Avenue Therapeutics lands an FDA adcomm for troubled flagship drug; FDA approves eye injection treatment for fluid buildup – Endpoints News

Intravenous tramadol-focused Avenue Therapeutics may not be out of the game just yet.
After receiving two CRLs for their drug, Avenue announced today that it has received a written interim response from the FDA’s Office of New Drugs that regulators will hold an adcomm to reach a decision on a formal dispute resolution request filed by Avenue back in July.
This occurred after the FDA sent Avenue the second CRL for their drug, an intravenous form of synthetic opioid tramadol.
The biotech said back in June that the FDA had denied its application as the “delayed and unpredictable onset” of pain reduction from tramadol didn’t suggest a benefit as a monotherapy. And at the time, there was not enough information to know whether it worked in combination with other therapies.
Avenue disagreed at the time, and said they would keep pushing for regulatory approval.
The FDA hasn’t yet announced when the adcomm will convene.  The OND will respond to the FDRR within 30 days after meeting.
Bausch + Lomb and Clearside Biomedical announced this morning that the FDA approved Xipere, a triamcinolone acetonide injectable suspension, for suprachoroidal use to treat macular edema associated with uveitis, a form of eye inflammation.
Macular edema is the buildup of fluid in the macula, located in the retina at the back of the eye. This buildup can cause retinal swelling and distorted vision — and can lead to permanent vision loss if left untreated, according to Bausch + Lomb.
The method of choice is unique. The treatment uses a microinjector — developed by Clearside — to inject Xipere into the suprachoroidal space of the eye. That space, which is between the sclera and choroid, may turn out to be a more effective method to improve targeted drug delivery.
According to Bausch Health chairman and CEO Joseph Papa, the company expects to make Xipere available in Q1 of next year.
“With this approval, we begin a new era in delivering therapies to the back of the eye,” said Clearside’s president and CEO George Lasezkay. “Xipere is the first commercial product developed by Clearside, the first product approved for injection into the suprachoroidal space and the first therapy approved for macular edema associated with uveitis.”
Third-Rock backed Cedilla Therapeutics expanded its Series B from last year with an additional $25 million, bringing the total amount raised to $82.6 million.
The Series B expansion announced today includes new investors RA Capital Management, Janus Henderson Investors, Woodline Partners and Logos Capital, alongside Third Rock.
The funds will support Cedilla’s continuing development of its two lead programs: a TEAD inhibitor for solid tumor treatment such as mesothelioma and certain squamous cell carcinomas, along with a highly selective CDK2/Cyclin E inhibitor for multiple tumor types, including CDK4/6-resistant breast cancer.
The company plans to initiate IND-enabling studies for its TEAD program by next June and for the CDK2 program by the end of 2022.
“With this financing, we plan to accelerate and expand our development efforts by progressing our most advanced programs toward the clinic while continuing to invest in ongoing discovery efforts against additional high value cancer targets,” said Cedilla president and CEO Sandra Glucksmann.
Jake Simson, a partner with RA Capital Management, will join Cedilla’s Board of Directors as part of the financing.
Chinese biotech Juventas Cell Therapy completed a Series C financing round, bringing in close to $63 million.
According to a statement, Juventas will use the funds to pursue an NDA in China and launch implementation of a commercialization and international research and development plan for partner CASI’s CAR-T treatment CNCT19.
CASI shares global co-commercial and profit-sharing rights with Juventas, and indirectly owns just over 12% of the company’s shares following completion of the Series C round.
Juventas’ financing was led by CICC Capital.
“The collaboration between CASI and Juventas will speed up the adoption of CAR-T therapy in China,” CASI CEO and chairman Wei-Wu He said in a statement.
Over a decade ago, some pharma executives fell in love with a molecule called rapamycin and its genetic target, called mTOR. (Literally: “molecular target of rapamycin.”)
It was easy to see why. Originally identified in 1972 by an Indian-Canadian chemist, who hid it in ice cream tubs in his freezer and then smuggled it into the US after the company he worked for asked him to abandon the program, it was finally approved in 1999 as an immunosuppressant for organ transplant recipients.
The management board of 4SC has discontinued its domatinostat program after the most recent clinical data has been released, the company announced Tuesday.
The orally administered small molecule class I selective inhibitor was being developed for cases of advanced cutaneous melanoma. The company will shift its focus to resminostat, an orally bioavailable inhibitor that was granted orphan drug designation to treat hepatocellular carcinoma. The company says it has enough cash to be funded through its RESMAIN study of resminostat.
A decade after the first-ever patients were infused with CAR-T, at least two of them remain cancer free and their genetically modified cells still appear active, surveilling their blood for any budding malignancies that dare crop up.
“We can now conclude that CAR-T cells can actually cure patients, based on these results,” Carl June, the University of Pennsylvania immunologist who designed the first treatment, told reporters Wednesday, adding the results came as a surprise. “We did not think that this would be a curative therapy at all in 2010.”
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Pfizer has found its new chief of drug development, and they’ve dispatched a raiding party to Basel to pluck him off the executive committee at Roche.
William Pao, who took over as head of pRED after John Reed exited to take the R&D chief post at Sanofi in 2018, is headed to the executive committee at Pfizer now, where he’ll report to Albert Bourla in New York. And he has a big remit that includes “inflammation and immunology, internal medicine, hospital, oncology and rare disease, as well as regulatory affairs in support of Pfizer’s R&D pipeline and portfolio of marketed therapies.”
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A little over 2 years after Pfizer paid Ionis $250 million cash to in-license rights to vupanorsen (AKCEA-ANGPTL3-LRx) – immediately vaulting the drug onto its list of top prospects — the pharma giant has decided to ax its ambitious late-stage work on the drug and hand it all back to Ionis, which has had more than its share of setbacks recently.
Pfizer had at one time been extremely bullish on this drug’s mid-stage data, grabbing exclusive worldwide rights, but researchers say they took a cold, hard look at the data from their Phase IIb and found the therapy wanting on efficacy as well as safety.
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It looks like antibiotics player Entasis may be getting off Nasdaq the same way it arrived — with a whimper.
Entasis revealed in an SEC filing that Innoviva, the holding company that already owns a good chunk of its shares, is offering to acquire all of its outstanding stock and take the biotech private.
At $1.80 per share, Innoviva’s non-binding proposal comes at a 23% premium to Entasis’ current trading price, which represents just a fraction of its IPO price back in 2018.
Drug discovery, historically, has been no easy task — it’s a lengthy, cost-intensive process hungry for breakthroughs. A UK startup thinks its speedy “protein printer” could be a winner, and the company is looking to press its advantage with some new backers on board.
Nuclera, a startup developing a printer it says can churn out protein models within 24 hours, has closed a $42.5 million Series B round with plans to flesh out a larger platform with the fresh influx of cash, according to a release.
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Three years after ViiV Healthcare, the HIV specialist majority owned by GlaxoSmithKline, first sued Gilead over alleged patent infringement on one of its top drugs, the two companies have settled the case.
Gilead will pay ViiV $1.25 billion in cash — while agreeing to set aside a 3% royalty on all US sales of Biktarvy until October 2027.
A megablockbuster triplet therapy given as a daily pill, Biktarvy brought in $6.09 billion from the US alone in 2020. By 2027, Jefferies analysts estimate that cumulative US sales would reach about $50 billion — translating to about $2 billion in total royalties for ViiV.
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The JAK class can count one more clinical failure, the latest in a long string of setbacks that continues to cloud the future of these therapies.
In its Q4 update today pharma giant Novartis noted that it has swept out a pan-JAK program for CEE321. Details are scant, and the work was very much early-stage, but Novartis had held it up as a bright prospect before for atopic dermatitis.
In their pipeline summary, the company noted that the program had been discontinued because it had failed to clear the bar on risk/benefit.
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