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)

Innate Pharma reports first half 2020 financial results and business update

On September 7, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2020 (Press release, Innate Pharma, SEP 7, 2020, View Source [SID1234564709]). The consolidated financial statements are attached to this press release.

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"In the first half of 2020, Innate has made meaningful progress across its portfolio, quickly resuming enrollment in the lacutamab Phase 2 study, TELLOMAK, for patients with Sézary syndrome and mycosis fungoides," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "In the second half of the year, our partner, AstraZeneca, expects to initiate the Phase 3 clinical study for monalizumab in combination with cetuximab in IO-pretreated patients with recurrent or metastatic head and neck squamous cell cancer. This represents a significant clinical and financial milestone, as we progress our first Phase 3 asset and advance a promising, potentially first-in-class treatment for a patient population that needs novel, effective and tolerable therapies. More broadly, we continue to execute on our long-term strategy, transitioning into a global commercial-stage biotech company as we assume full US commercial responsibilities for Lumoxiti by the end of the year."

Webcast and conference call will be held today at 2:00pm CEST (8:00am ET)

Webcast access: View Source
or Dial in numbers:
France: +33 (0)1 70 70 07 81 US only: + 1 877 870 9135
Standard International: +44 (0) 2071 928338
Conference ID: 7368163

The presentation and access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference.
A replay will be available on Innate Pharma’s website after the conference call.

Financial highlights for the first half of 2020:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2020 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €184.6 million (€m) as of June 30, 2020 (€255.9m as of December 31, 2019).
Revenue and other income amounted to €36.7m in the first half of 2020 (€59.2m in the first half of 2019) and mainly comprise of:
Revenue from collaboration and licensing agreements, which mainly resulted from the spreading of the upfront and opt-in payments received from AstraZeneca (LSE/STO/NYSE: AZN):
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €4.7m to €19.6m in the first half of 2020 (€24.3m in the first half of 2019), due to a catch up on the period of a non material decrease in the collaboration budget; and
(ii) Revenue from collaboration and licensing agreements for IPH5201 decreased by €13.8m to €8.7m in the first half of 2020 (€22.5m in the first half of 2019), primarily due to an extension of the recognition period of such revenue after the renewal in November 2019 of the collaboration with AstraZeneca for 12 months.
Revenue from invoicing of research and development (R&D) costs for avdoralimab (IPH5401) and IPH5201 was €1.1m the first half of 2020 (€4.4m in the first half of 2019), after IPH5201 transitioned to Phase 1, which is carried out and paid by AstraZeneca.
Government funding for research expenditures of €6.9m in the first half of 2020 (€7.6m in the first half of 2019).
Operating expenses of €46.0m in the first half of 2020 (€45.9m in the first half of 2019), of which 68.5% (€31.5m) are related to R&D.
R&D expenses decreased by €5.1m to €31.5m in the first half of 2020 (€36.6m in the first half of 2019), following the completion of regulatory work for certain pipeline programs, including the Lumoxiti filing in Europe and the Phase 1 transition of IPH5201 to AstraZeneca.
Selling, general and administrative (SG&A) expenses increased by €5.2m to €14.5m in the first half of 2020 (€9.3m in the first half of 2019) primarily as a result of the structuration of the US subsidiary and commercialization of Lumoxiti.
The Lumoxiti distribution agreement generated a net income of €0.9m in the first half of 2020 (net loss of €3.8m in the first half of 2019) primarily as a result of the transition of commercial costs from AstraZeneca to Innate Pharma.
A net financial loss of €2.0m in the first half of 2020 (net financial income of €3.8m in the first half of 2019), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 outbreak on the financial markets.
A net loss of €10.3m for the first half of 2020 (net income of €13.2m for the first half of 2019).

ACT Genomics ("ACTG") Completed the First Closing of latest Round of Equity Financing

On September 7, 2020 ACT Genomics reported that the completion of the first closing of the latest round of equity financing from a group of strategic investors including Aflac Ventures LLC and Kyoto University Innovation Capital (Press release, ACT Genomics, SEP 7, 2020, View Source [SID1234564708]).

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"We are very pleased to have reputable strategic investors from USA and Japan participating in the first closing of our latest round of equity fund raising which will further strengthen our capital base and will provide strategic value for our business expansion in Asia and globally. New capital from this round of investment will support ACTG’s strategic plan to further expand our technology, product portfolio and global presence. Partnering with our new strategic shareholders will enable ACTG to become a global player in cancer genomic diagnostics," said Dr. Hua Chien Chen, Co-Founder and CEO of ACTG.

ACTG is a leading DNA sequencing-based cancer solution provider and transforms science into actionable solutions empowering clinicians and patients with evidence-based information to fight cancer. Company’s mission is to provide every cancer patient personalized genomic information-based treatment plans. ACTG currently has Next Generation Sequencing ("NGS") labs in Taiwan, Hong Kong and Japan. Leveraging this strategic lab footprint, it also has operations throughout Asia, catering to the unmet precision medicine needs in the local markets.