Sign in or Register

Already a member?

Sign in

Or sign in with your account on:

Not a member yet?


Immuno-Oncology Game-Changers from Big Pharma and Small Biotechs

  +Follow June 30, 2014 12:35PM
Tickers Mentioned:

immuno-oncology stocks, cancer curing stocks, miracle treatment stocks, biotech stocks, big pharma stocksForecasting when we'll have a cure for cancer remains beyond the predictive powers of researchers and investors. But forecasting the focus of the latest American Society of Clinical Oncology meeting was in the cards: Immuno-oncology took center stage. In this interview with The Life Sciences Report, Medical Technology Stock Newsletter editor John McCamant describes the excitement surrounding this rapidly evolving sector, and names big pharma and small biotech players conjuring potential game-changers.

John McCamant: As many expected, immuno-oncology was all the rage at the recently concluded ASCO meeting. It was widely acknowledged that before ASCO, Bristol-Myers Squibb Co. (BMY) was the leader in the space, followed by Merck & Co. Inc. (MRK) and Roche Holding AG (RHHBY) . At the conference, however, AstraZeneca Plc (AZN) showcased its emerging immuno-oncology pipeline. The competitive landscape changes rapidly as this exciting sector evolves.

Bristol's lead drug exhibited further toxicity in both non-small cell lung cancer (NSCLC) and renal cell carcinoma trials, with some very real adverse events in lung cancer. Yervoy (ipilimumab) has been the primary culprit, but Bristol also reported some notable adverse events with its PD-1 blocker, nivolumab.

Just before ASCO, on May 6, Merck was granted priority review for its top PD-1 prospect, MK-3475, with a U.S. Food and Drug Administration (FDA) approval deadline of Oct. 28. Merck is expected to get first-mover position in the new wave of immuno-oncology therapies, which is expected to be a game changer in the oncology market. The initial indication is melanoma.

Despite the speed bumps, Bristol is still a leader. But it is becoming clear that Bristol may not have the best-in-class immuno-oncology drug candidates, leaving the company vulnerable to the next wave of competitive compounds.

The emergence of AstraZeneca's strong immuno-oncology pipeline is, in our view, the primary driver for the recent Pfizer Inc. (PFE) bid. Pfizer has little presence in the immuno-oncology sector, and AstraZeneca's emerging pipeline would have transformed Pfizer into an immuno-oncology player overnight.

While many investors were expecting a post-ASCO selloff, the exact opposite has occurred, as investors have begun to get in a back-to-bios mode. ASCO was a big pharma and biotech conference after all. Incyte Corp. (INCY) and Pharmacyclics Inc. (PCYC) stars shone brightly, while Bristol's immuno-oncology disappointed.

The immuno-oncology sector is primed to become a super blockbuster market. Most current Wall Street estimates for the immuno-oncology treatment space, of ~$10–15 billion (~$10–15B), are based on only a few cancer types (melanoma, NSCLC and renal), and that is changing. The signal at ASCO is that immuno-oncology, with all the new tools emerging, will impact the vast majority, if not virtually all, cancer types in some shape or form. A great example is the bladder cancer data reported by Roche, which showed a 50% response rate (including one complete response) with RG7446 in PD-L1+ patients with pretreated metastatic bladder cancer, a setting that typically has very limited treatment options. Adding immunotherapy in combination with radiation and chemotherapy is another reason the immuno-oncology market opportunity is poised to grow significantly over the next few years.

TLSR: Incyte Corp. presented results from RECAP, a Phase 2 trial of Jakafi (ruxolitinib) in metastatic pancreatic cancer, as well as preliminary results from an ongoing Phase 1/2 trial of its immuno-oncology compound for metastatic melanoma and results from RESPONSE, a pivotal Phase 2 trial of ruxolitinib in uncontrolled polycythemia vera (PV). Did the data validate the faith you have in the company's potential to become "an oncology powerhouse?"

JM: Immuno-oncology is clearly of high interest to investors, and the standing-room-only crowd that greeted the presenter for Incyte's INCB24360 ('360) indoleamine 2, 3-dioxygenase (IDO) poster is further illustration. In fact, the presenter was barely able to put the poster up for display due to crowding in the presentation area.

For immunotherapy-naïve patients in the 25mg twice-daily and 50mg twice-daily cohorts, the objective response rate was 42% and the disease control rate was an impressive 75%. In immunotherapy-experienced patients, there were two patients with stable disease. Data from a 300mg twice-daily cohort had some intriguing follow-up data, despite the study being stopped due to toxicity. Although treatment of the subgroup was discontinued before responses could be fully evaluated, six of the seven patients were alive after one year, including three who have not received subsequent checkpoint inhibitor immunotherapy. In our view, this shows that Incyte's '360 may have a sustained treatment effect even after therapy has stopped. We remain impressed with the data for '360, albeit that the results are from a small data sample. For those who doubted IDO after the ASCO abstracts were made available, major votes of validation have occurred this year, as Incyte has formed three IDO combination joint ventures with the leaders: Merck, AstraZeneca, and Bristol-Myers Squibb.

Incyte had a very productive ASCO, as the company also presented positive data for Jakafi in both PV and pancreatic cancer. The primary endpoint for the PV trial was a spleen volume reduction of 35%+ and hematocrit control at week 32. While only 21% of Jakafi-treated patients met the primary endpoint (versus 1% in control), 77% met at least one part of the primary endpoint. Also important was symptomatic control, with 64% of patients reporting a greater than 50% improvement in symptoms such as itching, muscle aches and night sweats. We expect Incyte to file a new drug application with the FDA for PV approval shortly.

The RECAP data in pancreatic cancer and the biomarker, C-reactive protein (CRP), were finally revealed at ASCO. The data was very strong from a small sample size and adds to our confidence that Jakafi will be effective in treating solid tumors.

TLSR: Pharmacyclics' supplemental new drug application (sNDA) for Imbruvica (ibrutinib) was recently granted priority review by the FDA for treatment of chronic lymphocytic leukemia (CLL). Is that the catalyst you were looking for, or is there more news to come?

JM: At ASCO, partners Johnson & Johnson and Pharmacyclics sponsored several symposia on CLL, and the Phase 3 RESONATE trial data was presented—and simultaneously published in the New England Journal of Medicine with major fanfare. The common term used among researchers at the conference and analysts after the presentations was "SOC," meaning Imbruvica is on its way to becoming the new "standard of care" for the treatment of CLL, the most common form of B-cell blood cancer.

In our view, ASCO data, including duration of response results now exceeding an astonishing 3 years, further solidifies the drug in the eyes of hematologists/oncologists. As Dr. Susan O'Brien from MD Anderson Cancer Center put it, "Imbruvica is the easiest drug I've ever prescribed." Prescription data recently spiked, and that was before the conference.

A post-ASCO pop is likely over the next few weeks. In addition, the FDA just accepted the company's sNDA application for a full CLL/small lymphocytic lymphoma (SLL) label, giving Imbruvica a priority review and setting a PDUFA date for Oct. 7. While some believe AbbVie Inc.'s (ABBV) ABT-199 has a chance to dethrone Imbruvica someday, most ASCO watchers note that its tumor lysis syndrome profile has hardly been fixed, and that its use in the community will be very difficult, especially compared with Imbruvica.

The train doesn't stop there, as Pharmacyclics' autoimmune compound, which has even greater commercial opportunity and financial leverage, will emerge later this year. In our view, investors will begin to appreciate the next leg up in the Pharmacyclics value proposition being created in autoimmune.

TLSR: Can you update us on the rest of your picks for the 2014 Life Sciences Report Biotech Watchlist?

JM: Earlier in June, Novavax Inc. (NVAX) announced a $100 million secondary offering of common stock. The underwriters are JPMorgan (JPM) and Citibank (C) , two global investment banks that currently do not cover the stock from a research standpoint. After speaking with management, the proceeds will be used to fund a standalone trial in the elderly that will accelerate the path to approval for the company's disruptive/novel combination influenza/respiratory syncytial virus (RSV) vaccine. As a result, Novavax now has a potential "seasonal" vaccine strategy for the elderly.

Prior to this, there was no standalone path to approval for the elderly. The new path provides the earliest license/commercialization potential for the "respiratory vaccine"—this combination flu/RSV vaccine that, in our view, will be highly differentiated and lead the company into the combined >$5 billion market for flu and RSV vaccines.

As a reminder, the Novavax F Protein RSV vaccine completed its fourth clinical trial since last year, and the company is about to meet with the FDA to begin the first RSV trial in pregnant women.

In an update call with senior management, Anthera Pharmaceuticals Inc. (ANTH) is expected to have a busy H2/14 with blisibimod (b-mod). Over the next month or so, the company is expected to take an interim look at the CHABLIS-SC1 trial in patients with lupus. The clinical/surrogate endpoint is a trend in the level of proteinuria and, while the interim look will not be confirmatory of the final results, it is an important catalyst and will give both the company and investors a first look at b-mod's post-PEARL-SC clinical trials.

The interim look may influence a potential partner's decision to form a collaboration, and the company is hopeful one may finally be struck by the end of the year. Such a partner will help fund and coordinate the second lupus trial, which is ready to go and is expected to begin by H2/14. In addition, a look at Anthera's IgA nephropathy trial is due by end of Q3/14 or in early Q4/14. There is a lot of sound science behind BAFF (B cell activating factor) inhibitors including b-mod, and we are cautiously optimistic of the outcome.

TLSR: John, thanks for your time.

John McCamant is the editor of the Medical Technology Stock Letter, a leading investment newsletter. McCamant has spent more than 25 years on the frontlines of biotechnology investing. He has established an extensive network that includes contacts throughout the investment banking and venture capital communities. His expertise in biotechnology investments is a subject of media interest. He is frequently consulted and quoted by The Washington Post, Reuters, Bloomberg, CBS and MarketWatch.

Source: Editors, The Life Sciences ReportWant to read more Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent interviews with industry analysts and commentators, visit our Streetwise Interviews page.

1) The editors of Streetwise Reports LLC, publisher of The Gold Report, The Energy Report, The Life Sciences Report and The Mining Report, conducted this interview, and provide services to Streetwise Reports as employees. They own, or their families own, shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services.
3) John McCamant: I own, or my family owns, shares of the following companies mentioned in this interview: Incyte Corp., Novavax Inc. I personally am, or my family is, paid by the following companies mentioned in this interview: None. My company has a financial relationship with the following companies mentioned in this interview: None. I was not paid by Streetwise Reports for participating in this interview. Comments and opinions expressed are my own comments and opinions. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview.
4) Interviews are edited for clarity. Streetwise Reports does not make editorial comments or change experts' statements without their consent.
5) The interview does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer.
6) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their families are prohibited from making purchases and/or sales of those securities in the open market or otherwise during the up-to-four-week interval from the time of the interview until after it publishes.

Streetwise – The Life Sciences Report is Copyright © 2014 by Streetwise Reports LLC. All rights are reserved. Streetwise Reports LLC hereby grants an unrestricted license to use or disseminate this copyrighted material (i) only in whole (and always including this disclaimer), but (ii) never in part..

Streetwise Reports LLC does not guarantee the accuracy or thoroughness of the information reported.

Streetwise Reports LLC receives a fee from companies that are listed on the home page in the In This Issue section. Their sponsor pages may be considered advertising for the purposes of 18 U.S.C. 1734.

Participating companies provide the logos used in The Life Sciences Report. These logos are trademarks and are the property of the individual companies.


DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions.

Signup for our daily newsletter and get our best articles emailed right to you!

Results for BMY
2 Mar 15 14:52:01
S&P100 #Stocks Performance $USD $CSCO $BA $TXN $RTN $V $HON $INTC $C $MET $DIS $HD $AMZN $MDT $LOW $BMY more@ http://t.co/cKkr8csQUU
Sleek Money
2 Mar 15 14:50:33
Bristol-Myers Squibb Sees Unusually Large Options Volume $BMY http://t.co/EucJctMEFl
Breaking News Now
2 Mar 15 14:48:04
$BMY: Bristol-Myers Squibb Sees Unusually Large Options Volume (BMY): http://t.co/F7qZ7ZNSKt
Kelvin Lam
2 Mar 15 14:46:25
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
US Banking News
2 Mar 15 14:42:19
Bristol-Myers Squibb Sees Unusually Large Options Volume $BMY http://t.co/uR7zIVjHeE
Helen Ong
2 Mar 15 14:16:38
Midday Glance: Pharmaceuticals companies. Pharmaceuticals. Gain $bmy $mrk $jnj $pfe - Yahoo Finance http://t.co/nnGD1DuDXZ
Wall Street
2 Mar 15 14:02:29
http://t.co/iQWRYq6dIh....Top penny stocks, NYSE, and NASDAQ trades from the stock market today. +296% last week. $AVP $ABEV $BMY $AA
RDL Investments Ltd
2 Mar 15 13:43:29
Bristol-Myers Squibb declares $0.37 dividend $BMY http://t.co/Fs0GJwQYz5
2 Mar 15 13:41:02
$BMY: Bristol-Myers Squibb Announces Dividend: http://t.co/4VwLyzHxVa
Quantpost Healthcare
2 Mar 15 13:37:00
$BMY News: "Bristol-Myers Squibb declares $0.37 dividend $BMY …" http://t.co/NdekbDQlt9 Board view: https://t.co/hjzKktkvhC
SA Breaking News
2 Mar 15 13:36:59
Bristol-Myers Squibb declares $0.37 dividend http://t.co/7TOp0j7I8n $BMY
Bristol-Myers Squibb
2 Mar 15 13:32:55
Announcing quarterly dividend http://t.co/eKfsqdcgcX $BMY
Venky Srinivasan
2 Mar 15 13:07:43
"@upsidetrader: $BMY not flashy, but slow & steady pays the bills, great setup, looks ready to grind higher http://t.co/8whukGsQj9"
Lori Vance
2 Mar 15 13:07:43
RT @PVCTinvestor: $PVCT $BMY Cost-benefit (News page, March 2) http://t.co/jQKFu8CYoe
R Mark Aaron
2 Mar 15 12:56:39
RT @SeekingAlpha: Is Now The Time To Pounce On The Pot Business? http://t.co/W19p4baAyK $ABBV $AMMJ $BMY $CBIS $GWPH $MJNA
2 Mar 15 12:22:50
RT @portefeuillefun: Innate Pharma bondit, porté par une décision de la FDA http://t.co/0tlStfdVSU. $BMY $IPH #lirilumab #nivolumab #opdivo
2 Mar 15 12:21:28
$BMY has been imporessive today, keeps motoring higher.
Yu Zhu
2 Mar 15 12:12:09
RT @dougheuringaria: BAML $BMY $MRK Opdivo lung filing accepted – June FDA decision (or sooner) http://t.co/8pK16qjG7b
Quick Stock Ideas
2 Mar 15 12:09:08
Is Now The Time To Pounce On The Pot Business? http://t.co/IHLtRzUyPv $ABBV $AMMJ $BMY $CBIS $GWPH $MJNA
Quantpost Healthcare
2 Mar 15 12:09:08
$ABBV $BMY News: "Is Now The Time To Pounce On The Pot Business? $ABBV $AMMJ …" http://t.co/GPICsPknLS Board view: https://t.co/HsMWPyOO4I
Seeking Alpha
2 Mar 15 12:09:08
Is Now The Time To Pounce On The Pot Business? http://t.co/W19p4baAyK $ABBV $AMMJ $BMY $CBIS $GWPH $MJNA
2 Mar 15 12:04:00
BAML $BMY $MRK Opdivo lung filing accepted – June FDA decision (or sooner) http://t.co/8pK16qjG7b
2 Mar 15 11:59:19
Not much I did today besides lock in some with $BMY, looks like it wants to b/o finally
Sy Mukherjee
2 Mar 15 11:55:07
$BMY's Opdivo could nab a lung cancer indication by June. But how far behind is $MRK's Keytruda? http://t.co/cQNcwSZ6Js
Lawrence Diana
2 Mar 15 11:49:21
B/W $BMY/Apr 62.5c @ 62.36deb/1.54cr. 2.8% gain if called in 46d. Possible .36 div as well. Stop 59.7
Wall Street
2 Mar 15 11:43:30
http://t.co/iQWRYq6dIh will not help you lose weight...but it will help you make money trading. Enjoy! $GG $FITX $BMY
BioPharma Dive
2 Mar 15 11:35:16
$BMY's Opdivo could nab a lung cancer indication by June. But how far behind is $MRK's Keytruda? http://t.co/a7zmWfdDSo
Lucky Jimmy
2 Mar 15 11:22:30
BMY Stock up +1.58% percent Today $BMY High is at 61.92 and the Low 61.04 with current volume of 755,023. Bris http://t.co/oqWGvOm8fF
Lucky Jimmy
2 Mar 15 11:22:08
$BMY BMY up +1.58% percent Today $BMY Stock High is at 61.92 and the Low 61.04 with current volume of 755,023. Bris http://t.co/acOKMTC4SA
Laura Kushner
2 Mar 15 11:07:19
RT @FiercePharma: Gilead's hep C star Harvoni, BMS' cancer med Opdivo lead ranks of 'exciting' launches http://t.co/kKuzG0gzbe $GILD $BMY #…
Anand Shah
2 Mar 15 10:36:42
RT @OptionsHawk: $BMY 1275 Mar. 61 calls bought, stock strong out of consolidation
Dominic Rodrigues
2 Mar 15 10:12:40
$PVCT $BMY Cost-benefit (News page, March 2) http://t.co/jQKFu8CYoe
Hep Magazine
2 Mar 15 10:10:37
"Hepatitis C Treatment Options for Genotypes 2 through 6" by @scribenyc http://t.co/UXKk2ClJuy #hepatitis #hepC #HCV $GILD $MRK $BMY
Danny Dobres
2 Mar 15 09:51:49
RT @MarketParse: @ddobss22 Your tweet about $BMY had a sentiment of 5 and was featured on Market Parse. http://t.co/5WyUW5R8WJ
2 Mar 15 09:50:31
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
Rouge Parry
2 Mar 15 09:44:41
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
2 Mar 15 09:34:01
Bristol-Myers Squibb Company (BMY) is 10% Away from 200 Day Moving Average http://t.co/Hr3VQztzCD $BMY #investor #stocks #investing
Market Parse
2 Mar 15 09:30:23
@AlexanderMunns $BMY Your tweet has been featured on Market Parse, for iPhone. http://t.co/YHInvBCk4m
Market Parse
2 Mar 15 09:30:23
@fda_tracker Your tweet about $BMY had a sentiment of 5 and was featured on Market Parse. http://t.co/5WyUW5R8WJ
Market Parse
2 Mar 15 09:30:23
@ddobss22 Your tweet about $BMY had a sentiment of 5 and was featured on Market Parse. http://t.co/5WyUW5R8WJ
Market Parse
2 Mar 15 09:30:23
@OptionAlarm $BMY Your tweet has been featured on Market Parse, for iPhone. http://t.co/YHInvBCk4m
Wall Street
2 Mar 15 09:19:15
http://t.co/iQWRYq6dIh....Top penny stocks, NYSE, and NASDAQ trades from the stock market today. +296% last week. $AVP $ABEV $BMY $AA
G Bend
2 Mar 15 09:16:07
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
Visabl Diagnostics
2 Mar 15 09:12:30
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
Open Outcrier
2 Mar 15 09:07:51
$BMY popping on volume
2 Mar 15 09:07:46
$BMY and $RIGL partner up for TGFb http://t.co/xLEhRk9GrI
2 Mar 15 08:42:20
RT @FierceBiotech: Bristol-Myers takes a big step in its PD-1 lung cancer race with Merck. http://t.co/UT2ksm3SVD by @DamianFierce $BMY $MRK
John Ablemann
2 Mar 15 08:33:27
$BMY 5 Things Bristol-Myers Squibb Co.'s Management Wants You to Know http://t.co/KFqQrJqaRi
Clair Voight
2 Mar 15 08:33:24
$BMY Bristol-Myers Squibb Co Daclatasvir/Sovaldi Combo Cured 97% In HIV-HCV Study http://t.co/NpmcxHDl29
2 Mar 15 08:29:22
$BMY: Bristol-Myers announces that the FDA acceptance for filing and review, the supplemental Biologics License... http://t.co/M41edln2sL
  +Follow June 30, 2014 12:35PM



blog comments powered by Disqus

About us

Equities.com is the most advanced interactive online social ecosystem for the financial industry, serving as a resource center and next-generation communication platform that connects self-directed investors with public issuers, market experts, and professional service providers and vendors. Registered members can leverage our exclusive proprietary research tools such as the Small-Cap Stars, which outperformed 90% of all small-cap mutual funds, and robust do-it-yourself E.V.A. research reports. The Equities.com Issuer Dashboard is the ideal tool to communicate and manage investor awareness campaigns to the investment community, as well as to access valuable resources to help your company grow.

Market Data powered by QuoteMedia.
Copyright © QuoteMedia. Data delayed 15 minutes unless otherwise indicated. Terms of Use.