R&D channel feed

Garry Menzel, TCR² Therapeutics CEO

TCR²'s ga­vo-cel sur­vives a PhI test. Now it's head-first in­to PhII with a half-dozen par­tial re­spons­es

A T cell biotech has some positive results, and now that the data are out, the biotech is moving forward on its next steps.

TCR² Therapeutics teased results from the Phase I portion of an ongoing Phase I/II study Tuesday, going on a conference call Wednesday to dive more into the details of what ended up happening. The company’s drug candidate, gavo-cel, is being investigated in solid tumors expressing mesothelin, a protein that has been examined as a biomarker in other T cell therapies.

New Jer­sey biotech nets $50M+ BAR­DA con­tract for res­pi­ra­to­ry can­di­date

Eagle Pharmaceuticals is keeping an eye on Enalare Therapeutics’ lead respiratory candidate, and apparently, so is the US government.

The New Jersey-based biotech struck a deal with BARDA worth up to $50.3 million to develop the lead compound, dubbed ENA-001, the company announced on Tuesday. The candidate is designed to simulate breathing and is meant to be used in emergency cases when treating drug overdoses or respiratory depression post-surgery.

Martin Lehr, Context Therapeutics CEO

Con­text Ther­a­peu­tics trims pipeline, cuts down on spend­ing to con­serve cash

To survive the current market conditions, Philadelphia-based Context Therapeutics has resorted to cost-cutting, a hiring freeze and pipeline pruning.

The company, which develops treatments for breast and gynecological cancers, is hoping that the new measures will help it sustain itself until the end of Q1, 2024.

“We were hoping that things would get better over the course of 2022, however, in our estimation, they’ve gotten more challenging for biotech,” Martin Lehr, CEO of Context Therapeutics, told Endpoints News.

Daniel Barber, Aquestive Therapeutics CEO

Aque­s­tive touts PhII da­ta — and speed — in po­ten­tial EpiPen re­place­ment can­di­date

A New Jersey biotech specializing in drug delivery via oral film is reporting new Phase II data, setting a countdown to have it before the FDA by end of 2023.

Aquestive Therapeutics announced new data Tuesday for its candidate AQST-109, an oral film using a prodrug of epinephrine to treat anaphylactic shock from an allergic reaction.

Per the biotech, a readout of the EPIPHAST II trial was to compare one dose of AQST-109 — basically a patch — to a dose of an EpiPen at 0.3 mg, and an intramuscular injection of 0.3mg of epinephrine that wasn’t EpiPen.

Avidity Biosciences CSO Art Levin and CEO Sarah Boyce

FDA slaps a par­tial hold on Avid­i­ty's mAb-siR­NA ther­a­py, paus­ing en­roll­ment in mus­cle weak­ness dis­ease study

Avidity Biosciences will have to wait to enroll new patients in a Phase I/II study of its therapy for myotonic dystrophy type 1, or DM1, which weakens muscles and leads to respiratory and cardiac issues.

The FDA is docking new enrollment in the MARINA study as the company and one of its trial investigators look into a serious adverse event reported in a patient in the 4 mg/kg cohort, the biotech said Tuesday morning. Patients currently enrolled can continue on the study drug or placebo and roll over into the open-label extension.

House Energy & Commerce committee chair Frank Pallone (D-NJ) (Kevin Dietsch/Pool via AP Images)

Com­plete­ly clean FDA-in­dus­try user fee deal at­tached to a must-pass gov­ern­ment spend­ing bill

With four days left in the fiscal year, FDA-related policy riders approved in both House and Senate committees, at least for now, appear dead, according to the text of a short-term government spending bill unveiled late last night to keep federal agencies open until Dec. 16.

But the absence of riders (both sides previously announced a “practically clean” deal last week) doesn’t mean Democrats are done fighting to add these accelerated approvals and other regulatory reforms for cosmetics, nutritional products and diagnostic tests.

Matthias Schroff, Exicure CEO

In sur­vival mode, Ex­i­cure cuts to the bone — paus­ing all R&D and chop­ping head­count by 66%

The drastic restructuring that Exicure undertook at the end of last year couldn’t save the biotech after all.

In fact, Exicure — whose take on gene expression once drew the backing of Bill Gates and a slate of tech investors — is going for another round of layoffs, this time cutting to the bone with 66% of the remaining staffers being let go, while halting all R&D activities and looking to divest its entire pipeline.

Frank Watanabe, Arcutis CEO

Ar­cutis' for­mu­la­tion of old As­traZeneca drug clears an­oth­er PhI­II test

Weeks after rolling out its first psoriasis treatment, Arcutis Biotherapeutics is racking up more positive Phase III data for a second formulation of an old AstraZeneca drug.

The Phase III ARRECTOR trial tested roflumilast foam in patients with scalp and body psoriasis, Arcutis said, and met both co-primary endpoints as well as all secondary endpoints. Nearly identical to its approved drug, Zoryve, which is a cream, the foam is water-based and moisturizing — properties that the biotech hoped could “overcome the challenges of delivering topical drugs in hair-bearing areas of the body.” Arcutis has previously compared it to hair mousse.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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