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Gates-backed Affinivax grabs $10M upfront and a major league partner for a groundbreaking attempt to beat Pfizer’s superstar vaccine
https://endpts.com/gates-backed-affinivax-grabs-10m-upfront-and-a-major-league-partner-for-a-groundbreaking-attempt-to-beat-pfizers-superstar-vaccine/
Over the past three years Steve Brugger and the crew at Cambridge, MA-based Affinivax have been working steadily on a next-gen platform for vaccine development, laying the groundwork — with key support from the Bill & Melinda Gates Foundation — for the first clinical trial of what they believe can be a breakthrough in the vaccines field.
This morning, Brugger is unveiling a collaboration with Astellas, which had earlier signed on to collaborate on a very early-stage vaccine program at the biotech. Now Astellas has come in with $10 million to front their pact on the lead effort, signing off on an undisclosed set of milestones and royalties while agreeing to shoulder the full cost of the clinical program that lies ahead.
The deal centers on a successor to Pfizer’s megablockbuster pneumococcus vaccine Prevnar 13, which brought in about $6 billion last year.
The biotech was organized back in 2014 with tech developed at Boston Children’s and a mission to break clear of the conjugation chemistry that lies at the heart of Prevnar 13.
If I remember correctly they expect to enroll ~65 patients between here and Australia so it is not going to be a huge trial. I believe they have enough cash to get the trials started at least. Also Australia has a 45% rebate on clinical trial expenses. Anyway, they will run out of cash in Q1 2018. If there is a cash raise, it could come sometime in 2H. All I can say is I don't expect a raise in the near term (1H 2017) particularly for the registration trial. They might raise later but for normal business needs.
Btw, Punit has said in recent presentations that they will fund this trial through non-dilutive means. Let's see.
There could be co-development/licensing conditions. As far as an upfront payment, I'm thinking their initial investment is the drug supply and if the trial succeeds they could offer an amount to co-develop or buy the pipeline. I don't know, just guessing. Maybe Punit says drug supply because he legally can't go around saying that they are finalizing a drug supply and a $ deal. So maybe there could be a cash component. We'll just have to wait and see. It is going to be a multinational (multi center) trial so it is going to be expensive and some upfront cash would make sense.
Hi kld2, I didn't get a chance to listen fully this afternoon, will do so tonight. Yes, regarding the drug supply being finalized, the messaging seems to suggest it is a certainty. It could however, be a plain vanilla drug supply only and no other features (upfront, exclusivity language) kind of deal at this time. If it's more great but I'm setting my expectations to expect the least.
They also mention licensing/ commercial partnerships separately for 2017 milestones. Now this one could be big. It could either be for current pipeline based on interim registration trial data or it could be for the multigene candidate. If former, the timing should be later in the year. If latter, maybe we will hear something by mid year. Regardless, it should be a good year for ONCS shareholders, IMO.
I am curious who else besides Dr. Alagzi and Dr. Gargosky will be on the KOL panel tomorrow.
LJPC +82% on Statistically Significant LJPC-501 Phase 3 Results
http://www.streetinsider.com/dr/news.php?id=12595008&gfv=1
La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension (CRH).
The analysis of the primary efficacy endpoint, defined as the percentage of patients achieving a pre-specified target blood pressure response, was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] for LJPC-501-treated patients.
Throughout the study, safety outcomes were followed by an independent Data Safety Monitoring Board (DSMB). The DSMB recommended that the study continue as originally planned. In this critically ill patient population: 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event. In collaboration with the investigators, La Jolla plans to present and publish detailed results from the ATHOS-3 study later this year.
Thanks Dew for your responses. I'll take a look at ENTA in detail.
The PR seems to leave the door open Opdivo patients as well, but my gut tells me it will be exclusively with MRK. Let's see.
They have mentioned on many occasions that they have no plan to go to market alone, and that they plan to go to market with the assistance of a big pharma. Punit has mentioned this a few times in recent public events.
Exactly twiz. There's a chance they might announce it very soon.
No, they have said "a drug supply partnership with a multinational like MRK or BMY" and "before registration trial begins in Q2." They haven't been specific on MRK.
This should at least make a lot more people and institutional investors pay attention to the KOL event tomorrow. We could see $2+ this week IMO. But it is when they announce a partnership with MRK that the MC should really take off. That's going to happen sometime soon, IMO (before registration trial begins in Q2 per the company).
Oncosec Medical (ONCS) Granted FDA Fast Track Designation for ImmunoPulse IL-12 to Treat Metastatic Melanoma
http://www.streetinsider.com/dr/news.php?id=12595028&gfv=1
OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class, Intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab.
"With the number of melanoma patients now being treated with either pembrolizumab or nivolumab in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy. Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies," said Punit Dhillon, OncoSec President and CEO. "With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti-PD-1 therapy, we are increasingly confident in ImmunoPulse® IL-12 to potentially convert 'cold' tumors to 'hot' tumors to effectively and safely improve the response rates of these patients."
"This Fast Track designation by the FDA serves as an additional validation for OncoSec's clinical development program," said Sharron Gargosky, Ph.D., Chief Clinical and Regulatory Officer. "As we launch our upcoming Phase 2b PISCES clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program."
The PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase 2b, Simon 2-stage, non-comparative, open-label, single-arm, multicenter study of ImmunoPulse® IL-12 (intratumoral pIL-12 plus electroporation) in combination with an intravenous anti-PD-1 antibody in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed according to RECIST v1.1 guidelines on, or within, 24 weeks of receiving approved anti-PD-1 antibodies on either pembrolizumab or nivolumab treatment (either as monotherapy or in combination with another approved checkpoint inhibitor). The primary endpoint for this registration-directed trial will be overall response rate (ORR) at 24 weeks with secondary endpoints of best overall response rate (BORR), duration of response (DOR), median progression-free survival (PFS) and overall survival (OS). This clinical trial is planned to initiate in the first half of 2017.
The FDA established the Fast Track program to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent communications and meetings with the FDA, to review the drug's development plan including the design of the proposed clinical trials, use of biomarkers, and the extent of data needed for approval. Fast Track designated drugs may qualify for expedited FDA review, and a rolling Biologics License Application (BLA), if certain criteria are met.
Excellent news!
If Merck does fund the drug supply and make some sort of exclusive deal with Oncosec I believe any money would be used to fund future clinical trial relating to the multi-gene candidate to start in 2018.
What are some good players to watch out for besides ICPT and GILD in NASH? Any thoughts on GALT, GLMD, or another company anyone? Thanks.
NASH Is Todd Hagopian's Top Biotech Sub-Sector For 2017
http://www.forbes.com/sites/kenkam/2017/02/24/nash-is-todd-hagopians-top-biotech-sub-sector-for-2017/#dd275591f3d4
Ken Kam: Tell me why you find the NASH market so appealing at this point?
Todd Hagopian: Well Ken, this is a market that most analysts believe could grow from zero to $20B by 2025. Biotech companies will typically trade at 4x – 8x revenue, so you are talking about a market cap of $160B to $320B for NASH based revenue alone. On top of that, there are relatively few major players with strong drug candidates, so we can already start to make strong predictions of who might become the leaders within this sub-sector.
Kam: If that is true, then why aren’t other analysts and fund managers making the same predictions?
Hagopian: As we’ve discussed in other articles, analysts typically make their recommendations based on the next 18 months. Despite the opportunity for a $20B market by 2025, most analysts are expecting just $1.6 Billion by 2020, which means most of the growth is beyond the time frame that they are focusing on.
The very first NASH drugs are on track to get approved in 2019, which puts them just barely out of reach of when the analysts would really begin to get excited about these companies. That said, we already see some stocks like Intercept (ICPT), which is heavily invested in the future of NASH, with analyst estimates almost twice at where the stock is trading now. So, I would say analysts are beginning to take notice.
As far as fund managers, they will be more likely to be purchasing these stocks already, but less likely to purchase them in the volume that I am suggesting. My strategy, as laid out in the previous strategy article, will be to hold between 15% - 20% of my portfolio in NASH companies moving forward.
Pharma company Incyte is moving to the S&P 500, and the stock is rallying
http://cnb.cx/2lCr4aD
Shares of Incyte closed more than 7 percent higher Friday, on news that the pharmaceutical company will join the S&P 500.
Drug development company Incyte will replace Spectra Energy on the S&P 500, effective at the open of trading next Tuesday, S&P Dow Jones Indices said in a press release on Friday.
Such index changes require fund managers whose investments track the S&P 500 to reallocate their holdings, including buying shares of stocks being added to the benchmark index.
Spectra is leaving the S&P 500 given its pending acquisition by Canada-based Enbridge, an oil and gas pipeline operator, the release said. U.S.-listed shares of Enbridge were 1 percent lower Friday, while Spectra traded little more than 0.5 percent lower.
Incyte specializes in oncology products and will be added to the S&P 500's biotechnology sub-industry index, according to the release.
Incyte shares hit a 52-week high Friday and are up about 30 percent for the year so far.
That is true and I'm guessing the majority of Keytruda recipient companies are in early to mid stages in their trials (just a guess, need to confirm). I'm curious if MRK is providing Keytruda for registration trials for free to other companies. I'll see if I can do some research over the weekend.
Some very good points hschlauch. Perhaps the KOL forum next week would be a good venue to ask them these questions, esp. the last one.
I was in ACTC (OCAT) for a small position. The company got bought out for $379M even though it was years away from market and had been tarnished by a shady management for years. ONCS is only 2 years away from the anti-PD1 refractory patients' market in melanoma which is $500M a year.
To be honest, and I might be wrong, I feel having this KOL meeting next week could mean the drug supply partnership announcement won't come immediately. It will come before trial begins in Q2 but maybe not as right away. JMO.
Well, if there's a PR that says "Merck will be supplying Keytruda" for the the registration trial (~65 patients x $150K = $9.75M worth of support), it should send a good signal to the market. Any upfront cash will also be good, and even if there is none, exclusivity language in the PR, for example "Merck will have exclusive rights to co-develop or purchase the treatment for the next x years" to that effect will send a stronger signal to the market. Let's see how they do it.
The only thing that will convince the market in the near term is a big pharma validation, IMO. The drug supply partnership should do it.
OncoSec has said they will announce a drug supply partnership "with a multinational" for the registration trial before it begins in Q2. They have said it's either going to be MRK or BMY but BMY has had no involvement with ONCS so far so it has to be MRK.
FWIW, the CEO has said on a recent public event that there could potentially be an exit opportunity for the lead program within 18 months, and on a few other occasions that they have no plans to get this treatment to market alone.
It is new and needs continuous testing but appears to be reliable.
http://www.jci.org/articles/view/87324
I stand corrected. You are right. Thanks for correcting.
Btw they are holding a KOL meeting next week for a select audience in NYC next week.
https://finance.yahoo.com/news/oncosec-host-kol-event-focused-110100311.html
Just to add, all patients in the upcoming p2 registration trial, and the 20 that will be added to the current p2b trial at UCSF, will be actual non-responders from previous anti-PD-1 monotherapy (mostly Keytruda). I cannot imagine MRK not being interested in acquiring ONCS (or their lead program) if they are able to produce 30%+ CRs in a larger non-responder population, esp. given this combination could be expanded to other solid tumors too.
Hi kld2, I think the data shared today (43% ORR; 48% BORR) was very good. While majority of the 22 patients were biomarker-predicted non-responders to anti-PD-1, there were 9 patients who were actual non-responders from prior checkpoint treatment, 3 of whom showed complete response (33%). The currently available second-line therapy for anti-PD-1 non-responders is treatment with Yervoy which had a 0% complete response, only 10% ORR, and 35% GRADE 3-5 SAEs in a trial with 40 patients. ONCS had a remarkable safety profile.
https://www.researchgate.net/publication/301696831_Efficacy_and_toxicity_of_treatment_with_the_anti-CTLA-4_antibody_ipilimumab_in_patients_with_metastatic_melanoma_after_prior_anti-PD-1_therapy
The reason why the market didn't respond well today IMO could be the small size of the study and perhaps the emphasis on predicted non-responders in the summary of the PR (despite the fact that there were some actual non-responders in the trial with complete responses). Also the market is generally cautious when digesting news from nanocap biotechs.
As to where we go from here, the company has made it clear in recent public presentations that they are on track to start a phase II registration trial, on their own (as in not an investigator-sponsored trial like this UCSF p2b trial), and on an accelerated approval framework, in Q2'17. They have also said they will announce a drug supply partnership for this trial with a "multinational" (they've said either MRK or BMY but it has to be MRK given their relationship so far) before the registration trial begins. A formal validation from MRK is much needed (like co-development exclusivity language in the deal PR) IMO, with or without an upfront payment. I expect the deal to be announced this quarter / early Q2.
By the way, the company has also said in recent presentations that they expect to announce collaborations within their newly established Technology Access Program (TAP) that uses their next generation TRACE device. They have reiterated a couple of times that these TAP deals will be announced shortly and will be "cash flow positive" and that the deals can be outside oncology as well.
Lots to look forward to in the near term IMO. I'm happy to have the opportunity to add one more lot at these prices.
So we need more patient data going forward which I believe we will get later on in this trial which will be enough positive data to get the green light for the registration trial.
I would also appreciate any dips before the drug supply and TAP deals are announced soon.
Results from the 7 new patients haven't been included in the abstract I think. If some of these are actual Keytruda nonresponders and they became responders, that would be significant. Let's see.
Pfizer, Merck, Lilly execs urge tax code revamp in letter to Congress
http://www.fiercepharma.com/pharma/pfizer-merck-lilly-execs-urge-tax-code-revamp-letter-to-congress
Pharma’s top U.S. execs haven’t been shy about expressing their desire for tax reform—and now, they’re taking those wishes directly to Congress.
Tuesday, 16 CEOs of major American companies—including Pfizer’s Ian Read, Eli Lilly’s David Ricks, Merck’s Ken Frazier and Celgene’s Mark Alles—put forth a letter to congressional leaders recommending a “comprehensive pro-growth” overhaul to the U.S. tax code, which they called a “major impediment to economic growth.”
The way they see it, lowering rates and enacting other changes proposed by Reps. Paul Ryan, R-Wis., and Kevin Brady, R-Texas, would “free up much-needed capital for companies to invest here in the U.S." and “help stop corporate inversions and acquisitions of U.S. companies.”
Read, for one, speaks from personal experience. After all, he was plenty vocal in dissing the U.S. tax code—which he said disadvantaged Pfizer in competition against its international peers—before attempting his own inversion move, a $160 billion Allergan deal that the U.S. Treasury quashed last year.
And Merck, Lilly and Celgene have already jumped at the chance to make their voices heard since the new administration took over. Frazier, Ricks and Celgene chairman and former CEO Bob Hugin, along with a slew of other industry leaders, met with President Donald Trump last month, promising new American hires if tax reform takes shape.
It's not hard to see why U.S.-based pharma execs may be eager for a change. Aside from the higher corporate tax rates they say they pay compared with many of their rivals, they also aren't too keen on the penalties they have to pay to repatriate foreign earnings, which leave some companies—Pfizer included—with a wealth of potential M&A funds trapped overseas.
Johnson & Johnson chief Alex Gorsky, though, has warned that pharma may not like all the changes that come its way if the tax code does get a revamp.
“There are going to be some things that all of us really like that are likely going to go away,” and “there’s going to be other things that we don’t necessarily like that may be introduced" in a new set of tax rules, he cautioned at the J.P. Morgan Healthcare Conference. “... At the end of the day it could mean for a company like Johnson & Johnson—and I would dare say others—that your tax rate could go up marginally.”
Because until a couple of months ago, partnerships and deals used to be mentioned in the company's strategy and goals. Recently they have moved under 12 month milestones with Punit emphasizing them at recent public events. I will trust him when he says they will be announced shortly and that they (TAP deals) will be cash flow positive. Drug supply deal may or may not have a cash component but should carry much needed validation from MRK in either scenario.
I personally think there will be at least two big pharma validations for ONCS in 1H17. Hence holding onto my shares at least until then.
I have set low expectations for tomorrow's immune monitoring data. However I expect drug supply partnership to be announced soon, maybe next week. Who knows? Counting more on that and TAP deals for SP gain. Any gains tomorrow will be welcome as well.
*investors and mostly swing traders, IMO. I myself am cautiously optimistic about the data tomorrow. I'm more looking forward to the drug supply partnership that the company has said will be announced with a "multinational" before registration trial begins enrolling in Q2. Will be interesting if it will be purely drug supply only or will also have an upfront payment and exclusivity terms. In addition to this, the company has said they will announce deals within their Tech Access Program shortly, and that these deals will be cash flow positive. Hence I am holding on to my full position at the moment.
Appears to be the case. Also the gains may be hard not to secure for many investors.
Buyout may come in 2018/19 if registration trial meets endpoints. Punit said at a presentation in January that they may have an "exit opportunity" for the lead program within 18 months.
As for a partnership, a drug supply partnership will be announced before patient enrollment begins in Q2'17 per Punit. Question is whether it will purely be drug supply only, or include an upfront payment, co-development exclusivity language, etc. It will be great for the stock even if it comes with the minimum characteristics as long as there's validation from MRK.
The abstract numbers are what we know already. Immune monitoring data will be new tomorrow in the full presentation.