1stOncology™: Cancer Intelligence Service – Page 12626 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BioInvent to Present BI-1206 Preclinical Data in Mantle Cell lymphoma at ASH 2019

On November 8, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it will make a poster presentation with preclinical data on BI-1206 at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida held December 7-10 (Press release, BioInvent, NOV 8, 2019, View Source [SID1234550797]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

The abstract, published here, highlights a preclinical study of BI-1206 in an ibrutinib-venetoclax dual resistant PDX model derived from a doubly-resistant mantle cell lymphoma (MCL) patient. Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance.

FcγRIIb was further shown to be highly expressed in 27/27 primary patient MCL samples examined. Along with previously published data demonstrating an important role for FcγRIIB in resistance to rituximab-based cancer immunotherapy, and BI-1206 in boosting rituximab efficacy and overcoming rituximab-resistance, these data indicate the significant potential of BI-1206 to address a significant unmet need in MCL and hematologic malignancy.

BioInvent CEO Martin Welschof said: "These pre-clinical data indicate a broad and clinically important role of FcγRIIb in mantle cell lymphoma, and highlight the potential of BI-1206 to help overcome resistance in this indication. This further reinforces our belief that FcγRIIb will become a key element for treating hematological and solid malignancies, and the potential of BI-1206 to play an important role in combating these diseases."

BI-1206, one of BioInvent’s proprietary anti-FcyRIIB antibodies and its lead compound, is currently being investigated in clinical trials in non-Hodgkin lymphoma, chronic lymphocytic leukemia and solid tumors.

Details of the poster:

Title: BI-1206, a Monoclonal Antibody Against FcyRIIIb, Showed Superior Anti-Tumor Activity in an Ibrutinib-Venetoclax Dual Resistant PDX Model in Mantle Cell Lymphoma

Session Name: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II

Time: Sunday, December 8, 2019, 6:00 – 8:00 PM

Location: Orange County Convention Center, Hall B

argenx announces full exercise of underwriters’ option to purchase additional ADSs

On November 8, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that the underwriters of its previously announced global offering of ordinary shares (including in the form of American Depositary Shares (ADSs)) have exercised their option to purchase 600,000 additional ADSs in full on the same terms and conditions as the global offering (Press release, argenx, NOV 8, 2019, View Source [SID1234550788]). This option exercise brings the anticipated total gross proceeds from the global offering to approximately $557 million (approximately €502 million) from the sale of an aggregate of 4,600,000 ordinary shares (including in the form of ADSs).

Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The closing of the global offering, including with respect to the ADSs subject to the option, is expected to occur on November 12, 2019, subject to customary closing conditions. On this timing, due to a public holiday in the United States, November 12, 2019 would count as T+2 settlement in the United States and a T+3 settlement for investors that purchase ordinary shares traded on Euronext Brussels.

The securities were offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

Oxford BioDynamics’ EpiSwitch™ Featured in Presentations on Development and Validation of Blood-Based Predictive Biomarkers in Immune Checkpoint Inhibitor Programs

On November 8, 2019 Oxford BioDynamics Plc (AIM: OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers for the pharmaceutical and biotechnology industry, reported that data yielded by application of its 3D genome architecture technology platform, EpiSwitch, will be presented at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting (Press release, Oxford Biodynamics, NOV 8, 2019, View Source [SID1234550787]). The poster presentations indicate that the biomarkers identified by EpiSwitch, using blood samples from patients treated with immune checkpoint inhibitors, provide information that can be used to understand various disease states and has the potential to shed light on the impact of treatment to improve clinical outcomes. The posters were co-authored with collaborating scientists from EMD Serono (the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada), Pfizer, Oxford BioDynamics and the Mayo Clinic.

In the studies, researchers profiled patients with non-small cell lung cancer (NSCLC) or melanoma treated with avelumab (an anti-PD-L1 antibody), pembrolizumab (an anti-PD-1 antibody), or pembrolizumab in combination with a non-platinum chemotherapeutic agent, and generated models to differentiate responders from non-responders using machine learning methods. All computational analyses for identification of classification models was performed by Oxford BioDynamics.

The findings are being presented as part of the following two posters:

(P142) "Development and Validation of Baseline Predictive Biomarkers for Response to Avelumab in second-line (2L) non-small cell lung cancer (NSCLC)"*
(P143) "Development and Validation of Baseline Predictive Biomarkers for Response to Immuno-Checkpoint Treatments in the context of Multi-Line and Multi-Therapy Cohorts using EpiSwitch Epigenetic Profiling"
Findings from both posters indicate that the chromosome conformation signatures identified retrospectively by EpiSwitch represent strong systemic cellular network deregulations associated with differences in clinical phenotypes and outcomes. Full results are being submitted for publication.

"These findings show that immuno-oncology biomarker development with EpiSwitch yielded robust exclusion of non-responders across indications and combinations, provided asset-specific classifiers with high PPV, and may enable IO drug development programs to advance with smaller patient cohorts," said Alexandre Akoulitchev, Director and Chief Scientific Officer of Oxford BioDynamics. "While this initial single-arm study design doesn’t permit differentiation between the prognostic and predictive values of the EpiSwitch classifiers, the rationale for a blinded, comparator arm test is compelling. The ability to stratify patients based on their genomic architecture to reduce the risk, cost and time to market for therapeutic development programmes would be a game changer in immuno-oncology."

The EpiSwitch research was funded by Merck KGaA, Darmstadt, Germany, as part of an alliance with Pfizer.

*Avelumab is not approved for the treatment of non-small cell lung cancer or melanoma.

About EpiSwitch

EpiSwitch is a novel epigenetic-based technology platform that supports precision medicine initiatives including: prediction of response to therapy, patient prognosis, disease diagnosis & subtyping and residual disease monitoring. The result of robust, validated, award-winning technology and methodology, EpiSwitch stratifies patients based on their genomic architecture to reduce the risk, cost and time to market for therapeutic development programmes, provide significant insights into disease mechanisms and help personalize therapeutics to ensure better outcomes. To learn more about EpiSwitch, please visit View Source

Eiger BioPharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update

On November 8, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for the three and nine months ended September 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 8, 2019, View Source [SID1234550784]).

"We are advancing four Breakthrough Therapy Designation programs into late stages, all with first-in-class therapies targeting rare diseases with no approved treatments," said David Cory, Eiger President and CEO. "We recently completed successful pre-NDA and pre-MAA meetings with both FDA and EMA for Progeria and Progeroid Laminopathies and plan to submit an NDA by year-end. We recently announced positive results from the HDV Lambda and Lonafarnib combination LIFT study, which will be presented as an oral late-breaker at AASLD. Our Phase 3 HDV global D-LIVR study continues to activate sites, enroll and dose patients. We look forward to updating on continued progress in the future."

Recent Highlights

Lonafarnib in Progeria and Progeroid Laminopathies

Positive pre-NDA meeting with FDA
Positive pre-MAA meeting with EMA
Peginterferon Lambda (Lambda) in Hepatitis Delta Virus (HDV)

Late-breaking oral presentation of positive Phase 2 LIFT (lambda + lonafarnib boosted with ritonavir) interim end-of-treatment results accepted for AASLD
95% of patients achieved primary endpoint of >2 log reduction in HDV RNA
>50% of patients were HDV RNA undetectable or BLOQ
Adverse events were mostly mild to moderate
Breakthrough Therapy Designation granted by FDA
Avexitide in Post-Bariatric Hypoglycemia (PBH)

Positive End of Phase 2 meeting with FDA for avexitide in PBH
Upcoming Milestones

Oral presentation of Phase 2 LIFT interim end-of-treatment results in HDV at AASLD
NDA submission for Progeria and Progeroid Laminopathies by year-end, followed by MAA submission in the first quarter of 2020
Phase 3 D-LIVR study in HDV (N=400) enrollment update after year-end
End of Phase 2 meeting for Lambda monotherapy in HDV in the first quarter of 2020
Third Quarter 2019 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2019 totaled $109.9 million compared to $125.3 million at June 30, 2019, a decrease of $15.4 million.

The Company reported a net loss of $18.6 million, or $0.76 per share for third quarter 2019, as compared to $17.1 million, or $1.20 per share, for the same period in 2018.

Research and Development expenses were $14.1 million for third quarter 2019, as compared to $13.2 million for the same period in 2018, an increase of $0.9 million. The increase was primarily due to employee-related costs, including stock-based compensation, and expenditures related to our clinical programs.

General and Administrative expenses were $4.2 million for third quarter 2019, as compared to $3.6 million for the same period in 2018, an increase of $0.6 million. The increase was primarily due to additional employee-related costs, including stock-based compensation.

Third quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.5 million for the same period in 2018.

As of September 30, 2019, Eiger had 24.5 million of common shares outstanding.

Mallinckrodt to Present at Jefferies London Healthcare Conference

On November 8, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that it will present at the Jefferies London Healthcare Conference in London on Wednesday, Nov. 20, 2019 (Press release, Mallinckrodt, NOV 8, 2019, View Source [SID1234550780]).

Bryan Reasons, Executive Vice President and Chief Financial Officer, will represent the company in a fireside chat at 8:40 a.m. GMT.

Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.