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Abstract for P1 TNBC:
www.abstracts2view.com/sabcs18/view.php?nu=SABCS18L_1496
Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Telli ML, Zablotsky K, Le MH, Canton D, Browning E, Bannavong D, Gargosky S, Wapnir I Stanford University School of Medicine, Stanford, CA; OncoSec Medical, San Diego, CA
Introduction: Triple negative breast cancer (TNBC) accounts for approximately 15% of breast cancer diagnoses and is associated with a higher risk of recurrence and more aggressive course in the metastatic setting. Emerging data suggest that some patients with TNBC benefit from immune-based therapies targeting the anti-programmed cell death protein 1 (PD-1)/PD-1 ligand 1 (PD-L1) axis, but success has been limited in poorly immunogenic tumors. Thus, combination therapies that drive an influx of CD8+ tumor infiltrating lymphocytes (TILs) and/or upregulate PD-L1 expression are required to increase response rates to these therapeutics. Intratumoral injection of plasmid IL-12 (tavokinogene telseplasmid; tavo) followed by electroporation (IT-tavo-EP) is a gene therapy approach that drives local expression of the proinflammatory cytokine, interleukin-12 (IL-12). Local expression of IL-12 is hypothesized to result in increased TILs and enhanced expression of proinflammatory cytokines, resulting in conversion of poorly-immunogenic/low TIL TNBC tumors into highly inflamed immunologically active lesions while demonstrating a high safety profile.
Methods: OMS-I140 is a phase I, non-randomized, open-label study of IT-tavo-EP in patients with inoperable locally advanced, metastatic and/or treatment-refractory TNBC (NCT02531425). Eligible patients have pre-treated TNBC and at least 2 anatomically distinct cutaneous or subcutaneous lesions accessible for injection and electroporation, with or without other regional or distant metastases. 10 patients are planned for enrollment. IT-tavo-EP is administered on Days 1, 5 and 8 of a single 28-day cycle. Tavo is injected intratumorally (based on tumor volume) at a concentration of 0.5 mg/mL and immediately followed by co-localized electroporation (6 pulses at 1500 V/cm with 1-second intervals). Tumor biopsies are obtained at baseline and post-treatment on day 28 of both treated and untreated lesions to determine if this therapy can promote a pro-inflammatory molecular and histologic signature. Pain scores and adverse events are recorded.
Results: To date, nine patients have completed study therapy. Reported treatment-related adverse events include pain associated with electroporation (grade 1) in 8 patients and fatigue (grade 1) in 1 patient. Median pain score (range 0-10) immediately after treatment was 2 (range 0-10) and 5 minutes post-treatment was 0 (range 0-6). In some patients, treatment-related increases in CD8+ TIL density have been observed by intratumoral chromogenic staining. Further immune profiling is being conducted to characterize the tumor microenvironment pre- and post-therapy. A subset of patients with treatment refractory TNBC received anti-PD-1 monotherapy as their immediate next therapy with clinical response observed. Updated data will be presented.
Conclusions: Our data suggest that IT-tavo-EP is a safe and tolerable TIL stimulating therapy in TNBC. Further study of IT-tavo-EP in combination with pembrolizumab in pretreated metastatic TNBC is planned.
Session: Poster Session 2: Treatment: Immunotherapy (clinical) (7:30 AM-9:00 AM)
Date/Time: Thursday, December 6, 2018 - 7:30 am
Room: Hall 1
OncoSec To Present Data in Late-Stage Triple Negative Breast Cancer (TNBC) at the 2018 San Antonio Breast Cancer Symposium®
November 13, 2018
Final Data from Clinical Trial of TAVO™ as a Monotherapy in Late-Stage TNBC
Initial Project Overview for KEYNOTE-890, a Phase 2 Clinical Trial of TAVO™ in Combination with KEYTRUDA® (pembrolizumab) will be provided
SAN DIEGO and PENNINGTON, N.J., Nov. 13, 2018 /PRNewswire/ -- OncoSec Medical Inc., (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, today announced that TAVO™ will be featured in two poster sessions during the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4-8 in San Antonio, Texas. Posters include data on TAVO™ as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with Merck's KEYTRUDA® (pembrolizumab) for the treatment of late stage triple negative breast cancer (TNBC).
"We are encouraged with the preliminary clinical observations we are seeing thus far, both in a monotherapy setting and in combination with checkpoint inhibitors," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "Based on this, we are excited to continue on the path toward developing novel treatment options for this large unmet medical need,"
Details on the poster presentations are as follows:
Presentation Title: Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Session Date & Time: Thursday, December 6, 7:00 – 9:00 a.m. CT (8:00 – 10:00 a.m. ET)
Session Title: Poster Session 2: Treatment: Immunotherapy (clinical)
Location: Hall 1, Henry B. Gonzalez Convention Center
Presentation Title: A phase 2 study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation with pembrolizumab in patients with inoperable locally advanced or metastatic triple negative breast cancer
Session Date & Time: Thursday, December 6, 5:00 – 7:00 p.m. CT (6:00 – 8:00 p.m. ET)
Session Title: Ongoing Clinical Trials: Immunotherapy
Location: Hall 1, Henry B. Gonzalez Convention Center
The abstracts for these presentations are now available online on the SABCS website at https://www.sabcs.org.
About OncoSec Medical Inc.
OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy platform – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates for use with its ImmunoPulse® platform. For more information, please visit www.oncosec.com.
Thanks TJ
SA article—Cancer research highlights: Oncosec attempt to pivot off “Negative” results.
Please note that I ( name not provided) am affiliated with Avisol Capital Partners and their Total Pharma Tracker service. They have also covered the companies in this article in their writings, and I wanted to make readers aware of the potential for overlapping coverage.
OncoSec Medical (ONCS) has built a lot of hype over the past several years with their attempt at a next-generation immune stimulator. They specialize in delivering the pro-inflammatory cytokine IL-12 directly to tumors using electricity. Some encouraging past data indicated that this cytokine could be used to help stimulate an immune response in certain tumors that would not respond to immune checkpoint inhibitors.
Thus, ONCS has plowed forward full bore with clinical trials intended to test the combination of their IL-12 delivery method and anti-PD-1 antibodies like pembrolizumab.
The news
ONCS reported preliminary findings from their phase 2b KEYNOTE-695 study, which combines their IL-12 method with pembrolizumab in patients with metastatic melanoma. The patients in this study had prior exposure and subsequent progression on a PD-1 inhibitor, suggesting that their tumors had become resistant to immune checkpoint inhibition.
The company divulged data from the first 9 patients to have completed 12 weeks of therapy and undergo an evaluation. Two of these patients achieved a partial response and another achieved stable disease as a best response. While this response rate appears to be low, it is worth remembering that these responders had either never achieved or lost response to anti-PD-1 therapy.
One of the trial investigators, Adil Daud, provided a comment: There is currently no approved therapy for the KEYNOTE-695 patient population. A 10% response rate is considered meaningful in this cohort, since this is about what we expect with additional chemotherapy, however, such responses lack durability. The preliminary tumor responses (22% BORR and 33% DCR) and supporting immune data observed here for the first time are important.
Looking forward
The results here appear to be an encouraging early sign of efficacy for the combination, given the difficult-to-treat population being targeted. However, the patient numbers are too low to say anything definitive, one way or the other. Certainly, the market thought harshly of the results, with ONCS taking an immediate 50% haircut in the aftermath of these findings.
ONCS followed up quickly with an announcement that they had dosed their first patient in another phase 2 trial targeting breast cancer, which would appear to be some well-timed damage control.
But the big questions are these: what really caused the stock market rout of ONCS, and is not a good time to take the jump in? Well, to the first question, I think the answer may be pretty clear: past data indicated that this trial would be a roaring success, with a ceiling for the response rate appearing to be 40%, which would be spectacular in this population. The company has been stable at a relative high since late last year when they presented preliminary data.
But the phase 2 has not been a strong consolidation of those results, early though they may be. And it would seem that this has deflated the hype balloon by quite a bit. This creates an interesting opportunity for those who are tolerant of risk. ONCS could very well come back in 6 months with a larger data set and confirmation of their higher observed response rates. At that point, you will very likely see a rapid doubling of the stock.
However, as you can see from the rout, current shareholders are voting with their feet, and they don't feel amazing about the long-term prospect of this approach. From my end, I don't quite see a reason to feel this down and out about the tech. To me, it looks like encouraging early data, although I am inclined to agree with critics that ONCS will need to generate something a lot more compelling to warrant a submission to the FDA.
Key investment takeaways
ONCS continues to be a company that works hard to control its optics. It is perfectly reasonable to expect that they'll deliver on a longer-term follow-up of these data by about the time of ASCO next year, so you have a potential meteoric catalyst, considering the company is currently sitting at a market cap of around $50 million.
Of course, by no means is a positive readout an assured thing. The data so far do not paint a picture of clear efficacy, only a promising signal. ONCS will need to have a very good showing for their next round, or this stock is probably going to lay flat for the foreseeable future.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
ONCOSEC REPORTS PRELIMINARY DATA FROM KEYNOTE-695 PHASE 2B REGISTRATION-DIRECTED CLINICAL TRIAL OF TAVO(TM) IN COMBINATION WITH KEYTRUDA® FOR METASTATIC MELANOMA AT SOCIETY FOR IMMUNOTHERAPY OF CANCER'S 33RD ANNUAL MEETING
TAVO™ in combination with KEYTRUDA® has shown early signals of reversing resistance in refractory metastatic melanoma patients previously treated and definitively progressed on either KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab) Of the first nine patients to complete 12 weeks of treatment and reach initial tumor evaluation (by RECIST v1.1), two patients had a partial response, one patient had stable disease (22% BORR and 33% DCR) and tumor responses occurred in both TAVO™ treated and untreated lesions
SAN DIEGO and PENNINGTON, N.J., Nov. 6, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing novel cancer immunotherapies based on its proprietary technology generating sustained intratumoral IL-12 levels, today reported preliminary data from KEYNOTE-695, a global, multicenter Phase 2b, open-label trial of intratumoral delivery of TAVO™ (tavokinogene telseplasmid / IL-12) with intravenous KEYTRUDA® (pembrolizumab) in patients with unresectable, advanced melanoma. Eligible patients had refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab).
As of September 1, 2018, 21 patients had been enrolled in the study. Out of the 21 patients, nine patients had completed 12 weeks of treatment and reached the first tumor evaluation point at approximately 12 weeks, while the remaining 12 patients had not yet reached the first tumor evaluation. All nine patients were previously treated and definitively progressed on anti-PD-1 therapies with 56% (5/9) having had more than one prior line of therapy. All enrolled patients had exceedingly low frequencies of intratumoral CD8+ peCTL (PD-1+/CTLA-4+) at screening with a notable increase in TIL density following treatment.
Two of the nine patients experienced a partial response and one patient had stable disease (22% BORR and 33% DCR) by RECIST v1.1. Tumor responses were noted in both treated and untreated lesions. Of the two responding patients, both had multiple prior rounds of anti-PD-1 therapy, with no response, and one had also progressed after 4 cycles of OPDIVO® and YERVOY® (ipilimumab), an FDA-approved anti-CTLA4 / anti-PD-1 antibody combination. Tumor responses were associated with treatment-related upregulation of immune-based transcripts in the tumor microenvironment, as well as increased frequencies of intratumoral T cells within three weeks of therapy.
"There is currently no approved therapy for the KEYNOTE-695 patient population. A 10% response rate is considered meaningful in this cohort, since this is about what we expect with additional chemotherapy, however, such responses lack durability. The preliminary tumor responses (22% BORR and 33% DCR) and supporting immune data observed here for the first time are important," said Adil Daud, MD, HS Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center.
KEYNOTE-695 enrollment criteria with respect to anti-PD-1 checkpoint failure is highly restrictive. In order to be considered an anti-PD-1 checkpoint failure, all patients must have Stage III/IV metastatic melanoma progressive disease after at least four prior cycles of either KEYTRUDA® or OPDIVO®. Disease progression is determined according to RECIST v1.1, measured by radiologic assessment, with confirmation of progression by second assessment. All patients must receive their first TAVO™ / KEYTRUDA® combination treatment within 24 weeks of the last dose of an FDA approved anti-PD-1 therapy, with no intervening therapies between such failure and KEYNOTE-695 enrollment. Patients that were BRAF eligible must have received and progressed following BRAF treatment.
"Although several clinical studies have reported late-stage melanoma data in anti-PD-1 failures, such failures are inconsistently defined. This is a critical point," continued Dr. Daud. "Since patients in KEYNOTE-695 have unequivocally failed approved anti-PD-1 therapies, these preliminary data, viewed in this context, carry weight."
TAVO™ was well-tolerated, with Grade 1 adverse advents associated with injection site or procedural pain. One TAVO™ related Grade 3 SAE of cellulitis was reported and resolved.
KEYNOTE-695 is a registration-enabled clinical trial. In order to be eligible for accelerated approval, a product candidate must treat a serious condition and provide a meaningful advantage over available therapies. In early 2017 and prior to the commencement of the study, the Company reviewed the patient inclusion criteria with FDA so that KEYNOTE-695 could be submitted to FDA for accelerated approval. KEYNOTE-695 is expected to be completed in 2019. Based on the outcome of the study and feedback from FDA, the Company plans to file for accelerated approval by end of 2019 or early 2020.
TAVO™ has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration.
New 8-K, On November 2, 2018, OncoSec Medical Incorporated (the “Company”) entered into a Sales Agreement between the Company and Cantor Fitzgerald & Co. regarding an at-the-market offering (the “Offering”) of up to $30,000,000 worth of shares of the Company’s common stock, par value $0.0001 per share. A copy of the Sales Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.
Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.
I think so Twiz, She’s been the overseer since it began so everything up to this point has her fingerprints on it and I think she’s simply being cited for the work up to this point.
ACTCFAN at BI add interesting DD on # of patients in upcoming data at SITC:
Was just reviewing the latest filing from 10/29. I realized that the filing tells us that the first cohort (23 patients) COMPLETED enrollment BEFORE JULY 31. The reason we know is that 250K options vest for O'Conner when cohort 1 reaches 100% enrollment. Per the below screenshots taken from the filing, they list them as exercisable as of July 31st.
The last day to submit changes (i.e. data updates) for late-breaking abstracts was 9/28/2018. 24 weeks before that would be mid-April. Might be a stretch that is was completed that early, but we at least know it was by July, and maybe even June. All this makes me much more hopeful that they could have data on as many as 20 patients.
From the filing: ir.oncosec.com/all-sec-filings/content/0001493152-18-014930/0001493152-18-014930.pdf
O'Conner's awards broken down in case you are interested:
Great post from Bioposter over at Biotech Investor site:
Of course the market has to tank during “ONCS run-up month” lol. So we should get the ONCS SITC PR on 11/1 and data on 11/6, which I think will be very good, if not great -- and I think the company has clearly telegraphed this:
+ This is open-label, not double-blinded, so insiders already know the data results. So what actions have they taken with this knowledge...
+ The primary endpoint is 30% BORR @24wk
+ In the original Simon two-stg design, they had to get at least 4/23 responses, or it would’ve been stopped for futility.
+ But they scrapped the Simon 2-stg design, and increased the trial size from 48 to 80, and in their 10-K, they explicitly say they did this after seeing data (“Since preliminary tumor responses...data have been observed, we believe eliminating the formal analysis and expanding the sample size is warranted.”). So if they did because of poor data, then this 10-K statement is an intentional misdirect and purposefully misleading, which is doubtful. Plus, as morangie stated, Merck would’ve had to agree to now provide Keytruda gratis for 80 patients. Doubt they would do that on bad data. So 4/23 means, at minimum, we have 17% ORR.
+ In both their 10-K and latest presentation pdf, they publicly state their intention to file for accelerated/conditional approval in late 2019/early 2020. So up till now (we’ll have to wait for confirmation from all 80 patients), they must be meeting their primary endpoint for positive data. So we must have at least a 30% BORR up to now.
+ Though this was just before Pisces start, the PI for the prior combo trial, Dr. Algazi, didn’t hesitate when he said this last year (from RLC’s transcript, p. 142 on this thread):
Q: (Robert Andtbacka?) What about the patient populations in the existing Phase 2b combo study and the upcoming PISCES study... are they different or are they similar
A: (Dr. Algazi) I think it's going to be exactly the same. It's really a validating study. Because I think the assay is a good one. ...I predict we're going to see exactly the same thing.
A (Robert Andtbacka?): It's one thing to have an assay that's highly predictive, it's another to have actual non-responding patients and that's why we're doing the PISCES now.
A (Dr. Algazi): It's really a validation. It's a really robust validation. We talked a lot about how the trial is designed and I think it's going to be a really robust test of the technology and I think this is going to be pretty definitive....
+ So since last year’s data on predicted non-responderd had a BORR of 50% (technically, 42% based on RECIST), with Dr. Algazi’s confidence, I think we’ll have at least a 42%-50% BORR! That’s my WAG! We’ll see.
Here’s the rest of my kool-aid reasons for great data:
+ If data was mediocre/poor, they wouldn’t release it at the “Super Bowl” of IO conferences -- SITC (and as a late-breaking abstract). They’d probably delay it till next year, hoping for better responses, and if still weak, then bury it at a smaller conference.
+ Though early on in Pisces, ONCS’ CSO Chris Twitty says this in person to poster waitforit last April:
"just wait very soon; this is going to be taking off," and ‘waitforit’ adding that he used “a hand gesture like a rocket taking off.”
+ Alpha Holding stakes $15M cold, hard cash at the market on ONCS, right before data, Steve Cohen is in. As well as venBIO, Nexthera (I think they were in ECYT, CPXX), so some smart money is definitely here.
+ And, of course, so far monotherapy data from all the various trials have been compelling. The science works.
+ Plus, they just filed requesting 10m preferred shares, I’m assuming, as a poison pill, so data must be compelling. So no low-ball takeover attempts after SITC data results. At least that’s my story!
So while I’m on this wild confirmation bias expedition, might as well share my WAG pps predictions. On these actual anti-PD-1 non-responders, if we see data results of...
* 30% BORR (w/20% CRs)(a little lower than last year’s results): meets the primary endpoint, so $3.50-$4 pps
* 42%-50% BORR (w/38%-41% CRs)(replicating last year’s data): $5+ pps
* If >50% BORR and >40% CRs: to da moon!
The wildcard is if BioTwitter jumps in on this -- hopefully with comments/write-ups by Timmerman, Herper, Loncar, Endpts, and an AF follow-up article, then who knows? Well, we’ll see if downing a gallon of kool-aid was too much!
Millennium Management LLC raised its stake in OncoSec Medical Inc (NASDAQ:ONCS) by 19.5% in the 2nd quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 1,195,315 shares of the biotechnology company’s stock after purchasing an additional 194,739 shares during the period. Millennium Management LLC’s holdings in OncoSec Medical were worth $1,650,000 as of its most recent SEC filing.
A number of other institutional investors and hedge funds also recently bought and sold shares of ONCS. Commonwealth Equity Services LLC lifted its position in shares of OncoSec Medical by 97.6% in the first quarter. Commonwealth Equity Services LLC now owns 76,510 shares of the biotechnology company’s stock valued at $143,000 after acquiring an additional 37,800 shares in the last quarter. BlackRock Inc. lifted its position in shares of OncoSec Medical by 1,303.5% in the second quarter. BlackRock Inc. now owns 238,940 shares of the biotechnology company’s stock valued at $330,000 after acquiring an additional 221,916 shares in the last quarter. DRW Securities LLC lifted its position in shares of OncoSec Medical by 157.1% in the second quarter. DRW Securities LLC now owns 180,000 shares of the biotechnology company’s stock valued at $248,000 after acquiring an additional 110,000 shares in the last quarter. Finally, Nexthera Capital LP lifted its position in shares of OncoSec Medical by 26.6% in the second quarter. Nexthera Capital LP now owns 2,614,297 shares of the biotechnology company’s stock valued at $3,608,000 after acquiring an additional 550,000 shares in the last quarter. 23.12% of the stock is owned by hedge funds and other institutional investors.
ONCS has been the topic of several recent research reports. Piper Jaffray Companies upped their price objective on OncoSec Medical to $5.00 and gave the company an “overweight” rating in a research report on Tuesday, August 14th. HC Wainwright set a $4.00 target price on OncoSec Medical and gave the company a “buy” rating in a research note on Tuesday, August 7th. Finally, Dawson James reiterated a “buy” rating on shares of OncoSec Medical in a research note on Monday, July 16th. One analyst has rated the stock with a hold rating and four have issued a buy rating to the stock. The company currently has a consensus rating of “Buy” and an average target price of $4.67.
OncoSec Medical stock opened at $1.64 on Tuesday. The firm has a market capitalization of $104.81 million, a P/E ratio of -1.55 and a beta of 3.02. OncoSec Medical Inc has a 52 week low of $1.12 and a 52 week high of $2.95.
OncoSec Medical Profile
OncoSec Medical Incorporated, a biotechnology company, engages in developing DNA-based intratumoral immunotherapies in the United States. The company's investigational technology, ImmunoPulseis designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or tavo) for the treatment of cancer.
See Also: What are the risks of holding treasury bonds?
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OncoSec Announces Publication of Data in Nature Gene Therapy Demonstrating the Ability of its Newly Optimized Intratumoral IL-12 Immunotherapy Platform to Increase Systemic Anti-tumor Responses in both Treated and Untreated Lesions
- Data demonstrates increased abscopal effect and transgene expression / efficacy in preclinical tumor models
SAN DIEGO and PENNINGTON, N.J., Oct. 24, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced the publication of a study in the peer-reviewed journal, Nature Gene Therapy (an open access article; https://www.nature.com/articles/s41434-018-0044-5), demonstrating that the newly optimized intratumoral IL-12 immunotherapy platform (electroporation-mediated intratumoral IL-12 gene therapy) induces immunological changes in both locally-treated and distant, untreated tumors. The publication provides new mechanistic insights into this systemic anti-tumor immunity including the observation that IL-12 primed effector T cells diminished expression of PD-1, which is particularly relevant to Oncosec's ongoing KEYNOTE-695 clinical study.
The paper, titled "Characterization of abscopal effects of intratumoral electroporation-mediated IL-12 gene therapy," by Mukhopadhyay et al., reported results from a pre-clinical study of OncoSec's optimized plasmid IL-12 (TAVO) therapeutic platform on both locally-treated and distant, untreated lesions, with a particular emphasis on understanding "abscopal" effects in distant non-electroporated tumors. Results from the study indicated that intratumoral IL-12 treatment led to an induction of IL-12-regulated genes, other cytokines and chemokines pathways, as well as genes for enhanced antigen processing and presentation in the treated tumor. These localized IL-12-mediated effects then led to the generation of systemic anti-tumor immune responses, including a surge of CD8+ T cells in the spleen and in non-treated tumors and when coupled with PD-1 modulation, suggests an orchestrated "armoring" of these effector T cells against T-cell checkpoints when primed in the presence of IL-12 in situ.
"Data from previously completed clinical and pre-clinical studies of our TAVO platform in multiple cancer settings has clearly demonstrated that our intratumoral electroporation-mediated IL-12 gene therapy is safe and produces systemic anti-tumor effects from a local delivery of this potent cytokine," said Christopher G. Twitty, PhD, Chief Scientific Officer of OncoSec. "Based on these outcomes, OncoSec is advancing an optimized version of TAVO that is designed to increase transgene expression and efficacy. The study published in Gene Therapy indicates that tumors treated directly with the optimized TAVO therapy rapidly engage IL-12/IFN-g regulated pathways, altering the tumor microenvironment's immunogenicity and effectively creating an in situ vaccine that ultimately drives an increase of tumor infiltrating lymphocytes and immune-specific gene expression in both treated and distant untreated tumors, indicative of a de novo immune response. These results confirm that OncoSec's TAVO platform may represent a mechanism by which local intratumoral IL-12 gene therapy can deliver a safe and effective abscopal response."
About OncoSec Immunotherapies
OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy platform – TAVO (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. In addition to TAVO, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its ImmunoPulse® platform. For more information, please visit www.oncosec.com.
The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of OncoSec. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by the Regents of the University of California, its officers, agents and employees.
CONTACT
Investor Relations:
Stern Investor Relations
Will O'Connor
Phone: (212) 362-1200
will@sternir.com
Media Relations:
David Schemelia / Jason Rando
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
dschemelia@tiberend.com
jrando@tiberend.com
SOURCE OncoSec Medical Incorporated
How about 100,000 shares 1 min. after close at $1.64
Oncosec Medical (ONCS) Commences KEYNOTE-890, a Phase 2 Clinical Trial of TAVO in Combination with Merck's (MRK) KEYTRUDA (pembrolizumab)
October 15, 2018 7:33 AM EDT
OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS) today announced that it has initiated KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck's (NYSE: MRK) KEYTRUDA® (pembrolizumab). The initiation of KEYNOTE-890 marks the second Phase 2 trial for OncoSec involving a combination of TAVO and KEYTRUDA®. The first, PISCES/KEYNOTE-695, is a global, multicenter Phase 2b trial of TAVO in combination with KEYTRUDA® for metastatic melanoma.
"Metastatic triple negative breast cancer represents an extreme unmet medical need, where pre-treated patients rarely achieve objective responses with PD-1/PD-L1 checkpoint treatments," said Dr. Pamela Munster, Professor of Medicine and Program Leader of Experimental Therapeutics at University of California San Francisco (UCSF). "The marked synergy of TAVO and checkpoint inhibition shown in previous clinical observations strongly suggests that IL-12 may prime the tumor microenvironment for PD-1/PD-L1 checkpoint treatments. This represents a highly promising therapeutic approach for TNBC."
KEYNOTE-890 is a multicenter Phase 2 open-label trial of TAVO in combination with KEYTRUDA® in patients with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least one prior line of approved systemic chemotherapy or immunotherapy.
Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of US breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women as well as African-American women,2 followed by Hispanic women.3
"The initiation of KEYNOTE-890 is an important milestone for OncoSec as it marks a significant expansion of our clinical pipeline as well as our expanding relationship with Merck," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "Our goal is to enroll this study as quickly as possible and provide preliminary topline data in 2019. Currently, overall survival for metastatic TNBC is one to two years from diagnosis, with therapies resulting in short-lived responses and/or significant toxicity. New approaches are desperately needed, and based on prior and ongoing clinical research, we beleive that TAVO in combination with KEYTRUDA® has the potential to be effective in treating this disease. Given the severe unmet medical need, it is possible that TAVO for the treatment of TNBC could be granted Fast Track designation, Breakthrough Therapy designation, and be a candidate for accelerated approval."
TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17
Reminder:SAN DIEGO and PENNINGTON, N.J., Oct. 8, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced that its Chief Scientific Officer Christopher G. Twitty, PhD, will give a presentation during the Advances In Immuno-Oncology Congress being held in San Diego, October 11-12.
Dr. Twitty's presentation, titled Intratumoral IL-12 in Combination with Pembrolizumab to Treat Metastatic Melanoma in Patients Unlikely to Respond to Anti PD-1 Therapies: Insights Gained from a Biomarker Program, will discuss ongoing research of TAVO (tavokinogene telseplasmid) in combination with KEYTRUDA®(pembrolizumab) as a potential treatment for metastatic melanoma.
The Immuno-Oncology USA Congress will feature over 20 presentations from companies at the forefront of immune-oncology, each presenting insights on new technologies, clinical discoveries and future targets in immuno-oncology research, from cancer vaccines to checkpoint inhibitors, alongside in-depth discussion of patient stratification and clinical development.
"Melanoma is but one of the many types of cancers where the largest part of the immune checkpoint market has yet to be unlocked due to poor/failed/no responses to checkpoint monotherapy, the so-called 'cold tumor' problem, which is well known to this audience," said Dr. Twitty, Chief Scientific Officer of OncoSec. "We are excited to share our finding with them indicating TAVO's ability to recruit more tumor infiltrating lymphocytes (TILs) into the tumors, paving the way for checkpoints to be effective in the largest, but still unresponsive, segment of the checkpoint market."
Details of the presentation are as follows:
Session Title: Translational Immuno-Oncology and Clinical Development
Presentation Title: Intratumoral IL-12 in combination with pembrolizumab to treat metastatic melanoma in patients unlikely to respond to anti PD-1 therapies: Insights gained from a biomarker program
Date and Time: Thursday, October 11, 2018 12:00 PM - 12:30 PM PST
Location: The San Diego Convention Center, Conference Room 5
Yep, but not til after 5 PM.
OncoSec to Present at Cantor Fitzgerald Global Healthcare Conference
SAN DIEGO and PENNINGTON, N.J., Sept. 25, 2018 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced that Daniel J. O'Connor, President and Chief Executive Officer of OncoSec, will present a corporate overview at the Cantor Fitzgerald Global Healthcare Conference on Monday, October 1, 2018 at 4:05 p.m. ET in New York City.
A live audio webcast of the presentation will be available on the Investors section of OncoSec's website at ir.oncosec.com, where it will be archived for approximately 30 days.
Hsch, You’re actually confirming my suspicions since the reception that I attended last April. The pieces trail Appears to be developing a baseline for Tavo with the PD-1. And that I doubt anything will come out of it, since the science has already developed beyond this basic combination and immunotherapy need to multi-gene cocktail With IL-12 at the base.
I can also tell that you’re not as big and the disruptive element, and that all ONCS—Rather than being at a point of licensing or buy out – – is simply turning the corner to head down another 2 to 3 years out research runway as they explore their multi-gene construct with the aid of Dr. Lo’s findings.
Am I reading you correctly hsch?
Cheers to that Brad!
Who took hschlauch "the believe in ONCS science guy" and left us with this now cynical one? From just last june:
Yep hsch, that could be taken as a "get ready to dump and run." Or is there another possible reason?
Alain Algazi, MD
Associate Professor
Medicine
UCSF School of Medicine
Alain.Algazi@ucsf.edu
415-353-7552
Publications (38)
Top publication keywords:
ImidazolesMelanomaProgrammed Cell Death 1 ReceptorProto-Oncogene Proteins B-rafAntineoplastic Combined Chemotherapy Protocols
Mortality risk after clinical management of recurrent and metastatic adenoid cystic carcinoma.
Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale 2018
Xu MJ, Wu TJ, van Zante A, El-Sayed IH, Algazi AP, Ryan WR, Ha PK, Yom SS
Major prognostic factors for recurrence and survival independent of the American Joint Committee on Cancer eighth edition staging system in patients with cutaneous squamous cell carcinoma treated with multimodality therapy.
Head & neck 2018
Xu MJ, Lazar AA, Garsa AA, Arron ST, Ryan WR, El-Sayed IH, George JR, Algazi AP, Heaton CM, Ha PK, Yom SS
Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study.
American journal of clinical oncology 2018
Cohen RB, Delord JP, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Damian S, Hong RL, Le Tourneau C, Day D, Varga A, Elez E, Wallmark J, Saraf S, Thanigaimani P, Cheng J, Keam B
High response rate to PD-1 blockade in desmoplastic melanomas.
Nature 2018
Eroglu Z, Zaretsky JM, Hu-Lieskovan S, Kim DW, Algazi A, Johnson DB, Liniker E
Dual MEK/AKT inhibition with trametinib and GSK2141795 does not yield clinical benefit in metastatic NRAS-mutant and wild-type melanoma.
Pigment cell & melanoma research 2017
Algazi AP, Esteve-Puig R, Nosrati A, Hinds B, Hobbs-Muthukumar A, Nandoskar P, Ortiz-Urda S, Chapman PB, Daud A
Melanoma treatment with intratumoral electroporation of tavokinogene telseplasmid (pIL-12, tavokinogene telseplasmid).
Immunotherapy 2017
Canton DA, Shirley S, Wright J, Connolly R, Burkart C, Mukhopadhyay A, Twitty C, Qattan KE, Campbell JS, Le MH, Pierce RH, Gargosky S, Daud A, Algazi A
Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2017
Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR
Partially exhausted tumor-infiltrating lymphocytes predict response to combination immunotherapy.
JCI insight 2017
Loo K, Tsai KK, Mahuron K, Liu J, Pauli ML, Sandoval PM, Nosrati A, Lee J, Chen L, Hwang J, Levine LS, Krummel MF, Algazi AP, Pampaloni M, Alvarado MD, Rosenblum MD, Daud AI
Liver Metastasis and Treatment Outcome with Anti-PD-1 Monoclonal Antibody in Patients with Melanoma and NSCLC.
Cancer immunology research 2017
Tumeh PC, Hellmann MD, Hamid O, Tsai KK, Loo KL, Gubens MA, Rosenblum M, Harview CL, Taube JM, Handley N, Khurana N, Nosrati A, Krummel MF, Tucker A, Sosa EV, Sanchez PJ, Banayan N, Osorio JC, Nguyen-…
Evaluation of clinicopathological factors in PD-1 response: derivation and validation of a prediction scale for response to PD-1 monotherapy.
British journal of cancer 2017
Nosrati A, Tsai KK, Goldinger SM, Tumeh P, Grimes B, Loo K, Algazi AP, Nguyen-Kim TDL, Levesque M, Dummer R, Hamid O, Daud A
Head and neck cancer in 2016: A watershed year for improvements in treatment?
Nature reviews. Clinical oncology 2016
Algazi AP, Grandis JR
A First-in-Human Phase I Study of a Bivalent MET Antibody, Emibetuzumab (LY2875358), as Monotherapy and in Combination with Erlotinib in Advanced Cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research 2016
Rosen LS, Goldman JW, Algazi AP, Turner PK, Moser B, Hu T, Wang XA, Tuttle J, Wacheck V, Wooldridge JE, Banck M
Durable treatment of ameloblastoma with single agent BRAFi Re: Clinical and radiographic response with combined BRAF-targeted therapy in stage 4 ameloblastoma.
Journal of the National Cancer Institute 2016
Faden DL, Algazi A
Increased FDG avidity in lymphoid tissue associated with response to combined immune checkpoint blockade.
Journal for immunotherapy of cancer 2016
Tsai KK, Pampaloni MH, Hope C, Algazi AP, Ljung BM, Pincus L, Daud AI
Clinical outcomes in metastatic uveal melanoma treated with PD-1 and PD-L1 antibodies.
Cancer 2016
Algazi AP, Tsai KK, Shoushtari AN, Munhoz RR, Eroglu Z, Piulats JM, Ott PA, Johnson DB, Hwang J, Daud AI, Sosman JA, Carvajal RD, Chmielowski B, Postow MA, Weber JS, Sullivan RJ
The efficacy of anti-PD-1 agents in acral and mucosal melanoma.
Cancer 2016
Shoushtari AN, Munhoz RR, Kuk D, Ott PA, Johnson DB, Tsai KK, Rapisuwon S, Eroglu Z, Sullivan RJ, Luke JJ, Gangadhar TC, Salama AK, Clark V, Burias C, Puzanov I, Atkins MB, Algazi AP, Ribas A, Wolchok…
Tumor immune profiling predicts response to anti-PD-1 therapy in human melanoma.
The Journal of clinical investigation 2016
Daud AI, Loo K, Pauli ML, Sanchez-Rodriguez R, Sandoval PM, Taravati K, Tsai K, Nosrati A, Nardo L, Alvarado MD, Algazi AP, Pampaloni MH, Lobach IV, Hwang J, Pierce RH, Gratz IK, Krummel MF, Rosenblum…
NCCN Guidelines Insights: Melanoma, Version 3.2016.
Journal of the National Comprehensive Cancer Network : JNCCN 2016
Coit DG, Thompson JA, Algazi A, Andtbacka R, Bichakjian CK, Carson WE, Daniels GA, DiMaio D, Fields RC, Fleming MD, Gastman B, Gonzalez R, Guild V, Johnson D, Joseph RW, Lange JR, Martini MC, Materin …
Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma.
JAMA 2016
Ribas A, Hamid O, Daud A, Hodi FS, Wolchok JD, Kefford R, Joshua AM, Patnaik A, Hwu WJ, Weber JS, Gangadhar TC, Hersey P, Dronca R, Joseph RW, Zarour H, Chmielowski B, Lawrence DP, Algazi A, Rizvi NA,…
Melanoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology.
Journal of the National Comprehensive Cancer Network : JNCCN 2016
Coit DG, Thompson JA, Algazi A, Andtbacka R, Bichakjian CK, Carson WE, Daniels GA, DiMaio D, Ernstoff M, Fields RC, Fleming MD, Gonzalez R, Guild V, Halpern AC, Hodi FS, Joseph RW, Lange JR, Martini …
Overall Survival and Durable Responses in Patients With BRAF V600-Mutant Metastatic Melanoma Receiving Dabrafenib Combined With Trametinib.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2016
Long GV, Weber JS, Infante JR, Kim KB, Daud A, Gonzalez R, Sosman JA, Hamid O, Schuchter L, Cebon J, Kefford RF, Lawrence D, Kudchadkar R, Burris HA, Falchook GS, Algazi A, Lewis K, Puzanov I, Ibrahim…
Pembrolizumab Cutaneous Adverse Events and Their Association With Disease Progression.
JAMA dermatology 2015
Sanlorenzo M, Vujic I, Daud A, Algazi A, Gubens M, Luna SA, Lin K, Quaglino P, Rappersberger K, Ortiz-Urda S
The combination of axitinib followed by paclitaxel/carboplatin yields extended survival in advanced BRAF wild-type melanoma: results of a clinical/correlative prospective phase II clinical trial.
British journal of cancer 2015
Algazi AP, Cha E, Ortiz-Urda SM, McCalmont T, Bastian BC, Hwang J, Pampaloni MH, Behr S, Chong K, Cortez B, Quiroz A, Coakley F, Liu S, Daud AI
The Hippo effector YAP promotes resistance to RAF- and MEK-targeted cancer therapies.
Nature genetics 2015
Lin L, Sabnis AJ, Chan E, Olivas V, Cade L, Pazarentzos E, Asthana S, Neel D, Yan JJ, Lu X, Pham L, Wang MM, Karachaliou N, Cao MG, Manzano JL, Ramirez JL, Torres JM, Buttitta F, Rudin CM, Collisson …
Tunable-combinatorial mechanisms of acquired resistance limit the efficacy of BRAF/MEK cotargeting but result in melanoma drug addiction.
Cancer cell 2015
Moriceau G, Hugo W, Hong A, Shi H, Kong X, Yu CC, Koya RC, Samatar AA, Khanlou N, Braun J, Ruchalski K, Seifert H, Larkin J, Dahlman KB, Johnson DB, Algazi A, Sosman JA, Ribas A, Lo RS
Comparative profile of cutaneous adverse events: BRAF/MEK inhibitor combination therapy versus BRAF monotherapy in melanoma.
Journal of the American Academy of Dermatology 2014
Sanlorenzo M, Choudhry A, Vujic I, Posch C, Chong K, Johnston K, Meier M, Osella-Abate S, Quaglino P, Daud A, Algazi A, Rappersberger K, Ortiz-Urda S
Combined BRAF (Dabrafenib) and MEK inhibition (Trametinib) in patients with BRAFV600-mutant melanoma experiencing progression with single-agent BRAF inhibitor.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2014
Johnson DB, Flaherty KT, Weber JS, Infante JR, Kim KB, Kefford RF, Hamid O, Schuchter L, Cebon J, Sharfman WH, McWilliams RR, Sznol M, Lawrence DP, Gibney GT, Burris HA, Falchook GS, Algazi A, Lewis K…
Melanoma immunotherapy.
Cancer biology & therapy 2014
Sanlorenzo M, Vujic I, Posch C, Dajee A, Yen A, Kim S, Ashworth M, Rosenblum MD, Algazi A, Osella-Abate S, Quaglino P, Daud A, Ortiz-Urda S
Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.
The New England journal of medicine 2013
Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, Wolchok JD, Hersey P, Joseph RW, Weber JS, Dronca R, Gangadhar TC, Patnaik A, Zarour H, Joshua AM, Gergich K, Elassaiss-Schaap J, Algazi A, …
Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial.
The Lancet. Oncology 2012
Long GV, Trefzer U, Davies MA, Kefford RF, Ascierto PA, Chapman PB, Puzanov I, Hauschild A, Robert C, Algazi A, Mortier L, Tawbi H, Wilhelm T, Zimmer L, Switzky J, Swann S, Martin AM, Guckert M, …
Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations.
The New England journal of medicine 2012
Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, Hamid O, Schuchter L, Cebon J, Ibrahim N, Kudchadkar R, Burris HA, Falchook G, Algazi A, Lewis K, Long GV, Puzanov I, Lebowitz P, …
Phase I clinical trial of the Src inhibitor dasatinib with dacarbazine in metastatic melanoma.
British journal of cancer 2011
Algazi AP, Weber JS, Andrews SC, Urbas P, Munster PN, DeConti RC, Hwang J, Sondak VK, Messina JL, McCalmont T, Daud AI
NRAS-mutant melanoma: response to chemotherapy.
Archives of dermatology 2011
Soon CW, Algazi AP, Cha EN, Webb EM, Daud AI
Phase II trial of sagopilone, a novel epothilone analog in metastatic melanoma.
British journal of cancer 2010
DeConti RC, Algazi AP, Andrews S, Urbas P, Born O, Stoeckigt D, Floren L, Hwang J, Weber J, Sondak VK, Daud AI
Treatment of cutaneous melanoma: current approaches and future prospects.
Cancer management and research 2010
Algazi AP, Soon CW, Daud AI
New horizons in melanoma treatment: targeting molecular pathways.
The Ochsner journal 2010
Soon CW, Algazi AP, Cha EN, Daud AI
Biology and treatment of primary central nervous system lymphoma.
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 2009
Algazi AP, Kadoch C, Rubenstein JL
Detailed analysis of immunologic effects of the cytotoxic T lymphocyte-associated antigen 4-blocking monoclonal antibody tremelimumab in peripheral blood of patients with melanoma.
Journal of translational medicine 2008
Comin-Anduix B, Lee Y, Jalil J, Algazi A, de la Rocha P, Camacho LH, Bozon VA, Bulanhagui CA, Seja E, Villanueva A, Straatsma BR, Gualberto A, Economou JS, Glaspy JA, Gomez-Navarro J, Ribas A
AH, if only it were that easy :o)
All right AKH, enough of the vacations: I can't handle the price drop when you go.
According to clinicaltrials.gov--TNBC "Estimated Study Start Date August 2018"
Estimated Primary Completion Date August 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
(submitted: June 13, 2018) Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
ORR by independent central review based on RECIST v1.1
WOW, ONCS chart reminds me of a Rorschach test ;/
ONCS as broke a diagonal resistance line beginning 11/13/2017 and extending through and beyond 4/5/2018 until today--we'll see if it holds.
Man, wouldn't it be nice to close above SMA 100.
I sure hope so Twiz, I noticed on clinical trials.gov that the Pisces trail his own but up to more centers to recruit that was very rare patients for the trial. And I hope they make that September deadline. Would love to see data from as many patients as Possible in November. And would love to see a late breaking abstract.
SITC Nov. 7-11: Important Abstract Dates
Regular and Late-Breaking
Date Details
April 3, 2018 Regular Abstracts, Young Investigator Award Abstracts, and Late-Breaking Abstracts Application Submission Site Opens
Aug. 1, 2018 Regular Abstracts, Young Investigator Award Abstracts, Late-Breaking Abstracts Application Site Closes at 5 p.m. PDT
Aug. 10, 2018 Late-Breaking Abstracts Application Notifications Sent
Aug. 15, 2018 Not Accepted Late-Breaking Abstracts Regular Abstracts Due at 5 p.m. PDT
Aug. 24, 2018 Late-Breaking Abstract Submission Site Opens for Accepted Applications
Aug. 31, 2018 Regular Abstract and Young Investigator Award Abstract Notifications Sent
Sept. 7, 2018 Regular Abstract Presentation Acceptance Confirmations Due
Deadline for Regular Abstract Withdrawals and Changes
Sept. 13, 2018 Late-Breaking Abstract Submission Site Closes at 5 p.m. PDT
Sept. 24, 2018 Late-Breaking Abstract Notifications Sent
Sept. 28, 2018 Late-Breaking Abstract Presentation Acceptance Confirmation Due
Deadline for Late-Breaking Abstract Withdrawals and Changes
Oct. 1, 2018 Regular Abstract Title and Author Information Released
Nov. 1, 2018 Late-Breaking Abstract Title and Author Information Released
Nov. 6, 2018 Embargo Lifted and Full Regular and Late-Breaking Abstracts Public at 8 a.m. EST
Regular Abstract Supplement Published in JITC
Nov. 7–11, 2018 33rd Annual Meeting and Pre-Conference Programs
Dec. 6, 2018 Late-Breaking Abstract Supplement Published in JITC
Ya gotta lighten up tj--you've lost your ability to extend benefit-of-a-doubt, especially with me for some reason a 6 year vet of this board.
yeah, yeah, thank you siri...I was on the treadmill--gotta proofread those messages or make myself vulnerable to SUCH mockery! ;o)
Akh, I think that’s the best take away from what you just said – – Dr. Lowe has already been able to see early Data and that is why he is moved so quickly from the grant to choosing TAVO to explore.
The time might just be approaching. I was just thinking about Lo Labs contribution in it's analysis of Tavo's mechanisms impacting cancer tumor death which can then possibly be extended down Onocsec's pipe line.
I think you meant 5 million short interest which is 10% out of a 50 million share float?
Yeah, and Lo is no chump, just last year:
Dr. Roger Lo to Receive Inaugural AACR-Waun Ki Hong Award for Outstanding Achievement in Cancer Research
3/29/2017
?PHILADELPHIA — The American Association for Cancer Research (AACR) will honor Roger S. Lo, MD, PhD, with the first AACR-Waun Ki Hong Award for Outstanding Achievement in Cancer Research during the AACR Annual Meeting 2017, to be held April 1-5 in Washington.
Lo, professor in the Division of Dermatology and associate professor in the Department of Molecular and Medicinal Pharmacology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), is being recognized for his pioneering research toward identifying the molecular underpinnings of metastatic melanoma and its response to therapy. His work provided the major scientific rationale for testing the effectiveness of inhibitors of BRAF and MEK in combination as a treatment for melanoma—a therapeutic approach that is now globally considered the standard of care.
He will present his lecture, “Therapeutic Resistance in Melanoma,” on April 3, at 3:30 p.m. ET in Hall D-E of the Walter E. Washington Convention Center.
The AACR established this award in recognition of AACR President (2001-2002) Waun Ki Hong, MD, FAACR, and his extraordinary contributions to cancer research, cancer care, and cancer prevention during his brilliant career as a physician-scientist. This award recognizes a worthy cancer researcher who has conducted highly meritorious laboratory, translational, or clinical cancer research anywhere in the world at a relatively early stage in his or her career. It will honor the outstanding research of a young investigator who has not yet reached 46 years of age at the time of the presentation of the award.
“On behalf of the American Association for Cancer Research, I wish to congratulate Dr. Lo on receiving the inaugural AACR-Waun Ki Hong Award for Outstanding Achievement in Cancer Research,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “His impressive achievements have earned him a reputation as an original thinker and creative researcher, and the AACR is thrilled to be recognizing such a talented early-career investigator. Supporting early-career investigators like Dr. Lo is a vital part of the AACR’s mission, because these are the individuals who will transform the treatment and prevention of cancer in the future.”
Lo has been an active member of the AACR since 2009. He served as a member of the AACR Annual Meeting 2017 Scientific Program Committee and the Annual Meeting 2016 Drug Resistance Section of the Experimental and Molecular Therapeutics Subcommittee.
The AACR has previously recognized Lo’s work with the 2013 AACR Award for Outstanding Achievement in Cancer Research and the AACR-AFLAC Scholar-in-Training Award, Translational Medicine 2008: Bridging the Lab and the Clinic in Cancer Medicine. He also received the 2014 Phillip A. Sharp Innovator Award from Stand Up To Cancer (SU2C), of which the AACR is the Scientific Partner, and a 2011 SU2C Innovative Research Grant.
Additionally, Lo has been honored with other awards, including the Young Investigator Award from the Society for Melanoma Research (2013) and the UCLA Diana Gordon Jonsson Cancer Center Award for Research Excellence (2014). He was named a Sidney Kimmel Translational Scholar by the Sidney Kimmel Foundation (2011) and is an elected member of the American Society for Clinical Investigation (2012) and the American Dermatological Association (2015).
Lo will be recognized at the opening ceremony of the AACR Annual Meeting, April 2, at 8:15 a.m. ET in Hall D-E of the Walter E. Washington Convention Center.
Lo received his medical degree from Cornell University Medical College in New York, and his doctorate from the tri-institutional program at Weill Cornell Medical College, Rockefeller University, and the Sloan Kettering Institute. He completed an internship in medicine and a residency in dermatology at UCLA.
Follow the AACR Annual Meeting 2017 on Twitter: #AACR17
The importance of Dr. Lo:
AMERICAN SKIN ASSOCIATION ANNOUNCES
ABBY S. AND HOWARD P. MILSTEIN INNOVATION AWARD
FOR MELANOMA/NON-MELANOMA SKIN CANCER RESEARCH
$750,000 Award to Fund Research of Roger Lo, MD, PhD of UCLA
April 18, 2018 - New York, NY – During its annual Spring Gala at The Plaza Hotel last Tuesday evening, American Skin Association (ASA) Chairman, Howard P. Milstein, announced the Abby S. and Howard P. Milstein Innovation Award for Melanoma/Non-Melanoma Skin Cancer Research (MIA).
Launched in 2008 to accelerate the search for prevention and cure, the Milstein Innovation Award funds advanced research through a three-year research grant with American Skin Association. The award is available only to established leaders in the fields of dermatology and cutaneous oncology who spend at least 80% of their professional time engaged in research focused on new discoveries in the basic and clinical sciences with current or potential impact on the understanding, treatment, or prevention of melanoma/non-melanoma skin cancers.
The 2018 recipient of the Milstein Innovation Award is Dr. Roger Lo of the David Geffen School of Medicine at UCLA. For the next three years Dr. Lo will receive funding for innovative melanoma research that will lead to great advances in the understanding of melanoma and in developing new treatments for this deadly disease. Dr. Lo’s work focuses on the field of cancer genetics and genomics, using next generation sequencing approaches to uncover the basis of resistance to both molecularly targeted therapies and immune checkpoint inhibitors.
"Our family is proud to fund this vital grant in melanoma research. We are so impressed with Dr. Lo’s exceptional work and what it promises for the future." said Howard P. Milstein.
At UCLA, Dr. Lo is a Professor, Associate Chief of Dermatology, Director of the Dermatology STAR Residency Program and the Melanoma Clinic. His lab has focused on how BRAF-mutant melanomas acquire late resistance to inhibitors, including how cell signaling, epigenetic reprogramming, melanoma cell dormancy and melanoma phenotypic plasticity may regulate resistance. The intention of his research is to uncover new therapeutic opportunities that can directly test in clinical trials. His work paves the way for new therapies from which melanoma cannot escape.
Dr. Lo’s research has been supported by the NIH and by all of the major funders of melanoma research, including American Skin Association. He has published his findings in top-tier journals such as Cell, Nature and Science, among others. It is clear that this critical support of Dr. Lo’s research will push forward the development of novel therapeutic approaches to melanoma.
Dr. Lo joins the ranks of an illustrious group of past recipients of the Milstein Innovation Award, including, Dr. Hensin Tsao of Massachusetts General Hospital, Dr. Lynda Chin of the University of Texas MD Anderson Cancer Center and Dr. Boris Bastian of UCSF Helen Diller Family Comprehensive Cancer Center. These previous awardees are all now recognized leaders and innovators in melanoma research.
ABOUT AMERICAN SKIN ASSOCIATION
ASA is a unique collaboration of patients, families, advocates, physicians and scientists, and has evolved over thirty-one years into a leading force in efforts to defeat melanoma, skin cancer and important inflammatory and genetic skin diseases. Established to serve the now more than 100 million Americans — one third of the U.S. population — afflicted with skin disorders, the organization's mission remains to: advance research, champion skin health — particularly among children, and drive public awareness about skin disease. For more information, visit
Pennington-based OncoSec hopes to make immunotherapy a better treatment option
By Diccon Hyatt - July 30, 2018
Daniel J. O’Connor, CEO of San Diego-based biotech firm OncoSec, has established East Coast headquarters in a historic Pennington building.
Immunotherapy for cancer is one of the hottest fields of research among the biotech companies of the Route 1 corridor. Simply put, it is the science of using the body’s immune system to fight cancer. For example, Opvido and Yerevoy, brought to market by Bristol-Myers Squibb, and Keytruda, made by Merck, are among the most commonly used immunotherapy drugs for several kinds of cancer.
These relatively new drugs, all of which have been approved by the FDA in the last decade, are typically used for people for whom conventional radiation and chemotherapy have not been effective. About one in three cancer patients respond very well to these drugs, part of a class known as checkpoint inhibitors. They work by blocking a signaling pathway that normally puts the brakes on the immune response, effectively giving the green light for the immune system to attack the cancerous cells.
In approximately 30 percent of patients, these drugs are often able to destroy all traces of cancerous tumors. In the biotech industry, their tumors, the ones that are receptive to immunotherapy treatment, are called “hot.” But in the remaining 70 percent, the tumors are deemed “immunologically cold” and the therapy seems completely ineffective. One question for cancer researchers is, why doesn’t immunotherapy work for everyone? And for those who don’t respond, is there a way to change that?
OncoSec, a company that has recently set up its headquarters in central New Jersey, is currently working on one possible answer to that question.
On the second floor of 24 N. Main St. in Pennington, a more than a century-old building that was once the fire house and later the Borough Hall, Daniel J. O’Connor, CEO of OncoSec, pulls up two photos on his computer. The first is a person’s ankle, ridden with melanoma tumors. Foothills of red, angry growths rise up around the ankle bone, signs of a life threatening disease taking hold. In the second, taken several months later, the growths are just about gone.
The photos are a dramatic illustration of what O’Connor believes is a new frontier in immunotherapy: turning those cold tumors hot.
OncoSec’s technology is based on the work of Adil Daud, an oncologist and melanoma specialist at the University of California San Francisco and scientific founder of the company. Daud developed a multi-step process to make cancerous tumors good targets for immunotherapy drugs.
Daud’s work focused on using a molecule called IL-12, a pro-inflammatory signaling cytokine, which encourages the immune system to attack. If cancer cells could be induced to produce IL-12, tumors throughout the body could theoretically become “hot” to immunotherapy drugs such as Keytruda.
To get the cells to produce IL-12, Daud decided to use plasmids, which are snippets of DNA that can be introduced into cells to change how they function. But simply injecting plasmids into a tumor would not be enough, since the plasmids would normally remain outside the walls of the cancer cells. The treatment, trademarked Immunopulse, begins with injecting trillions of copies of plasmids into a tumor. But to make those cells permeable, OncoSec follows up the injection with a probe that creates a series of short electrical pulses, which weaken the cell membranes enough to allow the plasmids to enter. After that, IL-12 is produced by the cell, the immune system recognizes the area as a target, and as an added effect “learns” to attack other cancerous cells throughout the body.
Dan O’Connor and OncoSec hope to make immunotherapy a better treatment option for cancer patients.
OncoSec in partnership with Merck is currently running a clinical trial of about 48 melanoma patients who are being treated with the Immunopulse system in combination with Keytruda. If this trial shows good results, the treatment will be well on its way to approval, since the FDA has granted it the “fast-track” status for orphan drugs.
If successful, one of the appealing aspects of the treatment is its cost. Plasmids are relatively inexpensive to make in a lab, and the second part, the electrical pulse probe and the machine to which it is attached, is small enough to keep on a desktop and would cost $10 to $20,000 to a doctor.
“I think the day of the cytokine has now arrived,” O’Connor says. “It was theorized a decade ago by Doctor Daud. He was a bit of a visionary, because what has happened in the intervening years is that the checkpoints have been the first wave of successful immunotherapies. The only limitation is that they typically work in a minority of patients that receive them.”
O’Connor, a Pennington resident, is no stranger to the Central New Jersey biotech sector. From 2013 through 2017, O’Connor was CEO at Advaxis, a College Road East-based company that used genetically modified bacteria to precisely target cancer cells.
A native of Westfield, O’Connor is the son of an antique store owner father and homemaker mother. He graduated from Boston University with an English degree and joined the Marines after graduation, serving in the Gulf War in 1990 as a captain. Following his military service, O’Connor went to law school at Dickinson and became a criminal prosecutor. His next career change took him to ImClone, where he was general counsel. ImClone, which was an early pioneer in a targeted cancer therapy research, a field related to immunotherapy.
O’Connor says he has been fascinated with immunotherapy since learning about it at ImClone. “It started out as an intuition or belief that immunotherapy was going to be the future of cancer research and cancer therapy,” he says.
“What, in the last five years, has really motivated me, is seeing it firsthand in clinical trials and personal experience. Seeing the side effects of chemotherapy has really put a very fine point on the need for immunotherapies. The entire premise is trying to avoid toxic therapies if we can. Everybody knows that chemotherapy and radiation therapy and surgery have saved so many people’s lives and are very effective medicines, but they come with a pretty heavy price.
“I wanted to be associated with what I perceived to be the future of cancer research, and having personally seen the effects of chemotherapy renewed my motivation to really push therapies which work and which use the body’s immune system which don’t carry the same side effects.”
(When O’Connor speaks of “personal experience,” he is referring to a colleague at ImClone whom he later brought over to Advaxis, as well as another colleague from a job he had in the insurance industry.)
O’Connor also has personal experience with the electro pulse probe, having tried it on himself. “Pain is subjective, but I wouldn’t describe it as painful,” he says, accompanied by slight twitching of the local muscles.
24 North Main Street has served as a fire house and as Borough Hall and now is home to OncoSec’s cutting-edge work in immunotherapy.
OncoSec is a public company listed on NASDAQ. According to its SEC filings, OncoSec was founded in Nevada in 2008 as “Netventory Solutions,” and was in the business of providing online inventory services to small and medium sized companies. In 2011 the company acquired the electric pulse technology from another biotech company, Inovio, for $3 million, and changed its name to OncoSec and moved to San Diego. At the time, the company shared a board chair, Atvar Dhillon, with Inovio.
Melanoma is the first target of the Immunopulse system, since it is on the surface of the skin and is easy to reach with the electrical probe.
OncoSec got its start in San Diego and still has its research lab there. However, it opened an office in Pennington this year, when O’Connor came on board. Currently the office has about four people working there, but this number is likely to increase to about 10 by the end of the summer, O’Connor says.
Clinical trial management, finance, human resources, administration, and other office functions are all taking place in New Jersey or will be in the future. “New Jersey is the medicine chest of the world and has a rich ecosystem for drug development,” O’Connor says, explaining the move across the country.
In addition to the available pool of employees, the state’s economic development department offers a program that allows pre-revenue companies such as OncoSec to sell their tax loss credits to other businesses — trading their tax credits for instant cash. The program requires OncoSec to have 10 employees, which is another reason for staffing up. “Getting cash today is tremendously helpful,” O’Connor says.
O’Connor was also able to get a bargain on real estate, opting to move into a building that had been on the market for a long time. Downtown Pennington also offers a community feel, and several restaurants within walking distance. (Emily’s and Vito’s are early favorites for OncoSec’s small workforce.)
O’Connor says that saving money on rent is crucial for a company at his stage. While he could have gotten a fancier office than the Main Street building (built in 1891) somewhere else, he prefers to spend every dime possible on getting the clinical trial data that will allow OncoSec to move forward with Immunopulse. “We want to make sure we use our dollars wisely,” he says.
The lab is staying in San Diego because “moving a lab is no small undertaking,” O’Connor says.
OncoSec expects to get results from the study soon and present its preliminary results at a medical conference later this year. An earlier trial showed promising results among a small group, 11 out of 23 subjects showed their tumors either shrinking significantly or going away entirely.
The company is also recruiting subjects for a trial of its IL-12 therapy technology in patients of “triple negative” breast cancer (a kind of cancer that does not respond to several other forms of therapy.) They are also recruiting for a second triple negative breast cancer trial which will use IL-12 in combination with Keytruda.
Immunopulse could be on the market for melanoma as early as 2020 if all goes well, and O’Connor says this could help literally thousands of patients. In addition to melanoma, OncoSec is working on treating breast cancer and lymphomas, both of which are in reach of the existing technology. OncoSec is also working on another type of probe to reach cancers that are deeper in the body, and is interested in other kinds of cancer that do not always respond to immunotherapy, such as renal cell cancer, lung cancer, head and neck cancer, and bladder cancer.
https://communitynews.org/2018/07/30/pennington-based-oncosec-hopes-to-make-immunotherapy-a-better-treatment-option/
I think the move also relates to the long term goal of Gov. Chris Christie
Governor Christie appoints Daniel J. O'Connor to the New Jersey Biotechnology Task Force
October 25, 2017 09:00 ET | Source: New Jersey Biotechnology Task Force
Trenton, NJ, Oct. 25, 2017 (GLOBE NEWSWIRE) -- Governor Chris Christie has appointed Daniel J. O'Connor of Pennington and BioNJ President and CEO Debbie Hart to the New Jersey Biotechnology Task Force. The Task Force was created to improve communication between State government and the industry to find ways to help retain and attract biotechnology companies to New Jersey. It is led by the New Jersey Economic Development Authority.
“I am honored to be appointed to this important Task Force,” said Daniel O’Connor. “This initiative has already had a significant impact on the industry and the State. I look forward to working with the other members of the Task Force to generate new strategies that will enhance and encourage the growth of dynamic biotech companies here in New Jersey in order to meet patient needs.”
When the Task Force was established in the early 1990s, there were approximately 30 biotech companies in New Jersey. Today there are hundreds. The Task Force has generated numerous strategies that have impacted the growth of this important industry in New Jersey.
The Task Force is composed of nine members, including Sen. Linda Greenstein (D-14), Sen. Robert Gordon (D-38), Sen. Robert W. Singer (R-30), Asm. Gary S. Schaer (D-36), Asm. Andrew Zwicker (D-16), Asm. Jack Ciattarelli (R-16); a representative from New Jersey Economic Development Authority; as well as O’Connor and Hart.
Mr. O’Connor has 20 years of executive, legal, and regulatory experience in the biopharmaceutical industry, including CEO and other executive leadership positions at Advaxis, Inc., ImClone Systems, Bracco Diagnostics, Inc., and PharmaNet (today, inVentiv Health). Most recently, Mr. O’Connor was the President, Chief Executive Officer and Director of Advaxis, Inc. located in Princeton, NJ. As CEO, Mr. O’Connor uplisted Advaxis onto NASDAQ and, in five years, transformed it into a well-funded, well-staffed, leading cancer immunotherapy company with collaboration partners including Amgen Inc., Merck & Co., Bristol Myers Squib and AstraZeneca.
In 2015, Ernst & Young named Mr. O’Connor Entrepreneur of the Year® in New Jersey. In 2016, he was the “Highly Commended” award winner for the 8th Vaccine Industry Excellence Award (ViE) Best Biotech CEO. In 2017, Mr. O’Connor was appointed Vice Chairman of BioNJ, leveraging his experience to guide and support the organization’s mission of fostering the innovation of research-based life science companies in the New Jersey region.
Mr. O’Connor is a 1995 graduate of the Penn State University’s Dickinson School of Law in Carlisle, Pennsylvania and currently serves as a Special Advisor to its Dean. Mr. O’Connor graduated from the United States Marines Corps Officer Candidate School in 1988 and was commissioned as an officer in the U.S. Marines, attaining the rank of Captain. He served in Saudi Arabia during Operation Desert Shield and received the National Service Metal and the Southwest Asia Service Medal. He is a former New Jersey criminal prosecutor.