Key pos­i­tive da­ta on month­ly HIV reg­i­men of­fer hope for pa­tients sad­dled with stan­dard dai­ly pills

HIV pa­tients have much to cheer about this week. Af­ter re­ports that a sec­ond HIV pa­tient has ex­pe­ri­enced sus­tained re­mis­sion fol­low­ing a bone mar­row trans­plant, a pair of drug­mak­ers on Thurs­day post­ed piv­otal da­ta that showed their month­ly in­jectable treat­ments worked as well as the stan­dard dai­ly three-drug cock­tail in sup­press­ing the virus that caus­es AIDS.

The in­jectable reg­i­men com­pris­ing two drugs — John­son & John­son’s $JNJ rilpivirine (sold as Edu­rant) and Vi­iV Health­care’s ex­per­i­men­tal treat­ment cabote­gravir — was test­ed in a two late-stage stud­ies in more than 1180 pa­tients al­to­geth­er. The to­tal dataset will be used to sub­mit ap­pli­ca­tions to mar­ket the in­jectable for­mu­la­tion to reg­u­la­tors lat­er this year, Vi­iV said.

The best way to thwart the spread of HIV is to use con­doms. But for those al­ready af­flict­ed with the virus, an­ti­retro­vi­ral ther­a­py must be tak­en every sin­gle day to sup­press the virus or un­bri­dled repli­ca­tion can over­whelm the im­mune sys­tem and even­tu­al­ly cause AIDS.

Apart from dras­ti­cal­ly re­duc­ing the num­ber of times treat­ment must be ad­min­is­tered to 12 from 365, the in­jectable reg­i­men — if ap­proved — could in cer­tain parts of the world re­duce the stig­ma of pick­ing up HIV pre­scrip­tions at phar­ma­cies.

Dai­ly pills al­so rack up ex­pen­sive bills in the Unit­ed States, with month­ly ex­pen­di­ture on treat­ment hit­ting thou­sands per month — de­pend­ing on the reg­i­men, in­sur­ance provider and re­bates/dis­counts. End­points News has asked the man­u­fac­tur­ers about their pric­ing plans for the in­jectable month­ly reg­i­men, and is await­ing com­ment.

Ac­cord­ing to the WHO es­ti­mates, 36.9 mil­lion peo­ple were liv­ing with HIV glob­al­ly in 2017.

In­ject­ed every four weeks, 48-week da­ta on the two-drug for­mu­la­tion from both stud­ies — FLAIR and AT­LAS — were pos­i­tive, with about 1% of pa­tients from ei­ther study de­vel­op­ing drug re­sis­tance, sim­i­lar to those who take stan­dard dai­ly ther­a­py, Vi­iV said.

Pos­i­tive AT­LAS da­ta was pub­lished last Au­gust. On Thurs­day, the two drug­mak­ers broke out the de­tailed num­bers for both AT­LAS and FLAIR.

The AT­LAS study found vi­ro­log­ic sup­pres­sion rates at week 48 were sim­i­lar be­tween treat­ment arms — (cabote­gravir + rilpivirine: 285/308 [92.5%]) ver­sus cur­rent an­ti­retro­vi­ral ther­a­py  (294/308 [95.5%]). In the FLAIR study vi­ro­log­ic sup­pres­sion rates at week 48 were al­so sim­i­lar be­tween treat­ment arms — (cabote­gravir + rilpivirine: 265/283 [93.6%]) ver­sus the stan­dard Tri­umeq reg­i­men: (264/283 [93.3%]).

Vi­iV — which was es­tab­lished in 2009 by British drug­mak­er GSK $GSK in part­ner­ship with Pfiz­er $PFE — is al­so test­ing the two-drug in­jectable ver­sion ad­min­is­tered every two months in the AT­LAS-2M study. It al­ready has an ar­se­nal of 13 ap­proved an­ti­retro­vi­ral med­i­cines.

GSK’s ap­proach to grab­bing mar­ket share from Gilead $GILD  — which cur­rent­ly dom­i­nates the HIV mar­ket that is es­ti­mat­ed to hit $22.5 bil­lion by 2025 — is to con­vince reg­u­la­tors, doc­tors and pa­tients to adopt its two-drug reg­i­mens, ver­sus Gilead’s triple-drug cock­tails, that could po­ten­tial­ly re­sult in few­er tox­ic side-ef­fects, re­duce dos­ing fre­quen­cy, and be more cost-ef­fec­tive — al­though crit­ics sug­gest this may not be the most ef­fec­tive strat­e­gy be­cause the virus will on­ly have to fight against two drugs which could cul­mi­nate in drug re­sis­tance. But if the in­jectable month­ly reg­i­men makes it to the mar­ket, Gilead’s crown may be more vul­ner­a­ble than ever.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.