On July 28, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, reported the first patient has been dosed in the Phase 2 ASPEN-04 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and standard chemotherapy for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC") (Press release, ALX Oncology, JUL 28, 2021, View Source [SID1234591859]).

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ASPEN-04 (NCT04675333) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 in combination with pembrolizumab and standard chemotherapy in patients with first line metastatic or unresectable, recurrent HNSCC who have not received prior systemic therapy for their advanced disease. This study will enroll patients regardless of PD-L1 expression status. The study is being conducted in collaboration with Merck and is based on promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148’s Fast Track Approval in HNSCC granted by the U.S. Food and Drug Administration.

"We are excited to expand the ALX148 clinical program with the initiation of a second Phase 2 trial, that has the potential to integrate ALX148 into current standard-of-care therapies for patients with PD-L1-unselected, treatment naive HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "The demonstrated tolerability of ALX148 with chemotherapy agents, when both myeloid and T cell checkpoints are inhibited, maximizes the potential anti-cancer immune response to novel tumor antigens. ASPEN-04 builds upon the promising combination activity we have already observed in patients with HNSCC, and provides an opportunity for more optimized anti-cancer activity."

About Head and Neck Cancers

Cancers that are known collectively as head and neck cancers usually begin in the squamous cells. These cells line the moist, mucosal surfaces inside head and neck structures like the mouth, the nose, and the throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease.

On July 28, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company committed to bringing the promise of cell therapy to life for more patients, reported that it has entered into an exclusive licensing agreement with world renowned cell therapy centre, the University of Pennsylvania (Penn), for the first CDH17 CAR (chimeric antigen receptor) T cell therapy (Press release, Chimeric Therapeutics, JUL 28, 2021, View Source [SID1234585274]).

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The novel CDH17 CAR T cell therapy targets CDH17, an oncogenic factor associated with poor prognosis and metastasis in neuroendocrine tumors as well as the most common gastrointestinal tumors including colorectal cancer, pancreatic cancer and gastric cancer.

More than a decade of research and optimization has gone into development of the novel CDH17 CAR T cell therapy, developed by leading cellular immunotherapy scientist Xianxin Hua, MD, PhD, and his team. Dr Hua is a professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator.

"Chimeric is incredibly excited to bring the CDH17 CAR T cell therapy into our pipeline. Our focus is on developing cell therapies that have the potential to be curative for patients and we believe that this CDH17 CAR T cell therapy has that transformative potential. We are very much looking forward to working with Dr Hua and his team to bring this CAR T to the clinic as soon as possible," said Jennifer Chow, Chimeric COO.

The CDH17 CAR T cell therapy is a next or 3rd generation CAR T cell therapy that utilizes novel technology to specifically address the challenges of solid tumors. Preclinical studies of the CHIMERIC THERAPEUTICS LIMITED | 2 LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA CDH17 CAR T have demonstrated safety, with no toxicity to normal tissues, and promising efficacy with complete eradication of tumor cells and no relapse of the tumor.

"The preclinical studies indicate that our CDH17 CAR T marks the recognition of an entirely new class of solid tumor antigen targets, that are highly susceptible to CAR T attack on tumor cells yet masked from attack by the CAR T in normal tissues," said Dr Hua.

Development is currently underway for a phase 1 clinical trial that is planned to begin in 2022 at the University of Pennsylvania.

A three-year commitment for further research and development has been made to Dr Hua and Penn.

Under the terms of the license agreement, Chimeric Therapeutics acquires the exclusive rights to develop and commercialize the CDH17 CAR T cell therapy for which it has agreed to pay Penn license fees, development milestones and royalty payments based on commercial net sales. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves.

The University of Pennsylvania is a globally recognized leader in cellular immunotherapy and widely known for being home to the 1st FDA approved CAR T therapy.

The Chimeric team will be leveraging its unique cell therapy expertise to ensure the timely development and commercialization of the novel CDH17 CAR T cell therapy, bringing the promise of cell therapy and curative potential to more patients with cancer.

Chimeric’s Executive Chairman Paul Hopper said "We are delighted to have secured the exclusive rights to this promising asset from one of the world’s pre-eminent cell therapy centres which has been a powerhouse in CAR T innovation for many years. We look forward to utilizing the deep cell therapy expertise of our team to develop and commercialize this CAR T."

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper

On July 28, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Wednesday, August 4, 2021 at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2021 and to provide a corporate update (Press release, INmune Bio, JUL 28, 2021, https://inmunebio.com/index.php/en/news-2/2021/464-muneionctoeporteconduarter2021inanciale20210728 [SID1234585291]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 11 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13721921.

On July 28, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that Derek Maetzold, president and chief executive officer, is scheduled to present a company overview at the Canaccord Genuity 41st Annual Growth Conference on Wednesday, Aug. 11, 2021, at 3:30 p.m. Eastern time (Press release, Castle Biosciences, JUL 28, 2021, View Source [SID1234585308]).

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A live audio webcast of the company’s presentation will be available by visiting Castle Biosciences’ website at View Source A replay of the webcast will be available for two weeks following the conclusion of the live broadcast.

On July 28, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that an IND application for the initiation of a phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with anti-PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers (HNC), has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Press release, I-Mab Biopharma, JUL 28, 2021, View Source [SID1234585325]).

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Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 ("rhIL-7") being developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show a therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Its T-cell properties comes with unique selectivity that only stimulates tumor-fighting lymphocytes and spares tumor-protecting Treg cells, differentiating it from other cytokines such as human IL-2.

The IND submission leverages accumulative clinical data from multiple previous studies of efineptakin alfa as monotherapy and in combination with checkpoint inhibitors in the treatment of advanced solid tumors, conducted by I-Mab in China and Genexine and NeoImmuneTech in South Korea and the U.S., respectively. Data from the phase 1b/2 Keynote-899 study, presented at SITC (Free SITC Whitepaper) 2020, have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC. According to the data from NIT-110 dose escalation presented at ASCO (Free ASCO Whitepaper) 2021, the combination treatment was safe and well-tolerated in the study. In addition, interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas that have undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 – 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with a one-year survival rate of 83.3% being observed so far.[1] Furthermore, a phase 1b trial (NCT04001075) in China is about to complete to facilitate the further development of efineptakin alfa.

"Current clinical data suggest that efineptakin alfa has the great potential to revolutionize the treatment in particularly difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "We have already initiated a phase 2 trial in lymphopenic patients with newly-diagnosed glioblastoma multiforme earlier this year. With these additional studies, we hope to fast-track the clinical development of efineptakin alfa in China and bring this potentially very valuable treatment to a large population of cancer patients."

[1] Data can be viewed in NeoImmuneTech’s poster presentation at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting at the following link: View Source;fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.