On November 2, 2020 Poseida Therapeutics, Inc., (Nasdaq: PSTX), a clinical-stage biopharmaceutical company dedicated to utilizing its proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported the U.S. Food and Drug Administration (FDA) has lifted a clinical hold on the Company’s Phase 1 study of P-PSMA-101 in metastatic castration-resistant prostate cancer (mCRPC) and plans to resume the trial immediately (Press release, Poseida Therapeutics, NOV 2, 2020, View Source [SID1234569732]). P-PSMA-101 is the company’s first solid tumor autologous CAR-T therapeutic candidate.

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The Company has agreed to implement protocol amendments intended to increase patient compliance and safety that include modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.

About P-PSMA-101
P-PSMA-101 is an autologous CAR-T therapeutic candidate in metastatic castration-resistant prostate cancer (mCRPC). It is designed to target prostate-specific membrane antigen (PSMA), which is expressed on mCRPC cells. It was developed using Poseida’s proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T (TSCM) cells. A Phase 1 trial of P-PSMA-101 in mCRPC was initiated in May 2020.

On November 2, 2020 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that management will present at the following virtual investor conferences (Press release, Insmed, NOV 2, 2020, View Source [SID1234569731]):

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The 29th Annual Credit Suisse Virtual Healthcare Conference on Tuesday, November 10, 2020 at 3:30 p.m. ET

The Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 10:00 a.m. ET
Each fireside chat will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. Each webcast will be archived for a period of 30 days following the conclusion of each live event.

On November 2, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that it will release its third quarter 2020 financial results and provide a corporate update on Monday, November 9, 2020, after the close of the U.S. financial markets (Press release, Arena Pharmaceuticals, NOV 2, 2020, View Source [SID1234569730]). The Company will host a conference call and live webcast to discuss the results with the investment community the same day at 4:30 PM ET.

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Please join the conference call at least 20 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website. A replay of the event will be archived for 30 days after the call.

On November 2, 2020 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, reported that the Company will present a business and financial update webinar on Thursday, November 5, 2020 at 4:30 pm EST (Press release, Ampio, NOV 2, 2020, https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-inc-to-host-conference-call-on-november-5th-301164428.html [SID1234569729]).

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Attending the conference call from Ampio will be Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The business update portion of the call will consist of a COVID-19 platform update from Dr. David Bar-Or and an update on the OAK Trial from Laura Goldberg. In addition to the business update, Daniel Stokely, CFO, will present a third quarter financial update.

To access the webinar, please log in to View Source approximately 10 minutes prior to the start of the call. To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International). Replay Passcode: 38512

On November 2, 2020 enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EG-70, a first-in-class non-viral gene therapy for the expression of innate and adaptive immune system activators circumscribed to the bladder (Press release, enGene, NOV 2, 2020, View Source [SID1234569728]). Under this IND, enGene intends to initiate its Phase 1/2, multi-center study in patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) in early 2021.

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"The FDA’s clearance of our IND for EG-70 is a significant moment in the field of gene therapy, and importantly, a major milestone for patients, as we are now one step closer to a treatment that is so critically needed," said Jason Hanson, President and Chief Executive Officer of enGene. "This milestone is a remarkably exciting one for us as we embark on our next chapter as a clinical stage company, harnessing the power of our non-viral gene therapy platform to impact the lives of patients around the globe."

"Our preclinical data suggest that EG-70 has the potential to produce meaningful and durable responses in patients with cancer," said Jose Lora, enGene’s Chief Scientific Officer. "EG-70 brings our technology to BCG-unresponsive NMIBC patients, a population with very limited therapeutic options. We believe EG-70 can change that."

"EG-70 entering the clinic is the culmination of a number of technological refinements to our platform and our ability to manufacture our proprietary DDX gene therapies at clinic-ready scale and quality," commented Anthony Cheung, Co-founder and Chief Technology Officer at enGene. "Our formulation work has resulted in a stability profile that enables storage and use of EG-70 in the same way that community urologists care for NMIBC patients today – a significant advantage over other gene therapy modalities."

The study design consists of an open label dose escalation Phase 1 study to evaluate the safety and tolerability of EG-70 and to determine the recommended Phase 2 dose, followed by a Phase 2 portion to evaluate efficacy and safety.

Jose Lora added "Based on our findings to date, we expect to achieve a crucial therapeutic advantage: locally harnessing the power of IL-12 and RIG-I activation without paying the price of systemic toxicity. Establishing this paradigm would provide a foundation for EG-70 to be examined across multiple tumor types with high unmet medical need."