On June 30, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics, reported the acquisition of Los Angeles-based Olimmune Inc (Press release, Scopus BioPharma, JUN 30, 2021, View Source [SID1234584530]).

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Olimmune is a developer of groundbreaking oligonucleotide immunotherapies for treatment-resistant and metastatic cancers. Olimmune’s lead drug candidate, OLIM-01, is being developed for genitourinary and head and neck cancers. It is anticipated that INDs for these indications will be submitted by Q1 2023.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "The acquisition of Olimmune dramatically expands our reach in immuno-oncology. Both companies have been pioneering proprietary technologies to address traditionally "undruggable" targets, such as STAT3. This combination positions Scopus as a global leader in bifunctional oligonucleotide cancer therapeutics."

Olimmune was co-founded by Marcin Kortylewski, Ph.D., a leading immuno-oncologist and Professor in the Department of Immuno-Oncology at City of Hope. Dr. Kortylewski and his laboratory were instrumental in the seminal discovery that successful cancer immunotherapy needs to combine both TLR9 immunostimulation and STAT3 inhibition. This strategy underpins CpG-STAT3siRNA, Scopus’ lead drug candidate, which is covered by certain patents licensed from City of Hope. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

Dr. Kortylewski stated, "While it’s necessary to deliver STAT3 inhibitors to the proper cells, STAT3 inhibition, by itself, is not sufficient. You also need to stimulate immune activation. Fortunately, the short CpG sequence also serves as a TLR9 agonist, so you get release of immunosuppression by the STAT3 inhibitor and immune activation through TLR9 activation, both of which are necessary for a robust anti-cancer response."

Dr. Kortylewski added, "City of Hope and Scopus are working closely to initiate a Phase 1 clinical trial evaluating CpG-STAT3siRNA for non-Hodgkin lymphoma. Now, we will work towards expanding our collaboration to other challenging cancer indications, such as head and neck, kidney, or prostate cancers using alternative STAT3 inhibitors."

Alan Horsager, Ph.D., President and Chief Executive Officer of Olimmune, stated, "Scopus BioPharma is the ideal home for Olimmune. The combination of immuno-oncology assets creates a comprehensive portfolio of complementary cell-selective oligonucleotide therapeutics. Moreover, Scopus’ clinical development will provide us with invaluable insights, experience and expertise in bringing our drug candidates into the clinic."

Olimmune has exclusive, worldwide licenses to certain patents from City of Hope to develop and commercialize CpG-STAT3ASO and CpG-STAT3decoy.

Terms of the acquisition have not been disclosed.

On June 30, 2021 BeiGene reported that it been approved to stage a $3 billion IPO on the Shanghai Star Stock Exchange (Press release, BeiGene, JUN 30, 2021, View Source [SID1234584527]). It will be the first Chinese biopharma to be listed in Shanghai, Hong Kong and the US. According to a Caixin report, BeiGene’s propectus meets the listing conditions and information disclosure requirements of the STAR Market, but regulators asked BeiGene to explain how it will protect the interests of domestic shareholders. Founded in 2010, BeiGene develops molecularly targeted and immuno-oncology drug candidates to treat cancer.

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On June 30, 2021 Cerus Corporation (NASDAQ: CERS) reported an agreement with LifeSouth Community Blood Centers (LifeSouth) to serve as a production partner for INTERCEPT Fibrinogen Complex, the company’s pathogen reduced cryoprecipitated fibrinogen complex product (Press release, Cerus, JUN 30, 2021, View Source [SID1234584526]). LifeSouth is the fifth production partner for INTERCEPT Fibrinogen Complex, enabling the initial commercial launch of the product to expand into the state of Florida.

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"We are delighted to add LifeSouth as a blood center manufacturing partner for INTERCEPT Fibrinogen Complex," stated Elan Weiner, general manager of Cerus Therapeutics. "The initial market response has been enthusiastic and as we gear up for a nationwide launch in 2022 following anticipated BLA approvals, we are happy to be able to offer this product in Florida through our partnership. LifeSouth’s strong presence throughout the Southeast will help ensure we have the ability to easily deliver product to hospitals in the region," Mr. Weiner continued.

As the third most populous state in the country, Florida is home to more than 30 Level 1, Level 2 and Pediatric trauma centers. Together with the other four states that are a part of the initial launch (California, Louisiana, Texas and Wisconsin), INTERCEPT Fibrinogen Complex will be available for use to nearly one-third of the U.S. population.

"We believe INTERCEPT Fibrinogen Complex is an exciting innovation in transfusion medicine, and we are pleased to partner with Cerus in the Florida market. Tools to help manage bleeding patients help fill a significant unmet need, and we are excited to contribute to making INTERCEPT Fibrinogen Complex available," noted Kimberly E. Kinsell, president and chief executive officer of LifeSouth.

On June 30, 2021 ArriVent Biopharma, Inc., industry leaders dedicated to accelerating the global development of innovative biopharmaceutical products, reported the launch of its company with up to $150 million in Series A financing and a potential best-in-class epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), furmonertinib, licensed from Shanghai-based, Allist Pharmaceuticals (Press release, ArriVent Biopharma, JUN 30, 2021, View Source [SID1234584525]).

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The financing, which provides the Company with $90 million upfront and additional proceeds upon completion of certain milestones, was led by Hillhouse Capital Group, with participation from Lilly Asia Ventures, OrbiMed, Octagon Capital Advisors, Boyu/Zoo Capital, and Lyra Capital.

"We are launching our company with a strong, expanding team that has in-depth scientific and clinical development expertise as well as substantial capital from leading healthcare investors. This financing has supported the in-licensing of our first asset, furmonertinib, and will continue to support the buildout of our portfolio of innovative medicines," said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent. "Our strategy focuses on identifying compounds, such as furmonertinib, that have been validated through rigorous discovery and development processes in China and other emerging biotech hubs to help bridge these global biopharma innovations to the U.S., EU and beyond. Securing ex-China development, manufacturing and commercialization rights to furmonertinib—a clinical-stage asset with best-in-class potential—is an important initial step toward potentially accelerating its global development for patients with difficult to treat cancers who presently lack viable treatment options."

Allist Pharma received approval for furmonertinib in EGFR T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) indications in China in March 2021. The company— which is focused on R&D, manufacturing and commercialization of targeted cancer therapies—is actively studying furmonertinib’s potential in other EGFR mutant NSCLC patient populations in China, both in the metastatic as well as adjuvant clinical settings.

ArriVent intends to file an investigational new drug application with the U.S. FDA to further develop furmonertinib in patients with EGFR mutant NSCLC, and potentially other solid tumors, by year-end and is exploring global development opportunities.

Commented Stuart Lutzker, M.D., Ph.D., Chief Medical Officer and Co-founder of ArriVent: "In the short time since our inception, ArriVent has built an impressive team of drug developers with established and broad expertise in clinical development, including registrational strategies, and deep experience working with biotech partners around the globe. We believe our company is well-positioned to realize the full potential of innovative drugs, broadening their reach to patients."

On June 30, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the combination expansion cohort of its ongoing Phase 1 clinical trial evaluating COM701, Compugen’s first-in-class anti-PVRIG antibody, in combination with Opdivo (nivolumab) (Press release, Compugen, JUN 30, 2021, View Source [SID1234584523]). The indications for the combination therapy expansion cohort, ovarian, breast, endometrial and colorectal cancers were selected based on preclinical biomarker assessments.

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"The data generated from the combination study of COM701 with Opdivo (nivolumab) in the dose escalation setting are encouraging, including a confirmed complete response in one patient and durable anti-tumor activity observed beyond one year in multiple highly refractory patients," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The activity observed strengthens our confidence that dual blockade of PVRIG and PD-1 may be key to driving antitumor immune responses in certain patient populations and we look forward to continued evaluation of this potentially promising regimen in the indications selected for the expansion cohort. The dosing of the first patient in the cohort expansion phase of this study follows expansion of our collaboration with Bristol Myers Squibb and speaks to our steady execution in the clinic. As the only company with clinical-stage candidates against both PVRIG and TIGIT, we believe that this study strengthens our first-mover advantage in evaluating the DNAM axis as a potential new foundational immunotherapy axis in cancer immunotherapy."

The Phase 1b combination cohort expansion study is part of the Phase 1 open-label clinical trial designed to assess the safety, tolerability and preliminary anti-tumor clinical activity of administering escalating doses of COM701 monotherapy, as well as in combination with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. The Phase 1b combination cohort expansion arm is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NCT03667716).

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. PVRIG and TIGIT, also discovered by Compugen’s computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.