|Bid||0.4167 x 1800|
|Ask||0.4250 x 2900|
|Day's Range||0.3911 - 0.4286|
|52 Week Range||0.2640 - 1.5700|
|Beta (5Y Monthly)||2.41|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Advaxis, Inc. (NASDAQ: ADXS), CEO Ken Berlin presented at the Benzinga Biotech Small-Cap Conference on March 24, 2021. Advaxis, Inc., a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, is making new waves as it takes definitive steps to prove that the company is “no longer your grandfather’s Advaxis,” according to company CEO Ken Berlin. Among Advaxis’s new steps is an agreement with the Columbia University Irving Medical Center to fund a Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The company has also announced new data relating to developing a novel flow immunophenotyping assay to accurately evaluate total PD-1 expression as a pharmacodynamic marker during PD-1 blockade. It highlighted translational data demonstrating immune responses correlated to observed clinical benefit from Advaxis’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA®. The report was presented as a poster at this year’s American Association for Cancer Research (AACR) annual meeting. The Columbia study, expected to begin in Q2 this year, will be the first clinical evaluation of ADXS-504, Advaxis’s off-the-shelf neoantigen immunotherapy drug candidate for early prostate cancer. Mark Stein, M.D., associate professor of medicine in the division of Hematology/Oncology at Columbia University Vagelos College of Physicians and Surgeons, will be the study’s principal investigator. The Phase 1 open-label study will evaluate the safety and tolerability of ADXS-504 monotherapy, administered via infusion, in 9-18 patients with biochemically recurrent prostate cancer, i.e., those with an elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy. The study will also evaluate preliminary clinical and immune responses following treatment with ADXS-504 monotherapy. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program that leverages Advaxis’s proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. “This presented data suggests our novel immunophenotyping assay has the potential to improve pharmacodynamic biomarkers in immunotherapy,” said Berlin. “This assay enables the detection of both free and drug-bound PD-1 expression. It’s independent of PD-1 receptor status or interference due to PD-1 blockade, enabling the accurate evaluation of PD-1 expression in patients undergoing treatment pembrolizumab.” Berlin added, “We believe this is another important step to further understand immune responses in patients treated with immunotherapy agents. It may provide important translational insights specific to PD-1 expression and immune modulation, which may help shape treatment strategies moving forward.” The Phase 1/2 clinical trial of ADXS-503 seeks to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with KEYTRUDA® in approximately 50 patients with NSCLC, in at least 5 sites across the U.S. The 2 dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently enrolling its efficacy expansion for up to 15 patients at dose Level 1 (1 X108 CFU + KEYTRUDA) with the potential to proceed to dose Level 2 (5 X108 CFU + KEYTRUDA) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA (1 X108 CFU + KEYTRUDA) as a first-line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients. “We’ve made a lot of changes in the company over the past few years. Our prostate cancer study is a good example. Treating men who are not very far down the road with prostate cancer and giving them low doses, while trying to stave off later stages, is the goal,” said Berlin. “This is a very exciting time for Advaxis.” Since presenting at the Benzinga conference, Advaxis has completed a $20 million financing that will allow further investment in its HOT program as well as enhance its ongoing efforts to acquire new technologies and products. See more from BenzingaClick here for options trades from BenzingaTimpane Says Being Successful in the Market Means Having the Right Mindset and Points to Schaeffer's Sentiment AnalysisGeoVax Vaccine Innovation Is Poised To Save Lives Globally© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Exciting and insightful biotech news was front and center at the Benzinga Biotech Small Cap Conference, a two-day event that kicked off virtually Wednesday. Viviane Mason, a biopharma industry veteran and investor, set the ball rolling with a session on what an investor should look for when investing in biotech stocks. Mason explained the long-winding drug approval process and the catalysts an investor needs to watch. Mason suggested looking for companies that have recently raised capital, as she said it's a signal a company has a cash runway. The following are biotech companies that investors heard from at the Benzinga conference. Presentations Lantern Pharma Inc. (NASDAQ: LTRN): Lantern CEO Panna Sharma recommends leveraging data — especially on similar classes of drugs in the market and early data from the pipeline — to zero in on companies that are likely to succeed. Sharma touched upon how Lantern leverages AI and machine learning to rescue and develop cancer therapies. Kintara Therapeutics, Inc. (NASDAQ: KTRA): CEO Saiid Zarrabian shed light on the company's glioblastoma multiforme asset VAL-083 and cutaneous metastatic breast cancer candidate REM-001. These two compounds, Zarrabian said, have a market opportunity of over $1 billion and about $500 million, respectively. PDS Biotechnology Corporation (NASDAQ: PDSB): PDS Biotech, which develops cancer treatments and T-cell-activating vaccine candidates, was represented by CEO Frank Bedu-Addo. He underlined the company's Versamune platform-based immunotherapies that promote a powerful M-vivo tumor-specific CD8+ killer cell T cell response. The company also said its subunit COVID-19 vaccine candidate PDS0203 could be commercially available in 2023. Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT): John Kovach, CEO of Lixte, with four decades of research in oncology, shed light upon its proprietary clinical-stage compound LB-100, which is a targeted cancer therapy. Related Link: The Daily Biotech Pulse: Bristol-Myers Squibb's Skin Cancer Readout, Cellect Strikes Reverse Merger Deal, Lava Therapeutics Makes Nasdaq Debut Qualigen Therapeutics, Inc. (NASDAQ: QLGN): Qualigen was represented by Michael Poirier, CEO, and Amy Broidrick, EVP and chief strategy officer. Poirier projected the company will be a standout due to its novel platform technologies meant to treat cancer and viral diseases. RedHill Biopharma Ltd.'s (NASDAQ: RDHL) CEO Dror Ben-Asher gave an overview of the company's commercial products and pipeline, including COVID-19 treatment candidates that are in Phase 2/3 trials. Sorrento Therapeutics, Inc. (NASDAQ: SRNE) CEO Henry Ji elaborated on multiple products in late-stage development and the company's COVID-19 portfolio. OncoSec Medical Incorporated (NASDAQ: ONCS): CEO Daniel O'Connor explained the company's platform, which is intended to treat visceral, cutaneous and subcutaneous tumors. Immutep Limited (NASDAQ: IMMP): Immutep CEO Marc Voigt elaborated on the company's therapeutics based on LAG-3, which is a promising immune checkpoint, and its partnerships. Advaxis, Inc. (NASDAQ: ADXS): The immuno-oncology company's CEO Kenneth Berlin spoke on three key programs: ADXS-503 in non-small cell lung cancer, ADXS-504 in pancreatic cancer and ADXS-PSA, which is being evaluated in combination with Keytruda. AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) was represented by CEO Vincent Angotti. He discussed the company's focus on the management of acute pain in medically supervised setting. Chief Medical Officer Pamela Palmer presented on the company's FDA-approved pain medication Dsuvia and its mechanism of action. Lineage Cell Therapeutics, Inc. (NYSE: LCTX) CEO Brian Culley spoke about how manufactured transplant cells are the new paradigm in therapeutics. Hoth Therapeutics, Inc. (NASDAQ: HOTH) was represented by its CEO Robb Knie. Knie shed light on the company's Biolexxa platform that combines two drugs to treat atopic dermatitis in adolescents. Lexaria Bioscience Corp. (NASDAQ: LEXX), Alzheimer's drug company Alpha Cognition, Daxor Corporation (NYSE: DXR), aTyr Pharma, Inc. (NASDAQ: LIFE) and Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) were among the other presenters. Panel Discussions Cancer Immunotherapies: Fighting Cancer With the Power of Immune System: The panel included Bedu-Addo, Mark Newman, chief scientific officer of GeoVax Labs, Inc. (NASDAQ: GOVX) and Snehal Patel, CEO of Greenwich LifeSciences, Inc. (NASDAQ: GLSI). The panelist shared key upcoming readouts. How AI Is Leading The Fight Against Cancer: Lantern CEO Sharma and Kiromic BioPharma, Inc. (NASDAQ: KRBP) CEO Maurizio Chiriva-Internati explained how they incorporate AI in drug development. COVID-19's Impact: Jason Kolbert, Director of Research, Dawson James, moderated a panel comprising Sorrento's Ji, ProPhase Labs, Inc. (NASDAQ: PRPH) CEO Ted Karkus and ADiTx Therapeutics, Inc. (NASDAQ: ADTX) CEO Amro Albanna. The panel discussed how leveraged they are to COVID and what to know about the COVID treatment and vaccine landscape. Coming Together to Address Unmet Medical Needs: Lineage's Culley and Hoth's Knie joined a panel discussion to give a sense of what an unmet medical need is, the regulatory incentive available for companies engaged in developing therapies for unmet medical needs and what drives the quest. Related Link: FDA Decisions For Pfizer, Eli Lilly And Bluebird Bio, Bristol-Meyers Squibb, Plus New Data And Earnings See more from BenzingaClick here for options trades from BenzingaThe Daily Biotech Pulse: Bristol-Myers Squibb's Skin Cancer Readout, Cellect Strikes Reverse Merger Deal, Lava Therapeutics Makes Nasdaq DebutThe Daily Biotech Pulse: Dynavax-Clover Start Phase 2/3 Vaccine Study. BrainStorm Reports Positive MS Readout, NeoGenomics Goes Shopping© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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