Arch Oncology Raises $50 Million Series B Financing

On March 25, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 antibody therapies, reported a successful $50 million Series B financing (Press release, Arch Oncology, MAR 25, 2019, View Source [SID1234534595]). The Company plans to use the proceeds from this financing to advance its anti-CD47 antibody AO-176’s ongoing Phase 1 clinical trial in select solid tumors, as well as its pipeline.

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This financing included Arch Oncology’s existing investors, RiverVest Venture Partners, Roche Venture Fund, and 3×5 Partners, and was led by new investor Lightchain (Scottrade Founder and former CEO Rodger Riney’s family office).

"Our investors share our commitment to the exciting work we are doing to develop best-in-class antibodies aimed at improving treatment options for patients with cancer," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "This financing supports our ongoing Phase 1 clinical trial for AO-176, our highly-differentiated anti-CD47 antibody, as we continue to dose patients. Additionally, these proceeds enable us to advance our discovery-stage pipeline. With the backing of our investors and the hard work of our experienced team, we look forward to developing new cancer treatment options for patients."

"Over the past year, the Arch Oncology team under Julie’s leadership has successfully executed on plans to advance AO-176 from the laboratory, through IND submission, and into the clinic," said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. "We believe AO-176 has a best-in-class profile among agents in the anti-CD47 space and we are excited to see the progress advancing the pipeline."

Onxeo will present new data demonstrating the interest of AsiDNA ™ through 5 posters at the 2019 Annual Conference of the American Association for Research Against Cancer (AACR)

On March 25, 2019 Onxeo SA (Euronext Paris, NASDAQ Copenhagen: ONXEO), (" Onxeo " or "the Company "), a clinical stage biotechnology company specializing in the development of innovative oncology drugs targeting tumor DNA damage response mechanisms (DDR), in particular to fight against rare or resistant cancers, reported that information on the five study presentations presenting important data on AsiDNA , its most advanced candidate, which will be presented in the form of posters in Congress American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting , March 29 – April 3, 2019, Atlanta, Georgia, United States (Press release, Onxeo, MAR 25, 2019, View Source [SID1234534611]).

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Françoise Bono, Scientific Director of Onxeo, says :"We are very pleased that these five studies have been accepted for presentation at the prestigious AACR (Free AACR Whitepaper) Conference. This recognition illustrates the interest, quality and diversity of translational research that we are currently conducting with AsiDNA . Our data once again demonstrate the singularity of our lead compound and its unique properties, particularly to prevent the emergence of treatment resistance, one of the most troubling issues in oncology today. All these data complement and reinforce our arguments for the further clinical development of AsiDNA , which is scheduled to begin in the coming weeks, now that we know the doses for which AsiDNA activates its cellular targets and confirmed its favorable safety profile, in the phase 1 study, DRIIV. We look forward to presenting the very promising results we have achieved and discussing them at this conference. "

Details of the sittings of April 1st and 2nd, 2019:

Abstract 2095 / Poster 2 – AsiDNA , a targeted treatment with no acquired resistance

Session: PO.ET03.03. Drug Resistance 3
Date: Monday 1 st April
Time: 1:00 p.m. to 5:00 p.m. AND
Location: Section 11

AsiDNA is the first antitumor drug in the field of DDR acting as an agonist 1. It causes a strong warning signal of the presence of DNA damage. This study demonstrates that long-term exposure of cancer cells to this warning signal does not promote the emergence of AsiDNA resistance. In contrast, repeated exposure downregulates the targeted repair pathways, a condition that persists for several months after AsiDNA treatment. This property is due to the singular mechanism of action of AsiDNA , which simulates a signal of DNA damage through over-activation (agonist effect) of the DNA-PK and PARP enzymes. This property is not observed with other DNA repair inhibitors such as PARP inhibitors olaparib and talazoparib which all eventually induce resistance. Long-term treatment with AsiDNA instead decreases the "vigilance" of the tumor cells, which improves the effectiveness of the product. These results indicate that agonist drugs such as AsiDNA may induce tumor cell evolution with a reduction in their ability to respond when signaling lesions on their DNA.

Abstract 2130/7 – Development of a biomarker-based patient selection strategy for AsiDNA treatment (collaboration with Institut Curie)

Session: PO.ET04.04 – Molecular Classification of Tumors
Date: Monday 1 st April
Time: 1:00 p.m. to 5:00 p.m.
Location: Section 12

_______________
1 Agonist: who has the property to activate

It remains very difficult to accurately assess and predict the response to cancer treatment. Stratification biomarkers are a valuable aid in identifying the patients most likely to respond to a particular drug, or even to distinguish between early and delayed responses. In this study, we identified a genetic signature that predicts the efficacy of AsiDNA treatment in patients. AsiDNA is currently in clinical trial and rapid validation of the most sensitive gene cluster is possible, with a view to developing a biomarker-based patient selection strategy for AsiDNA treatment.

Abstract 2918/6 – Molecular analysis of the mechanism of action of AsiDNA provides new clues to the regulation of DNA damage response

Session: PO.TB09.01 – Tumor Radiosensitivity or Resistance
Date: Tuesday, April 2
Time: 8:00 – 12:00
Location: Section 8

In this study, the different stages of AsiDNA activity were analyzed. The data show that AsiDNA inhibits the joining of non-homologous ends of DNA (NHEJ) and the repair of DNA double-strand breaks by homologous recombination by preventing the recruitment of key enzymes at the site of the break. Inhibition of recruitment of proteins involved in NHEJ is the first event and requires the activity of PARPs. Inhibition of homologous recombination proteins occurs late and depends on the activation of DNA-PK. PARP activation induces a metabolic change that could participate in the antitumor activity of AsiDNA .

Abstract 2865/6 – AsiDNA , a novel DNA repair inhibitor for sensitizing aggressive subtypes of medulloblastoma (Institut Curie)

Session: PO.TB09.01 – Targets and Therapies in Pediatric Cancer
Date: Tuesday, April 2
Time: 8:00 – 12:00
Location: Section 6

Medulloblastoma is a tumor of the cerebellum, and is the most common malignant brain tumor in children. There is often significant treatment-related mortality. It is therefore important to improve treatment efficacy for the most aggressive subgroups and to reduce treatment-related mortality for all subgroups. In this study, no increase in post-irradiation toxicity was observed with AsiDNA . In vivo, AsiDNA alone significantly improves survival rates (p = 0.005) and the effectiveness of radiotherapy. In combination with radiation therapy, AsiDNA can delay tumor growth and improve survival compared to radiotherapy alone.

Abstract 3797/2 – AsiDNA abrogates acquired resistance to PARP inhibitors

Session: PO.ET03.05 – Drug Resistance 5
Date: Tuesday, April 2
Time: 1:00 pm – 5:00 pm
Location: Section 10

PARP inhibitors (PARPi) are approved for the treatment of cancers with a deficient homologous recombination pathway. Despite the success of this approach, resistance to these drugs remains a clinical problem. In this study, long-term exposure of cancer cells to PARPi showed resistance in all independent populations tested, raising the question of the clinical benefits of long-term continuation of PARPi monotherapy. Interestingly, populations treated with AsiDNA (2.5 μM – low non-cytotoxic dose) in combination with talazoparib or olaparib had a significantly lower probability of resistance. Furthermore, AsiDNA partially blocks resistance to talazoparib in resistant populations. The results indicate that AsiDNA may be able to abrogate and reverse the acquired resistance to PARPi by normalizing the expression and activity of the proteins involved.

Advaxis Granted U.S. Patent Relating to Axalimogene Filolisbac

On March 25, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Patent and Trademark Office has granted patent number 10,189,885 titled "Non-Hemolytic LLO Fusion Proteins and Methods of Utilizing Same (Press release, Advaxis, MAR 25, 2019, View Source [SID1234534596])." This composition-of-matter patent extends protection for axalimogene filolisbac (AXAL) through March 2028.

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"We are pleased to receive another patent to further expand our robust intellectual property portfolio of more than 400 issued or pending patents worldwide," said Robert G. Petit, Ph.D., Chief Scientific Officer of Advaxis. "The issuance of this patent provides additional intellectual property protection for AXAL, which has demonstrated clinical activity across multiple tumor types."

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. The U.S. Food and Drug Administration (FDA or Agency) has granted AXAL Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer, and a Special Protocol Assessment (SPA) for the Phase 3 AIM2CERV trial evaluating its potential to delay or prevent the recurrence of locally advanced cervical cancer. The FDA has also granted AXAL orphan drug designation in three clinical indications.

Advaxis is in discussions with FDA regarding the partial clinical hold on its Phase 3 AIM2CERV trial and is working to address the questions raised by the Agency surrounding prior AXAL chemistry, manufacturing and controls matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment, although no new patients are being enrolled. Advaxis is also in dialogue with FDA to request an amendment to the SPA to include an earlier interim analysis for efficacy.

Ascentage Pharma Announces Nine Abstracts To Be Presented at the 2019 American Association for Cancer Research Annual Meeting

On March 25, 2019 Ascentage Pharma, globally-focused, clinical-stage biopharmaceutical company developing novel small molecule therapies for cancers, hepatitis B and age-related diseases, reported that research results of its pipeline of small molecule therapeutics will be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Atlanta, March 29-April 3, 2019 (Press release, Ascentage Pharma, MAR 25, 2019, View Source [SID1234534612]).

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AACR abstracts include:

Title: Predicting Drug Sensitivity to A Novel BCL-2 and BCL-xL Dual Inhibitor In Solid Tumor PDX TrialsSession Title: BCL-2 Family ProteinsSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number: 2503
Title: MDM2 Inhibitor APG-115 Synergizes With CDK4/6 Inhibitors In A Patient Derived Xenograft Model of Dedifferentiated LiposarcomaSession Title: Credentialing of Molecular TargetsSession Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM EDTPoster Number: 1253
Title: Activation of P53 In the Tumor Microenvironment by MDM2 Inhibitor APG-115 Synergizes With PD-1 Blockade Independently of P53 Status of Tumor CellsSession Title: Combination Immunotherapies 2 Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM EDTPoster Number: 3192
Title: BCL-2 Selective Inhibitor APG-2575 Synergizes with BTK Inhibitor in Preclinical Xenograft Models of Follicular Lymphoma and diffuse Large B-cell LymphomaSession Title: Apoptosis, Necrosis, and Cancer Cell SurvivalSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number: 2058
Title: Synergistic Effect of BCL-2 Inhibitor APG-2575 and CDK9 Inhibitor in Acute Myeloid Leukemia and DLBCL Preclinical Tumor ModelsSession Title: Novel Antitumor Agents 1Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM EDTPoster Number: 3068
Title: FAK Blockade Enhances Antitumor Effect of BTK Inhibitor In Esophageal Squamous Cell Carcinoma via EGFR-ERK-Akt Pathway InhibitionSession Title: Combination Approaches to Novel TherapiesSession Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM EDTPoster Number: 309
Title: A Novel Bcl-2/Bcl-XL Inhibitor APG-1252-12A as A Potential Therapeutic Strategy for Gastric CarcinomaSession Title: Apoptosis, Necrosis, and Cancer Cell SurvivalSession Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM EDTPoster Number:2054
Title: FAK Inhibition Reduces Tumor Infiltration of Tregs Via Restricting CCL5 Release and Boosts the Present Therapeutic Regimen for BRAFV600E -mutated Colorectal CarcinomaSession Title: Immunomodulation by Chemotherapy and Targeted AgentsSession Date and Time: Tuesday, April 2, 2019 1:00 PM – 5:00 PM EDTPoster Number: 3958
Title: Novel FAK/ALK/ROS1 Inhibitor APG-2449 Synergizes with Osimertinib in Preclinical Xenograft Models of EGFR-mutant NSCLCSession Title: Tyrosine Kinase and Phosphatase Inhibitors 2Session Date and Time: Monday, April 1 2019 1:00 PM – 5:00 PM EDTPoster Number: 2204

H3 Biomedicine Announces Multiple Presentations at Upcoming AACR Annual Meeting

On March 25, 2019 H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported multiple presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held March 29 through April 3, 2019 at the Georgia World Congress Center in Atlanta, GA (Press release, H3 Biomedicine, MAR 25, 2019, View Source [SID1234534597]).

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Leveraging its integrated data science, human biology and precision chemistry discovery engine, H3 is advancing a pipeline of highly targeted, investigational breakthrough medicines to address critical unmet needs in the treatment of hematologic and solid tumor cancers. The company currently has three precision medicine therapeutic programs in clinical study with several additional research programs advancing toward the development stage.

H3’s presentations at this year’s AACR (Free AACR Whitepaper) Annual Meeting showcase the company’s breadth of expertise in oncology research and the molecular insights enabled by its unique discovery engine.

The schedule for H3’s presentations is as follows (in chronological order):

Oral Presentation/Education Session:

Title:Targeting the spliceosome; perspectives from structural biology

Session:Chemistry to the Clinic: Part 2: Novel Chemical Tools and Leads for Unprecedented Targets

Date and Time: Saturday, March 30, 2019; 10:15 a.m. – 12:15 p.m. EDT

Location: Room A311-312

Presenter: Nicholas Larsen, Ph.D., Director, H3 Biomedicine

Poster Presentations:

Abstract Number: 281

Title: Sensitivity to splicing modulation of BCL2 family genes reveals cancer therapeutic strategies for splicing modulators

Session: Combination Approaches to Novel Therapies

Date and Time: Sunday March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 12; Poster Board Number 2

Abstract Number:498

Title: Integrating bulk and spatial profiling technologies for the discovery of RNA and protein biomarkers in muscle invasive bladder cancer

Session: Imaging the Tumor Microenvironment

Date and Time: Sunday, March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location:Exhibit Hall B; Poster Section 20; Poster Board Number 11

Abstract Number: 2467

Title: Heme-CMap: Generation and characterization of ~20K L1000 profiles across 11 hematologic malignant lines

Session: Databases and Computational Tools for Cancer Discovery

Date and Time: Monday April 1, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 31; Poster Board Number 7

** In collaboration with the Broad Institute