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Welcome to the troll-free, moderated message board for Immunomedics (IMMU). IMMU is in a very exciting phase, one that promises real benefits for patients. As far as the company is concerned: - the new management (aka Gold for the proxy ballot color) is delivering on the stated plan - 132, now known as Trodelvy, has received AA (accelerated approval). - The phase lll Ascent trial has been halted for “compelling efficacy” pretty much assuring full and final approval later this year, 2020. - the share price has enjoyed a very nice run-up since January 2017 - Cash in the bank is at an all time high after an over subscribed offering was completed in April 2020 and raised $420 million. - IMMU sold it’s first treatment of Trodelvy April 29th, 2020. - IMMU's status: -- Company website: -- immunomedics.com Clinical trials Prostate cancer clinicaltrials.gov Trodelvy combined with PARP for TNBC clinicaltrials.gov Phase lll Ascent trial. Halted for compelling efficacy clinicaltrials.gov Rollover Study for patients who are still responding after their trial has ended clinicaltrials.gov Study of IMMU-132 in HR+/HER2- MBC (TROPICs-02) clinicaltrials.gov Trodelvy in TNBC (NeoSTAR). Primary end point—% of complete responses in treatment naive patients. clinicaltrials.gov A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03) clinicaltrials.gov Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer clinicaltrials.gov A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) clinicaltrials.gov A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (Morpheus-TNBC) clinicaltrials.gov A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma clinicaltrials.gov Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 clinicaltrials.gov Trodelvy/Keytudra in: invasive breast cancer, metastatic BC, HR positive and HR2 negative BC clinicaltrials.gov Now that we have approval of a potential blockbuster treatment in Trodelvy, where do we go from here? Here are a couple of posts that suggest where things could go from here. End the end, it will be all about the data. Stockdoc’s post just after approval of Trodelvy: “ The street is vastly underestimating how good this asset is. I emphatically dont want the company sold. If you look at Behzad's approach, he has always been a "swing for the fences" type, a strategy which I think had been coming up poorly till the early ASCENT readout saved all of us. But now that the two biggest risks are out of the way, I don't see him selling for 50 what could be worth 150 in 3 years. He knows how big a product 132 can be. I'll say it again, an effective and non-toxic ADC for solid cancers is a first in class game changer for oncology. We will see 132 move up the food chain in combo with CPIs and other approaches. As a safe targeting MAb it can be combined with other companies' payloads (FATE comes to my immediate attention). Trop 2 is an antigen present on a wide range of solid cancers. As to biosimilar competition many years from now, making a biosimilar to 132 is going to be tough. Not only do you have to replicate SC, you have to demonstrate equivalent govitecan binding and then release characteristics and clinical outcome. That is going to be a very high wall to climb. There are myriad new solid cancer therapies in the pipeline, but unless something is curative, everything will get used. The most effective and least toxic will be firstline and 132 is going to move in that direction.” From Tinfoil on two new trials announced in the Q2 2020 press release and Conference Call: The HR+/HER2- trial is for 2nd line patients who DO express PDL1, and the backbone is the same: Trodelvy alone in one arm and the combo in the other. Can you believe that Pembro alone is not even being considered? I am not surprised given what I have been saying a long time here. Trodelvy is better than Pembro in TNBC,and Dana Farber now believes Trodelvy is better than Pembro in HR+/HER2- even if a patient expresses PDL1. That is a big fricken deal. The breast cancer key opinion leaders at Dana Farber Cancer institute have analyzed the data and determined to pick Trodelvy as patient's best stand-alone choice in 2nd line therapy as opposed to Pembro standalone. I'm blown away. The HR+/HER2- trial will most likely show the combo has better efficacy, but will also show the heavy immune-related side effects of pembro that may not beat the modest side effect profile of Trodelvy alone in 2nd line therapy. However the TNBC trial, 1st line Trodelvy alone vs the combo in PDL1 negative patients?? That one is a toss up, and I'm leaning towards thinking that as soon as SABCS, and as late as ASCO next year, the jury will have decided that Trodelvy is the champ in breast cancer. Dana Farber has just hypothesized as much. Let's see if any analysts pick this up besides stir the pot Tin and his ganja hat. Target to beat is Tecentriq's modest 7.5m PFS from Impassion130. That is a low bar. Trodelvy is on the path to becoming standard of care in breast cancer. You heard it here first. Etiquette: This board is moderated, meaning the moderator (me) can stop people from posting here if they violate our norms. What are "our norms"? Well, be adult, play nice about sums it up. There are three responses I encourage for keeping the discussion civil and useful when you encounter a post that annoys you. In order of preference: 1> report a ToU violation to the SI admins via the link at the bottom of each post, they're good at dealing with problems. 2> send the person who posted a private message and work it out. Privately. 3> send me a private message. Wait a couple of days before doing so please, I'll usually see the message in that time frame and act (or not). 4> stay focused on IMMU and leave politics out of it, even by inference. There are numerous forums you can spend as much time expounding on your favorite "why (insert favorite hot-button) is evil", we don't need to reiterate all that here. 5> do not engage in discussions about poster's motivations, etc. First of all, it's unprovable. Second I'd rather not wade through the inevitable pointless back-and-forth over something that'll never be settled anyway. This board provides a forum for honest, civilized and friendly conversation. It is not a vehicle for spam or hidden agendas. New posters are not only welcome but are an important way to bring additional information and insights to the board. Over the years new posters have been welcomed into the group and have helped make the board successful. However, if you’re a new poster it is especially important to be sure that material assertions, be they pro or con, are thoughtful and supportable. While all posters must abide by the TOU, leeway can and will be granted to long-time posters who have made substantive contributions to the board and whose credibility has been established. Please consider becoming a paid member. The SI admins do a very good job at keeping this board useful/fun. If you derive value from this forum, then SI deserves your support! Finally, we all have internet connections and the like, please just skip all the breathless "It's up/down $X.Y in the first hour!" posts. Short-term price moves are generally noise anyway absent major news so we can wait until the evening to discuss price moves if we discuss them at all. Again, welcome! I think you'll find this a place to learn about and contribute to others' understanding of IMMU and its prospects. | ||||||||||||||
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