On November 29, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that Khursheed Anwer, Ph.D., executive vice president and chief science officer, will be making a presentation on the Company’s GEN-1 interleukin 12 (IL-12) immunotherapy program at the Cytokine-Based Cancer Immunotherapies Summit being held in Boston on November 30 to December 2, 2021 (Press release, Celsion, NOV 29, 2021, View Source [SID1234596191]). Dr. Anwer’s presentation, titled "A Non-Viral Gene Therapy Approach to IL-12 Delivery for The Treatment of Cancer," will be delivered on December 2 at 8:10 a.m. Eastern time. The Company was invited to submit a poster presentation which aligns with Dr. Anwer’s oral presentation on the GEN-1 IL-12 program. The poster presentation will contain a subset of his presentation slides. Dr. Anwer will also be participating in two panel discussions.

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In his presentation, Dr. Anwer will be discussing how local delivery of IL-12 without significant systemic toxicity is feasible with a non-viral gene therapy approach that involves administration of an IL-12 plasmid with a synthetic DNA delivery system (GEN-1). Dr. Anwer will also be discussing how weekly intraperitoneal administration of GEN-1 yields durable increases in IL-12 and IFN-, and why repeated weekly administration of GEN-1 in combination with standard chemotherapy remodels the tumor immune environment to favor immune stimulation over immune suppression.

"We are pleased that the Cytokine-Based Cancer Immunotherapies Summit is recognizing Celsion’s leadership for and potential efficacy of cytokines as an immunotherapy for the treatment of serious malignancies," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion. "Results from the Company’s Phase I Study of GEN-1 in advanced ovarian cancer is attracting the interest of leading researchers in the field of immunotherapy."

Dr. Anwer will also participate in two panel discussions:

On December 1 at 8:30 a.m. Eastern time titled, "What Do We Know & Where Do We Want to Go?"
On December 2 at 11:30 a.m. Eastern time titled "Side Effects – Mitigating Against Hypotension + Fever With Immune-Stimulating Agents (NK Cell Engagers, PD-1s, Cytokines, T-Cell Engagers) = Cytokine Release Syndrome (CRS)?"
About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation and maturation. The company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. GEN-1 in combination with neoadjuvant chemotherapy is the subject of the ongoing randomized Phase II OVATION 2 Study in subjects with advanced-stage ovarian cancer (Stage III/IV), with enrollment now exceeding 75% and full enrollment targeted by the first half of 2022.

On November 29, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual investor conferences (Press release, BioMarin, NOV 29, 2021, View Source [SID1234596190]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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On November 29, 2021 Quell Therapeutics (Quell) reported $156 million in oversubscribed Series B financing to advance its pioneering multi-modular engineered T Regulatory (Treg) cell therapy pipeline and platform (Press release, UCLB, NOV 29, 2021, View Source [SID1234596189]).

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The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC.

The biotechnology company and world leader in developing engineered (Treg) cell therapies, will use the proceeds raised to fund the clinical development of QEL-001 in liver transplantation, to accelerate development of its product pipeline across transplantation, neuroinflammatory and autoimmune diseases, and enhance its multi-modular engineered Treg platform and manufacturing footprint.

Quell builds on the expertise of leading academics within the Treg, cell engineering, solid organ transplantation and autoimmune disease fields from three world class institutions: UCL, Kings College London (KCL) and Hannover Medical School.

Formed in 2019 Quell provided the opportunity for UCL founders – Professors Hans Stauss and Emma Morris of the Institute of Immunity & Transplantation, to further develop their research and know-how, alongside counterparts at KCL and Hannover Medical School, in turn translating their expertise into medical impact.

"It’s fantastic to see Quell go from strength to strength as it moves a step closer towards generating real patient benefit through leading, cutting edge regulatory T cell expertise." Comments Barny Cox, the UCLB Senior Business Manager who supported Quell throughout its early formation. "Backed by this welcome injection of finance, I look forward to seeing the company grow, building upon its academic foundations as a fine example of the successful translation of pioneering, high-quality scientific research."

On November 29, 2021 Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of cancer immunotherapies, reported that it has entered into a strategic multi-year research collaboration with Moffitt Cancer Center ("Moffitt") for pre-clinical development of investigational tumor-infiltrating lymphocyte ("TIL") therapies (Press release, Turnstone Biologics, NOV 29, 2021, View Source [SID1234596188]). The partnership will focus on new clinical candidates utilizing Turnstone’s next-generation selected TIL approach in multiple solid tumor types, in addition to IND submission of Turnstone’s lead TIL program, TIDAL-01.

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"Moffitt has established itself as a leader in the development of cutting-edge cell-based therapies," said Sammy Farah, Ph.D., MBA, President and CEO, Turnstone Biologics. "With Moffitt’s world leading researchers and unique capabilities to support translational research, we believe this collaboration will be crucial in bringing our transformative TIL therapies to people with cancer. We look forward to working closely with the team at Moffitt as we advance our innovative strategy in this field."

Under the terms of the agreement, Moffitt will collaborate on the development of Turnstone’s pipeline of selected TILs for the identification, enrichment and expansion of neoantigen reactive TILs in solid tumor indications, including melanoma, breast and colorectal cancers. Furthermore, Turnstone will transfer their proprietary TIL manufacturing process to Moffitt to produce cell products for upcoming clinical studies of Turnstone’s TIL product candidates. Turnstone will provide financial support for research and development at Moffitt over the multi-year collaboration.

"Turnstone’s strong commitment to support its novel TIL platform and pipeline aligns on Moffitt’s expertise and singular focus on developing truly life altering cancer treatments," said Shari Pilon-Thomas, Ph.D., Associate Member of the Immunology Department at Moffitt Cancer Center. "We are excited to collaborate with Turnstone to help propel the development of TIDAL-01 as well as progress investigation of multiple next-generation TIL immunotherapies with the potential to improve clinical outcomes for cancer patients."

Turnstone’s lead TIL therapy candidate, TIDAL-01, builds on the success of clinically validated treatment protocols while enriching for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients, with the ultimate goal of extending the benefit of TIL therapy across a wider range of solid tumor types. Turnstone aims to drive clinical efficacy in harder to treat, lower mutational burden cancer indications with its TIL platform. The TIDAL-01 program is expected to enter the clinic in early 2022.

On November 29, 2021 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 that its partners Alphamab Oncology (stock code: 9966.HK) and 3D Medicines (Beijing) Co., Ltd. announced that envafolimab (KN035), the world’s first single-domain PD-L1 antibody formulated for subcutaneous injection received marketing authorization from the Chinese National Medical Products Administration (NMPA) (Press release, Tracon Pharmaceuticals, NOV 29, 2021, View Source [SID1234596187]).

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Envafolimab was approved for adult patients with microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior systemic treatment and have no satisfactory alternative treatment options.

Prior to this approval, all marketed PD-1 and PD-L1 antibody drugs required intravenous infusions. As a subcutaneously administered PD-L1 antibody, envafolimab can be administered within 30 seconds in the physician’s office—thereby increasing convenience, shortening treatment time and sparing patients from the risk of infusion reactions.

In a pivotal phase 2 clinical study in patients with advanced dMMR/MSI-H tumors who received one or more lines of treatment, envafolimab demonstrated an objective response rate (ORR) by blinded independent radiographic review (BIRR) of 44.7%, including 12 (11.7%) cases of complete response. Responses were durable, with duration of response at 12 months in responding patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all responding patients of 89%, 100%, 100%, and 93%, respectively. Median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%. The confirmed ORR by BIRR in MSI-H/dMMR 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 treatment and the 33% confirmed ORR reported for KEYTRUDA in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan treatment in cohort A of the phase 2 KEYNOTE-164 trial. Envafolimab was well tolerated in this study and no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis were reported.

"We are pleased the dedication of our partners Alphamab Oncology and 3D Medicines has resulted in the initial approval of the first subcutaneously administered checkpoint inhibitor," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Importantly, the TRACON sponsored pivotal ENVASARC trial of envafolimab for the treatment of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the United States continues to enroll well at 26 sites, and we look forward to the Independent Data Monitoring Committee review of interim efficacy and safety data before the end of the year."

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor approved by the NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the U.S. sponsored by TRACON and a Phase 3 pivotal 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.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. 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 into 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.