On November 10, 2020 Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company focuses on developing novel cellular immunotherapy, reported that their preliminary data including the pre-clinical development, manufacturing, and investigator initiated trial (IIT) results for CTA101, a CRISPR/Cas9-engineered off-the-shelf CD19/CD22 dual-targeted CAR-T cell product, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held virtually on December 5-8, 2020 (Press release, Bioheng Biotech, NOV 10, 2020, View Source [SID1234570980]). The study was designed to evaluate the feasibility of CTA101 in patients with relapsed/refractory B-cell acute Lymphoblastic Leukemia (r/r B-ALL).

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"CTA101, a CRISPR-engineered allogeneic dual-targeted CAR-T, has showed manageable safety and promising efficacy in the treatment of r/r B-ALL patients," said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. "It has preliminarily verified the feasibility of generating allogeneic CAR-T by CRISPR gene editing and provided evidence for extended application in the future. As an allogeneic CAR-T, CTA101 tackles several limitations associated with conventional CAR-T therapy, such as possible manufacturing failures, undesirable waiting period between leukapheresis and CAR-T infusion, poor product consistency due to bespoke manufacturing process for individual patient, and unaffordable cost. In addition, its dual-targeted design may be a viable solution to reduce the relapse rate of B-ALL. I would like to expect more allogeneic CAR T cell products for clinical use, which certainly provide more choices to address the unmet medical needs."

Oral Presentation

Title: 499 The Safety and Efficacy of a CRISPR/Cas9-Engineered Universal CAR-T Cell Product (CTA101) in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Session: 801. Gene Editing, Therapy and Transfer I
Date: Sunday, December 6, 2020
Time: 2:30 p.m. ET (11:30 a.m. PT)
View Source

"We are looking forward to sharing initial data on the feasibility, safety and efficacy of our first allogeneic CAR T cell product, CTA101, at the ASH (Free ASH Whitepaper) 2020 annual meeting," said Xiaohong He, PhD, CEO of Bioheng Biotech. "CTA101 is based on our first-generation allogeneic CAR T technology platform, which can be timely infused to patients without HLA matching. Bioheng has always been committed to the development and commercialization of allogeneic CAR-T cell technologies and products. The positive results of CTA101 will further promote the development and translation of our multiple allogeneic CAR T pipelines."

On November 10, 2020 Anaveon, an immuno-oncology company, reported that it will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting being held from Monday, November 9, 2020 to Saturday, November 14, 2020 (Press release, Anaveon, NOV 10, 2020, View Source [SID1234570895]).

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The abstract is available on the SITC (Free SITC Whitepaper) website and the accompanying poster will be available in the Virtual Poster Hall open from 8.00 a.m. EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 and is also available on Anaveon’s website.

ANV419, Anaveon’s lead programme, is a powerful and selective interleukin-2 (IL-2) agonist that is in late stage preclinical development for the treatment of cancer. It represents a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds to the same site as the IL-2 alpha receptor and is able to completely abolish its binding.

The data demonstrates that ANV419 presents IL-2 to the beta/gamma IL-2 receptor with similar potency as native IL-2 and thus provides a natural growth signal to anti-tumor CD8+ T cells and natural killer (NK) cells while it avoids promoting pro-tumor regulatory T cells. The compound is a high molecular weight biologic that behaves like an antibody and has an outstanding safety profile in non-human primates.

"We are excited by the data demonstrating that ANV419 has a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds the same site as the alpha receptor and is able to completely abolish its binding," said Christoph Huber, Chief Scientific Officer of Anaveon. "With its high level of activity on anti-tumor immune cells and excellent safety profile we look forward to starting our first clinical study in Q1 2021 and to exploring ANV419’s applicability in a range of cancer indications, as well as in combination with other therapeutics."

Details of the poster presentation:

Title: ANV419 is a novel CD122-selective IL-2/anti-IL-2 antibody fusion protein with potent CD8 T cell and NK cell stimulatory function in vitro and in vivo

Live Q&A: Poster #571 – Wednesday, Nov. 11 from 5:15-5:45 p.m. EST and Friday, Nov. 13 from 4:40-5:10 p.m. EST

Anaveon was founded in December 2017 by Andreas Katopodis, previously Director at the Autoimmunity, Transplantation & Inflammation Group at the Novartis Institutes for BioMedical Research and Onur Boyman, Professor and Chair in the Department of Immunology at the University of Zurich. The Company is developing selective IL-2 Receptor Agonists, a type of protein that could therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Under certain situations, T-cells are able to attack tumors and, consistent with this, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer. The lead compound, ANV419, is designed to overcome known challenges with human IL-2. These include severe, dose-limiting side effects and a short half-life that requires frequent infusions. This type of drug, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

On November 10, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing a pipeline of novel T cell therapies for patients suffering from cancer, reported that the Company has established a manufacturing partnership with ElevateBio, LLC, to leverage the extensive technical capabilities at ElevateBio BaseCamp, a world-class cell and gene therapy manufacturing facility based in Waltham, MA (Press release, TCR2 Therapeutics, NOV 10, 2020, View Source [SID1234570870]). The strategic partnership will focus on the production of TC-210, TCR2’s TRuC-T cell targeting advanced mesothelin-expressing cancer, to support demand for the anticipated Phase 2 clinical trial.

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"After observing meaningful tumor regression in patients at our first, and presumably suboptimal, TC-210 dose, we are pleased to announce a manufacturing partnership with ElevateBio, an innovative organization that has significant technical expertise in the cell and gene therapy field," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "To date, we have successfully manufactured T cell products for all patients treated. In anticipation of expanding our Phase 1/2 clinical trial, manufacturing with ElevateBio BaseCamp will increase both our capacity and technical capabilities to meet potential demand for clinical material for larger cancer patient populations."

Elevate BaseCamp was established as a center of innovation dedicated to cell and gene therapy research and development, process development and cGMP manufacturing operations, using state-of-the-art facilities designed to rapidly develop single and multi-product cell and gene therapies, regenerative medicine and immunotherapies. The BaseCamp partnership enables TCR2 Therapeutics to establish additional manufacturing capacity and technical capabilities in the U.S., in addition to its existing Stevenage, UK, manufacturing facility, and will support the Phase 2 expansion portion of the TC-210 Phase 1/2 clinical trial once a recommended Phase 2 dose is defined.

"We are excited to have entered this partnership, enabling TCR2 to leverage our cell therapy expertise and state-of-the-art center of innovation to expand their manufacturing capacity as their lead TRuC-T cell targeting solid tumors advances through the clinic," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "BaseCamp is a world-class facility designed to support the manufacturing of cutting-edge cell therapies for our portfolio companies and for selective partners with highly innovative therapies like TCR2, allowing high-quality production at scale. We look forward to working with TCR2 and enabling their vision to cure cancer patients."

On November 10, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company"), reported that members of its senior management team are scheduled to participate in the following upcoming virtual investor conferences (Press release, Innate Pharma, NOV 10, 2020, View Source [SID1234570700]).

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Bryan Garnier & Co Virtual European Healthcare Conference
Date: November 17, 2020
Fireside Chat: November 17, 2020 at 10:00 a.m. CET

Jefferies Virtual London Healthcare Conference
Date: November 18, 2020

SVB Leerink Oncology 1×1 Day
Date: November 19, 2020

Oddo – Tech40 Digital Forum 5th Edition
Date: November 24-25, 2020

Evercore ISI 3rd Annual HealthCONx
Date: December 1-3, 2020
Fireside Chat: December 2, 2020 at 8:50-9:10 a.m. ET

A replay of Innate’s presentation at the Bryan Garnier conference and a live webcast of Innate’s presentation at the Evercore ISI conference will be accessible through the News & Events page of the Investors section of the Company’s website at www.innate-pharma.com.

On November 10, 2020 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 49.6 million in the third quarter of 2020 (Q3 2019: NOK 51.1), with the U.S. market continuing the COVID-19 rebound with a growth of 20% (Press release, PhotoCure, NOV 10, 2020, View Source [SID1234570650]). Photocure has successfully launched the European Hexvix operations and reiterates the strong outlook and 2023 ambitions.

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President & CEO Daniel Schneider comments: "The important U.S. market continued to rebound in the third quarter with a 17% increase in YOY unit sales as fewer procedures were postponed and business disruptions eased. We have deliberately maintained our full commercial capabilities throughout the uncertainty of the COVID pandemic in order to maximize the agility and flexibility necessary to engage our customers personally, virtually and digitally. Photocure expects continued changes in business conditions, but we are well positioned to capitalize on opportunities through various methods. For this reason, we are confident that we will weather the disruptions well and business will return to the pre-COVID-19 strong growth rates once the pandemic resolves.

We also concluded a successful transition of Ipsen’s European operations to Photocure and launched our European commercial operations on October 1. We have invested in our European commercial organization, establishing an efficient distribution and third-party logistics network throughout Europe. The entire European team has worked tirelessly to ensure we hit the ground running, and I am very pleased with the seamless transition. We are deploying our full commercial capabilities to grow and expand these new markets".

Photocure reported total group revenues of NOK 49.9 million in the third quarter of 2020 (NOK 60.8 million), with an EBITDA before restructuring of NOK -5.4 million (NOK 8.3 million). The Hexvix/Cysview revenues were NOK 49.6 million (NOK 51.1 million). The demand in the U.S. market continued to rebound during the quarter, with the in-market unit sales up 17 per cent, while the Ipsen transition contributed to a one-off revenue reduction of NOK 8.9 million in the European market and had a negative EBITDA impact of approximately NOK 7 million.

The installed base of rigid cystoscopes in the U.S. was 253 at the end of the third quarter, an increase of 42 units or 20% since the same quarter last year. Blue Light Cystoscopy (BLC) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the 3rd quarter, a total base of 33 flexible cystoscopes have been installed giving more patients access to the procedure with less constraints.

"We experience a solid underlying development across markets. In Europe, the preparations for the commercial Hexvix operations had a one-off impact on the revenues in the third quarter and the growth will be evident from the last quarter of the year, while the sales development in the U.S. continues to accelerate. By maintaining our commercial resources during the Covid-19 pandemic we can ensure a rapid recovery as the situation improves," Schneider adds.

Over the past six months, Photocure has built the commercial infrastructure to launch direct to market operations for Hexvix in the European markets formerly operated by Ipsen. The successful transition and launch of European Hexvix operations on October 1st has created a robust platform for accelerated growth and expansion for Photocure.

The Hexvix rights were transferred to Photocure with the official launch of the commercial operations beginning 1 October 2020. Photocure has paid Ipsen EUR 15 million for regaining the Hexvix rights and Ipsen will also receive earn-out payments in the range of 10 -15% of sales (years 1-7 post-transfer) and 7.5% of sales (years 8-10) in the former Ipsen markets.

"The U.S. and Europe are Photocure’s main growth markets, with large untapped opportunities, and the Ipsen agreement is expected to be EBITDA accretive from the full-year 2021 and beyond. Based on the outlook and strategic opportunities, Photocure maintains its group revenue ambitions for 2023 in the range of NOK 1 billion, with EBITDA margins of approximately 40%," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the third quarter 2020 financial report on page 22-23.

Photocure will present its third quarter 2020 report on Tuesday 9 November 2020 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20201110_3 . The presentation is scheduled to conclude at 14:45 CET.