On September 27, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, reported that they have entered into a strategic collaboration and license agreement for the development and commercialization of orismilast in China (Press release, Innovent Biologics, SEP 27, 2021, View Source [SID1234590356]).

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Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including participating in and recruiting Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of USD 20 million and is further entitled to receive up to USD 247 million in milestone payments as well as tiered royalties on sales of orismilast in China. UNION will retain global rights for orismilast outside of China.

In China there are approximately fifty million patients suffering from atopic dermatitis and six million patients suffering from psoriasis, and their prevalence is rising with changing lifestyles. Current standard of care treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in efficacy, safety or route of administration, presenting significant unmet clinical needs. In Phase 2a clinical studies, orismilast has demonstrated potential best-in-class profiles in these conditions, with a combination of improved efficacy and tolerability, and could be well positioned to address the unmet needs of these patient populations.

Dr. Yongjun Liu, President of Innovent, said: "We are very pleased to enter a collaboration with UNION. We have been impressed with our partner’s capability to advance the global development of orismilast and we are excited to help bring orismilast to patients in China. This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio. Innovent is proud to be an ideal partner for worldwide biotech and pharmaceutical companies in terms of accelerating the development and commercialization progress of novel assets to benefit a broader patient population."

Kim Kjøller, Chief Executive Officer of UNION therapeutics, said, "We are excited to enter into this strategic collaboration with Innovent, whose deep insights and presence in China make them an ideal partner to bring orismilast to Chinese patients. We are impressed by Innovent’s track record of international partnering, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the best-in-class potential of orismilast, and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is core to our strategy of maximizing the value of our product candidates, and we are therefore excited to enter this collaboration with an internationally recognized partner."

About orismilast

Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best- or first-in-class treatment option in both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to result in an attractive therapeutic window, i.e., the combination of improved efficacy and tolerability, compared to other PDE4 inhibitors. UNION has two product candidates with orismilast in Phase 2 clinical development: UNI50001, an oral PDE4 inhibitor investigated for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast investigated for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical currently approved and marketed.

On September 27, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab"), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported a research collaboration with Leeds University to further study the role of CCL24 in the vascular damage associated with systemic sclerosis (SSc), a rare rheumatic disease with high morbidity and mortality (Press release, Chemomab, SEP 27, 2021, View Source [SID1234594670]). The collaboration will be led by Francesco Del Galdo, MD, PhD, Professor of Experimental Medicine at the University of Leeds and Head of the Scleroderma Program at the Leeds Musculoskeletal Biomedical Research Centre. Prof. Del Galdo is a recognized expert in the study of SSc and other rheumatic conditions.

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CCL24 is a soluble protein that has been shown to play a key role in mediating fibrotic and inflammatory processes that are the hallmark pathologies related to SSc. It is the novel target for Chemomab’s CM-101, a first-in-class, CCL24 neutralizing monoclonal antibody that Chemomab plans to assess in a Phase 2 trial in SSc patients beginning early next year. Chemomab has generated substantial mechanistic data related to CCL24-associated fibrosis and inflammation in SSc, as well as early data showing that CCL24 is potentially involved in the vascular damage associated with SSc. The partnership with Prof. Del Galdo will seek to provide additional insights into the mechanisms underlying CCL24-associated vascular damage and could also uncover additional application opportunities for CM-101.

"We are delighted to partner with Prof. Del Galdo and his team to further study how CCL24 contributes to the vascular damage in SSc," said Dr. Adi Mor, CEO of Chemomab. "They have developed state-of-the art models of vascular damage based on their large collection of SSc patient samples. At Chemomab, we have extensively studied how CCL24 causes fibrosis and inflammation in preclinical SSc models. This collaboration is expected to increase our understanding of the association between CCL24 and vascular damage using human samples, with the aim of helping guide future SSc registration trials and ultimately providing benefit to these patients who have no effective treatment options."

Prof. Del Galdo said, "Systemic sclerosis is a connective tissue disease caused by an unfortunate combination of fibrosis, inflammation and vascular damage. Because of the nature of the tissue damage caused by SSc, it remains one of the most severe autoimmune diseases, with a poor prognosis and very limited treatment options. Extensive preclinical studies indicate that CCL24 is an important mediator of fibrosis and inflammation. We welcome the opportunity to partner with Chemomab to better understand the role of CCL24 in causing the vascular damage that contributes significantly to the overall morbidity and mortality of SSc patients."

About Systemic Sclerosis

SSc, also known as scleroderma, is a rare autoimmune rheumatic disease characterized by fibrosis and inflammation of the skin, joints and internal organs, as well as vascular abnormalities. It predominantly affects women and is typically diagnosed when patients are between 30 and 50 years old. It is the most lethal of the systemic rheumatic diseases with a median survival of only 10 years. There is no approved disease modifying drug for SSc. There currently are an estimated 100,000 SSc patients in the US.

On September 27, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the, "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that Mark Lowdell, PhD, Chief Scientific Officer and Chief Medical Officer, will be participating in an oncology panel at the B. Riley Fall 2021 Best Ideas in Oncology Series (Press release, INmune Bio, SEP 27, 2021, View Source [SID1234590294]).

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Panel details:

Title: Improving Strategies to Harness the Immune System

Date: Thursday, September 30, 2021

Time: 9:00am ET

This event is open to institutional investors. Interested parties may register for the panel here.

On September 27, 2021 TYME Technologies, Inc. ("TYME" or the "Company") (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that the first patient has been dosed in the Phase II OASIS trial in patients with metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer who previously received a CDK4/6 inhibitor regimen being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner (Press release, TYME, SEP 27, 2021, View Source;Breast-Cancer-After-Treatment-with-a-CDK46-Inhibitor [SID1234590323]).)

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"Metastatic breast cancer is still an incurable disease and represents the second-leading cause of cancer death in women.2 The sobering statistics speak to the urgent need to find novel effective therapies that address this difficult-to-treat cancer. As this important trial begins, we are encouraged by the results in breast cancer patients from our prior first-in-human study and compassionate use program, which showed broad anti-tumor activity, including complete responses. We believe the compelling data support our strategic decision to further evaluate oral SM-88 in this setting, and we are hopeful that we will repeat the promising early activity. If so, we believe an effective drug with SM-88’s demonstrated tolerability profile would offer patients an attractive treatment option, while maintaining quality of life," said Richie Cunningham, Chief Executive Officer of TYME.

"We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients. Dosing the first patient is a critical milestone in advancing oral SM-88 as a potential treatment option prior to chemotherapy for this patient population. This is a significant opportunity for TYME, and we look forward to providing updates as the OASIS trial progresses," concluded Cunningham.

The Phase II OASIS Trial

The OASIS clinical trial is an investigator-initiated multicenter Phase II single-arm, prospective open-label study of oral SM-88 used with methoxsalen, phenytoin, and sirolimus ("MPS") in metastatic HR+/HER2- breast cancer who have received a prior CDK4/6 inhibtor regimen. The study is designed to determine efficacy, defined as the overall response rate ("ORR") of this investigational treatment. It is designed as a two-stage trial, initially enrolling 30 patients, with potential expansion up to a total of 50 patients without concurrent cancer therapies. The primary endpoint is RECIST v1.1 tumor response; collection of cell-free DNA from patients will also occur at several time points in their treatment. If anti-tumor activity or a signal is observed among the first 30 patients, the trial may be expanded to confirm the findings.

With this trial, the Company is also incorporating mechanism-of-action and biomarker research, both preclinically and clinically. Preclinically, the Company is working with a Georgetown laboratory on SM-88’s effect in breast cancer models, including models of CDK4/6 inhibitor resistance. Clinically, the Company is collecting cell-free DNA samples from patients at multiple timepoints in their treatment and through progression to possibly identify biomarkers that could further inform future development work.

CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma, with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

About Breast Cancer

According to the American Cancer Society, in 2021 in the United States, approximately 1 in 8 women will be diagnosed with invasive breast cancer in their lifetime, and 1 in 39 women will die from the disease. Breast cancer is the most commonly diagnosed cancer in women, with approximately 280,000 women diagnosed in the U.S. annually and more than 3.8 million breast cancer survivors in the United States today. In the United States, HR+/HER2- represents 73% of diagnoses and is the largest subtype of breast cancer.

On September 27, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial to test PC-002, an inhibitor that targets MYC mutations, in combination with carboplatin and etoposide (PE) in patients with castration resistant and neuroendocrine prostate cancer (NEPC) (Press release, Cothera Bioscience, SEP 27, 2021, View Source [SID1234618851]).

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NEPC most frequently develops in patients with castration-resistant prostate adenocarcinoma following standard treatment with androgen receptor antagonists, other hormonal therapy or taxane-based chemotherapy. Clinically, NEPC is highly aggressive and metastasizes to visceral organs, such as the liver, much more avidly than prostate adenocarcinoma. MYC is overexpressed in the majority of NEPC and appears to be critical to the development of NEPC. Recent data indicate that NEPC occurs in approximately one out of six patients who develop progressive hormone-resistant prostate cancer. The incidence of treatment-related NEPC is expected to rise due to the prevalent use of hormonal therapies in prostate cancer.

PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancers involving MYC dysregulation.

Dr. Vernon Jiang, Co-founder and EVP of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials in NEPC is another important milestone for Cothera. The team worked efficiently to file the IND and obtained approval expeditiously. We will continue our effort to launch and execute late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."