On June 4, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will participate in a virtual fireside chat at the Raymond James Human Health Innovation Conference at 12:20 p.m. ET on Thursday, June 18, 2020 (Press release, AngioDynamics, JUN 8, 2020, View Source [SID1234560906]).

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A live webcast of the fireside chat will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On June 8, 2020 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the expansion of the company’s pipeline of small molecule candidates across a range of highly prevalent human diseases (Press release, Nimbus Therapeutics, JUN 8, 2020, View Source [SID1234560891]). These preclinical programs — AMPKβ2 (AMP-activated protein kinase, β2 subunit), CTPS1 (CTP synthase 1), Cbl-b (Cbl proto-oncogene B), and WRN (Werner syndrome ATP-dependent helicase) — represent promising targets across oncology, immunology and metabolism, for which Nimbus’ structure-based discovery approaches are uniquely suited.

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"The additional programs we’re unveiling today are a testament to Nimbus’ exceptional talent, the unwavering support of our investors, and the dynamic scientific collaborations we have built over the past decade," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Our prolific pipeline reflects the breadth of potential we see for our discovery engine going forward, and a new chapter in Nimbus’ leadership of structure-based drug discovery. We look forward to progressing these programs forward to the clinic within our development organization, which advanced our ACC inhibitor to an early proof of mechanism and is currently progressing our Tyk2 inhibitor toward Phase II."

"With the addition of these targets, we’ve built a pipeline of promising therapeutics for the treatment of patients with diseases that have limited or no therapeutic options," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "Each of these targets represents the ‘sweet spot’ for Nimbus’ approach — they are known to be fundamental drivers of highly prevalent diseases but have proven difficult for the industry to drug. As we have demonstrated with our progress on HPK1, which is being presented at AACR (Free AACR Whitepaper) this month, we believe our structure-based drug discovery engine can generate the potent, selective small molecule therapeutics needed to move the needle on these targets."

A brief overview of our newly disclosed programs follows:

AMPKβ2 for cellular metabolic regulation
AMPK is a kinase that serves as a critical regulator of energy-sensing and metabolic homeostasis in many tissues. Small molecule activation of AMPK has long been recognized as a potential strategy to treat multiple metabolic disorders and other pathologies. Nimbus’ approach leverages new understandings in AMPK subunit structure to identify activators selective for the AMPKβ2 subtype of the protein to improve glucose and lipid homeostasis, while reducing undesired effects.
CTPS1 for controlling immune activation
CTPS1 is a key enzyme in the pyrimidine synthesis pathway in lymphocytes, making it a drug target for autoimmune diseases and cancer. Selective inhibitors of CTPS1 hold promise for attenuating lymphocyte proliferation and providing effective treatments for T and B cell-driven diseases. Nimbus is using structure-based and other computational chemistry approaches to identify small molecules that are highly potent inhibitors of CTPS1 with selectivity over CTPS2.
Cbl-b for enhancing immune sensitivity in cancer
Cbl-b is an E3 ubiquitin ligase that directs the degradation of signaling proteins across a variety of immune cells. Cbl-b is a well-validated immuno-oncology target, given that Cbl-b knockout mice spontaneously reject tumors with enhanced T and NK cell responses, and Cbl-b deficient T cells can be activated in the absence of co-stimulatory signals. Nimbus is pursuing a structure-based approach to designing inhibitors of Cbl-b that can enhance anti-tumor immunity.
WRN as a selective approach to targeting MSI-high tumors
WRN, a helicase required for DNA replication and repair, is a validated target for treating microsatellite-instability high tumors ("MSI-H tumors"). Pharmacological inhibition of helicases has proven difficult in the past, but WRN is now amenable to structural biology approaches, allowing Nimbus to design both active-site and allosteric inhibitors of WRN that should induce synthetic lethality in tumors with microsatellite instability.

On June 8, 2020 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, Cancer Research UK and Cambridge University Hospitals NHS Foundation Trust ("CUH"), reported a collaboration to identify and develop microbiome co-therapeutics and biomarkers for cancer patients receiving immune checkpoint inhibitor therapy (Press release, Microbiotica, JUN 8, 2020, View Source [SID1234560907]).

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The collaboration is based on clinical studies conducted by CUH that evaluate immune checkpoint inhibitor drug response in cancer patients, combined with Microbiotica’s unrivalled microbiome profiling and analysis capability.

Two clinical studies are involved: MELRESIST, a completed class-leading melanoma study, and MITRE, a major landmark study in melanoma, lung and renal cancer, involving 1,800 patients, specifically designed for evaluation of microbiome and other biomarker effects.

The MITRE study will be co-led by Dr Trevor Lawley, Microbiotica’s co-founder and CSO, and Dr Pippa Corrie, Consultant in Medical Oncology at CUH, and will involve comprehensive patient sample collection, data collection and biochemical analysis, with medicines provided by the NHS. Microbiotica will undertake mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis.

Checkpoint inhibitors have transformed the management of cancer, due to the range of cancers that can be treated and their high levels of efficacy, including complete remission in some cases. However, response rates are low, typically in the range 10-40% of patients. There is therefore a major unmet need for co-therapies to extend the number of responders and for biomarkers to stratify patients for treatment.

Several studies have shown that the gut microbiome plays a critical and causative role in determining which patients respond to these medicines. However thus far they have failed to identify a consistent gut bacterial signature associated with treatment response or resistance. Microbiotica has used its unique microbiome profiling platform with MELRESIST data to identify for the first time a common signature predictive of drug response across multiple melanoma studies, and this is being progressed within the Company. MITRE will take this further by examining the effects in different cancers, a range of immunotherapy regimens, as well as association with side-effects of immunotherapy.

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype. The Company also has capabilities to develop and take such products to the clinic.

The collaboration will identify specific gut bacterial signatures correlated with drug efficacy and side effects in patients under treatment for melanoma, non-small cell lung cancer and renal cancer. From these signatures, Microbiotica will progress live bacterial products as co-therapies and microbiome biomarkers predictive of immunotherapy response and toxicity into the clinic.

On June 8, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that Avi Oler, Senior Vice President, Corporate Development, will present at BIO Digital 2020, being held virtually June 8 – 12, 2020 (Press release, Onconova, JUN 8, 2020, View Source [SID1234560892]).

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Mr. Oler will provide an overview of the Company’s corporate development objectives and upcoming milestones for its lead candidate rigosertib and its oncology product candidate pipeline. The presentation will be available here for viewing on-demand.

Mr. Oler will be available for virtual meetings throughout BIO Digital. To arrange a meeting, please visit the BIO One-on-One Partnering webpage.

On June 8, 2020 Alphamab Oncology (stock code: 9966 HK) a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi (EURONEXT: SAN andNASDAQ: SNY), a global biopharmaceutical leader, reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones (Press release, Alphamab, JUN 8, 2020, View Source [SID1234560908]).

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KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

Taxotere (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies. There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026’s China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients."

Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "Building on Sanofi’s heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China. This strategic partnership also demonstrates Sanofi’s ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies."

Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.