On October 2, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has closed its $33 million Series B financing (Press release, Elicio Therapeutics, OCT 2, 2019, View Source [SID1234540027]). Proceeds from the financing will be used to advance Elicio’s pipeline of novel lymph node targeted immuno-therapies, including ELI-002, an Amphiphile mKRAS vaccine (AMP KRAS). ELI-002 targets all seven KRAS mutations that drive 99% of all mKRAS-driven cancers, estimated to be 25% of all human solid tumors.

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"We believe ELI-002 can become a universal mKRAS vaccine with the potential to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer," said Robert Connelly, CEO of Elicio. "This new funding is a strong endorsement of this program, the Amphiphile platform, and our progress."

Elicio has established an international investor base, including Clal Biotechnology Industries, Livzon Pharmaceutical Group and Efung Capital. "We are gratified to be able to expand our investor base and strengthen our balance sheet as we advance multiple Amphiphile immuno-therapies towards initial patient studies," Connelly said.

Elicio’s AMP KRAS vaccine ELI-002 has completed preclinical validation, IND-enabling GLP toxicology studies, GMP manufacturing, and a pre-IND meeting with the FDA and Elicio intends to begin an initial patient study in pancreatic cancer patients in the first half of 2020. These trials will be multi-site, randomized, controlled studies. Initial ELI-002 pancreatic cancer patient data is expected in the second half of 2020.

About the Amphiphile Platform
The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On October 2, 2019 IASO Biotherapeutics (IASO BIO), a clinical stage biotechnology company advancing the development of innovative therapies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that IASO BIO has received National Medical Products Administration (NMPA) approval for an Investigational New Drug Application (IND) for CT103A—an innovative therapy for the treatment of relapsed refractory multiple myeloma (rr/mm) patients (Press release, IASO BioMed, OCT 2, 2019, View Source [SID1234540026]). IASO Bio and Innovent will start a Phase Ib/II study to confirm the R2PD and move to phase II shortly after, with approval anticipated in 2021.

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Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems and bone fractures. With a global annual incidence rate of 2/100,000 persons, it is one of the most commonly diagnosed blood cancers, second only to non-Hodgkin lymphoma.

Hu Guang, Ph.D., Director of R&D at IASO BIO, commented that: "This is an important milestone that allows us to continue with CT103A’s clinical development for the treatment of rr/mm. We’re a young company, and this is a big step forward in achieving our objectives to develop and bring to market the most advanced therapies for treating patients more effectively."

News of the IND approval coincided with the latest presentation of CT103A clinical results at the 17th Annual International Myeloma Workshop, Boston, September 12-15 (Abstract #440).

This annual event is devoted to fostering scientific and clinical exchange on the latest breakthroughs in multiple myeloma and related plasma cell disorders.

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, researchers presented compelling results for efficacy and persistence of a therapy that may provide patients, having relapsed from a prior CAR-T, an option for CAR-T retreatment.

In general, the treatment was well tolerated, with dosage levels ranging from 1X106, 3X106 and 6X106 CAR-T/kg.

CRS occurred in 17/18 patients (Grade 1&2- 66.6% (12), Grade 3- 22.2% (4), Grade 4- 5.6% (1)), but was generally manageable with no neurotoxicity.

At even the lowest dosage level (1 x106 cells/kg), CT103A remains effective with an improved safety profile. For response, 7/8 evaluable patients achieved VGPR or better. With respect to safety, only 1/8 evaluable patients experienced CRS at > grade 2.

About CT103A:

CT103A is an innovative therapy co-developed by IASO BIO and Innovent Biologics, Inc. Previous studies indicated patients with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.

About Nanjing IASO Biotherapeutics:

Founded in March 2017, IASO BIO is a clinical stage biotechnology company advancing the development of innovative cell therapies for cancer. IASO BIO is dedicated to curing cancer using engineered autologous/allogenic T cell therapies designed to enhance the immune system’s ability to recognize and eradicate cancer cells.

Currently, IASO BIO is developing over 10 high-potential, high-end biopharmaceutical products, utilizing a fully-human scFv sequence targeting hematological, solid and virus associated tumors. Additional development efforts include unique TCR-like CAR-T cell therapy products for indications such as gastric cancer, nasopharyngeal carcinoma and viral infection related solid tumors.

IASO BIO has developed broad capability including; a proprietary phage library（>1×1011）supporting the development of CAR-T products, antibody drugs and intracellular targets, a screening system using high-throughput CAR-T analysis techniques and large scale data mining to obtain Best-in-class CAR-T drug candidates, in-house plasmid, lentivirus and CAR-T production technology platforms meeting the requirements for IND submissions and clinical research. For more information, please visit: www.iasobio.com

On October 2, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that it will be presenting clinical biomarker data from its ongoing ALX148 phase 1 clinical program at the SITC (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland (Press release, ALX Oncology, OCT 2, 2019, View Source [SID1234540025]).

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Poster Presentation Information
Title: Pharmacodynamic biomarker characterization of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy (Abstract P449)
Date: Friday, November 8, 2019
Time: 7:00 am – 8:00 pm

On October 2, 2019 Torque Therapeutics, a clinical stage, product-platform company developing proprietary, first-in-class Deep Primed adoptive cell transfer therapeutics with uniquely broad potential to treat patients with a wide range of hematologic and solid malignancies, reported the appointment of John Cox as Chief Executive Officer (Press release, Torque Therapeutics, OCT 2, 2019, View Source [SID1234540024]).

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Douglas Cole, Lead Director of Torque and Managing Partner at Flagship Pioneering, said, "I am thrilled that John has taken on the role of CEO of Torque. His accomplishments delivering value to shareholders are among the most significant in the biotechnology industry. Over the course of his career, he has demonstrated his ability to advance and commercialize products, build teams, and guide and drive organizations. He is a true leader. I am excited to work with John as he leads development of Torque’s growing pipeline of clinical and preclinical proprietary products, continues to build on Torque’s robust Deep Primed T Cell platform, and expands the Torque capital base."

Mr. Cox was most recently Chief Executive Officer of Bioverativ. He led the Bioverativ spin-out from Biogen in 2016 and the sale of Bioverativ to Sanofi for $11.6B in 2018. He previously served in roles of increasing seniority at Biogen, ultimately as Executive Vice President of Pharmaceutical Operations and Technology overseeing global manufacturing facilities, supply chain operations, technical development, quality and engineering, and development and commercialization of Biogen’s biosimilars business.

"I am delighted to take leadership of Torque Therapeutics," Mr. Cox said. "After the sale of Bioverativ, I assessed many opportunities to run a company that could really change patients’ lives. I believe Torque represents one of the most compelling approaches to do that."

Cox went on, "Torque is poised to move the field of adoptive cell transfer from niche use in small groups of late-stage patients with particular hematologic malignancies to broad use across multiple groups of early- and late-stage patients with a broad range of range of hematologic and solid malignancies. Torque’s Deep Primed product-platform is the only approach that has been developed that combines the ability to address the inherent variability of each patient’s malignancy, safely harness the critical power of cytokines and other immune agonists, and cost-effectively manufacture therapeutic products. With a clinical trial of its first clinical candidate already underway, trials of its second and third clinical candidates slated to begin in the next two quarters, and additional product candidates advancing in the expanding pipeline, Torque has enormous potential to create value in the near term and beyond."

Cox became Executive Chairman of Torque in January, 2019. During his tenure as Executive Chairman, Torque successfully transitioned from a pre-clinical to a clinical stage company, advanced multiple product candidates in its pipeline, expanded its team with key hires in business development and finance, received Fast Track designation for its lead TRQ-1501 product, and announced a collaboration with Thermo Fisher Scientific to manufacture Torque’s Deep Primed T Cell immunotherapies, as well as a clinical trial collaboration with Merck to evaluate its lead TRQ-1501 product in combination with Keytruda.

On October 2, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that multiple Company drug development programs will be the subject of presentations at upcoming medical and scientific conferences (Press release, Celldex Therapeutics, OCT 2, 2019, View Source [SID1234540023]).

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Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting & Pre-Conference Programs (SITC 2019), November 6-10 in National Harbor, Maryland

CDX-1140: The abstract (Abstract ID: P827) entitled, "Phase 1 study of the CD40 agonist monoclonal antibody (mAb) CDX-1140 alone and in combination with CDX-301 (rhFLT3L) in patients with advanced cancers" will be presented in a poster presentation by Rachel Sanborn, MD, Co-director of the Thoracic Oncology Program and Leader of the Phase 1 Trials Program at Providence Cancer Institute and a lead investigator in this study, on Friday, November 8, 2019 from 8:00 am to 8:00 pm ET. Michael Yellin, MD, Vice President of Clinical Science at Celldex will also present a talk entitled CD40: A Target for Systemic Immune Modulation at the Workshop on Intratumoral Immunomodulation on Thursday, November 7, 2019 at 3:00 pm ET.

CDX-527: The abstract (Abstract ID: P700) entitled, "Combining CD27 costimulation and PD-1 blockade into a bispecific antibody improves T cell activation and anti-tumor activity over combination of individual antibodies" will be presented in a poster presentation by Tibor Keler, PhD, Executive Vice President and Chief Scientific Officer at Celldex, on Saturday, November 9, 2019 from 8:00 am to 8:00 pm ET. This program will also be highlighted in a short talk by Dr. Keler during the preconference program session "Novel Multi-Targeted Therapeutic Platforms" on Wednesday, November 6, 2019 at 4:45 pm ET.

American College of Allergy, Asthma & Immunology Annual Scientific Meeting, November 7-11 in Houston, Texas

CDX-0159: The abstract (Abstract ID: 8071) entitled, "CDX-0159, An Anti-KIT Monoclonal Antibody, As A Modulator of Mast Cell-related Diseases" has been accepted for presentation by Richard Gedrich, PhD, Executive Director of Translational Medicine at Celldex, in the Distinguished Industry Oral Abstract Session on Saturday, November 9, 2019 at 4:35 pm CT.

Copies of these presentations will be made available on the Celldex website after presentation.