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 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported planned poster presentations at upcoming scientific meetings highlighting new preclinical data on the Company’s lead programs: ALPN-101, a first-in-class dual CD28/ICOS inhibitor for the treatment of autoimmune diseases, and ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of cancers (Press release, Alpine Immune Sciences, OCT 2, 2019, View Source [SID1234540010]).

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2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting – National Harbor, MD

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit Potent Anti-Tumor Immunity Superior to Checkpoint Blockade Alone
Poster #: P793
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Enhances the Activity of Multiple Standard of Care Modalities
Poster #: P467
Date: Friday, November 8, 2019
Time: 7:00 a.m. – 8:00 p.m. ET

American College of Rheumatology 2019 ACR/ARHP Annual Meeting – Atlanta, GA

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis
Session Title: Spondyloarthritis Including PsA–Clinical Poster II: Treatment of Axial Spondyloarthritis and Psoriatic Arthritis
Date: Monday, November 11, 2019
Time: 9:00 a.m. – 11:00 a.m. ET

Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Associated with Sjögren’s Syndrome
Session Title: Sjögrenʼs Syndrome–Basic & Clinical Science Poster I
Date: Tuesday, November 12, 2019
Time: 9:00 a.m. – 11:00 a.m. ET

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 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 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that data with the Company’s lead product candidate, RP1, will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C. from November 6-10, 2019 (Press release, Replimune, OCT 2, 2019, View Source [SID1234540012]). The poster which will be presented on November 8, 2019 highlights results from the Phase 1 portion of the Phase 1/2 clinical trial of RP1 as a single agent and in combination with Opdivo (nivolumab) in patients with solid tumors.

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Details of Replimune’s poster presentation:

Abstract Title: Initial results of the phase 1 portion of an ongoing phase 1/2 study of RP1 as a single agent and in combination with nivolumab in patients with solid tumors

Poster #: P433

Date: Friday, November 8, 2019, 7:00 a.m. ET – 8:00 p.m. ET

Location: Gaylord National Hotel & Convention Center