Asco-GI – narrow bile duct win sets Imfinzi on an approval course

 Astrazeneca’s Imfinzi could soon add front-line bile duct cancer to its approved uses, though its supporting Topaz-1 study, being presented in full at Asco-GI, has revealed a benefit that might appear underwhelming. In the trial, toplined last October, Imfinzi plus chemo reduced risk of death by 20% versus chemo alone, but median overall survival was just 1.3 months longer than for chemo. However, Dave Fredrickson, Astrazeneca’s head of oncology, told Evaluate Vantage that the medians belied a strong tail in the survival curves, adding: “At two years one in four patients are alive on the Imfinzi/chemo regimen versus one in 10 on chemo alone.” As for biomarkers, he said patients’ PD-L1 status did not seem to be an obvious reason for the late survival benefit. Bile duct cancer patients have seen US approvals of Incyte’s Pemazyre and Bridgebio’s Truseltiq, both in FGFR2-mutant disease, and Agios’s Tibsovo, but these have all been second line. Whether follow-on use of any of these might have affected the Topaz-1 data has yet to be analysed. Either way, Topaz-1 marks the first win for IO here, and 2023 should see data from front-line studies of Merck & Co’s Keytruda (Keynote-966) and Roche’s Tecentriq (Imbrave-151).

Summary of Topaz-1 data
	Imfinzi + chemo	Chemo
mOS (primary endpoint)	12.8mth	11.5mth
Stats	HR=0.80 (p=0.021)
mPFS (secondary endpoint)	7.2mth	5.7mth
Stats	HR=0.75 (p=0.001)
ORR (secondary endpoint)	26.7%	18.7%
Grade 3/4 AEs	75.7%	77.8%
Treatment-related deaths	2/341	1/344
Source: Astrazeneca & Asco-GI. https://www.evaluate.com/vantage/articles/events/conferences-snippets/asco-gi-narrow-bile-duct-win-sets-imfinzi-approval

Vertex upped to Outperform from Market Perform by BMO

 Target to $274 from $202

https://finviz.com/quote.ashx?t=VRTX&ty=c&ta=1&p=d

Evolus upped to Buy from Hold by Truist

 Target $11

https://finviz.com/quote.ashx?t=EOLS&ty=c&ta=1&p=d

Audientes Enters Initial Phase of Mass Production of Self-Fitting Hearing Aid

 Audientes announced that it has now entered the initial phase of mass production of their self-fitting hearing aid, Ven, with the first shipment, in branded retail-ready packaging, now off the production line and in transit to India. The shipment is earmarked for channel education and sales enablement and is therefore primarily being distributed to key stakeholders in Audientes' growing partner network in India. Audientes has been ramping up to mass production since the latter part of the fourth quarter of 2021. A critical element of this has been extensive product testing, including comprehensive assessments of Ven's Bluetooth technology, which is a requirement from the Indian authorities to sell commercially there. Production of Ven will now ramp up with full mass production expected in February 2022.

https://www.marketscreener.com/quote/stock/AUDIENTES-A-S-112637568/news/Audientes-Enters-Initial-Phase-of-Mass-Production-of-Their-Self-Fitting-Hearing-Aid-Ven-37597979/

Marker Therapeutics Shares Rise on Key FDA Designation

 Shares of Marker Therapeutics Inc. rose more than 10% in premarket trading Thursday after the clinical-stage immuno-oncology company said the U.S. Food and Drug Administration granted orphan-drug designation to its MT-601 T-cell therapy for the treatment of pancreatic cancer.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing-exclusivity period against competition.

Houston-based Marker said MT-601 is its second multi-antigen targeted T-cell therapy to receive the designation, and its first in a solid tumor indication.

https://www.marketscreener.com/quote/stock/MARKER-THERAPEUTICS-INC-46699740/news/Marker-Therapeutics-Shares-Rise-Premarket-on-Key-FDA-Designation-37595672/

Nuvation Bio Gets FDA Approval for IND Application for Cancer Treatment

 Nuvation Bio Inc. said the U.S. Food and Drug Administration has cleared its investigational new drug application to evaluate NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal inhibitor.

The company said NUV-868 is used for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer and triple negative breast cancer.

Nuvation Bio said it is looking to advance the program into Phase 1 development in mid-2022.

With the clearance of this IND for NUV-868 in advanced solid tumors, Nuvation Bio would be initiating a Phase 1/2 study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types. A Phase 2 monotherapy study would also be initiated in mCRPC patients as well to further explore safety and efficacy.

https://www.marketscreener.com/quote/stock/NUVATION-BIO-INC-111170007/news/Nuvation-Bio-Gets-FDA-Approval-for-IND-Application-for-Cancer-Treatment-37596223/

Compass Gets FDA Go-Ahead for Phase 2 Cancer Trial

 Compass Therapeutics Inc. said Thursday that a decision from the U.S. Food and Drug Administration will allow the company to proceed with a global Phase 2 trial evaluating its drug designed to treat advanced biliary-tract cancers.

The Boston-based pharmaceutical company said the FDA has accepted its investigational-new-drug application for CTX-009, an antibody that Compass is developing for people whose biliary-tract cancer hasn't responded to other treatments.

Compass is already studying the drug in a Phase 2 study in South Korea. Data from that trial will be rolled into an expanded trial that includes U.S. sites following the FDA's clearance, Compass said.

The expanded second stage of the Phase 2 study is expected to begin in the second quarter of 2022, Compass said.

https://www.marketscreener.com/quote/stock/COMPASS-THERAPEUTICS-INC-115071909/news/Compass-Gets-FDA-Go-Ahead-for-Phase-2-Cancer-Trial-37597544/