On October 5, 2021 CN Bio, a leading Organ-on-a-chip Company (OOC) that designs and manufactures single- and multi-organ microphysiological systems (MPS), reported the commercial launch of its Oncology Service in response to the global need to improve cancer drug discovery approval rates (Press release, CN Bio Innovations, OCT 5, 2021, View Source [SID1234590842]).

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Understanding the relationship between pharmacokinetics, pharmacodynamics (PK/PD) and efficacy is critical to the successful development of new medicines, but at present this relationship is primarily investigated using animal models – a process that is time-consuming, ethically undesirable and prone to a lack of translation. This contributes to the low success rate of oncology medicines in the clinic. Expanding CN Bio’s portfolio, the Oncology Service provides a unique means to explore these relationships in vitro, offering a new approach to accelerate the development of cancer therapeutics.

Despite the advancement of in vitro models, the ability of existing approaches to mimic the dynamic drug concentrations found in the human body is limited, with none currently able to recreate PK profiles and investigate their effect on cells and tissues. CN Bio’s Oncology Service addresses this gap in research by enabling researchers to create human and animal PK profiles and apply them to 3D tumour models and organoids.

Harnessing novel technology licensed from the Vanderbilt Institute for Integrative Biosystems Research and Education (VIIBRE), led by Professor John Wikswo, the proprietary PhysioMimix PK system exposes 3D tumour models to in vivo-like profiles by periodically changing the drug concentration in the well. This feature is not currently possible in standard in vitro experiments as the concentration is fixed.

Offering significant time and cost savings, the service enables customers to study dose combinations and schedules which previously required large and expensive xenograft studies. In doing so, the new Oncology Service aims to support improved oncology drug discovery success rates and facilitate precision medicine using patient cells.

Dr Tomasz Kostrzewski, Director of Biology, CN Bio, said: "The expansion of CN Bio’s service offering to support oncology studies amplifies the breadth of solutions we provide into a critical area of research, that hasn’t been possible before. The Service supports scientists to decide with greater confidence which projects to invest in, in a fraction of the time and cost of comparable approaches, giving a marked competitive edge, whilst demonstrating our continued focus on driving innovation within the Life Sciences."

Dr David Hughes, CEO, CN Bio, commented: "Ninety percent of drugs entering phase 1 trials fail, often due to a lack of efficacy, and consequently resulting in billions wasted in R&D costs. There is certainly a concerted move towards replacing the use of animal models in drug discovery, as illustrated by the recent vote in the EU parliament. CN Bio’s Oncology Service supports this movement by evidencing how the technology better recapitulates scenarios in vivo, to reduce reliability on conventional testing models."

Professor John Wikswo, Director, Vanderbilt Institute for Integrative Biosystems Research and Education (VIIBRE), added: "Oncology drug discovery is a fantastic application of our technology. I am thrilled by the CN Bio team’s elegant translation of my group’s work to a commercial service; demonstrating the possibility to use microfluidic pumps and valves to impose different pharmacokinetic profiles across each well of a multi-well plate. Many of us within this field predict the PhysioMimix PK system and Oncology Service will be a disruptive technology that will accelerate cancer therapeutic development, reduce the number of failed or wrongly-dismissed drugs, and help to eliminate animals from the drug-development pipeline."

For further details about the Oncology Service, please visit: View Source

On October 5, 2021 I-Mab (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel or highly differentiated biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, reported that data from the preclinical studies of TJ-CD4B/ABL111 and TJ-L14B/ABL503, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021), taking place November 12 – 14, 2021 (Press release, I-Mab Biopharma, OCT 5, 2021, View Source [SID1234590876]).

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Developed in collaboration with ABL, TJ-CD4B/ABL111 and TJ-L14B/ABL503 are part of I-Mab’s highly differentiated bispecific antibody pipeline that target the 4-1BB co-stimulatory molecule on T-cells and mount an anti-tumor response. Both target a highly specific epitope on 4-1BB, which results in localized action and reduced systemic toxicity.

TJ-CD4B/ABL111 engages the Claudin18.2 (CLDB18.2) tumor antigen mainly on gastric and pancreatic cancers to produce localized T-cell activation at the cancer site. It has demonstrated a strong affinity to CLDN18.2-positive cancer cells even at low levels of CLDN18.2 and has potential application in a wide range of cancers. TJ-CD4B/ABL111 is currently undergoing phase 1 trials in the U.S. (NCT04900818) and soon will be in China, in patients with advanced solid tumors, including gastric cancers.

TJ-L14B/ABL503 is a novel bi-specific antibody targeting both PD-L1 and 4-1BB. It engages the PD-L1 molecule on cancer cells and exerts a strong anti-tumor activity through localized activation of T-cells and it is designed to overcome the limited efficacy of anti-PD-L1 therapies and anti-4-1BB-related toxicity. TJ-L14B/ABL503 is currently undergoing a phase 1 clinical trial in the U.S. (NCT04762641) in patients with locally advanced or metastatic solid tumors.

Details of the poster discussion session are as follows:

Abstract Number: 702

Title: TJ-CD4B (ABL111), a Claudin18.2-targeted 4-1BB tumor engager induces potent tumor-dependent immune response without dose-limiting toxicity in preclinical studies

Poster Session: Poster hall, 12-14th November 2021, 7.00 am-5.00 pm

Presenter: Dr. Wenqing Jiang, I-Mab

Abstract Number: 892

Title: ABL503 (TJ-L14B), PD-L1x4-1BB bispecific antibody induces superior anti-tumor activity by PD-L1-dependent 4-1BB activation with the increase of 4-1BB+CD8+ T cells in tumor microenvironment

Poster Session: Poster Hall, 12-14th November 2021, 7.00am-5.00pm

Presenter: Dr. Gihoon You, ABL Bio

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About TJ-CD4B/ABL111

TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement while silent elsewhere. TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL.

About TJ-L14B/ABL503

Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s "Grabody-T" bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

On October 5, 2021 Exo Therapeutics, Inc., a small molecule drug discovery and development company with a pioneering technology to address intractable pharmaceutical targets, reported the completion of a $78 million Series B financing (Press release, Exo Therapeutics, OCT 5, 2021, View Source [SID1234590843]). New investor, Nextech Invest, led the oversubscribed round with participation from BVF Partners, L.P., Samsara Biocapital, Morningside and Casdin Capital. Existing investors Newpath Partners, Novartis Venture Fund, CRV and 6 Dimensions Capital also participated in the financing. Proceeds will be used to advance therapeutic candidates in oncology and inflammation derived from the company’s proprietary ExoSightTM platform towards proof-of-concept and into the clinic. The proceeds will also be used to expand Exo’s pursuit of new targets with the ExoSight platform. As part of the financing, Thilo Schroeder, PhD, Partner at Nextech Invest, and Kanishka Pothula, Managing Director at BVF Partners, L.P., have joined Exo’s Board of Directors.

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Exo is building a deep pipeline of drug candidates that bind exosites, distal and unique binding pockets that reprogram enzyme activity for precise and robust therapeutic effect. Focusing on exosites overcomes the common challenges of competitive binding and off-target activity that occur with active site and allosteric modulators, potentially yielding better therapeutic windows, greater selectivity and fewer side effects. Exo’s approach also creates the opportunity to discover first-in-class candidates directed at novel targets across a wide range of diseases.

"Exo is well positioned to capitalize on the tremendous opportunity that exosites represent," said Michael Bruce, PhD, CEO of Exo Therapeutics. "With the support of our world-class investor syndicate and foundational work by professors David Liu and Alan Saghatelian, and their former student Juan Pablo Maianti, we are equipped to expand our ExoSight platform, discover new exosite targets and advance our initial programs towards the clinic. Exo was formed with the mission of developing impactful new medicines that act by targeting exosites, and with this financing we are now one step closer to achieving that goal."

"I am thrilled to work with Exo on building a robust pipeline of exosite-targeting therapeutics," said Schroeder. "The company’s initial work has shown compelling results on how exosites can unlock traditionally challenging targets and modulate them with precision and potency. We are particularly enthusiastic about Exo’s platform, which is poised to significantly expand the number and diversity of targets that they can pursue."

"Exo has made rapid progress in the past year both in building an accomplished scientific team and on their four initial programs in oncology and inflammation," said Pothula. "We are proud to support Exo during this pivotal stage of the company’s de

On October 5, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that the Company will present at the H.C. Wainwright 5th Annual NASH Investor Conference being held virtually on October 12, 2021 (Press release, Lipocine, OCT 5, 2021, View Source [SID1234590877]).

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H.C. Wainwright 5th Annual NASH Investor Conference, October 12, 2021

Presentation time: 3:30 pm ET

Webcast link: View Source

A webcast of Lipocine’s presentation will be available on Lipocine’s website under "Events & Presentations" in the Investors section or using the webcast link above. The webcast will be available on the Lipocine’s website for 90 days.

On October 5, 2021 NBTS reported that it can be hard to keep track of new brain tumor clinical trial opportunities opening across the United States, especially as we continue to navigate the public health crisis created by the coronavirus (COVID-19)(Press release, National Brain Tumor Society, OCT 5, 2021, View Source [SID1234590821]). There are many clinical trials actively enrolling patients, and this report provides a summary of the studies that have recently opened or started for primary brain tumor patients. To learn more about each trial, and to contact the party responsible for enrolling patients.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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ONC206 for newly diagnosed or recurrent diffuse midline gliomas and other recurrent malignant brain tumors (PNOC 023)
This phase I trial studies the effects and best dose of the drug ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that are newly diagnosed or have come back (recurrent) or in other recurrent primary malignant brain tumors.
A comprehensive evaluation of tumor oxygenation, metabolism, and blood supply of high-grade glioma using dynamic FAZA PET and multiparametric MR
This is a pilot trial evaluating the use of several advanced medical imaging techniques to study high-grade glioma tumors.
Multimodality MRI and liquid biopsy in GBM
This is a non-therapeutic pilot trial that will evaluate imaging methods and liquid biopsy techniques to study glioblastoma.
Simultaneous multinuclear metabolic MRI in newly diagnosed or recurrent glioma
This clinical trial develops and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.
Study of PBI-200 in subjects with NTRK fusion-positive solid tumors
This is a first-in-human, phase I/II trial of the drug PBI-200 in subjects with NTRK fusion-positive advanced or metastatic solid tumors, including brain tumors.
PEACH TRIAL: Precision medicine and adoptive cellular therapy
This phase I study will evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy.
Study of DSP-0390 in patients with recurrent high-grade glioma
This phase I study will evaluate the safety and efficacy of the investigational treatment DSP-0390 in patients with recurrent high-grade glioma.
Combination intraventricular chemotherapy pilot study: 5-Azacytidine (5-AZA) and trastuzumab infusions into the fourth ventricle or resection cavity in children and adults with recurrent or residual posterior fossa ependymoma
The purpose of this early phase I study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar cerebrospinal fluid (CSF) cytology.
A study of BPM31510 with Vitamin K1 in subjects with newly diagnosed glioblastoma
This is a phase II therapeutic study that will assess the effects of combining the drug BPM31510 with standard of care treatments for subjects with newly diagnosed glioblastoma.
177Lu-DTPA-omburtamab radioimmunotherapy for recurrent or refractory medulloblastoma
Children and adolescents diagnosed with medulloblastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab in this phase I/II trial.
Testing the addition of the immunotherapy drugs tocilizumab and atezolizumab to radiation therapy for recurrent glioblastoma
This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent).