On November 16, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease, reported that Company management will participate at two upcoming virtual conferences (Press release, Atara Biotherapeutics, NOV 16, 2020, View Source [SID1234574477]).

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Stifel 2020 Virtual Healthcare Conference
Wednesday, November 18, 2020 at 4:40 p.m. EST
Fireside Chat with Pascal Touchon, President and Chief Executive Officer

Evercore ISI 3rd Annual Virtual HealthCONx Conference
Wednesday, December 2, 2020 at 8:50 a.m. EST
Fireside Chat with Pascal Touchon and Jakob Dupont, Global Head of Research and Development

Live video webcasts of both presentations will be available by visiting the Investor Events and Presentations section of atarabio.com. Archived replays will be available on the Company’s website for approximately 14 days following the live webcasts.

On November 16, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application (NDA) for the approval of envafolimab (KN035) in the indication of MSI-H/dMMR cancer to the National Medical Products Administration (NMPA) (Press release, Tracon Pharmaceuticals, NOV 16, 2020, View Source [SID1234571129]).

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"We congratulate our partners on the regulatory submission of data from the registration trial of envafolimab in MSI-H/dMMR advanced solid tumors including colorectal and gastric cancer, which marks an important milestone in the development and potential commercialization of the program," said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. "The submission for approval highlights the advanced status of envafolimab product development. Envafolimab is being studied in two additional registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by 3D Medicines and Alphamab, and TRACON’s ENVASARC trial in sarcoma in the U.S., which recently opened multiple sites and expects to dose multiple patients prior to the end of the year."

About Envafolimab (KN035)

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines have submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About ENVASARC (NCT04480502)

The ENVASARC registration trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On November 16, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported clinical implementation of its UltraPorator system, a device exclusive to Precigen for the scale-up of rapid and cost-effective decentralized manufacturing of UltraCAR-T therapies (Press release, Precigen, NOV 16, 2020, View Source [SID1234571153]). Precigen and its clinical partners have now successfully dosed the first patients with UltraCAR-T cells manufactured using the UltraPorator system. The patients were dosed with PRGN-3005 UltraCAR-T cells in the intraperitoneal (IP) arm of the ongoing Phase 1 study for advanced ovarian cancer patients conducted in collaboration with the University of Washington/Fred Hutchinson Cancer Research Center and with PRGN-3006 UltraCAR-T cells in the ongoing Phase 1/1b study for patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS) conducted in collaboration with the Moffitt Cancer Center. UltraCAR-T eliminates ex vivo expansion, which reduces manufacturing time to allow for rapid next day administration of UltraCAR-T cells following non-viral gene transfer.

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"Dosing the first patients with UltraCAR-T cells manufactured using our proprietary UltraPorator system in both of our UltraCAR-T trials represents a major advance in our ability to transform how personalized cancer therapies are manufactured and administered within a medical center’s own labs. This milestone positions UltraPorator as the essential go-to platform for cell therapy manufacturing," said Helen Sabzevari, PhD, President and CEO of Precigen. "Our long-term goal is to streamline the process of oncology drug manufacturing so that healthcare professionals can treat their patients as quickly as possible in a commercially viable and expedient way."

UltraPorator is a high-throughput, semi-closed electroporation system for reprogramming T-cells using Precigen’s next generation Sleeping Beauty non-viral gene transfer technology. UltraPorator reduces manufacturing risk and allows the medical center to generate UltraCAR-T cells within its own facilities. UltraPorator is capable of handling the electroporation of billions of T-cells in minutes, and further streamlines the UltraCAR-T overnight manufacturing process, allowing for rapid manufacturing of UltraCAR-T cells in higher doses and quantities, which is critical as the Company moves to expansion phases for its clinical studies.

"Current methods for non-viral gene transfer require labor intensive, manual handling of samples, which may increase contamination risk, requires multiple batches and involves extensive hours to manufacture a single dose," said Mary L. (Nora) Disis, MD, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 study. "The UltraPorator system is a critical piece of the puzzle for personalized manufacturing by significantly reducing processing times, further streamlining UltraCAR-T manufacturing and allowing us to deliver personalized treatment to patients faster than ever."

"Time is critical when selecting and administering treatment to relapsed or refractory AML patients," said David A. Sallman, MD, lead investigator for the PRGN-3006 study at the Moffitt Cancer Center. "The ability to conveniently manufacture PRGN-3006 UltraCAR-T cells using the UltraPorator device overnight and administer treatment the next day can be a game-changer for these patients."

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn.

About PRGN-3005 UltraCAR-T
PRGN-3005 UltraCAR-T is a multigenic autologous CAR-T cell treatment utilizing Precigen’s Sleeping Beauty system to simultaneously express a CAR specifically targeting the unshed portion of MUC16, which is highly expressed on ovarian tumors with limited normal tissue expression; membrane bound IL-15 for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile. PRGN-3005 is being evaluated in collaboration with the University of Washington and Fred Hutchinson Cancer Research Center in an investigator-initiated open-label, dose escalation Phase 1 study to evaluate the safety and maximal tolerated dose of PRGN-3005 delivered by intraperitoneal infusion (IP) or intravenous infusion (IV) (clinical trial identifier: NCT03907527). The study population includes patients with advanced stage (III/IV) recurrent ovarian, fallopian tube, and primary peritoneal cancer who are platinum-resistant and have progressed after receiving standard-of-care therapies or are not eligible to receive available therapies with known clinical benefit.

About PRGN-3006 UltraCAR-T
PRGN-3006 UltraCAR-T is a multigenic autologous CAR-T cell treatment utilizing Precigen’s Sleeping Beauty system to simultaneously express a CAR specifically targeting CD33, which is over expressed on acute myeloid leukemia blasts with lesser expression on normal hematopoietic stem cell populations and minimal non-hematopoietic expression; membrane bound IL-15 for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for improved safety profile. PRGN-3006 is being evaluated in collaboration with the Moffitt Cancer Center in a nonrandomized, investigator–initiated Phase 1/1b dose escalation study to evaluate the safety and maximal tolerated dose of PRGN–3006 UltraCAR-T (clinical trial identifier: NCT03927261). The study population includes patients with relapsed or refractory acute myeloid leukemia or higher risk myelodysplastic syndrome.

Trademarks
Precigen, UltraPorator, UltraCAR-T and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners

On November 16, 2020 Danaher Corporation (NYSE: DHR) reported that Executive Vice President and Chief Financial Officer, Matt McGrew, will be presenting at the Wolfe Research Healthcare Conference on Thursday, November 19, 2020 at 12:00 p.m. ET (Press release, Danaher, NOV 16, 2020, View Source [SID1234571174]). The audio will be simultaneously webcast on www.danaher.com.

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On November 16, 2020 Moberg Pharma’s subsidiary OncoZenge reported that it has received binding undertakings regarding a directed issue of shares of SEK 10 million and a fully secured rights issue of shares of approximately SEK 60 million (Press release, OncoZenge, NOV 16, 2020, View Source [SID1234571199]). The investors, which include John Fällström, Linc AB and Moberg Pharma’s largest shareholder, Östersjöstiftelsen, are subscribing for shares in the directed issue and have committed to subscribe for their parts and guarantee the remainder of the rights issue in OncoZenge.

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On November 6th, 2020, Moberg Pharma announced its intention to distribute OncoZenge ("OncoZenge" or "the Company") through a Lex ASEA distribution before listing the Company on Nasdaq First North Growth Market, and to evaluate opportunities to finance OncoZenge’s operations. OncoZenge is developing the BUPI project under the brand name BupiZenge for treatment of pain due to oral mucositis, a serious side effect of cancer treatment. BupiZenge has demonstrated promising results in a Phase 2 study, and the next step is a Phase 3 study which could serve as the basis for registration in Europe.

The capital requirement to finance the Phase 3 study, expected to begin in early 2022, and the Company’s continuing operations is approximately SEK 60 million. To secure working capital ahead of OncoZenge’s listing, an initial directed issue of SEK 10 million will be completed after the previously announced extraordinary general meeting in Moberg Pharma on December 1, 2020 which also will resolve on, amongst other things, a Lex ASEA distribution. The next steps, planned in the first quarter of 2021, are a separate listing on Nasdaq First North Growth Market and a fully guaranteed rights issue where Moberg Pharma’s shareholders (as shareholders of OncoZenge following the completed Lex ASEA distribution) are offered to participate.

Directed Issue
To secure its initial capital requirements, OncoZenge has received binding commitments for a directed issue of approximately SEK 10 million ("Directed Issue"). The largest investors in the Directed Issue are John Fällström, Linc AB and Östersjöstiftelsen. Based on the subscription price in the Directed Issue, the value of OncoZenge before the Directed Issue is approximately SEK 50 million, resulting in a dilution of approximately 16.7 percent from the Directed Issue. The Directed Issue is contingent on approval by the extraordinary general meeting in Moberg Pharma on December 1, 2020 for the distribution of OncoZenge according to Lex ASEA. Linc AB has expressed interest for representation on the Board of Directors of OncoZenge, which is supported by the Company’s principal shareholders.

Spin-off through Lex ASEA distribution and separate listing on Nasdaq First North
The Board of Directors of Moberg Pharma has called an extraordinary general meeting on December 1, 2020 and propose that its shares in OncoZenge will be distributed to Moberg Pharma’s shareholders according to Lex ASEA. The Company’s assessment is that the distribution qualifies as a Lex ASEA distribution and will not be subject to taxation for the shareholders. The Company has requested an advance ruling from the Swedish Tax Agency for further clarification, which will be published on Moberg Pharma’s website when available. The record date to receive shares in OncoZenge is expected to fall in January/February 2021.

Provided that the extraordinary general meeting approve the distribution of OncoZenge, the Company intends to apply for a separate listing on Nasdaq First North Growth Market with the first day of trading expected in the first quarter of 2021.

Rights Issue
The Directed Issue of approximately SEK 10 million is expected to finance planned activities in OncoZenge until the start of 2022, when the clinical Phase 3 study is planned to commence. To finance the clinical study and other activities, OncoZenge intends to carry out a fully guaranteed rights issue ("the Rights Issue"), which is expected to provide the Company with proceeds of around SEK 60 million before costs. The subscription price in the Rights Issue will correspond to a valuation of around SEK 60 million, i.e., the same valuation as in the Directed Issue adjusted for the issue proceeds of SEK 10 million from the Directed Issue. The subscription period for the Rights Issue is expected to begin directly after the first day of trading of the shares in OncoZenge. Further details on terms and conditions and the timetable will be announced in January 2021.

The Directed Issue is expected to be registered before the record date for the Rights Issue. As a result, investors in the Directed Issue will be able to subscribe for their parts in the Rights Issue. All investors in the Directed Issue have committed to subscribe for their parts in the Rights Issue. Moreover, Östersjöstiftelsen, which through its ownership in Moberg Pharma and participation in the Directed Issue will own around 10 percent of the shares in OncoZenge, has committed to subscribe for its parts of the Rights Issue. Through the Lex ASEA distribution, shareholders in Moberg Pharma will receive shares in OncoZenge and thereby qualify to participate in the Rights Issue. In total, the Rights Issue is secured by subscription commitments amounting to approximately 26 percent, while the remaining approximate 74 percent is comprised of guarantee commitments by the investors in the Directed Issue. The guarantee compensation corresponds to eight percent of the guaranteed amount (i.e., on the portion exceeding each investor’s pro rata share).

"The great interest from well-reputed investors is very positive and enables BupiZenge to further progress its clinical program and OncoZenge to become a listed company in the near future. I look forward to leading the continued development focusing on our upcoming Phase 3 study in an indication area with significant need for better treatment alternatives. The goal is to offer patients much better pain relief and to create value for our shareholders," says Pirkko Tamsen, CEO of OncoZenge.

"The separate listing on Nasdaq First North and subsequent Rights Issue provide an opportunity to develop the potential in BupiZenge and also provide shareholders of Moberg Pharma an opportunity to invest and participate in the value creation in OncoZenge," says Anna Ljung, CEO of Moberg Pharma.