2024 - A possible WIN for ENTA?

Reply to Response to Motion Fri 07/19 4:10 PM
SEALED REPLY in Support of 296 MOTION to Compel Defendant Pfizer Inc. to Produce Documents and Provide Deposition Testimony filed by Enanta Pharmaceuticals, Inc..(Cook, Savannah)

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

me too
Given the biomarker data that can be generated in healthy volunteers it could happen pretty quickly, although THRD didn't have liver tox until a POC study bc that AE cropped up only after several weeks of dosing, so it could be after a longer phase 1b to get a good deal, and by then the competitive landscape will start to shape up. so it's probably a 2026 type of thing as a wild guess if all goes according to plan

ENTA will be behind THRD and BPMC in the oral kit space, but not by a lot and given the number of indications and commercial opportunity I would hope there is a place for more than one player (and you never know when someone will stumble). The drugs may also have different profiles that enable them to carve a place in the universe of mast cell mediated diseases

There ought to be prospective partners for an oral drug capable of addressing the various autoimmune indications you cited.

So the bottom line is I think ENTA is going to have to partner this drug early on
CLDX has over 800M in cash

That would make me happy.

These are not small trials, and this is only one indication of many. they are in phase 2 in 3-4 other programs, probably to start phase 3 soon in CINDU (inducible urticaria), and the pipeline doesn't even mention asthma which is perhaps the largest indication but also costliest
So the bottom line is I think ENTA is going to have to partner this drug early on
CLDX has over 800M in cash

CLDX announces phase-3 CSU program for Barzolvolimab:

https://www.globenewswire.com/news-release/2024/07/16/2913721/24180/en/Celldex-Therapeutics-Initiates-Global-Phase-3-Program-for-Barzolvolimab-in-Patients-with-Chronic-Spontaneous-Urticaria.html

ENTA volume is high again today. I could get used to these $1 jumps in ENTA stock price. Could be momentum players piling in or a leak of good news. Obviously I prefer the latter but who knows!

It's difficult for me to know. The rate of ascent is good. Friday's volume was good too.
Per Finviz https://finviz.com/quote.ashx?t=ENTA&p=d
Perf Week 19.49%
Perf Half Y 34.00%
Perf YTD 70.03%

Sometimes money just rotates out and moves back in when a catalyst approaches.
And sometimes/often money jumps in leading up to a quarterly earnings report.
I will note our last high of about $16 dollars was the 3 months before the ENTA August ER.

I'm hopeful that in the coming weeks we will have a positive data release from RSV trials.
I'm very hopeful about some positive news on the ENTA/PFE covid patent litigation

Could be getting out of a short position

I'm surprised because every time I have looked the bid ask spread after hours is very wide. I wonder if some of the after hours volume involves negotiated trades

What has peeked my interest is the after-market trading. Approximately 2 weeks ago, I started accumulating shares en masse due to the fact that 100K- 300K+ additional shares were being traded in the after hours. Not sure if this has anything to do with the uptrend. However, psychologically - remember approximately 3 years ago the stock was $100+ PPS. Something very positive is happening - legal, clinical trials, M & A (with the new attorney on board) & the FLO Foundation is riding the wave!

https://www.nasdaq.com/market-activity/stocks/enta/after-hours

There’s been a lot of activity on the legal front that’s for sure. I would think a ruling on summary judgment is a couple months out still but that’s just a guess. Sure are a lot of documents to go through and more seem to be piling up every day

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Not sure why ENTA has jumped some 25% this week but I do like it! Maybe there has been a leak about ENTA getting a favorable ruling in their lawsuit against PFE or a settlement by PFE. A guy can dream, can't he??

HMPV

There is a cluster of kids admitted with HMPV in my area. ENTA stopped development of this asset, but it could be resurrected easily enough. This is bullish for MRNA IMO bc I know they are working on a combo vaccine incorporating this virus

IMHO - all these patents would be a significant value incentive for a merger or a buyout -

As of June 25, 2024 -

Apoptosis signal-regulating kinase 1 inhibitors and methods of use thereof

Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, ester, stereoisomer, tautomer, solvate, hydrate, or combination thereof: which inhibit the Apoptosis signal-regulating kinase 1 (ASK-1), which associated with autoimmune disorders, neurodegenerative disorders, inflammatory diseases, chronic kidney disease, cardiovascular disease. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from ASK-1 related disease. The invention also relates to methods of treating an ASK-1 related disease in a subject by administering a pharmaceutical composition comprising the compounds of the present invention. The present invention specifically relates to methods of treating ASK-1 associated with hepatic steatosis, including non-alcoholic fatty liver disease (NAFLD) and non-alcohol steatohepatitis disease (NASH).
Type: Grant
Filed: December 2, 2022
Date of Patent: June 25, 2024

Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Jiang Long, Jun Ma, Xuechao Xing, Yong He, Brett Granger, Jing He, Bin Wang, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

https://patents.justia.com/patent/12018017

A series of studies using ASK1-deficient mice have indicated that ASK1 plays important roles in many stress-related diseases, including cardiovascular and neurodegenerative diseases, suggesting that small compounds that inhibit ASK1 activity could possibly be used for the amelioration of the development and/or progression of these diseases.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491083/

O/T ----

We need some LEVITY here. One of my favorite movie scenes.

Might as well continue to list patents as they are granted. Who know what leverage they'll have in a potential acquisition or merger?

Hepatitis B antiviral agents
Patent number: 12011425
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: X-A-Y-L-R??(I) which inhibit the protein(s) encoded by hepatitis B virus (HBV) or interfere with the function of the HBV life cycle of the hepatitis B virus and are also useful as antiviral agents. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HBV infection. The invention also relates to methods of treating an HBV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: January 25, 2023
Date of Patent: June 18, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Yao-Ling Qiu, Xuri Gao, Jorden Kass, Hui Cao, Wei Li, Xiaowen Peng, Byung-Chul Suh, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

RSV competition
Shionogi's L inhibitor challenge study expected to be completed by Q3 - exactly the same as ENTA
I view this as the stiffest competition to ENTA's RSV programs

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/e20240614.pdf

Keller : Indeed, Enanta’s compound is the closest competitor in terms of mechanism. As you understand, we
are also conducting challenge trials to collect clinical data. What we are confident about is that this targeting
mechanism allows us to rapidly reduce viral load and achieve efficacy.
We think that data will be available by the end of this year.

Muraoka : As for your compound S-337395, when will we see the clinical data on it?
Keller : The results of the challenge study are important data. They will come out later this fiscal year.
Muraoka : Is it the second or the third?
Keller : I think it will be in Q3.

FWIW - Addendum - Barbara Fiacco - ENTA, if only -

Represented Dana-Farber as lead counsel in second case against Bristol-Myers Squibb and Ono Pharmaceuticals, asserting claims for unjust enrichment and unfair competition for depriving Dana-Farber of its co-ownership rights under eight patents directed to cancer immunotherapy. On the eve of trial, in the face of Dana-Farber’s claim for hundreds of millions of dollars in damages, Defendants settled, making a substantial lump sum payment to Dana-Farber and agreeing to make potential additional payments, contingent on future events.

https://foleyhoag.com/people/fiacco-barbara/#Experience

ENTA has an outstanding litigator in their representation - Barbara Fiacco

Quote - The following Foley Hoag partners were also recognized for excellence in the industry in the following jurisdictions, and were described by IAM as:

Barbara Fiacco (National) and Donald Ware (MA) ranked in the Gold tier for litigation.

“Two of the most high-quality trial lawyers Boston has to offer,” and “A formidable team in life sciences litigation, securing multiple victories for the Dana-Farber Cancer Institute, resulting in significant payouts as well as co-ownership of groundbreaking cancer treatment patents.”

https://foleyhoag.com/news-and-insights/news/2024/june/foley-hoag-10-partners-recognized-in-2024-edition-of-iam-patent-1000/

https://foleyhoag.com/people/fiacco-barbara/

Here's the latest. Appears that ENTA is progressing well as of June 13. Comments?
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Since the HMPV program has been dropped I am impressed with the persuasive marketing and sales success of the legal firm that serviced all of these patents. I have always acknowledged the giant patent portfolio of Enanta, but is it in vain? Vanity -- hmm?

Two more for the books -

Patent number: 12006291
Abstract: The present invention relates to processes for preparing a Compound (1): or a pharmaceutically acceptable salt or solvate thereof. Compound (1) is useful as in many pharmaceutical agents, especially is useful as key intermediate in the synthesis of certain SARS-CoV-2 3CLpro inhibitors.
Type: Grant
Filed: January 10, 2023
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Kaicheng Zhu, Tao Wang, Jiajun Zhang, Hui Cao, Ruichao Shen, Guoqiang Wang, George G. Wu, Yat Sun Or

Antiviral heterocyclic compounds
Patent number: 12006326
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: which inhibit Human Respiratory Syncytial Virus (HRSV) or Human Metapneumovirus (HMPV) inhibitors. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HRSV or HMPV infection. The invention also relates to methods of treating an HRSV or HMPV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: August 24, 2022
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Adam Szymaniak, Kevin McGrath, Jianming Yu, Tyler Mann, Long Nguyen, Kaicheng Zhu, In Jong Kim, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

June 11, 2024
Enanta Pharmaceuticals gets grant for macrocyclic compounds inhibiting coronavirus replication

....the patent outlines methods for treating viral infections, particularly coronavirus infections, by administering the disclosed compound. The methods include oral, subcutaneous, intravenous, or inhalation administration of the compound. Additionally, the patent covers inhibiting viral 3C protease or viral 3CL protease in a subject by administering the compound. The patent specifies the treatment of various strains of coronaviruses, including 229E, NL63, OC43, HKU1, SARS-CoV, and MERS coronavirus, highlighting the broad spectrum of antiviral activity claimed in the patent.

https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-gets-grant-for-macrocyclic-compounds-inhibiting-coronavirus-replication/

both parties submitted motion for summary judgement - ENTA for damages arguing facts are undeniable so no need for trial, PFE that patent is invalid or obvious that they didn't infringe and toss the case
There were some posts about this on the board w DD opining that most likely neither party wins on summary judgement (although I suppose someone can win in part and case still goes to trial)
things are coming to a head

Summary judgment hearing for whom?

sounds like the time of the hearing was changed

ELECTRONIC NOTICE Resetting Daubert and Motion for Summary Judgment Hearing. Motion Hearing set for 7/31/2024 10:00 AM in Courtroom 11 (In person only) before Judge Denise J. Casper. NOTE TIME CHANGE ONLY (Hourihan, Lisa)

Explanation needed. T.I.A.

Docket last updated: 10 hours ago
Thursday, June 06, 2024 Notice Setting or Resetting Hearing on Motion Thu 06/06 11:17 AM
ELECTRONIC NOTICE Resetting Daubert and Motion for Summary Judgment Hearing. Motion Hearing set for 7/31/2024 10:00 AM in Courtroom 11 (In person only) before Judge Denise J. Casper.

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

The fact that an antiviral course is short makes it not that challenging from a medical standpoint to stop things like statins while taking paxlovid, so the impetus for an EUA path is not really that justified. however if you have a drug without DDIs it makes it a no brainer to just Rx that over another drug given the hassle of going though med lists and figuring out what to hold for a week or so

It would have been nice if 235 was granted EUA for use in populations where DDI is of concern.

I don't know but ensitrelvir suffers from DDIs much like paxlovid and EDP-235 doesn't so even if it were to gain approval in the west (more of an uphill battle after the recent phase 3 readout), EDP-235 should still have appeal based on DDI alone. This is why shionogi is bringing forward another PI that is closer to 235 in its profile. Perhaps ensitrelvir fares better in the EU from a regulatory standpoint who knows
I don't know that a partner will view 235 as having a good chance of approval if the FDA insists on the 15 symptom endpoint so ironically it is better IMO if ensitrelvir gets the nod from FDA on the narrower symptom subset bc again 235 has the DDI advantage (and perahps an efficacy advantage we have to see the data from SCORPIO-HR)
If ENTA were to prevail in the paxlovid litigation they have more interest in ensitrelvir not making it to market though

Legitimate question, I am not clowning around. Does everyone agree that Shionogi's COVID assets, are all going to be limited to markets in Japan and some parts of Asia? With Enanta dropping its improved COVID program, and not demonstrating any success in partnering its EDP 235 asset it seems like Paxlovid is the cat's meow for now and the future.

Shionogi R and D day slides:
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/E_final.pdf

No new info on ensitrelvir
Slide 46 discusses a new PI for covid with fewer drug interactions and no teratogenicity which should be entering phase 2 soon
Slide 48 discusses their L protein inhibitor for RSV which is in a human challenge study so same stage of development as ENTA's L inhibitor.

It sounds like there may be some psychology involved, i.e., if there is more at stake, then in general a person will not want to be the sole decision maker. The follow-on psychological response is that when this goes to trial there will be a lot of average Joes on the jury hating big pharma, unless they credit Paxlovid with saving the lives of their loved ones, but of course those average Joes will be dismissed from the candidate pool.

Averages that include all US patent litigation (such as the ones you cited) would seem to be unreliable for a case like this one that has so much money at stake. Many patent cases have minimal commercial relevance, which intuitively ought to increase the likelihood of a summary judgment.

I think the odds of summary judgment in favor of PFE is higher than that for ENTA, but that the odds of no summary judgement for either is still the most likely outcome. The foundation for the active moiety does predate the pandemic after all bc the molecule is based on a structure designed for the virus that caused the earlier SARS outbreak in the early aughts. That said it does seem like the patent itself, if it stands, does cover paxlovid bc one of PFE's arguments that is public is that the patent was altered after the chemical structure of nirmatrelvir was revealed in 2021 so this could actually go in ENTA's favor as well if the judge really feel the patent shouldn't be invalidated

On April 6, 2021, at a virtual meeting of the American Chemical Society (“ACS”), Pfizer's scientists publicly revealed the chemical structure of nirmatrelvir.... It is Pfizer's position that significant revisions of the patent are based on Pfizer's work in developing nirmatrelvir, disclosed in the April 2021 presentation

https://casetext.com/case/enanta-pharm-v-pfizer-inc-2

In various locations on the internet there are declarations that the rate of summary judgment for a patent case is 66% and that the rate of summary judgments in favor of the patentee is around 30%. It is my hope that Enanta embarked on this suit expecting to go to trial and expecting to win.

My probability estimate of no summary judgment for either party is 85%, FWIW. (I am not a lawyer.)

Thx Mouton
I guess there are 3 obvious outcomes here. PFE wins summary judgment and case is over, ENTA can win summary judgement, or the judge doesn't grant it to either party and it goes to trial. The second possibility, however small, would be hugely bullish, and the third option would as well bc once it goes to trial I would think PFE is more likely to settle
I guess a 4th option is the judge grants summary judgement in part narrowing the scope of what goes to trial?
always good to get a lawyer's opinion here thx - I have no idea how to handicap any of these possibilities frankly, but it seems at least so far today the remote possibility of a judgement in ENTA's favor in the next 2-3 months is dawning on some investors

I've read the Bloomberg article, and Dewophile, you are correct. The article just quotes a sentence from each of the summary judgement motions and then observes, as you do, that "the bulk of the arguments" of each side are under seal and that neither company responded to a request for comment.

I don't but pretty much everything is sealed so I am not sure how much info this article could possibly have:

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

ENTA did seem to score a small victory proving most (but not all) of certain documents that PFE was hoping to get unsealed are in fact privileged. This is from early May:

https://casetext.com/case/enanta-pharm-v-pfizer-inc-2

On the present record before the Court, therefore, Enanta has not met its burden to prove that the redacted information is privileged. Nevertheless, this Court will give Enanta an opportunity to do so. Within two weeks, Enanta shall file declaration(s) supporting its assertions

Enanta was given time to support the redaction which was granted yesterday on most counts:

order Order Wed 05/29 1:09 PM
Magistrate Judge Jennifer C. Boal: ELECTRONIC ORDER entered. On May 7, 2024, this Court issued an order on Pfizer's Motion to Compel Production of Documents Improperly Withheld as Privileged (Docket No. 160 ). See Docket No. 247 . This Court ordered Enanta to submit declarations supporting its assertions of privilege with respect to Exhibits B, F (slide 2), L, O, R, and S. On May 21, 2024, Enanta submitted declarations supporting its assertion of privilege with respect to Exhibits B, F (slide 2), L (emails dated April 7, 2020, 3:16 PM, and April 7, 2020, 4:14 PM), R, and S and it withdrew its privilege assertions with respect to Exhibit O and Exhibit L (email dated April 7, 2020, 8:32 PM). After review and consideration of Enanta's submissions, this Court finds that the redactions to Exhibits B, F (slide 2), L (emails dated April 7, 2020, 3:16 PM, and April 7, 2020, 4:14 PM), R, and S are privileged. (Hutchins, Aaron)

Anyone have access to this full article dated May 29, 2024?

Pfizer, Enanta Launch Dueling Bids to Gut Paxlovid Patent Case

https://news.bloomberglaw.com/health-law-and-business/pfizer-enanta-launch-dueling-bids-to-gut-paxlovid-patent-case

So far, all of the patent filings have benefitted the legal team that wrote and submitted them.

Do these patents really matter? (Contrary to my earlier post! )

Saturated spirocyclics as antiviral agents
Patent number: 11993600
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: December 6, 2022
Date of Patent: May 28, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Joseph D. Panarese, Samuel Bartlett, Yat Sun Or

https://patents.justia.com/assignee/enanta-pharmaceuticals-inc

Enanta Pharmaceuticals to Participate at the Jefferies Global Healthcare Conference
May 29, 2024

WATERTOWN, Mass.--(BUSINESS WIRE)--May 29, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, and Tara L. Kieffer, Ph.D., Chief Product Strategy Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2024 at 7:30 a.m. ET in New York, NY.

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-participate-jefferies-global-healthcare-0

FWIW - Good news for a potential buyer?

Enanta Pharmaceuticals sees highest patent filings and grants during February in Q1 2024

Excerpts:
Enanta Pharmaceuticals saw the highest growth of 199% in patent filings in February and 499% in grants in January in Q1 2024. Compared to Q4 2023, Q1 2024 saw an increase in patent filings by 24% and grants by 499%.

Patents related to rare diseases and Covid-19 lead Enanta Pharmaceuticals's portfolio
Enanta Pharmaceuticals has the highest number of patents in rare diseases followed by, Covid-19 and climate change. For rare diseases, nearly 50% of patents were filed and 38% of patents were granted in Q1 2024.

Respiratory syncytial virus (rsv) infections related patents lead Enanta Pharmaceuticals portfolio followed by cardiovascular disease, and fatty liver disease
Enanta Pharmaceuticals has highest number of patents in respiratory syncytial virus (rsv) infections followed by cardiovascular disease, fatty liver disease, non alcoholic fatty liver disease (nafld), and non-alcoholic steatohepatitis (nash).

Read more:
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-patent-activity/?cf-view

Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024.Is that a typo that should be May 31?

Thanks.
I just saw this amd thought there may be a counter suit.


Counter Claimant
Pfizer Inc.
Represented By
Thomas H.L. Selby
Williams & Connolly, LLP
contact info
Lee C. Bromberg
Mccarter & English, LLP
contact info
David I. Berl
Williams & Connolly, LLP
contact info
Wyley S. Proctor
Mccarter & English, LLP
contact info
Julie Tavares
Williams & Connolly LLP
contact info
Christopher Yeager
Williams & Connolly LLP
contact info
Erik Paul Belt
Mccarter & English, LLP
contact info
Counter Defendant
Enanta Pharmaceuticals, Inc.
Represented By
Donald R. Ware
Foley Hoag LLP
contact info
Barbara A. Fiacco
Foley Hoag LLP
contact info
Defendant
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Represented By
Thomas H.L. Selby


https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Clown finger is double clicking and iHub is taking it literally by posting my message twice.

I have not heard of any countersuit. It looks to me like the schedule of events I relayed on September 1, 2023 has been fulfilled:

Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024

Are there any clowns anywhere?