On December 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on December 9th, 2021, that its Data & Safety Monitoring Committee (DSMC) has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, DEC 9, 2021, View Source [SID1234596725]). All patients have now been recruited into the study. The safety profile of RV001 (onilcamotide) was considered excellent, and the DSMC concluded that the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. RhoVac currently estimates finalising the study and presenting results in the first half of the 2022. The objective of the study is to show that RV001 (onilcamotide) can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted by the DSMC last week, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous DSMC conclusions on BRaVac, as well as with the findings of the phase I/II study, including follow-up studies. And therefore, the study continues without modifications.

RhoVac CEO, Anders Månsson, comments: "RhoVac has handled its study recruitment well in spite of the difficulties circumstances brought about by the covid pandemic. We had no reason to anticipate anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence and metastatic disease. An effective cancer vaccine with this profile could fulfil a huge unmet medical need in prostate cancer as well as in on other common cancers".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-12-2021 08:42 CET.

On December 9, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the presentation of preliminary translational data from patient biopsies demonstrating immune activation in the tumor microenvironment (TME) after treatment with COM701, Compugen’s potentially first-in-class anti-PVRIG antibody, as a monotherapy and in combination with nivolumab at the TIGIT Therapies Digital Summit (Press release, Compugen, DEC 9, 2021, View Source [SID1234596724]).

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"These translational data are exciting as they represent the first demonstration of immune activation in the TME of patients who have been treated with COM701 monotherapy or in combination with nivolumab and add to previous data showing immune activation in peripheral blood taken from treated patients," said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "In addition, we are encouraged by the observed increases in clonal expansion of T cells, immune infiltration and immune activation in an MSS-CRC patient with a confirmed response after COM701 and nivolumab combination therapy given this is an indication that is unlikely to respond to PD-(L)1 blockade. These results are consistent with our earlier findings supporting PVRIG pathway involvement in early differentiation memory T cell priming and activation and provide important evidence of immune modulation at the location critical for efficacy, the tumor site."

Dr. Ophir continued "These data, combined with our earlier findings suggest PVRIG plays a distinct role within the DNAM-1 axis. We look forward to continued investigation of PVRIG blockade in the clinic which we believe has the potential to drive immune responses to address both inflamed and less inflamed tumor types that are typically unresponsive to current checkpoint inhibitors".

Key new findings from the presentation titled, "Harnessing PVRIG & TIGIT Combination in Anti-Cancer Immunity" presented by Dr. Ophir include:

Increased TME immune activation and TCR clonality was observed in a patient with PVRL2+, PD-L1low MSS-CRC with a partial response following treatment of COM701 in combination with nivolumab
COM701 induced immune activation in the TME of a patient with ovarian cancer, showing increased CD8+ T cells and markers of immune activation
COM701 in combination with nivolumab induced markers of activated dendritic cells in the serum of 2 responding patients
The presentation will be available on the publication section of Compugen’s website.

On December 9, 2021 M2GEN, a bioinformatics company accelerating discoveries in oncology research through superior data and analytics, reported it is partnering with Microsoft to advance and scale its unique data-driven solutions for the discovery, research and development of new oncology therapies (Press release, M2Gen, DEC 9, 2021, View Source [SID1234596723]). The collaboration brings together Microsoft’s healthcare-focused technologies and M2GEN’s scientific capabilities, including its industry-leading clinico-genomics database, enabling oncology researchers to unlock the future of cancer therapeutics.

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Big data, advanced analytics, and machine learning/AI have the potential to power innovation in the life sciences, but this potential can only be realized through high-quality data collection, healthcare expertise and technological innovation. M2GEN is positioned to meet this potential as the technological hub of the Oncology Research Information Exchange Network (ORIEN), a growing alliance of 18 leading National Cancer Institute (NCI)-Designated cancer centers. Since 2014, M2GEN has collected a world-class dataset comprised of tumor and germline genomic data matched with longitudinal, lifetime-consented clinical data from over 300,000 patients. In that time, M2GEN has transformed this dataset into a vital tool that frictionlessly delivers complex oncology data and analytics solutions to researchers in pharmaceuticals, biotechnology, and academia, leading to breakthroughs in oncology science that can improve cancer patient care.

M2GEN will collaborate with Microsoft to quickly and meaningfully enhance this tool into a scaled platform that leverages Azure Synapse Analytics with Microsoft Azure Healthcare APIs to enable broad and deep clinico-genomic analysis capabilities and services. The platform will be built on the foundation of Azure Data Lake Storage Gen2 and Azure Purview, the unified data governance solution. Microsoft’s engineers will work side-by-side with M2GEN’s top-tier technology team led by Chief Technology Officer Wilf Russell, who brings over 30 years of software industry building and leadership experience. Working alongside the M2GEN team will give Microsoft key insights to help inform product features and influence roadmap decisions that are key to M2GEN and the industry’s needs.

"The M2GEN team, with its diverse background in oncology research, bioinformatics and technology, is dedicated to providing, data-driven solutions for oncology drug discovery and development. Our collaboration with Microsoft will allow us to scale these efforts, as they are providing access to advanced tools to power every part of the data cycle," said Jim Gabriele, President and Chief Executive Officer of M2GEN. "Microsoft’s commitment to life science and its superior technologies make them a partner of choice for M2GEN. Together, our two companies will accelerate the impact of data and analytics on personalized cancer care for patients."

"At Microsoft, we have long recognized the tremendous opportunity for advanced computational data to improve global health outcomes for all patients in need," said Tom McGuinness, Corporate Vice President for Global Healthcare & Life Sciences at Microsoft. "M2GEN has taken the first step, assembling an extensive cancer dataset that has already fueled important breakthroughs in precision oncology. We look forward to working with M2GEN to produce meaningful solutions for oncology researchers."

On December 9, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it will hold a call with investors at 8:00 a.m. EST on December 14 to provide an in-depth analysis of the most recent clinical data from an ongoing clinical trial of lemzoparlimab in combination with rituximab in relapsed or refractory non-Hodgkins’s lymphoma (Press release, I-Mab Biopharma, DEC 9, 2021, View Source [SID1234596722]).

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I-Mab Conference Call Information

Investors and analysts are invited to join the conference call at 8:00 a.m. EST on December 14 via Zoom:

Meeting URL: View Source
Meeting ID: 914 2193 6788
Password: 249389

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic maliglencies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies will potentially support registrational trials later in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On December 9, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has entered into a clinical collaboration with Clover Biopharmaceuticals, Ltd. ("Clover"; Stock Code: 2197.HK) to evaluate Ascentage Pharma’s APG-1387, a second mitochondria-derived activator of caspase (SMAC)-mimetic/inhibitor of apoptosis proteins (IAP) antagonist, in combination with Clover’s SCB-313, a recombinant human TRAIL-trimer fusion protein, in a Phase Ib/II study in patients with advanced peritoneal carcinomatosis (Press release, Ascentage Pharma, DEC 9, 2021, View Source [SID1234596720]).

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Ascentage Pharma and Clover will jointly conduct this open-label, multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics (PK/PD), and efficacy of APG-1387 in combination with SCB-313 for the treatment of patients with primary or secondary peritoneal carcinomatosis from different primary tumor origins in China and Australia.

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly specific next-generation IAP antagonist and the first IAP antagonist entering clinical development in China. To advance the clinical development of APG-1387 globally, Ascentage Pharma has completed a Phase I dose-escalation for the treatment of solid tumors in China and Australia, and is currently conducting multiple clinical studies of APG-1387 combinations for the treatment of solid tumors in China and the US. Meanwhile, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

Clover’s SCB-313 is a trimeric fusion protein in clinical development for the treatment of intracavitary malignancies. Based on positive Phase I interim analyses, Clover plans to advance SCB-313 into a Phase II clinical trial for malignant ascites in the first half of 2022. SCB-313 is also in Phase I clinical trials for malignant pleural effusions and peritoneal carcinomatosis. Clover also plans to initiate new Phase I trials for SCB-313 in new indications, such as bladder cancer, in 2022.

"Safe and effective combination therapies represent an increasingly important approach in cancer treatment. We hope APG-1387 in combination with Clover’s SCB-313 will demonstrate synergistic effect," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We look forward to working closely with Clover to advance this clinical collaboration which hopefully will offer a new treatment option to patients with peritoneal carcinomatosis."

"Clover is excited to enter into this partnership with Ascentage Pharma to explore innovative treatment options and alternatives to surgery for patients suffering from peritoneal carcinomatosis," said Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals. "Combination treatment is a cornerstone of cancer therapy. By targeting different nodes within the apoptosis pathway, we believe the combination of SCB-313 and APG-1387 could provide a synergistic benefit to patients."

About APG-1387

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly selective next-generation inhibitor of apoptosis proteins (IAP) antagonist that can degrade IAPs by mimicking endogenous second mitochondria-derived activator of caspase (SMAC) molecule to induce programmed cell death or apoptosis. To advance the clinical development of APG-1387 globally, Ascentage Pharma has already completed a Phase I dose-escalation study in patients with solid tumors in China and Australia, and is currently conducting a Phase Ib/II clinical study of the APG-1387 plus pembrolizumab combination in patients with solid tumors in the US, and a Phase Ib/II study of APG-1387 plus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer in China. Moreover, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

About SCB-313

SCB-313, an innovative, recombinant human TNF-related apoptosis-inducing ligand (TRAIL)-Trimer fusion protein engineered using the Trimer-Tag technology platform to target the extrinsic apoptosis pathway. Binding of SCB-313 to the death receptors (DR4 and DR5) leads to physiologic trimerization and potent activation of the extrinsic apoptosis pathway.