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The PR was weak IMO. I have seen (and believe posted here) non-cash collaborations where a MRK rep comments on the trial. That sort of validation was lacking and hence the reaction from the market. Having said that, this does not in any way change my outlook for the registration trial. It might seem like we just keep on saying the next milestone will do it, but the fact is that the registration trial incorporates what the market will value (true non-responders and whether they respond). As Punit has mentioned in the past, they will be in a lot better position to negotiate a deal if and after they've met the primary endpoint for the trial. Until then, I don't see much action, unless there is a surprise ex-US partnership (there is a commercial partnership/licensing bullet in the 2017 milestones) in between.
The study completes in June. Not sure if data will be ready (or significant) for ASCO though (just phase 1 data).
Fair enough. Do you think there could be additional data from the current p2b trial at UCSF? Or TNBC phase I data? Other than these they shouldn't have any clinical data that I'm aware of.
Thanks Twiz. I wish the PR had been a bit more substantive. Anyway, glad it has been announced. Having to pay for the drug on their own would have been terrible.
They are not presenting at ASCO in June. Abstract titles were released on April 20.
Recall that UCSF p2b IST was first announced in the fall of 2014 and enrollment started only about a year later. There were questions raised about the delay. Perhaps to avoid a similar situation this time, they want to announce the agreement as close to the start of the trial as possible. Just my guess.
Thank you for the detailed response misiu143.
hschlauch, if we don't hear anything in the next couple of weeks, I would also agree that something probably didn't work out with MRK and that ONCS will be buying the drug for the trial. It would be a big surprise though, as finalizing a drug supply agreement has been presented as a key 2017 milestone by the company. They have said that it will happen in 1H 2017 so there's still time but each week without a PR does get concerning. I'm not sure why it would be a big deal for MRK to provide the drugs for free as they do that with many biotechs (they provided it to UCSF for free as well). Guess we will find out soon.
Anyone have any thoughts on Theratech-Taimed BLA submitted last week? They have ODD, meaning if approved, they will have some market exclusivity. Are their mechanism of action and target HIV patients different than that of CYDY's? Thanks.
http://www.marketwired.com/press-release/theratechnologies-partner-submits-biologics-license-application-hiv-monoclonal-antibody-tsx-th-2213957.htm
I hear you ahab but here are some of my thoughts ...
- Drug supply news should come any day now since the trial begins enrollment on June 1st. I expect to see a spike to around $1.50 - 1.90. It spiked to this level on Fast Track news. Big pharma validation should do at least the same, if not better. Like I've said before, it will depend on the contents of the PR. While it is known that there will not be a capital component, there could well be comments from a MRK representative on the trial and there could be exclusivity clauses for future development or rights to acquire. These would help sustain any spike in SP IMO. If we see these, maybe the SP will settle over $2. Time will tell.
- A few months ago, Punit walked the audience through a PowerPoint slide listing companies that have valuations in a few hundred million dollars while ONCS sat at $23M. He said this year is going to be an inflection year for ONCS's valuation. This is also the first time a licensing/commercial partnership bullet is listed as a milestone for 2017. I am expecting an ex-US partnership, with cash, in 2017 in TNBC or head and neck cancer. This milestone IMO does not pertain to the registration trial. Punit has mentioned ex-US collaboration in a recent presentation. I sense there's something significant coming in this area.
- I expect to hear something on the collaboration with MighTy Biopharmaceuticals. I don't think this one is just going to be a TAP deal. MighTy collaboration could bring some VC money from MighTy's side. But at this time, this is just speculation on my part.
- A cash raise is almost certain this summer/fall IMO. May come after drug supply news. If I'm right about ex-US partnership, may come after that. Wouldn't that be something? Again, just speculating here.
I personally am not worried about the current share price. I don't think this is going to go below a dollar. If it does go below a dollar just on technicals and without negative news from the company, I will take it as an opportunity to buy some more shares and risk some more capital on the milestones that I expect to see this year. I would like to stress that this is still a risky bet, but one that I'm ok taking with a limited amount of my capital. GL to you and everyone who is doing the same.
ASGCT 2017: DNA-based Antibody Therapy via In Vivo Electrotransfer
- Kevin Hollevoet, PhD. KU Leuven – Leuven University, Leuven, Belgium
http://www.asgct.org/UserFiles/file/UpdatedFinalVersion.pdf
Thanks twiz. I just like to play around with Google in my spare time.
In case anyone is interested, I use below sample Google searches to find out about events in advance.
[Company name] + [Month * Year]
example:
Oncosec + "June * 2017"
[Person name (CEO/scientist/officer)] + [Month * Year]
examples:
"Adil Daud" + "June * 2017"
"Sharron Gargosky" + "May * 2017"
You can change the month and year to look further ahead (or back) in time. The asterisk is a wildcard used in searches that captures any characters. For our purposes, it will capture numbers from 1-31, representing the days in a month, as well as the comma that is contained in dates.
When the first term is a name with two words, you want to put them in quotation marks to search for that unique name. Otherwise, Google will return all results that have to do with an Adil and a Daud that aren't the same person. Also sometimes conferences or journals use middle initials as well. To account for that, just insert an asterisk between the first and the last name. This way, it will capture the "H" or an "H." in "Robert H. Pierce" for example.
example:
"Robert * Pierce" + "journal of" + 2016
Lastly, relevant results, if any, do not always show up on the first page of the search results. So you might have to skim through the multiple pages of the search results to find them.
I haven't found one and I don't expect to find a comprehensive list anyway.
https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=140891790
Company Overview
Merck Research Venture Fund is a sector fund specializing in fund of fund investments in biotechnology sector. It typically invests in early-stage startups. The fund seeks to make fund of fund investments in life-science venture firms. It prefers to invest in therapeutics sector. The fund can also consider making direct investments in biotech companies in future.
Chickpea, Merck-Ventures is an arm of the German Merck (Merck KGaA). Merck Research Venture Fund (MRVF) is an arm of the American Merck (Merck & Co.). The two Mercks have no connection with each other since the US government confiscated the US branch during World War I.
Venture capital firms are allowed to keep their investments anonymous by the SEC, unlike hedge funds.
Call me speculative, but my personal opinion on why we have not seen and will not see a $ deal with MRK at this time (until eventual BO if registration trial is successful) is that MRK is already funding ONCS via MRVF as I've discussed (speculated) with some reasonable questions in my post #37779. It makes no sense for a normal VC fund to invest $40M in a company and keep the investment anonymous, IMO.
7th European Post-Chicago Melanoma/Skin Cancer Meeting
June 29th–30th, 2017, Munich, Germany
http://www.sidemast.org/download/sidemast_20170401171039.pdf
PARALLEL SESSION I
Intralesional treatments: current developments
CHAIRPERSONS: MERRICK ROSS, HOUSTON, USA
OLIVIER MICHIELIN, LAUSANNE, SWITZERLAND
13:30–13:42 T-VEC alone or in combination?
Olivier Michielin, Lausanne, Switzerland
13:45–13:57 L19-IL2 (Darumab) alone or in combination?
Benjamin Weide, Tuebingen, Germany
14:00–14:12 IL-12 electroporation
Adil Daud, San Francisco, USA
14:15–14:27 PV-10
Merrick Ross, Houston, USA
SYMPOSIUM I
My personal highlights at ASCO 2017
CHAIRPERSONS: ADIL DAUD, SAN FRANCISCO, USA
CAROLA BERKING, MUNICH, GERMANY
09:40–10:00 … in immunotherapy
Adil Daud, San Francisco, USA
10:05–10:25 … in targeted therapies
Dirk Schadendorf, Essen, Germany
10:30–10:50 … in combined/sequential schedules
Georgina Long, Sydney, Australia
That is correct, there will be only one combo using EP-IL 12 + Keytruda on patients who regressed on either Keytruda or Opdivo. The non-responders can come from any prior treatment. But yes, as clearly indicated on clinicaltrials.gov, the biological for the registration trial besides IL-12 is only going to be Pembrolizumab (Keytruda) and not Opdivo.
https://clinicaltrials.gov/ct2/show/NCT03132675?term=oncosec&rank=1
Intervention
Biological: pIL-12
Biological: Pembrolizumab
Device: Immunopulse
[OT] NIH to get a $2 billion funding boost as Congress rebuffs Trump’s call for cuts
https://www.statnews.com/2017/05/01/nih-funding-congress-trump/
The National Institutes of Health will get a $2 billion funding boost over the next five months, under a bipartisan spending deal reached late Sunday night in Congress. The agreement marks a sharp rejection of President Trump’s proposal to cut $1.2 billion from the medical research agency in the current fiscal year.
The deal does not address funding for 2018, when Trump has called for a slashing the NIH’s budget by about a fifth, or $5.8 billion.
But it sends a clear signal that lawmakers on both sides of the aisle prioritize funding for medical research and intend to honor the agreements laid out in the 21st Century Cures Act, a bipartisan bill that called for raising NIH funding and speeding approvals of new drugs and medical devices. This will be the second year running that Congress gives a $2 billion funding bump to the agency, which funds medical research across the country.
“The omnibus is in sharp contrast to President Trump’s dangerous plans to steal billions from lifesaving medical research, instead increasing funding for the NIH by $2 billion,” House Minority Leader Nancy Pelosi said in a statement.
The roughly $1 trillion spending agreement, which funds the government through the end of September, also more than quadruples funds to fight opioid addiction. That money — about $800 million total, up from $150 million in the last budget — will be divided among opioid addiction programs at the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration.
In addition, the plan permanently extends a health insurance program for coal miners, which had been on the brink of shutting down. It preserves federal funding for Planned Parenthood, for now, though Republicans are still expected to push hard to eliminate that in the 2018 budget.
And in a victory for Democrats, Puerto Rico’s health commissioner announced on her Facebook page that the budget includes $295 million to shore up the territory’s Medicaid program, which should help avert cuts that could have resulted in major coverage losses.
The NIH funding hike includes an extra $400 million to research Alzheimer’s disease and an additional $476 million for the National Cancer Institute. And it boosts spending on two of former President Barack Obama’s big science projects: the Precision Medicine Initiative, which will get an increase of $120 million as it seeks to recruit volunteers for genetic testing and health tracking; and the BRAIN Initiative, which will get an extra $110 million to support work mapping the human brain.
The spending agreement is a firm repudiation of the Trump administration’s vision of a much leaner federal research program.
Health and Human Services Secretary Tom Price had suggested at a congressional hearing that the NIH budget could be cut significantly without harming medical research by reducing grants for “indirect costs” — the federal dollars that help research universities pay for utility bills, heating costs, pricey equipment, and other expenses that support their biomedical labs. University administrators, who make up a powerful lobbying group, did not take kindly to that suggestion.
And from the moment Trump proposed such steep cuts, Republicans have joined Democrats in rejecting them.
The Republican members who chair the health appropriations subcommittees in the House and Senate — Senator Roy Blunt of Missouri and Representative Tom Cole of Oklahoma, respectively — have been steadfast in their support for NIH funding. Senator Lamar Alexander of Tennessee has likewise advocated for research spending, especially as he helped shepherd the 21st Century Cures Act into law.
The agreement lives up to Cole’s word from March, when he told STAT that Trump was unreasonable in requesting a $1.2 billion NIH cut within a budget Congress had largely negotiated before the 2016 presidential election. As he put it then: “Not going to happen.”
NTRP -44% /PM on topline data
https://finance.yahoo.com/news/neurotrope-announces-positive-top-line-103000432.html
AEZS -62% /PM on failure to meet p3 primary endpoint
http://mobile.reuters.com/article/idUSFWN1I3033
Thanks for the early warning Dew!
Roadshow in London this Wednesday.
http://www.rayleighcapital.com/rayleigh/event/oncosec-london/?instance_id=409
Stumbled upon this from a random Google search "oncosec + London". Punit had mentioned there will be recruitment sites for the registration trial in Europe in the later stages (guessing 2nd cohort). However, London may just be a roadshow stop and not necessarily a future recruitment site for the trial.
Anytime twiz! Had been visiting clinicaltrials.gov almost daily for the last two weeks. Glad to know June 1st is the start date. The drug supply deal has to be announced in May. Let's just hope there's some substance in the PR as big pharma validation has been listed as a 2017 milestone by the company.
Looking forward to some updates next week. They like to release PRs early in the month. Btw, came across this video (unrelated to ONCS but related to breast cancer immunotherapy space):
Lack of Immunotherapy in Breast Cancer Treatment
Lack of Immunotherapy in Breast Cancer Treatment https://t.co/t7QF4Ej4cP pic.twitter.com/eDJAxfmxnO
— Oncology Tube (@oncologytube) April 28, 2017
I expect an offering around July-August. IMO it will come after the drug supply partnership news for sure, which may or may not lift the PPS (depends on the contents of the PR - comments from Merck (validation) and/or exclusivity language).
Not sure how likely it is, but there is a chance IMO, that the 2017 milestone that says "Secure licensing or commercial partnership(s)" refers to an ex-US partnership in an indication other than melanoma. Recall Punit mentioning in recent presentations (few months ago) that a significant licensing deal on the current lead program will not happen until 2018, and also that the registration trial does not preclude them from doing ex-US collaborations. So what's this 2017 licensing/commercial partnership milestone indicating? I personally think we could see a collaboration, with upfront cash (since for this one it does not specify "drug supply agreement"), with someone like Roche on TNBC or head and neck cancer. OncoSec could really do its investor base a favor for their loyalty by doing the raise after this potential milestone.
One might say the current TNBC trial is only in phase 1 with 10 patients. I don't think it would be a factor. For example in 2014, Roche bought a company (a 1 year old spinoff) for $1.7B with a phase 1 breast cancer trial. I don't think it is unreasonable to expect a partnership this early.
http://www.pmlive.com/pharma_news/roche_makes_$1.7bn_oncology_acquisition_581862
So they're going to be using Keytruda to treat Keytruda AND Opdivo non-responders. Imagine the value of this treatment if successful, from Merck's perspective, being able to treat a rival's non-responders.
Registration trial up on clinicaltrials.gov
pIL-12 and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment (PISCES)
https://clinicaltrials.gov/ct2/show/NCT03132675?term=oncosec&rank=1
Expecting drug supply partnership to be announced soon.
MDxHealth and EXAS Sign Collaboration Agreement
http://finance.yahoo.com/news/mdxhealth-exact-sciences-sign-collaboration-050202825.html
IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, April 27, 2017
MDxHealth SA (Euronext:MDXH.BR) today announced that it has signed a five-year agreement with Exact Sciences Corp. (EXAS) for collaboration in the growing field of epigenetics and molecular diagnostics.
Building on a long-standing relationship spanning more than a decade, the new agreement will allow MDxHealth and Exact Sciences to share proprietary technologies arising from their respective ground-breaking discovery and development efforts in the fields of epigenetics and molecular diagnostics. Over the course of the collaboration, the parties may identify opportunities to share technologies in a range of indications, including urologic and lung cancers.
Contemporaneously with the execution of the collaboration agreement, Exact Sciences is also acquiring MDxHealth patents directed toward colorectal cancer, including its DNA methylation biomarker, NDRG4, as well as technology covering the use of FIT (fecal immunochemical test) in combination with methylation. These acquisitions include one-time fees totaling $15 million, including payments accrued since July 2016.
"With its ground-breaking achievements in molecular diagnostics, Exact Sciences is an ideal partner for us to collaborate with in the identification and development of new biomarkers for clinical diagnostic products," said Prof. Dr. Wim van Criekinge, CSO of MDxHealth. "The collaboration may allow each party to better capitalise on its cutting-edge epigenetic research and development efforts to bring new products and services to market to improve patient lives."
"MDxHealth has established itself as a leader in the discovery and development of epigenetic and molecular diagnostics technologies, particularly in the field of urology," said Dr. Graham Lidgard, CSO and SVP of R&D of Exact Sciences. "We are delighted to continue our long-standing scientific co-operation through this new agreement, which has the potential to benefit both companies` product development programs."
About MDxHealth
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company`s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company`s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
About Exact Sciences
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company`s website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.
Immunotherapy Pioneer James Allison Has Unfinished Business with Cancer
- Why do most patients fail to respond to the newest cures?
https://www.technologyreview.com/s/604086/immunotherapy-pioneer-james-allison-has-unfinished-business-with-cancer/
Immunotherapy Pioneer James Allison Has Unfinished Business with Cancer
- Why do most patients fail to respond to the newest cures?
https://www.technologyreview.com/s/604086/immunotherapy-pioneer-james-allison-has-unfinished-business-with-cancer/
Special Investor Breakfast - OncoSec Medical, Inc.
http://pbbusinessgroup.com/event/special-investor-breakfast-oncosec-medical-inc
Wednesday, April 26, 2017 - 8:00am
On Wednesday, April 26, we host a special investor breakfast at the Pavilion Room of the Chesterfield Hotel,from 8:00 a.m. until 9:30 a.m. The presenting company is OncoSec Medical, Inc. Click here for their website or here for their stock chart on Google. They are developing IL-12 cotherapy with PD-1 monoclonal antibody immunotherapy to improve the cure rate for melanoma, currently stuck in the 20s% due to the fact that some tumors are simply not very immunogenic, and thus never attract the immune system to either target or protect the tumor. On their website you can see their investor presentation and corporate profile. A summary of the company is below.
Trump Executive Order Could Revive Allergan-Pfizer Merger
https://www.thestreet.com/story/14097797/1/trump-executive-order-could-revive-allergan-pfizer-merger.html
Not sure if we will see additional data from the current trial. I think it has served its purpose and it is now up to the registration trial to prove things conclusively once and for all on patients who are all actual nonresponders. As to the market's reaction to the last data set, I suppose it wanted more confidence from results from more than just 9 actual nonresponders.
RE: TNBC data, it's only 10 patients, phase I, and a monotherapy. I would not expect it to do anything significant at this stage. Data-wise, interim data from the melanoma registration trial in Q4 may be the only significant event for 2017 and it will be make or break data for the company.
In the long run, there could definitely be big implications as the stickied posts discuss, but as far as 2017, I'm not sure if we will see a big $ collaboration with MighTy. Guess it depends on how much money MighTy launches with. Usually private companies announce their financial backing when they launch so we will have to wait and see. Anyway, it would be a start.
By ex-US collaboration, I wasn't referring to MighTy actually. I think there will be a partnership with someone like Roche on something like head and neck cancer. That's where I'm guessing we will see a big inflection point in terms of share price this year.
Interim data from the registration trial could also really help the stock if the first 23 real non-responders show a 30% response in Q4. It is possible that the "secure licensing & commercial partnerships" milestone could be referring to the registration trial and possible $ deal with MRK. But seems more likely to me at least that the milestone could be hinting more at an ex-US partnership.
Two more 2017 milestones to note:
1. Strategic partnerships: I'm guessing this is going to be with MighTy Biopharmaceuticals (Kevin Hollevoet's startup that's launching in the near future). I've been keeping an eye on any MighTy-related news. Will be interesting to know if they announce VC $ support when they launch.
2. Licensing and commercial partnerships: They have been very careful in choosing their words, like being specific that the registration trial will only have a drug supply partnership. So when they say licensing and commercial partnerships, I think they mean it, and they could potentially be referring to an ex-US collaboration for the lead program that Punit hinted at a couple of months ago when he said the lead program would not be precluded from ex-US partnerships even if they have some sort of collaboration for the registration trial in the US. This one could potentially have an upfront payment.
[OT] NAKED MOLE RAT CAN SURVIVE FOR 5 HOURS WITHOUT OXYGEN ‘BY TURNING ITSELF INTO A PLANT’
http://www.newsweek.com/naked-mole-rat-oxygen-depletion-survival-metabolism-586725
- these naked mole rats are largely immune to cancers
- scientists are also studying these rats to develop treatments for humans who suffer from oxygen deprivation
Interesting article.
Hi chickpea, I've been doing my google scans regularly but nothing on my radar as of yet as far as events/conferences.
The next milestone is going to be the announcement of drug supply partner for the registration trial that is slated to begin this quarter. So we can assume the announcement is coming sometime this quarter. Since big pharma validation is one of the a major checklist items in their 2017 milestones, I'm guessing the PR will at least have someone from MRK comment on the trial and there may or may not be exclusivity language.
It has indeed felt like watching paint dry lately. Let's hope that changes this quarter.
Sabby is the biggest publicly reportable owner of ONCS. There is some VC fund that owns more ONCS shares and warrants than Sabby but has chosen to remain anonymous as the SEC does not require VC funds to disclose their positions. From 2014 - 2016, this fund has invested a little over $40M in ONCS. I expect ONCS to raise some cash from them this year as well around mid-summer - early fall.
A $12 billion startup you've probably never heard wants to cure baldness and smooth out your wrinkles
http://www.businessinsider.com/samumed-wants-to-regenerate-hair-bone-cartilage-2017-3
Samumed is a $12 billion private biotech startup you've probably never heard of.
The San Diego-based company has attracted $300 million in funding and a heady valuation thanks to a pipeline of what could be revolutionary treatments to regenerate hair, skin, bones, and joints.
It offers the promise of reversing conditions related to aging by regrowing hair on balding heads, smoothing out wrinkles, and regenerating cartilage to worn-down joints in people with osteoarthritis.
If that seems to be too good to be true, the company is well aware.
"We get that reaction from anyone who actually listens to our story," CEO Osman Kibar told Business Insider in January.
That skepticism has only grown with the company's valuation, which is now one of the highest for a private biotech company. The firm's list of backers - lacking as it does specialist healthcare investors - and secrecy over its science have also raised questions.
Then there's Theranos, the onetime $9 billion startup that has fallen from grace and now casts a pall over the healthcare-startup space.
Cevdet Samikoglu, Samumed's chief financial officer, understands all of that. In fact, he asked many of the same questions. Samikoglu met Kibar more than 30 years when they both attended Robert College, a high school in Istanbul. Kibar had worked in venture capital, launched a company that later sold to pharma giant Novartis, and eventually created an incubator where he came across the technology that would become the backbone for Samumed.
Samikoglu signed on as an investor in Samumed initially in 2007, at which point he asked the same question.
"I'd basically badger [Kibar] with that question time and again," Samikoglu said. "When I came on board, the first few months I was kind of thinking about that, 'I can't believe we're sitting on this, I can't believe the potential of it.'"
Unlike Theranos, Samumed has been open about presenting its data, and before it gets to the market, the treatments will have to be approved by the FDA.
In the end, Samikoglu simply became too busy to think about it.
"We might be sitting on a molecule that already has the answer," he said. "But taking that and making it into a drug is a decade-long struggle."
...
...
...
[OT] The big one is coming, and it's going to be a flu pandemic
http://cnn.it/2nKd5gS
The IDO-Inhibitor Race Is On to Improve Cancer Treatment
$MRK, $RHHBY, $INCY, $NLNK
https://www.fool.com/investing/2017/04/13/the-ido-inhibitor-race-is-on-to-improve-cancer-tre.aspx
NewLink Genetics (NASDAQ:NLNK) and Incyte Corporation (NASDAQ:INCY) are racing a new class of drugs through clinical trials, and if these trials are successful, these new drugs may change how doctors treat cancer, including melanoma.
IDO-what?
Indoleamine 2,3-dioxygenase (IDO) is a protein that suppresses the immune system that cancer cells sometimes hijack. By inhibiting IDO, NewLink Genetics and Incyte hope to restore immune system responses so that cancer cells can be more easily identified and destroyed.
At NewLink Genetics, researchers are working on two IDO-inhibitors: indoximod, which it's developing on its own, and GDC-0919, which it's developing with Roche Holdings (NASDAQOTH:RHHBY).
Last week, NewLink Genetics unveiled updated results from a 60-person phase 2 study evaluating indoximod alongside Merck & Co.'s (NYSE:MRK) Keytruda in advanced melanoma. In this trial, 52% of patients responded to this two-drug therapy, and 73% had either a complete response, partial response, or stable disease.
The response rates are intriguing in part because the FDA approved Keytruda monotherapy in advanced melanoma after 33% of Keytruda patients responded to the drug in trials.
Incyte is also putting up impressive results in trials evaluating its IDO-inhibitor, epacadostat. In December, Incyte reported a 58% overall response rate in advanced melanoma patients who were given epacadostat and Keytruda. Overall, 74% of patients saw a complete response, partial response, or stable disease in this trial.
Which one's better?
NewLink Genetics data failed to impress investors who were hoping for a better than Incyte result, and because of that, NewLink Genetics shares have fallen.
However, investors might not want to draw too many conclusions between the two drugs and their efficacy. After all, these drugs are not being studied in head-to-head trials, so it's bad science to compare these trials with one another, especially since Incyte's trial included only 19 patients, while NewLink Genetics trial included 60 patients. Also, while both of these drugs target IDO, they do so differently. Epacadostat targets the IDO enzyme directly, while indoximod inhibits the effects of IDO via cell-signaling.
Because of differences in trial size and mechanism of action, investors are probably best served considering the results from both of these trials as evidence that targeting IDO puts both of these companies on the right track.
What's next
NewLink Genetics and Incyte are also evaluating IDO-inhibitors in solid tumors.
NewLink Genetics and Roche Holdings' GDC-0919 works in a manner that's more similar to epacadostat than indoximod, and results from a phase 1b study evaluating its use alongside Roche's Tecentriq (a drug that's similar to Keytruda) in solid tumors should be available later this year. Meanwhile, Incyte's epacadostat studies include seven trials that could support FDA filings for approval, if they're successes.
Of course, it's anyone's guess if these trials pan out, but if they do, then IDO-inhibitors may not only transform how we treat advanced melanoma, but also how we treat non-small lung cancer, triple negative breast cancer, and bladder cancer, too. And, that's potentially very big news for both of these companies.