RCUS Abuzz, FDA Approves First Therapy For LG UTUC, VNDA Joins COVID-19 Battle

Today’s Daily Dose brings you news about Gilead reportedly mulling a stake in Arcus; disappointing results of Oragenics’ oral mucositis trial; FDA approval of the first therapy for low-grade upper tract urothelial cancer and Vanda initiating a phase III trial in the treatment of neurogenic inflammation of the lung secondary to COVID-19.

Read on…

Shares of Arcus Biosciences Inc. (RCUS) were up more than 47 percent in extended trading on Wednesday after Bloomberg reported that Gilead Sciences Inc. (GILD) is mulling a stake in the Hayward, California-based cancer therapeutics company.

When we had alerted readers to Arcus stock on January 27, 2020, it was trading around $9.

The Company’s drug candidates include AB928, which is under phase Ib and phase II trials, in multiple tumor types; AB154, under a phase II study in non-small cell lung cancer and AB680 in a phase I trial in pancreatic ductal adenocarcinoma (PDAC), among others.

Arcus Biosciences has set itself a couple of corporate milestones to achieve in the coming months:

— A Phase 1b/2 platform trial to evaluate the efficacy and safety of AB928 in multiple rationally selected combinations for the treatment of mCRPC, dubbed ARC-6, is expected in the first half of 2020.
— Preliminary Phase 2 randomization data from the two clinical collaborations with Genentech with AB928 in CRC and PDAC is expected in the fourth quarter of 2020.
— Preliminary Phase 2 randomization data with AB154 from the ARC-7 trial in first-line NSCLC is expected in the fourth quarter of 2020.
— Preliminary Phase 1b expansion data with AB928 in multiple tumor types is expected starting in mid-2020.
— Phase 1a dose-escalation data in the ARC-8 trial evaluating AB680 in combination with zimberelimab and gemcitabine/nab-paclitaxel in patients with PDAC, is anticipated starting in mid-2020; Phase 1b expansion cohort is expected to start in mid-2020.

RCUS closed Wednesday’s trading at $15.58, down 7.21%. In after-hours, the stock was up 47.63% at $23.00.

Accelerate Diagnostics Inc. (AXDX) expects net sales for the first quarter of 2020 to be $2.3 million, compared to $1.8 million in the first quarter of 2019.

Analysts polled by Thomson Reuters have a consensus revenue estimate of $2.32 million for the quarter.

As a result of the uncertainty surrounding the duration of the COVID-19 pandemic and related customer impact, the Company said that it is withdrawing the 2020 annual financial guidance it provided on January 15, 2020.

The Company will report full financial results for the first quarter of 2020 after the market close on Thursday, May 7, 2020.

AXDX closed Wednesday’s trading at $8.36, down 15.56%.

Compugen Ltd. (CGEN) is slated to present updates on its ongoing Phase 1 clinical trial evaluating COM701, a potential treatment for advanced solid tumors, in an oral presentation at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I on April 27, 2020.

As of February 9, 2020, a total of 28 patients with a variety of tumor types who had failed all available standard therapies were enrolled onto the study, 16 patients in the COM701 monotherapy dose-escalation arm and 12 patients in the COM701 in combination with Opdivo dose-escalation arm.

The presentation on April 27 will include updates from the dose-escalation arms of COM701 monotherapy and in combination with Opdivo.

CGEN closed Wednesday’s trading at $11.45, up 5.92%. In after-hours, the stock was up 7.07% at $12.26.

Shares of Oragenics Inc. (OGEN) plummeted on Wednesday, following disappointing early top-line results of the Company’s phase II clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients.

The trial did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to the placebo. AG013 was found to be safe based on a review of topline adverse event information, the Company noted.

Commenting on the results, Alan Joslyn, president, and CEO of Oragenics stated, “We have now received the first cut of top-line results for the study of AG013 in the prevention of oral mucositis in chemoradiation treatment of head and neck cancer. The results are equivocal in relation to the efficacy outcomes and we now await a more detailed ongoing analyses to determine if there may be potential efficacy for sub-patient populations, which we expect over the coming weeks.”

OGEN closed Wednesday’s trading at $0.45, down 43.22%.

The FDA has granted expedited approval to UroGen Pharma Ltd.’s (URGN) Jelmyto, the first therapy for the treatment of adults with low-grade upper tract urothelial cancer.

The approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.

Jelmyto consists of mitomycin, an established chemotherapy, and sterile hydrogel, using UroGen’s proprietary sustained release RTGel technology. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

Analysts expect the drug to achieve peak sales of $500 million

Low-grade upper tract urothelial cancer (LG UTUC) is a rare cancer that develops in the lining of the upper urinary tract, ureters, and kidneys. In the U.S., there are approximately 6,000 to 7,000 new or recurrent LG UTUC patients annually.

The current standard of care includes multiple surgeries and most patients require a radical nephroureterectomy, which includes the removal of the renal pelvis, kidney, ureter and bladder cuff. Jelmyto offers a new, non-surgical treatment approach for patients who otherwise may require treatment by radical nephroureterectomy, according to the Company.

URGN closed Wednesday’s trading at $21.04, down 14.71%. In after-hours, the stock was up 8.13% to $22.75.

Vanda Pharmaceuticals Inc. (VNDA) has commenced a phase III trial of Tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection.

The trial, dubbed ODYSSEY, is being conducted in collaboration with Northwell Health’s research arm, The Feinstein Institutes for Medical Research.

ODYSSEY is expected to randomize approximately 300 patients with confirmed COVID-19 pneumonia who receive either Tradipitant or placebo. The first patient in the study has been enrolled at Lenox Hill Hospital in New York City.

VNDA closed Monday’s trading at $10.42, down 7.79%. In after-hours, the stock was up 6.53% to $11.10.

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