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Thanks for your reply hschlauch. Looking forward to additional insights whenever you get the chance.
Also we shouldn’t forget ONCS has Orphan Drug Designation. If approved (AA) in 2019, they will have market exclusivity for 7 years for intratumoral electroporation of IL-12. So even if their patents expire in 2022, they will have protection until 2026. By that time the multi gene pipeline will have matured to a good extent as well. I see no reason to be concerned here. I also doubt these facts were not considered by Steve Cohen before he decided to invest.
Hschlauch, looking forward to your take on this, esp. with regards to new patent filings that you’ve mentioned here in the past. Thanks!
#SITC17 Oncosec heats up tumours, and so might competition https://t.co/6HHrtbYyfM via @JacobPlieth @EdwinElmhirst @EPVantage pic.twitter.com/jD8BH4seH4
— Evaluate Pharma (@evaluatepharma) November 15, 2017
Bitcoin Hits $13,500 in Zimbabwe as Tanks Roll Through the Capital
https://news.bitcoin.com/bitcoin-hits-13500-in-zimbabwe-as-tanks-roll-through-the-capital/
Genentech inks $650M deal with protein degradation pioneer Arvinas
https://endpts.com/genentech-inks-650m-deal-with-protein-degradation-pioneer-arvinas/
What has Genentech so interested? Arvinas is a bit of a pioneer in a new modality called protein degradation. Arvinas’ CEO John Houston tells me the company was the first to take the concept beyond academia. The science has since gained popularity, with companies like C4 Therapeutics and Kymera jumping on board. Even major pharmas like Celgene, Takeda, GSK and Novartis have efforts in the space.
The concept behind protein degradation is simple enough. Where protein inhibition has led to some advanced medicines, degrading proteins could prove a much more durable solution. In short, Arvinas plans to tag certain disease-causing proteins for destruction by recruiting an E3 ligase to the target, thereby sending the protein to the cell’s natural “garbage disposal” called the ubiquitin-proteasome system.
Houston said the platform, in theory, could be widely applicable to several diseases.
Neoepitopes as cancer immunotherapy targets: key challenges and opportunities
https://www.futuremedicine.com/doi/full/10.2217/imt-2016-0146
———
From previous post:
Novel cancer vaccine encodes 20 neoepitopes on a single mRNA molecule to elicit a completely individualized immune response--
Potential advantages of GENESIS™ with TRACE™ for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.
SAGE Prices 3.53M Share Common Offering at $85/Sh
https://www.streetinsider.com/dr/news.php?id=13509841&gfv=1
Sage Therapeutics (NASDAQ: SAGE) today announced the pricing of an underwritten public offering of 3,529,411 shares of its common stock at a public offering price of $85.00 per share. The gross proceeds to Sage Therapeutics from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $300.0 million. The offering is expected to close on or about November 17, 2017, subject to the satisfaction of customary closing conditions. In addition, Sage has granted the underwriters a 30-day option to purchase up to an additional 529,411 shares of its common stock.
J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint book-running managers for the offering. Cowen and Company, LLC and Leerink Partners LLC are serving as lead managers. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Moderna Announces First-in-Human Dosing for Phase 1 Study (KEYNOTE-603) of mRNA-4157, a Personalized Cancer Vaccine, for the Treatment of Solid Tumors
http://www.businesswire.com/news/home/20171115005760/en/Moderna-Announces-First-in-Human-Dosing-Phase-1-Study
--Novel cancer vaccine encodes 20 neoepitopes on a single mRNA molecule to elicit a completely individualized immune response--
--Moderna and Merck collaborating to evaluate mRNA-4157 in combination with KEYTRUDA® (pembrolizumab)
— — —
This $5 Billion Startup Made Its First Cancer Vaccine—For Just One Person
https://www.bloomberg.com/news/features/2017-11-15/this-5-billion-startup-made-its-first-cancer-vaccine-for-just-one-person
Google backs I/O startup Arcus in $107M deal
https://endpts.com/google-backs-io-startup-arcus-in-107m-deal/
From what I recall Punit saying at conferences last year, doing a domestic collaboration will not preclude them from doing an international one with some other pharma.
Even in the US, I think they can collaborate with any another US pharma. They just have to do their own clinical trials. It is likely the FDA will allow other combos to start from phase 2 as well (current combo did not have a phase 1 trial).
Licensing route should be pretty open for ONCS and given Dan’s arrival, I think this is exactly why he’s been brought in. He managed to get MRK, BMY, AZN, AMGN to collaborate with ADXS. Even before his arrival, consider the TAP deals. They would be a moot point if there was no option for future collaborations with the companies.
What I do believe now is Punit does not want ONCS to be a lowball sale to MRK post Pisces. Dan has been brought in for a reason. Otherwise Punit would have stayed on as CEO until Pisces data and potential BO IMO.
Just Keytruda (Pembrolizumab). Before they announced this trial, they said they would look to do a combo for anti-pd1 refractory patients and would list Keytruda or Opdivo but now it’s clear in the trial name and requirements that it’s only going to be Pembro (Keytruda). Opdivo, Tecentriq are completely different drugs and would need their own combo trials with ONCS.
[OT] Boston Dynamics’ latest robot dog is slightly less terrifying
https://www.theverge.com/platform/amp/2017/11/13/16645762/boston-dynamics-spotmini-robot-dog-less-terrifying-wtf
On a high level, MighTy is trying to do using DNA what Moderna is trying to do using RNA - manufacture mAbs within the patients, which would be a big threat to the expensive checkpoint inhibitors industry. As you may know, Moderna is privately valued at $3B (used to be $5B).
Some successful spinoffs from KU Leuven:
Complix - Merck collaboration for up to $280M
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126776345
Few other big $ big pharma collaborations
http://investorshub.advfn.com/boards/replies.aspx?msg=126776345
State of play and clinical prospects of antibody gene transfer
https://www.ncbi.nlm.nih.gov/pubmed/28592330
From previous post:
Following administration of the DNA that encodes a therapeutic antibody, the site of DNA delivery (muscle, skin or tumor) is turned into an antibody ‘factory’, which releases the therapeutic into the bloodstream for a prolonged period of time.
The OncoSec GENESIS™ research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)
TRACE™ technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS™ with TRACE™ has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.
Potential advantages of GENESIS™ with TRACE™ for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.
Thanks hschlauch! Whenever you have the time, we would love to hear your take on this.
I expect JNJ to do a similar deal with MighTy Biopharma (co. not yet launched) in the near future (2018).
Ku Leuven Spin-Off Project MighTy Wins International Jlinx Boot Camp With Swift And Cost-Effective Production Of Biological Therapeutics
https://lrd.kuleuven.be/en/news/ku-leuven-spin-off-project-mighty-wins-international-jlinx-boot-camp-with-swift-and-cost-effective-production-of-biological-therapeutics
MighTy is dedicated to the development of an innovative DNA platform for antibody therapy. Antibodies are recombinant biological proteins that have an enormous impact on the treatment of cancer and inflammatory diseases. However, the high production costs, long-term need for repeated delivery, and often limited single-agent effect of conventional antibody protein therapy hamper accessibility and implementation in other disease areas.
MighTy’s elegant technology addresses these hurdles by enabling the patient’s body to produce its own medicine, thereby avoiding the need for expensive production facilities. Following administration of the DNA that encodes a therapeutic antibody, the site of DNA delivery (muscle, skin or tumor) is turned into an antibody ‘factory’, which releases the therapeutic into the bloodstream for a prolonged period of time. This swift and cost-effective approach also allows for the simultaneous in vivo production of multiple antibodies, increasing the success rate of these biological therapeutics in fighting a disease.
Just speculating. Whoever they are, if they have a sense of an impending catalyst, it’s in their best interest to have the shares in their brokerage accounts so that they can sell at the pop when news hits. Again, pure speculation on my part.
Warrants exercised by last year’s anonymous investor. Expecting a catalyst on the horizon.
That’s exactly what Danny O’Connor managed to get AMGN to do with ADXS last year.
The preclinical partnership includes an upfront of $40 million alongside a $25 million investment, giving the cash-poor small cap plenty of runway to keep moving forward.
It was a few months ago, I don’t have search feature on iHub. Sorry. Trust me on this one :)
Don’t know why they haven’t released poster. As hschlauch said a while ago, they’re keeping their multigene cards very close to their chest for some reason. (A very good reason I’m hoping.)
I’m speculating that a multigene collaboration will be announced by end of the year.
For what it’s worth, multi $B biotechs with single arm, uncontrolled studies...
billion(s) in present day mkt cap doesn't incorporate imp caveats to all the uncontrolled, single-arm IO combo studies $FPRX $INCY $NKTR
— zach (@zbiotech) November 13, 2017
RIO—One of the World's Biggest Miners Is About to Go Coal-Free
https://www.bloomberg.com/news/articles/2017-11-10/one-of-the-world-s-biggest-miners-is-about-to-go-coal-free
- Rio Tinto is in the process of selling its last coal mines
- Rivals are sticking to or boosting exposure to dirtiest fuel
Just five years ago it would have been almost unthinkable that one of the world’s biggest mining companies would not dig any coal. It’s now likely to become a reality.
Rio Tinto Group, the world’s second-largest miner, has been steadily backtracking from coal to focus on better assets. It’s now looking for buyers for its remaining coal mines in Australia, and a sale will mark a complete exit from the fuel.
Rio’s potential coal-free future is in stark contrast with many of its rivals. Glencore Plc, the world’s top coal shipper, this year increased its exposure by agreeing to pay $1.1 billion plus royalties for a large stake in Australian assets sold by Rio. The fuel, which generates about 40 percent of the world’s electricity, is one of BHP Billiton Ltd.’s main strategies, while Anglo American Plc has pulled back on plans to sell out of the commodity.
...
Does anyone know if the poster for the multigene data is available yet? Thanks!
I have read up on him and also noticed the rise and decline of ADXS shareholder value in the last four years. He managed to get ADXS to collaborate with four big pharmas. Perhaps the company's science/data was not up to par and the big pharma didn't take the next step. Can't blame him for FDA holds when the clinical trials produce bad data. We like to point fingers and find scapegoats. Let's see what he manages to do with OncoSec's science and data. I'll withhold judging him until then.
If that's the case, hypothetically speaking, I think it would actually be better for ONCS. I'd rather have a CEO who is hungry to prove himself than someone who is resting on his laurels.
That’s still an assumption. But let’s say if that is true, why didn’t they have a permanent replacement in line? Normally boards always have a replacement ready before they push a CEO out.
How do you know?
He resigned and was not fired per company PR.
Or maybe not (re: cannibalism) if you think about it. Patents eventually expire and no matter how successful your drug is, it will eventually lose market share when that happens. New drugs take time to develop (average drug development time is 10+ years). So it may not be a bad idea for someone like MRK to invest in OncoSec's multigene construct despite Keytruda being their flagship drug now.
Merck & Co.'s Patent Cliff In 2017
https://www.fool.com/investing/2016/10/27/merck-cos-patent-cliff-in-2017.aspx
The above article right now supports the idea behind Merck's need for Keytruda to over-deliver (hence good for ONCS' lead combination program) more than MRK's need to replace Keytruda's in the future. Nevertheless a relevant article IMO.
Also if I were to speculate, we may see a collaboration on the multigene candidate in coming months. O'Connor was instrumental in getting an early stage collaboration for ADXS last year. I'm expecting him to try to do something similar with OncoSec's multigene construct.
https://www.fiercebiotech.com/biotech/amgen-does-preclinical-i-o-tie-up-small-cap-advaxis-for-up-to-540m
Lastly if I were to speculate further, such a collaboration would likely be with a pharma that does not have a checkpoint/IDO inhibitor and is lagging behind in the I/O race. For the ones already in the race, the multigene construct could cannibalize their lead I/O drugs. Just my 0.02.
Wainwright analyst seems to think so. They already have Fast Track for PISCES. Given the high CR rate, I’m curious if they could apply for BTD as a first line treatment. I’m not in the field so do not know what it takes for first line treatment. If this is the best CR rate so far for a Keytruda or any combination therapy in melanoma, it has to have a good shot at BTD IMO. Maybe not be in first line setting, but likely in the refractory setting. We shall find out in the coming months. For what it’s worth, slide 13 of the company presentation lists ODD, Fast Track, AA, Breakthrough Status in a box. The first two have been checked off. It’s clear that they seek to apply for AA if interim data is positive next year. So I’m assuming they also plan to apply for Breakthrough Status for PISCES given they have listed it in this slide.
OncoSec Medical November 2017 Corporate Presentation
https://content.equisolve.net/_cccf0395bc21ba1e67b40d366c1a855f/oncosec/db/34/277/presentation/ONCS+November+2017+Presentation+Deck.pdf
They should be done by December. These are patients who have already enrolled for keytruda monotherapy (and failed). Given MRK’s involvement in this trial, non-financial as it may be, they still have a working committee and ONCS should have a list of keytruda refractory patients on speed dial IMO. Recruitment should be smooth and timely.
The major known catalyst is of course interim data from the registration trial in mid 2018. Smaller expected catalyst will be completion of enrollment of first cohort by EOY most likely. Lastly, with Dan O’Oconnor on board, there could be surprise collaborations in between. He has done many as CEO of ADXS. He knows people at the top of major big pharma.
On I/O trial sizes in general, big pharma don't seem to be that concerned about getting big number of patients enrolled either.
Luke IDO $BMY #SITC17 pic.twitter.com/QZpJR5tgkG
— Andy Kinley (@AndyKinley) November 11, 2017
Other than targeting refractory patients to checkpoint inhibitors, do you think ONCS has a shot as a first line combination therapy in the future? Is it too early to determine/talk about that?
Thanks for your insights as always hschlauch! I found this on Nature:
FOXP3+ regulatory T cells and their functional regulation
https://www.nature.com/articles/cmi201510
Looking forward to Dan unlocking OncoSec’s value in coming months using his past relationships with big pharmas.