| ||||||||||||||||||||||||
 | ||||||||||||||||||||||||
|
Monday, July 26, 2021
3 of 4 Sell Siders Start Acumen Pharma at Buy
Pfizer-Arvinas: Search for next SERD
Last week’s licensing deal between Arvinas and Pfizer, worth an impressive $1bn if its equity element is included, highlighted again the resurgence of selective oestrogen degradation as an approach to treating ER-positive/Her2-negative breast cancer. And, though Pfizer is not the most advanced player, this was its third move into this space in recent years.
The current Serd leaders, Sanofi and Radius Health, will be paying close attention to any newcomer that could muscle its way into this treatment space. This is especially as, after Sanofi’s recent delay, the upcoming months could prove key in yielding pivotal data validating this mechanism of action.
Some will point out that the mechanism had already been partly validated by Astra’s now off-patent Faslodex, a Serd with efficacy but poor bioavailability and intramuscular delivery. Despite its shortcomings Faslodex did become a blockbuster, showing just how big the market for an even better drug could be.
| Serds in clinical development for ER+ve/Her2-ve breast cancer | |||
|---|---|---|---|
| Project | Company | Design | Detail |
| Phase 3 | |||
| Amcenestrant | Sanofi | Ameera-5 (ph3) 1st-line, +Ibrance, vs Femara+Ibrance | Ph2 (2nd-line) registrational Ameera-3 data delayed from Q2 to Q3 2021 |
| Elacestrant | Radius Health | 2nd-line, postmenopausal, vs SoC | Emerald trial data expected Q4 2021 |
| Giradestrant | Roche | 1st-line, +Ibrance, vs Femara+Ibrance | Study began Oct 2020 |
| Camizestrant | Astrazeneca | 1st-line, +Ibrance, vs Femara+Ibrance | Serena-4 trial began Jan 2021 |
| LY3484356 | Lilly | 2nd-line, postmenopausal, vs physician's choice | Ember-3 study beginning Aug 2021 |
| Phase 1 | |||
| ARV-471 | Arvinas/Pfizer | 3rd-line, postmenopausal, +/-Ibrance | Further data at SABCS 2021 |
| ZN-c5 | Pfizer/Zentalis | 2nd-line, peri/postmenopausal, Ibrance combo | Early monotherapy data reported Jun 2021; combo data expected H1 2022 |
| Rintodestrant | G1 Therapeutics | +/-Ibrance | Study ends Jan 2022 |
| LSZ102 | Novartis | 2nd-line, single-agent or various combos | Data imminent |
| D-0502 | Inventisbio | 2nd-line, pre/postmenopausal, Ibrance combo | Data possible 2021 |
| OP-1250 | Olema/Pfizer | Single-agent, dose-escalation | Study began Aug 2020; data due later in 2021 |
| ZB716 | Zeno Pharmaceuticals | +/-Ibrance | Study began May 2021 |
| SHR9549 | Jiangsu Hengrui Medicine | 3rd-line, single-agent | Study status unknown |
| Source: EvaluatePharma & clinicaltrials.gov. | |||
Until recently all eyes were on Sanofi’s amcenestrant, whose phase 2 Ameera-3 study in third-line ER+ Her2- breast cancer was to have yielded results in the second quarter, potentially paving the way to an immediate US filing.
However, Ameera-3’s readout slipped into the third quarter, putting it level with Radius/Menarini’s Emerald study of elacestrant. Sanofi also quietly terminated the Ameera-4 study, in preoperative first-line patients, though this was likely down to its decision to start a new trial, Ameera-6, in the adjuvant setting.
Much controversy surrounds Ameera-3, concerning the extent of CDK4/6 inhibition patients might have progressed on, and the possible effect of ESR1 mutation, a resistance mechanism to endocrine therapy. Sanofi looks at PFS in all-comers, while Radius has co-primary endpoints in ESR1-mutant and all-comer patients.
However this plays out, Pfizer likely saw its chance to make a move into Arvinas’s approach, whose early data could be extremely important should amcenestrant and/or elacsetrant underwhelm. Results are due to be presented at the San Antonio Breast Cancer Symposium in December.
Last Thursday Pfizer gave Arvinas $650m up front plus a $350m premium-priced equity investment for rights to ARV-471, a Serd that is now Arvinas’s most advanced Protac protein degrader. Evercore ISI describes Protacs as heterobifunctional molecules that can trigger multiple rounds of degradation, and are not driven by receptor occupancy.
If Arvinas’s stock movement seemed somewhat muted, rising 9% on Thursday and 13% the following day, maybe this was down to the company committing to funding half of all development costs – for a 50% profit share, of course. Alternatively, perhaps investors were somewhat dismayed by the lack of a full takeover.
Another foray
Either way, the deal represented yet another foray into this space for Pfizer, which in 2018 signed a collaboration with Zentalis to study the latter’s Serd ZN-c5 in combination with the US pharma group’s CDK4/6 inhibitor Ibrance. Then, last November, it struck a similar clinical trial tie-up concerning Olema’s OP-1250, which that biotech describes as a “complete ER antagonist and Serd”.
OP-1250 has yet to yield clinical data, though these are expected later this year, while ZN-c5 recently showed two remissions among 21 patients given 150-300mg doses. However, Zentalis says the likely phase 2 dose will be 50mg, which has yet to show any efficacy, suggesting that lack of a therapeutic window is ruling out ZN-c5’s potential as monotherapy.
Last December Arvinas reported initial data from 21 subjects, showing three partial remissions after one monotherapy cycle, though only one of these responses was independently confirmed. One read of last week’s deal is that Pfizer likes the Serd mechanism but is unconvinced by molecules originated by Olema and Zentalis.
https://www.evaluate.com/vantage/articles/news/deals/search-better-faslodex-continues
Jobless sue Florida for ending $300 unemployment benefits early
Out-of-work Americans in Florida filed a lawsuit against Republican Gov. Ron DeSantis on Monday seeking to reinstate a pandemic relief program that paid out an extra $300 a week in unemployment benefits.
In a complaint filed late Sunday on behalf of 10 unemployed Floridians, three attorneys – Gautier Kitchen, Marie Mattox and Scott Behren – argued that DeSantis, as well as the Florida Department of Economic Opportunity and its director Dane Eagle, violated their "clear legal and statutory duty to secure such benefits for employees" by prematurely ending the benefits.
The attorneys are requesting an emergency injunction to force Florida to reinstate the $300 a week benefit until the case is decided, as well as provide four weeks of retroactive benefits.
"The unemployed of Florida need these benefits to pay basic living expenses such as rent, utilities, food and medicine," the suit said.
Florida is one of 26 states – nearly all of which are led by Republican governors – that decided to prematurely end one of three federal unemployment programs that provided out-of-work Americans with an extra $300 a week, on top of their regular state benefits, and extended eligibility for contract workers as well as those who had exhausted their regular state benefits.
Unemployed residents in Indiana, Texas and Maryland also filed lawsuits against their respective states for the early termination of the program. State judges in Indiana and Maryland ruled the states must continue paying out the money to its jobless residents.
The programs, which Congress created in March 2020 and voted twice to extend, are not slated to expire until Sept. 6, 2021. Roughly 4 million people will lose their jobless aid as a result of the new policies, according to one estimate from the left-leaning Century Foundation.
GOP lawmakers have blamed the extra unemployment aid for anemic job growth in April and May, although economists have also cited a lack of child care and fears of contracting COVID-19 for the hiring shortage.
Unemployment benefits in the state currently max out at $275 a week. With the federal supplement, Americans are receiving a maximum of $605 in weekly unemployment benefits. (For comparison's sake, that's about $31,500 annually, or roughly $16 an hour).
President Biden and Democrats have rejected the notion that Americans are choosing to stay home and collect the extra unemployment benefits – part of the $1.9 trillion coronavirus relief law passed in March – rather than returning to work.
Still, Biden has emphasized that the unemployment benefits will end in September as planned, despite momentum among some of his party's members to make the extra money permanent.
"It’s going to expire in 90 days," Biden said recently. "That makes sense."
There remain about 6.8 million fewer jobs than there were in February 2020, before the pandemic shut down broad swaths of the nation's economy. Florida's unemployment rate, at 5%, represents about 523,500 jobless Americans out of a workforce of about 9.8 million, according to the Labor Department.
https://www.foxbusiness.com/politics/florida-sued-ending-unemployment-benefits
S.Korea says Moderna reports 'production issue' as vaccination widens to 50s
South Korea said on Monday it has been informed by Moderna of an unspecified production issue involving its COVID-19 vaccine, as the country expands its inoculation campaign for people aged 55-59 amid a fourth wave of infections.
It was not immediately clear what the production issue is, how much and long shipment will be impacted and whether other countries will be also affected by the problem.
Moderna did not immediately reply to a Reuters' request for comment.
"Moderna has informed that it has a production issue," health official Park Jin-young told a briefing, adding that consultations are being held to figure out details.
"We're mobilising all available administrative and diplomatic capabilities to establish facts and devise countermeasures," Park said.
South Korea has been struggling to turbocharge its immunisation drive amid supply shortages and shipment delays, with about 33% of its 52 million population having received at least one dose and 13% fully vaccinated.
About 6.17 million people, or 84% of those in their 50s, have signed up for this week's vaccinations, and authorities had already switched to Pfizer/BioNTech's products from Moderna for some people in the group because of shipment delays.
But the production issue would not affect the total shipment volume planned for this month, Korea Disease Control and Prevention Agency (KDCA) director Jeong Eun-kyeong said, without providing specific numbers.
South Korea has a contract for 40 million doses of the Moderna vaccine, of which about 1.1 million have arrived so far.
The vaccine rollout for people in their upper 50s had sputtered to a week-long halt this month after a record high number of new cases sparked a rush for shots, exhausting available supplies and crashing an official reservation website. .
Mass testing and tracing have helped the country suffer lower COVID-19 death rates than other developed countries so far without a full lockdown, but the new wave of infections prompted the government on Sunday to tighten social distancing rules across most of the country this week to head off transmission in the summer holidays.
The KDCA reported 1,318 new coronavirus cases for Sunday, bringing total infections to 190,166, with 2,077 deaths.
https://finance.yahoo.com/news/1-korea-says-moderna-reports-093940905.html
Subscribe to:
Posts (Atom)