Immunotherapy — Trading Ideas on TradingView

ImmunityBio: Catalyst for a New Era?ImmunityBio, Inc. is rapidly emerging as a significant force in the biotechnology sector, propelled by the success and expanding potential of its lead immunotherapy asset, ANKTIVA® (nogapendekin alfa inbakicept-pmln). The company achieved a pivotal milestone with the FDA approval of ANKTIVA in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. This approval addresses a critical need and leverages ANKTIVA's unique mechanism as a first-in-class IL-15 agonist, designed to activate key immune cells and induce durable responses. Building on this success, ImmunityBio is actively pursuing global market access, submitting applications to the EMA and MHRA for potential approval in Europe and the UK by 2026. Beyond regulatory progress, ImmunityBio proactively tackles challenges in patient care, notably addressing the U.S. shortage of TICE® BCG. Through an FDA-authorized Expanded Access Program, the company supplies recombinant BCG (rBCG), providing a vital alternative source and expanding treatment access, particularly in underserved areas. This initiative supports patients and establishes a new market channel for ImmunityBio's therapies. Commercially, ANKTIVA's U.S. launch gains momentum, facilitated by a permanent J-code that simplifies billing and broadens insurance coverage, reaching over 240 million lives. ImmunityBio's strategic vision extends to other major cancer types. The company is advancing ANKTIVA's potential in non-small cell lung cancer (NSCLC) through a confirmatory Phase 3 trial with BeiGene. This collaboration follows promising Phase 2 data demonstrating ANKTIVA's ability to rescue checkpoint inhibitor activity in patients who have progressed on prior therapies, showing prolonged overall survival. This highlights ANKTIVA's broader potential as a foundational cytokine therapy capable of addressing lymphopenia and restoring immune function across various tumors. ImmunityBio's recent financial performance reflects this clinical and commercial traction, marked by a significant revenue increase driven by ANKTIVA sales and positive investor sentiment.

CVM; Breakout from bear pennant, prime for liftoff Disclaimer General disclaimer here. Short but sweet, we have sustained breakout from the bear pennant, we have a dwindling short pool (460k as of today borrowable from Fidelity, down from ~600k on Monday). Less kick in the shorts, and they have until the 20th of this month to sustain the price channel and try to get it under 7.5. Meanwhile, more and more groups are buying up shares in small amounts, likely on the back of bigger entities buying up, as State Street increased their position on the drop from $25. We are only a few weeks away from a catalyst with the pre-BLA meeting, pushed by more and more FDA breakthrough news. This is a great time to look for an entry on shares. If you buy options, a good rule I use is 90-10. Only use 10% of funds on the options, that way if they go south, you are still likely to end up green on the overall trade. With that said, we have no ceiling as the drop from 26 was abberative manipulation, we have a gamma squeeze lining up from $9 and into the $20s. Theoretical M&A prices are obscenely high, even conservative values at $5 billion would give this a x15 multiple. Have fun y'all, always be safe, and please do your own research to verify. And always ask questions! whalewisdom.com

SENS Back Testing The 382 Fib Watching To Act As Support The thing about SENS is that it's been a company crushing it in 2021. When it was first discussed this year it was still trading below $1. Despite recent volatility, it's up significantly year-to-date. I think volume remains steady but definitely on the lower end of the range. But good data from the last presentation on its PROMISE study seems to have sparked more attention. "The data evaluating the safety and accuracy of the next generation Eversense system was presented by Satish Garg , MD, Professor of Medicine at the Barbara Davis Center of the University of Colorado, Denver , and the PROMISE study group Principal Investigator (PI). The Company presented previously released information demonstrating performance matching that of the current 90-day sensor available in the United States , with reduced calibration, down to one per day, with duration extended to 180 days. Accuracy measurements discussed in the oral presentation include a mean absolute relative difference (MARD) of 9.1% for the primary sensor and confirmed hypoglycemia alert detection rates at 60 mg/dL of 87% and at 70 mg/dL of 93%. For the subset of 43 modified sensors (referred to as the SBA sensor), the MARD was 8.5% and the confirmed hypo alert detection rates at 60 mg/dL and 70 mg/dL were 90% and 94%, respectively." Another area of potential support/resistance is just below the 382 fib line (in yellow), which has held so far this week. It was resistance a few weeks back. With SENS failing almost right at the 236 Fib line, technical traders are liking monitoring these levels closely. Latest on SENS: Best Penny Stocks to Buy Right Now? 7 Small-Caps For Your Morning List

#Ultimovacs $ULTI announce FOURTH randomized phase 2 trial FOCUS Note that information about the third study is still expected before year end. Ultimovacs ASA – Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab Oslo, 22 December 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company’s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.” The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage. “This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,” commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. “I am excited to apply my own insights as well as my team’s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options.” “We have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations.” Dr. de Sousa added: “Although we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end.”

Targovax has the cheapest oncolytic virus on the market ONCOS-102 is one of the most promising oncolytic viruses with >200 patients treated. Targovax stock has been under pressure for years after equity offerings at fairly low pricing, but has been making a strong move recently, quite without many investors taking notice. Norwegian Biotech especially in the field of cancer immunotherapy may be ready for a new round of interest after the recent news about Vaccibody partnering with Genentech.