|From: Fitzhughlaw||9/12/2019 8:54:59 AM|
|ESMO "Investor Event" presentation scheduled for this coming Saturday from Barcelona (12:30 p.m. EST), and some of the big hitters in oncology for this indication (Tagawa) and in an interesting but not to be overlooked development, breast cancer (Rugo), are participating:|
Immunomedics to Host Investor Event and Webcast on September 28, 2019 During ESMO Congress
MORRIS PLAINS, N.J., Sept. 12, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. ( IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that it will host an Investor Event on Saturday, September 28, 2019 at 6:30 p.m. Central European Summer Time in Barcelona, Spain, during the Congress 2019.
The event will feature presentations by key opinion leaders including Scott Tagawa, M.D., MS, Richard A. Stratton Associate Professor in Hematology & Oncology, Associate Professor of Medicine & Urology, Weill Cornell Medicine, and Associate Attending Physician, NewYork-Presbyterian – Weill Cornell Medical Center, who will present the interim results from TROPHY-U-01 at the Congress. Cora N. Sternberg, M.D., FACP, Clinical Director, Englander Institute for Precision Medicine and Professor of Medicine in Hematology & Oncology, Weill Cornell Medicine and NewYork-Presbyterian will discuss the implications of these data in an evolving metastatic urothelial cancer landscape.
In addition, Hope S. Rugo, M.D., FACP, Professor of Medicine; and Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, will lead the discussion on the Company’s breast cancer programs. Members of Immunomedics leadership team will also be present to provide a corporate update.
For additional information and/or to RSVP for the event, please contact Dr. Chau Cheng at firstname.lastname@example.org. The investor event will be webcast live via the Investors page on the Company’s website at https://immunomedics.com/investors/. Approximately two hours following the live event, a replay of the webcast will be available for approximately 30 days.
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|To: Fitzhughlaw who wrote (52460)||9/12/2019 9:48:03 AM|
|In addition to what you quoted of the FDA's guidance, it continues to say that one of the ways to demonstrate substantial improvement is:|
"The new drug has an important safety advantage that relates to serious adverse reactions (e.g., those that may result in treatment interruption) compared with available therapies and has similar efficacy."
That would appear to be 132's path to BTD.
FWIW, statistically the chance is not great: In the first 3 quarters of the federal fiscal year beginning Oct 1 2018, the FDA received 118 BTD requests. 36 were granted, 46 denied, and the rest are pending. On the other hand, in mUC, 9 drugs since 2014 have received BTD.
Considering the way things are moving toward targeted therapies, I think targeting Trop2 in mUC would guarantee 132's chance at BTD and position it better vs EV. Trop2 is expressed in 83% of mUC. Eliminating those 17% of patients that wont respond will elevate the ORR on par with EV. And it would be better for patients. I wonder if they collected tissue samples for a post hoc look (they are doing that in the prostate study).
Then again, what company schedules an investor event if the data isn't impressive?
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|To: li3511 who wrote (52470)||9/12/2019 10:12:29 AM|
|IMMU had it's best day in almost 2 years. And then followed through. Add to that several analysts made positive comments about the competitive landscape on the Daiichi news. It may have helped that the sector was up some, but this wasn't sector rotation. The 1062 news was meaningful.|
IMMU is a mid cap. How many mid caps bios made 15% moves in a day?
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|To: ladyPI who wrote (52478)||9/12/2019 5:05:15 PM|
|I know it was a rhetorical question - but wait, there's more! The "sleeper" in the PR is that Cora Sternberg is joining Dr. Tagawa in the presentation of the UTC data, and here's something about her issued in January by Weill Cornell Medicine:|
World-Renowned Medical Oncologist Cora Sternberg, M.D. Joins the Englander Institute for Precision Medicine as Clinical Director
The Englander Institute for Precision Medicine (EIPM) is excited to announce that world-renowned medical oncologist Cora Sternberg, M.D., has joined our staff as Clinical Director.
Dr. Sternberg is a leading international researcher and expert in the field of medical oncology, genitourinary cancers, and drug development. Before joining the EIPM, she became well-known for her influential work in developing novel therapies and targeted agents for the treatment of prostate, renal and bladder cancers while working as Chief of the Department of Medical Oncology at the San Camillo-Forlanini Hospital in Rome, Italy, and as adjunct Professor of Oncology at La Sapienza University in Rome. Dr. Sternberg has published extensively with over 375 articles and holds a distinguished position as a core faculty member of the European School of Oncology (ESO). She has received the European Society of Medical Oncology ESMO Award for Outstanding Contribution to the Development of Medical Oncology. She also received the honor of being elected as the 2019 chairman of the nominating committee of ASCO’s board of directors.
She also published an article (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218109/) last October after the ESMO conference in Germany, and here's an excerpt:
Clinical Trials Corner
Piyush K. Agarwal, MD, Associate Editor, Bladder Cancer, Head, Bladder Cancer Sectiona and Cora N. Sternberg, MD, FACP, Associate Editor, Bladder Cancer, Clinical Director, Englander Institute for Precision Medicineb
Author information Article notes Copyright and License information Disclaimer
aUrologic Oncology Branch, National Cancer Institute, Bethesda, MD, USA
bWeill Cornell Medicine, New York-Presbyterian, New York, NY, USA
The European Society for Medical Oncology just completed its annual meeting in Munich this month and we would like to highlight several trials presented during this meeting. In the previous issue, we previously discussed the antibody-drug conjugate enfortumab vedotin and the pan FGFR inhibitor INCB054828.
Study Title: A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers
Clinicaltrials.gov identifier: NCT01631552
Sponsor: Immunomedics, Inc.
Rationale: Patients with advanced epithelial cancers, including metastatic urothelial cancer (mUC), have a poor prognosis and this phase I/II trial looks at the safety and efficacy of a novel antibody-drug conjugate, IMMU-132 (hRS7-SN38), also known as Sacituzumab Govitecan. The antibody, hRS7, is a humanized anti-Trop-2 monoclonal antibody attached to SN38 which is the active metabolite of irinotecan (CPT-11). The drug targets Trop-2 which is overexpressed in aggressive epithelial cancers including up to 83% of urothelial tumors and the conjugate binds to Trop-2 and delivers the active metabolite of a topoisomerase I inhibitor.
Study Design: The Phase I/II trial included an expansion cohort of 41 patients with metastatic urothelial cancer that progressed after one or more prior systemic therapies. Patients were treated until progression or unacceptable toxicity.
Endpoints: The primary endpoint was safety and antitumor efficacy was the secondary endpoint.
Results: This was a heavily pre-treated cohort as patients received a median of 3 prior therapies including prior platinum chemotherapy in up to 93% of patients. Furthermore, 34% of patients had received a checkpoint inhibitor (CPI). Overall, the treatment was highly tolerable with grade 3-4 neutropenia being the most commonly seen adverse event (AE) in 39%. The overall response rate (ORR) was 34% with 2 complete responses. The response rate was 29% in patients who had received a previous checkpoint inhibitor. The median overall survival was 16.1 months.
Ongoing Trials: TROPHY-U-01 ( NCT03547973) is a single-arm, open-label, global phase 2 trial evaluating the antitumor activity and safety of Sacituzumab Govitecan (IMMU-132) in 140 patients with advanced urothelial cancer after progression on platinum-based chemotherapy or anti-PD-1/PD-L1 checkpoint inhibitor therapy. The primary cohort (progression after platinum chemotherapy and CPI) will enroll 100 pts in a Simon 2-stage design with >90% power accounting for dropouts to exclude the null hypothesis or ORR <12%. A second cohort (40 pts) will comprise cisplatin-ineligible pts who received prior CPI. The primary objective is ORR assessed by central review per RECIST 1.1. Secondary objectives include response duration, PFS, OS, and safety/tolerability. Enrollment began in August 2018.
Comments: Similar to data presented at ASCO 2018 for another antibody-drug conjugate, enfortumab vedotin, this trial demonstrates that IMMU-132 (hRS7-SN38), Sacituzumab Govitecan, also has good activity in patients who have not only failed prior platinum chemotherapy but also in patients who have failed prior checkpoint inhibitor therapy. The ongoing trial will further establish its activity.
I think the fact that she is presenting along with Dr. Tagawa is a good indicator that she likes the "activity established" since then, and thus her support for SG. With her credentials, that is a big plus for the company.
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|From: erickerickson||9/13/2019 8:59:12 AM|
|People don't learn. There was a message after we added another buck on Wednesday about how that was good. And you awakened the "Gris Gris". Shame shame shame! ;)|
I try to not get excited about moves either up or down at this point, we're waiting for
Pretty much everything else is noise.
Just to contradict myself though, I do find it interesting that IMMU didn't slack off after the CRL, they continued full steam ahead. I'm sure they may have trimmed back on some new expenditures, and maybe left some positions open that they would have filled if there were no CRL. And sure, good news for UC will be welcome (and any other study results of course). It's just that until the CRL issues are fixed (and the FDA agrees), I'm not going to get giddy...
Imagine the CRL if Dr. G. were still in charge and we had only had a few months operating expenses in the bank.....
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