Imago BioSciences to Participate in Upcoming Investor Conferences

On September 8, 2020 Imago BioSciences, Inc. ("Imago"), a private clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that Hugh Young Rienhoff, Jr. M.D., chief executive officer, will present a corporate overview at two upcoming investor conferences (Press release, Imago BioSciences, SEP 8, 2020, View Source [SID1234564710]).

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Citi’s 15th Annual BioPharma Virtual Conference
Date: Tuesday, September 8th 2020
Time: 2:20 p.m. ET
Logistics: If you’d like to register and attend the company presentation, click here to learn more.
H.C. Wainwright 22nd Annual Global Investment Virtual Conference
Date: Monday, September 14th 2020
Time: 10:00 a.m. ET
Logistics: If you’d like to register and attend the company presentation, click here to learn more.

Amplia Receives Human Research Ethics Committee Clearance to Conduct Phase 1 Clinical Trial

On September 8, 2020 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received clearance from the Alfred Hospital Human Research Ethics Committee (HREC) to conduct a Phase 1 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in healthy volunteers (Press release, Amplia Therapeutics, SEP 8, 2020, View Source;[email protected] [SID1234564702]). With this clearance in hand, Amplia expects to initiate its Phase 1 trial in the coming weeks with the first subject likely to be dosed by early October.

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The double blind, placebo-controlled Phase 1 trial is designed to establish the safety profile of oral doses of AMP945 in up to 64 healthy adult volunteers as well as provide data on the pharmacodynamics and pharmacokinetics of the drug in human subjects. The trial protocol that has been approved by the HREC includes an initial single ascending dose (SAD) study, followed by a multiple ascending dose (MAD) study. With the HREC clearance now in hand, Amplia is on track to complete dosing of subjects for the SAD component of the Phase 1 trial by the end of the year and have data from the completed trial in the first half of 2021. Recruitment for the trial is not expected to be impacted by the current COVID-19 pandemic.

Data from this trial will be used to support Phase 2 clinical trials of AMP945 for the treatment of patients with specific, hard-to-treat cancers or with certain fibrotic diseases. Earlier this year, Amplia secured Orphan Drug Designations (ODDs) from the US Food and Drug Administration (FDA) covering the use of AMP945 in the treatment of both pancreatic cancer and idiopathic pulmonary fibrosis (IPF). As the Phase 1 trial is being conducted in healthy volunteers rather than in patients, data from the trial is expected to support the progression of AMP945 into Phase 2 trials for a range of different diseases (indications). Amplia is also continuing with the conduct of a program of non-clinical studies to further define and enhance the next stage of the clinical development program for AMP945.

"We are very excited to receive ethics approval for Amplia’s first clinical trial and to deliver on our commitment to advance AMP945 into human clinical trials during 2020" said Chief Executive Officer, Dr John Lambert. "Despite the challenges thrown up by the current COVID-19 pandemic, in the past few months we have managed to secure two Orphan Drug Designations, complete the preclinical studies required to support the Phase 1 trial, secure funding to conduct the trial, and now receive the approval required to initiate the trial. We are extremely grateful for the support we have received from our partners, providers and shareholders that has allowed us get to this stage and initiate the first-in-human study for AMP945."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

IcanoMAB GmbH founded with private funding to develop precision canonical monoclonal antibodies in Oncology, Immune-modulation, Acute Inflammation and most urgently for Covid-19

On September 7, 2020 IcanoMAB, a privately-funded biotech company focusing on the pre-clinical and clinical development of novel precision canonical antibodies for the treatment of cancer, immune-system related diseases and Covid-19, reported that it has been successfully founded and funded.

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The company has secured three clinical candidates in IND-enabling stage and funding from MAB Discovery GmbH, originally generating the licensed antibodies from a novel antibody discovery platform. After 10 years of more than 50 successful monoclonal antibody discovery projects with large Pharma and mid- and large-size Biotech companies, MAB Discovery sold its antibody production platform and laboratory to BioNTech (NASDAQ: BNTX) in 2019. At the end of 2019, a preclinical project in the field of Immuno-oncology was licensed to a Top Pharma company.

IcanoMAB will use the proceeds to advance the clinical candidates to allow IND-enabling activities and respective partnering activities with selected third parties.

Particularly urgent are effective treatments for Covid-19 and its potentially fatal outcome driven by Acute Respiratory Distress Syndrome (ARDS) and Cytokine Release Syndrome (CRS). While Vaccine development is progressing and sufficient broad population protection yet to be demonstrated, risks of detrimental effects via Antibody Dependent Enhancement (ADE) will require specific therapeutic intervention. In any case, an effective treatment is urgently needed as an option for clinicians to treat severely affected late-stage Covid-19 patients.

Significant improvement of clinical outcome is also required for treatment of acute inflammatory conditions including several severe rare diseases like Macrophage-Activation Syndrome, SJIA / Still’s Disease or IBD and Gout where sometimes even specific treatments are missing, addressing the underlying cause.

The same holds true for clinical outcome in cancer therapy, whether it is the treatment of women with early Breast Cancer and especially through neo-adjuvant treatment, or via novel immunooncology treatments across multiple solid cancers.

While monoclonal antibody discovery has progressed significantly in the last decades, precise canonical antibodies have not been well exploited to address clinically validated and/or clinical targets in a physiological manner. The technology of MAB Discovery was developed to generate an unlimited number of diverse antibody-producing B-cells (>10,000) with optimal variability without additional in vitro maturation or engineering to optimize therapeutically relevant paratopes. Resulting antibodies have been applied to Pharma-derived high throughput screening in functional assays to identify lead candidates that fulfill a predefined list of biological activities and provide optimal potency essential for differential therapeutic application. Potential leads have gone through a sophisticated sequence optimization: Humanization, elimination of T-cell epitopes & potential CMC liabilities. Addressing validated targets generated proprietary molecules with novel modes of intervention and the knowledge of first-generation molecules enabled a well guided in vitro differentiation. This approach allows focused activities for in-vivo PoC in animal models and in the clinic with limited remaining CMC risks.

Addressing those needs, IcanoMAB’s clinical lead candidates have been developed to date and are in collaborations with leading experts and renowned organizations across the world like
– The Dinarello Lab, Department of Medicine, University of Colorado Denver, Aurora, Colorado/USA and Department of Medicine, Radboud University Medical Center, Nijmegen/The Netherlands;

– Division of Immunology and Allergy, Karolinska Institutet, Stockholm/Sweden;

– Department of Infectious Disease and Institute of Clinical Medicine Aarhus University Hospital, Aarhus/Denmark;

– Department of Gynecology and Obstetrics, Medical Center University Regensburg/Germany;

– Division of Genetics, University of Erlangen/Germany;

– Division of Asthma Exacerbation & Regulation, Research Center Borstel, Leibniz Lung Center, Borstel/Germany and

– Vall d’Hebron Institute of Oncology (VHIO), Barcelona/Spain

(Press release, IcanoMAB, SEP 7, 2020, View Source [SID1234662156])

AnHeart Licenses Two Clinical Stage Oncology Candidates from Daiichi Sankyo

September 7, 2020 AnHeart Therapeutics reported that AnHeart has entered into license agreements with Daiichi Sankyo to acquire rights to two novel clinical stage oncology candidates (previously Daiichi Sankyo codes DS-1001 and DS-1205, now AnHeart codes AB-218 and AB-329, respectively) (Press release, AnHeart Therapeutics, SEP 7, 2020, https://anhearttherapeutics.com/en/2020/09/08/anheart-licenses-two-clinical-stage-oncology-candidates-from-daiichi-sankyo/ [SID1234574254]). Under the terms of the agreements, Daiichi Sankyo is eligible to receive upfront payments, as well as development, regulatory and commercial milestone payments and royalties on net sales following market approval of the products.

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AB-218 is a novel, potent, highly selective mutant IDH-1 inhibitor, which has high permeability of the blood-brain barrier and has demonstrated encouraging safety and efficacy signals in a Phase 1 trial of glioma patients. AnHeart will develop this compound for glioma and potentially other indications including acute myeloid leukemia (AML) and cholangiocarcinoma globally, except in Japan where Daiichi Sankyo will retain exclusive rights.

AB-329 is a novel, potent, highly selective AXL inhibitor, which AnHeart plans to test in combination with checkpoint inhibitors or third generation EGFR inhibitors in non-small cell lung cancer (NSCLC) as well as other solid tumors and hematological malignancies. AnHeart has global rights to the compound.

"We are extremely pleased with our highly productive relationship with Daiichi Sankyo," said Junyuan (Jerry) Wang, PhD, Chief Executive Officer of AnHeart. "These two clinical stage assets represent the expansion of our initial taletrectinib agreement, and are both differentiated and promising with multiple potential therapeutic applications for the global markets. These new license agreements highlight AnHeart’s progress towards our strategic goal of building a pipeline of targeted oncology therapeutics to help serve patients with unmet needs all over the world."

September 15th, Gerard Soula, Adocia CEO, to Present at H.C. Wainwright Global Investment Conference

On September 7, 2020 Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of proteins and peptides, reported that CEO, Gérard Soula, will present a company overview at the H.C. Wainwright 22nd Annual Global Investment Conference, held virtually this year, September 14-16, 2020 (Press release, Adocia, SEP 7, 2020, https://www.adocia.com/september-15th-adocia-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234565004]).

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Presentation details:

Presenter: Gérard Soula, CEO
Presentation Day: September 15, 2020

Time: 1:00 PM (EDT) / 7:00 PM (CEST)
Link to the online presentation (live and archived for 90 days)