J&J’s Stelara shows positive action in late-stage Crohn’s study

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies announces positive preliminary data from a Phase 3b clinical trial, STARDUST, evaluating Stelara (ustekinumab) in patients with moderately to severely active Crohn’s disease. The results are being presented at the European Crohn’s and Colitis Organization (ECCO) Annual Congress in Vienna.

At week 16, 79% of patients achieved clinical response and 67% were in clinical remission after receiving one ~6 mg/kg intravenous dose followed by one 90 mg subcutaneous dose of Stelara.

It expects to present primary endpoint data later this year.

https://seekingalpha.com/news/3542140-j-and-js-stelara-shows-positive-action-in-late-stage-crohns-study

FDA accepts Epizyme’s application for tazemetostat for follicular lymphoma

Under Priority Review status, the FDA has accepted Epizyme’s (NASDAQ:EPZM) marketing application seeking approval of Tazverik (tazemetostat) for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least two prior lines of systemic therapy.

The agency’s action date is June 18.

The FDA OK’d the methyltransferase inhibitor last month for epitheloid sarcoma.

https://seekingalpha.com/news/3542147-fda-accepts-epizymes-application-for-tazemetostat-for-follicular-lymphoma

AstraZeneca slips 2% on Q4 results

AstraZeneca (AZN) Q4 results:

Revenues: $6,664M (+3.8%); Product Sales: $6,250M (+8.4%); Collaboration Revenue: $414M (-36.2%).

Key product sales: Tagrisso: $884M (+49%); Lynparza: $351M (+68%); Symbicort: $712M (+12%); Nexium: $353M (-10%); Brilinta: $428M (+14%); Farxiga: $419M (+6%); Pulmicort: $413M (+6%); Crestor: $296M (-4%); Imfinzi: $424M (+62%); Faslodex: $166M (-39%).

Net Income: $313M (-69.7%); EPS: $0.24 (-70.7%); non-GAAP EPS: $0.89; CF Ops: $4,861M (+26.9%).

2020 Guidance: Total revenue: growth increase by a high single-digit to a low double-digit percentage; Core EPS: to increase by a mid- to high-teens percentage.

Shares are down 2% premarket.

Previously: AstraZeneca EPS beats by $0.33, misses on revenue (Feb. 14)

https://seekingalpha.com/news/3542169-astrazeneca-slips-2-on-q4-results

SmileDirectClub down 5% premarket on reported aligner problems

SmileDirectClub (NASDAQ:SDC) slips 5% premarket on average volume on the heels of an NBC news report that some customers have experienced problems with its dental aligners, an issue that has surfaced before.

The Better Business Bureau has received more than 1,800 complaints, mostly about customer service issues.

Last month, nine members of Congress asked the FDA and FTC to investigate the company “to ensure that it is not misleading consumers or causing patient harm.”

California enacted a law in January requiring x-rays for all teledentistry patients before beginning online aligner treatment. Virginia is considering the same.

Chief Legal Officer Susan Greenspon-Rammelt counters that the company has helped more than 750K people with its network of licensed dental professionals, adding that network dentists, not the company, are responsible for treatment plans and undesirable outcomes may occur if patients don’t follow the program correctly. She also says that the company reviews all patient scans before sending the first treatment kits and only to those it considers to be good candidates (~95% of those reviewed are accepted).

The company’s September 2019 IPO was a flop. Shares debuted at $23, then bottomed at $8.73 about a month later. The stock has clawed back ~75% since then.

Update: In a statement, the company takes issue with NBC’s “misrepresentations.” It says NBC had the opportunity to connect with customers who either had no concerns with treatment or who did and resolved their issues with their treating doctor but declined to include these customers in its report. It also says there is no investigation by the FDA or FTC into its business, adding that when customers request a refund outside of its published policy, it asks that they sign a general release that contains a confidentiality provision which is standard business practice and similar to recommendations from the American Association of Orthodontists.

https://seekingalpha.com/news/3542180-smiledirectclub-down-5-premarket-on-reported-aligner-problems

ImmunoGen +16% premarket on Q4 beat; revenues up 235%

ImmunoGen (IMGN) Q4 results:

Revenues: $44.9M (+235.1%).

Net Income: $4.8M (+111.5%); EPS: $0.03 (+110.7%); Quick Assets: $176.2M (-32.8%).

2020 guidance: Revenues: $60M – 65M.

Anticipated 2020 events: Present initial data from the Phase 1b FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with Avastin (bevacizumab) in mid-2020.

File IND for IMGC936 in H1 2020.

Transition next generation anti-folate receptor alpha (FRα) ADC, IMGN151, to pre-clinical development in mid-2020.

Shares are up 16% premarket.

Previously: ImmunoGen EPS beats by $0.08, beats on revenue (Feb. 14)

https://seekingalpha.com/news/3542200-immunogenplus-16-premarket-on-q4-beat-revenues-up-235

Sellas Life Sciences up 11% premarket on advancement of nelipepimut-S

Nano cap SELLAS Life Sciences (NASDAQ:SLS) is up 11% premarket on increased volume in reaction to its announcement that it has finalized the design and plan for a pivotal Phase 3 clinical trial evaluating the combination of nelipepimut-S and trastuzumab (marketed as Herceptin by Roche), for the adjuvant treatment of patients with triple-negative breast cancer who have received standard-of-care therapy.

If successful, the data may support a U.S. marketing application.

https://seekingalpha.com/news/3542211-sellas-life-sciences-up-11-premarket-on-advancement-of-nelipepimut-s

Asco-GU 2020: revving up for Peloton deal validation

The meeting’s abstracts point to studies from Merck & Co, Exelixis and others that should be on investors’ radar.

Last year Merck & Co paid over $1bn to buy Peloton Therapeutics on the back of data that, while very impressive, came from just 55 subjects. An update from this first-in-human study on Saturday should give a better idea whether this was money well spent.
The venue for the presentation will be the Asco Genitourinary Cancers Symposium, which starts in San Francisco tomorrow and continues with presentations into Saturday. Also on the radar are clinical results with Cabometyx, which look to reverse Exelixis’s 2014 failure in prostate cancer, though investors should look for more information on a treatment-related death mentioned in the abstract.
Exelixis’s Cosmic-021 trial combines Cabometyx with Roche’s Tecentriq, and its Asco-GU abstract refers to a very early data cut in castration-resistant prostate cancer subjects who had progressed on novel hormone therapy. This showed a 32% overall remission rate for the combo.
Cosmic-021 aims to enrol 1,732 patients across various cancers, but for now only the uncontrolled combo data are available, so a comparison is tricky. Stifel analysts reckon 8-18% remission rates in Merck’s Keynote-365 study of Keytruda plus Lynparza provides a benchmark of sorts.
Investors will want to know why Cosmic-021 shows promise when in the similar setting of Cosmic-1 Cabometyx failed against prednisone (Exelixis wiped out after Comet-1 crash lands, September 2, 2014). They should also ask about the treatment-related death from dehydration of a 90-year-old Cosmic-021 subject.
Riding in the Peloton
Meanwhile, the Asco-GU abstract for Merck’s MK-6482 relate to a May 2019 cut-off, and were already known at the time of Peloton’s $1.05bn takeout: a 24% ORR in 55 subjects with second-line or later renal cell carcinoma. The presentation on Saturday should provide a more up-to-date dataset.
MK-6482 is claimed to be the first small-molecule inhibitor of HIF-2α, and another closely watched indication for it is von Hippel-Lindau disease. According to EvaluatePharma sellside consensus MK-6482 has yet to be included in most analysts’ models, so more validation of the Peloton takeover is keenly awaited.

Selected Asco-GU 2020 abstracts
Project	Company	Mechanism	Detail	Study	Abstract
Thursday 13 February
ADXS-PSA	Advaxis/Merck & Co	Anti-PSA vaccine	Keytruda combo in mCRPC	Keynote-046 part B	126
Pasotuxizumab	Bayer/Amgen (ex Micromet)	Anti-PSMA BiTE	First-in-human study in mCRPC	NCT01723475	124
Talabostat	Bioxcel	DPP & FAP inhibitor	Keytruda combo in mCRPC	NCT03910660	140
SHR3680	Jiangsu Hengrui	Antiandrogen	First-in-human study in mCRPC in China	NCT02691975	90
Cabometyx	Exelixis	TKI	Tecentriq combo in mCRPC	Cosmic-021 cohort 6	139
Friday 14 February
Padcev	Seattle Genetics/Astellas	Anti-nectin-4 ADC	Keytruda combo in 1L urothelial cancer	EV-103	441
Guadecitabine	Otsuka (ex Astex)	DNMT inhibitor	Platinum-refractory germ cell tumors	NCT02429466	408
Infigratinib	Novartis	FGFR inhibitor	3/4 CRs in FGFR3-altered nonmuscle-invasive bladder cancer	NCT02657486	510
Saturday 15 February
MK-6482	Merck & Co (ex Peloton)	Oral HIF-2α inhibitor	First-in-human stdy in ≥2L RCC	NCT02974738	611
Sitravatinib	Mirati	TKI	Opdivo combo in 2L RCC	NCT03015740	612

Other Asco-GU abstracts that have caught analysts’ eyes include an update on Seattle Genetics’ EV-103 study of Padcev, and Mirati’s sitravatinib plus Opdivo combo in advanced renal cancer.
The latter yielded a 38% ORR, which Leerink said was promising and beat the 20-22% seen with Opdivo or sitravatinib monotherapy in another study. Mirati, of course, is an all-in bet on the Kras inhibitor MRTX849, so sitravatinib could give the sellside reason to raise target prices yet further.
Padcev, Seattle/Astellas’s anti-nectin-4 antibody drug conjugate, secured accelerated US approval in December for anti-PD-(L)1-relapsed urothelial cancer on the basis of the EV-201 trial. EV-103 is a front-line study in combination with Keytruda, and had already impressed at last year’s Esmo meeting.
The Asco-GU abstract relates to a June data cut, with ORR now 73% (71% at Esmo) and a 12.3-month median progression-free survival. Since Tecentriq plus chemo yielded 8.2 months of mPFS in Imvigor-130 the updated data presentation, due on Friday, should make EV-103 one of the highlights of Asco-GU.
https://www.evaluate.com/vantage/articles/events/conferences/asco-gu-2020-revving-peloton-deal-validation