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).

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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.

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.

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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

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]).

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"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.

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]).

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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.

On November 8, 2019 Alkermes plc (Nasdaq: ALKS) reported new data from the company’s ARTISTRY clinical development program related to ALKS 4230 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD (Press release, Alkermes, NOV 8, 2019, View Source [SID1234550779]). ALKS 4230 is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the IL-2-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The company presented preliminary clinical data from ARTISTRY-1, the ongoing phase 1/2 study investigating ALKS 4230 administered intravenously, as well as study design details and preliminary safety data from ARTISTRY-2, the ongoing phase 1/2 study investigating ALKS 4230 administered subcutaneously. Both studies are evaluating ALKS 4230 as a monotherapy and in combination with pembrolizumab (KEYTRUDA). The posters presented by the company at SITC (Free SITC Whitepaper) and a corporate presentation related to the ALKS 4230 program are available on the Investors section of www.alkermes.com.

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"The early signs of clinical efficacy and safety that we have seen so far with ALKS 4230 as both monotherapy and in combination with pembrolizumab are encouraging, and have been observed in multiple solid tumor types, including in PD-(L)1 inhibitor unapproved indications," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "In addition to the preliminary data from ARTISTRY-1, we are making progress in ARTISTRY-2 and are now enrolling the next set of cohorts that will evaluate once-weekly and once-every-three-week dosing regimens. We look forward to presenting data from ARTISTRY-2 at a future medical meeting."

"Despite the introduction of immunotherapies and other innovations in the field of oncology, there remains a high unmet need for new treatments, as many patients are not eligible to receive certain medications such as checkpoint inhibitors, or don’t respond well to such medications," said Ulka N. Vaishampayan, M.D., Professor of Oncology at Wayne State University and Director of the Phase I Program at the Karmanos Cancer Institute. "The emerging data from the ARTISTRY clinical program are encouraging, with ALKS 4230 demonstrating initial signs of clinical benefit and a safety profile that is generally consistent with what is expected with cytokine therapy. Importantly, no evidence of vascular leak syndrome, which is the most significant limitation to currently available IL-2 therapy, has been observed as of October 31st."

The following preliminary safety and efficacy findings from the ARTISTRY-1 monotherapy and combination therapy cohorts are as of Aug. 2, 2019, unless otherwise noted:

Data presented from the ongoing monotherapy dose-escalation stage of ARTISTRY-1 included five completed cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day:

A total of 36 patients with refractory advanced solid tumors were treated.
Consistent with earlier non-clinical findings, treatment with ALKS 4230 selectively expanded natural killer (NK) and CD8+ T cells and had negligible, non-dose-dependent effects on regulatory T cells (Tregs).
ALKS 4230 3 µg/kg/day dose was selected for initial evaluation in combination with pembrolizumab, based on the cell expansion and tolerability profile seen at this dose.
ALKS 4230 6 µg/kg/day dose was identified as the monotherapy recommended phase 2 dose (RP2D) for intravenous administration. Data from this dose demonstrated our targeted tolerability profile, along with the targeted lymphocyte cell expansion without corresponding IL-2-induced Treg activation.
At doses of 3 µg/kg/day and 6 µg/kg/day of ALKS 4230, 8 of 14 patients with evaluable initial scans had stable disease.
This includes one patient in the 6 µg/kg/day group with heavily pretreated pancreatic adenocarcinoma who received monotherapy ALKS 4230 for 10 months, with stable disease maintained for approximately 6 months. Following progressive disease, this patient rolled over to combination therapy with pembrolizumab for 4.5 months.
The most frequently reported adverse events (AEs), regardless of relationship to ALKS 4230, were fever and chills, which are anticipated effects of cytokine administration. No Grade 4 or 5 treatment-related AEs were reported, and no signs of vascular leak syndrome were observed at any dose.
The maximum tolerated dose of monotherapy intravenous ALKS 4230 has not been determined and dose escalation is ongoing.
Data presented from the combination stage of ARTISTRY-1 focused on the cohort of PD-(L)1 inhibitor unapproved tumor types and one monotherapy rollover patient. These patients received the ALKS 4230 3 µg/kg/day dose in combination with pembrolizumab:

26 patients (n=1 monotherapy rollover, n=25 PD-(L)1 inhibitor unapproved tumor types) were treated in the cohort.
12 of the 18 patients with evaluable scans achieved stable disease or better, including:
One patient with ovarian cancer had a confirmed partial response at Cycle 6 and demonstrated complete normalization of her CA-125 (tumor marker) levels at Cycle 4, which continued in the normal range: 282 U/mL (screening) to 12.6 U/mL (Cycle 10). As of Oct. 31, 2019, this patient remains on therapy.
One patient with triple negative breast cancer showed a >50% reduction in target lesion size at Cycle 8. As is common with checkpoint inhibitor treatment, small new lesions developed for this patient at Cycle 2. The decrease in her target lesions and in these small new lesions qualified her for an immune-partial response (iPR) based on iRECIST (Response Evaluation Criteria in Solid Tumors) criteria. As of Oct. 31, 2019, this patient remains on therapy.
The most frequently reported adverse events (AEs), regardless of relationship to ALKS 4230 were fever and chills. No Grade 4 or 5 treatment-related AEs were reported, and no signs of vascular leak syndrome were observed.
In addition to data from ARTISTRY-1, the company also presented a trials-in-progress poster on ARTISTRY-2. The study’s initial dose escalation cohort (n=7) has been completed at the once-weekly 0.3 mg subcutaneous dose of ALKS 4230. Initial signals of tolerability were observed, and no patient discontinued treatment due to AEs.

As of Oct. 31, 2019, 6 of 7 patients from the first cohort remained on therapy. Enrollment in the next two dose escalation cohorts, to evaluate ALKS 4230 0.6 mg once-weekly and ALKS 4230 1.0 mg once-every-three-weeks, is ongoing. The company plans to present data from ARTISTRY-2 at a future medical meeting.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the IL-2-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently initiated monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.