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BMY

Bristol-Myers

$61.99

-0.59 (-0.94%)

07:05
11/10/17
11/10
07:05
11/10/17
07:05

Bristol-Myer says 'encouraging response observed' for Opdivo plus BMS-986205

Bristol-Myers Squibb Company announced updated results for Opdivo plus BMS-986205, a selective, once-daily oral indoleamine 2,3-dioxygenase 1 inhibitor from the ongoing Phase 1/2a dose escalation and expansion study, CA017-003. In the dose escalation phase, the maximum tolerated dose of BMS-986205 in combination with Opdivo was 200 mg. Based on safety and pharmacodynamic data, the recommended dose for further study was determined to be 100 mg. In the dose expansion phase, findings for anti-tumor activity were reported in two cohorts - heavily pre-treated bladder and cervical cancer patients. In the bladder cancer cohort, the objective response rate and disease control rate were 32% and 44%, respectively. In the cervical cancer cohort, the ORR was 14% and DCR was 64%. The study also measured ORR by PD-L1 expression levels; in patients who express PD-L1 greater than or equal to1%, ORR was 46% and 25% in the bladder and cervical cancer cohorts, respectively. In patients who express PD-L1 less than1%, ORR was 22% in the bladder cancer cohort; no response was observed in cervical cancer patients. Response was observed regardless of prior lines of therapy. IDO1 is an enzyme that breaks down tryptophan, an essential amino acid which fuels cytotoxic T cells, to help regulate the immune system and avoid an over-response to threats. Some tumors express excessive amounts of IDO1 and deplete tryptophan, resulting in kynurenine production, which starves T cells of their fuel and prevents the immune system from responding appropriately to the cancer. Preclinical studies evaluating BMS-986205 suggest that targeting the IDO1 pathway in combination with other possible complementary immune pathways has the potential to more effectively activate the anti-tumor response. Early clinical data also show anti-PD-1 therapy may upregulate IDO1 expression in patients. The primary objectives of the dose escalation study are to establish the safety, tolerability, dose-limiting toxicity and maximum tolerated dose, maximum administered dose or alternate dose; BMS-986205 doses from 25 to 400 mg once-daily were evaluated in combination with Opdivo given 240 mg every two weeks. The secondary objectives in the dose escalation phase include pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity. The primary objective of the dose expansion phase is to investigate preliminary anti-tumor activity, as well as safety and tolerability with BMS-986205 in combination with Opdivo. In this portion of the study, patients received BMS-986205 100 or 200 mg orally QD in combination with Opdivo 240 mg intravenously every two weeks, or 480 mg intravenously every four weeks. The study evaluated potency of BMS-986205 by measuring serum kynurenine, an immune-modulating metabolite produced by the IDO1 enzyme that potentially allows cancer cells to escape the immune response. In addition to the anti-tumor activity data presented at SITC, additional results included evidence of increased kynurenine inhibition in the blood, with 56% inhibition achieved at the 100 mg dose selected for further evaluation. Kynurenine was also evaluated in pre- and on-treatment tumor samples, with reductions of up to 100% noted. Proliferating CD8 positive T cells were also increased in the paired tumor samples from a range of tumor types, providing evidence of immunomodulation within the tumor microenvironment by an IDO1 inhibitor in combination with a PD-1 inhibitor. Across doses from 25 to 400 mg of BMS-986205 in combination with Opdivo, treatment-related Grade 3/4 toxicities occurred in 11% of patients. Those occurring in two or more participants included increased AST, increased ALT, anemia, autoimmune hepatitis, fatigue, pneumonitis, hepatitis, hyponatremia, hypophosphatemia and increased lipase. In the study, 1.4% of patients were discontinued due to study-drug toxicity.

  • 15

    Nov

  • 05

    Mar

BMY Bristol-Myers
$61.99

-0.59 (-0.94%)

11/08/17
LEER
11/08/17
NO CHANGE
LEER
Outperform
Leerink sees Five Prime recovering some of yesterday's losses
After hosting an investor call to obtain additional information on the efficacy and safety profile of cabiralizumab in pancreatic cancer, Leerink analyst Michael Schmidt expects shares Five Prime Therapeutics (FPRX) will recover some of the losses from yesterday. The efficacy observed in yesterday's data look "quite promising," while safety looks very similar to what has been seen in Opdivo monotherapy trials historically, Schmidt tells investors in a research note. He notes that Five Prime partner Bristol-Myers (BMY) remains highly engaged in the cabiralizumab program. The analyst maintains an Outperform rating on Five Prime shares. The stock in midday trading is up 15%, or $3.85, to $29.71.
11/03/17
STFL
11/03/17
NO CHANGE
Target $25
STFL
Buy
NewLink Genetics price target lowered to $25 from $29 at Stifel
Stifel analyst Stephen Willey trimmed his price target on NewLink Genetics (NLNK) to $25 from $29 to reflect incremental dilution from its recent equity fundraising and forecast for increased operating expenses given that the company will soon initiate its pivotal Phase 3 melanoma trial. The analyst, who expects NewLink shares to remain sensitive to near-term data points on the IDO inhibitor front from Bristol-Myers (BMY) and the partnership of Incyte (INCY) and Merck (MRK), keeps a Buy rating on NewLink shares.
10/30/17
10/30/17
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Intel (INTC) upgraded to Outperform from Market Perform at BMO Capital with analyst Ambrish Srivastava saying the company is starting to execute on delivering operating leverage and also show discipline in its operating model. 2. Conagra Brands (CAG) upgraded to Buy from Hold at Stifel with analyst Christopher Growe citing the stock's valuation, the company's operating profit growth and its optionality to do "aggressive" share repurchase and M&A. 3. Praxair (PX) upgraded to Buy from Neutral at Citi with analyst P.J. Juvekar citing the company's accelerating growth. 4. Bristol-Myers (BMY) upgraded to Buy from Hold at SunTrust with analyst John Boris saying Merck's (MRK) KN-189 data delay to 2019 and withdrawal of its EU 1L NSCLC filing improves the company's competitive position. 5. Curtiss-Wright (CW) upgraded to Buy from Neutral at BofA/Merrill with analyst Kristine Liwag saying it is a significant beneficiary of US Navy submarines and embedded computing. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/30/17
RHCO
10/30/17
UPGRADE
Target $75
RHCO
Buy
Bristol-Myers to benefit from Merck's KN-189 data delay, says SunTrust
As reported earlier, SunTrust analyst John Boris upgraded Bristol-Myers (BMY) to Buy from Hold and raised his price target to $75 from $55, saying Merck's (MRK) KN-189 data delay to 2019 and withdrawal of its EU 1L NSCLC filing improves the company's competitive position. Boris models an additional $2B in 2021 revenue as a result, adding that he has increased confidence in the Opdivo + Yervoy arm of CM-227 trial expected in 2018 to generate overall survival benefits.

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DE

Deere

$145.25

6.02 (4.32%)

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$312.60

-5.21 (-1.64%)

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TSLA

Tesla

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-5.21 (-1.64%)

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GSK

GlaxoSmithKline

$35.06

0.25 (0.72%)

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Innoviva

$13.42

0.01 (0.07%)

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SVM

Silvercorp Metals

$2.51

-0.07 (-2.71%)

07:52
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CEL

Cellcom Israel

$10.00

-0.1 (-0.99%)

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GASS

StealthGas

$4.07

0.36 (9.70%)

07:06
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CPRT

Copart

$41.01

4.31 (11.74%)

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  • 19

    Dec

DE

Deere

$145.25

6.02 (4.32%)

06:56
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  • 28

    Nov

DE

Deere

$145.25

6.02 (4.32%)

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  • 28

    Nov

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SECO

Seeco Holding

$8.34

0.14 (1.71%)

04:55
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  • 23

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BASFY

BASF

$27.39

-0.13 (-0.47%)

04:55
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RBS

RBS

$7.30

-0.04 (-0.54%)

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L

Loews

$49.36

-0.02 (-0.04%)

, GE

General Electric

$18.15

0.32 (1.79%)

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Loews

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GE

General Electric

$18.15

0.32 (1.79%)

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BRFS

BRF S.A.

$12.77

-0.16 (-1.24%)

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SU

Suncor

$35.42

0.2 (0.57%)

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  • 05

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