On March 10, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will present updated clinical data from its AWARE-1 window-of-opportunity study in patients with early-stage breast cancer, as well as results from preclinical studies evaluating pelareorep-based combination therapies, in poster presentations during Week 1 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place virtually from April 10-15, 2021 (Press release, Oncolytics Biotech, MAR 10, 2021, View Source [SID1234576400]).

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Oncolytics Biotech Logo (PRNewsfoto/Oncolytics Biotech, Inc.)
Details on the posters and corresponding abstracts are shown below. All posters will be made available on the conference website on April 10, 2021.

Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1)
Session Type: E-Poster Session
Session Category: Phase II Clinical Trials
Session Title: Phase II Clinical Trials
Abstract Number: CT191 (late-breaking abstract)

Oncolytics will provide details on the results described in this abstract following publication of the abstract and corresponding poster at the AACR (Free AACR Whitepaper) Annual Meeting in April, in accordance with conference embargo policies regarding late-breaking abstracts.

Title: Mechanisms of therapeutic synergy between pattern recognition response agonists and cdk4 inhibitors
Session Type: E-Poster Session
Session Category: Molecular and Cellular Biology / Genetics
Session Title: Cell Cycle
Abstract Number: 1960

New preclinical studies identify the mechanisms of therapeutic synergy between pelareorep and the CDK4/6 inhibitor palbociclib. Data show that combining pelareorep with palbociclib augmented pelareorep-induced endoplasmic reticulum (ER) stress signaling and increased innate immune activation and effector function. These results suggest that this combination can be exploited to enhance anti-cancer efficacy with pro-immunogenic consequences and suggest that pelareorep may have the potential to broaden the therapeutic applicability of CDK4/6 inhibitors.

The full text of the corresponding abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting 2021 website (link).

Title: Talazoparib interacts with oncolytic reovirus to enhance death-inducing signaling complex (DISC)-mediated apoptosis and immune response
Session Type: E-Poster Session
Session Category: Molecular and Cellular Biology / Genetics
Session Title: Apoptosis
Abstract Number: 1932

New preclinical data show that combining pelareorep with talazoparib, a clinically approved poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor, led to enhanced anti-tumor efficacy that correlated with an increased immune response in murine tumor models. These data provide a scientific rationale for combining pelareorep with PARP-1 inhibitors to exploit immunogenic responses in cancer treatment.

The full text of the corresponding abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting 2021 website (link).

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

For more information about the AWARE-1 study, refer to View Source

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On March 10, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process (Press release, Bavarian Nordic, MAR 10, 2021, View Source [SID1234576416]). The offering (the "Offering") of new shares in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 4 of 9 March 2021.

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Bavarian Nordic has successfully completed a directed issue and private placement of 5,150,000 new shares (the "New Shares") at an offer price of DKK 223 per share, raising gross proceeds to Bavarian Nordic of DKK 1,148.45 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 4 of 9 March 2021.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members of Bavarian Nordic’s board of directors and executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 63,600,112 shares of DKK 10 each, equivalent to a registered share capital of DKK 636,001,120.

The New Shares represent approximately 8.81 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 8.1 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061535853. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S on or around 15 March 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Friday 12 March 2021 Settlement and payment for the New Shares
Friday 12 March 2021 Registration of the capital increase with the Danish Business Authority
Monday 15 March 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Tuesday 16 March 2021 Merger of the temporary ISIN code with the permanent ISIN code
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

MANAGERS
Danske Bank A/S, Jefferies International Limited, Jefferies GmbH and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners (jointly the "Joint Global Coordinators and Joint Bookrunners") in connection with the Offering. Nordea Danmark, filial af Nordea Bank Abp, Finland acts as settlement agent for the Offering.

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On March 10, 2021 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2020 financial results for the period ended December 31, 2020 (Press release, Merrimack, MAR 10, 2021, View Source [SID1234576432]).

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"We are pleased that both Ipsen Pharmaceuticals and Elevation Oncology continue to pursue separate clinical stage programs which could result in milestone payments to Merrimack." said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We have continued to see reduced operating expenses and remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen and Elevation."

Fourth Quarter and Full Year 2020 Financial Results

Merrimack reported net loss of $3.0 million for the year ended December 31, 2020, or $0.22 per basic share, compared to a net loss of $17.3 million, or $1.30 per basic share, for the same period in 2019.

Merrimack reported a gain on sale of assets for the year ended December 31, 2020 of $2.1 million compared to $4.9 million for the same period in 2019.

General and administrative expenses for the year ended December 31, 2020 were $5.0 million, compared to $16.2 million for the same period in 2019.

As of December 31, 2020, Merrimack had cash and cash equivalents and investments of $14.0 million, compared to $16.6 million as of December 31, 2019.

As of December 31, 2020, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On December 1, 2020 Ipsen held a capital markets day briefing with investors. On February 11, 2021 Ipsen released its full year 2020 financial results. In both of these updates Ipsen provided guidance to investors that it may file with the FDA for accelerated approval of ONIVYDE as a treatment of second line small cell lung cancer in 2021. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma.

Elevation Oncology

– On November 18, 2020 Elevation Oncology announced that it had raised a $65 million Series B financing. This announcement included confirmation that Elevation’s phase II CRESTONE study evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion is continuing to enroll patients.

On March 10, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin therapeutics, reported the upcoming presentation of four posters with data supporting three of the company’s immunotherapy programs at the American Academy for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting running April 10-15, 2021 (Press release, Molecular Partners, MAR 10, 2021, View Source [SID1234576520]).

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The accepted research describes multiple aspects of validation for the unique mechanisms of these therapies in development for treating a wide range of tumor types.

Accepted abstract titles include:

MP0317 (targeting CD40 and FAP)
MP0317, a FAPxCD40 targeting multi-specific DARPin therapeutic, drives immune activation and leads to macrophage repolarization in vitro and ex vivo
T-cell engager programs
Novel multi-specific DARPin T-cell engager with an improved therapeutic window to overcome dose limiting toxicities in AML therapies.
A solution to T-cell engager toxicity: An anti-CD3 Prodrug DARPin (CD3-PDD) shows no toxicity, but potent anti-tumor activity in a humanized mouse model
Peptide-MHC program
Application of the DARPin technology for specific targeting of tumor-associated MHC class I: peptide complexes
For MP0317, the company’s multi-specific DARPin candidate targeting both FAP and CD40 to enable tumor-localized immune activation, the research describes how the candidate’s activation of immune cells in-vitro, as well as on human tumor samples, was dependent on the presence of the FAP protein, which is highly expressed in the stroma of a broad range of solid tumors. Furthermore, the research observed that immunosuppressive macrophages associated with tumor growth and spread were reverted by MP0317 into an anti-tumor phenotype. These data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation avoiding systemic toxicity seen in other agents. MP0317 is anticipated to begin clinical trials in the second half of 2021.

For the T-cell engager program, two accepted research abstracts detail the construction of next generation T-cell engager DARPin molecules designed to overcome the limited tumor specificity and the immune hyperstimulation associated with other T-cell engager approaches. By linking a T cell engaging CD3 DARPin binder to additional DARPin binder domains that optimally engage tumor-specific antigens in parallel, the company generated candidates that displayed strong in vitro potency, and low levels of cytokine release ex vivo – suggesting low systemic immune activation. Furthermore, an anti-CD3 Prodrug DARPin (CD3-PDD) was successfully designed to have its immunostimulatory effects inactivated by a linked ‘blocking’ DARPin domain, and become activated only in the tumor microenvironment, upon cleavage of the linker by tumor-associated proteases. In an in vivo humanized mouse tumor model, this candidate demonstrated anti-tumor activity and no toxicity when administered systemically. Together, the research supports Molecular Partners’ DARPin technology ability to control immunostimulation through a validated mechanism with a heightened level of precision relative to existing approaches.

Finally, for the peptide-MHC (pMHC) program, the research provides updates on the development of pMHC binders in the T cell engager format. The successful screening and engineering of the bispecific DARPin candidates (pMHC-CD3) achieved highly potent and specific T cell activation only in the presence of the target peptide, resulting in T-cell mediated tumor cell killing. A vast majority of tumor or viral antigens are presented as peptides on the cell surface by MHC molecules for immune cell recognition and have potential to be leveraged as versatile targets for immunomodulating therapeutics. However, to-date, antibody and T-cell receptor-based pMHC binders have been challenged by their low target abundance, weak affinity, cross-reactivity to other pMHCs, or challenging biochemical properties.

On March 9, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a license agreement with Biokit, a Werfen Company, to incorporate Affimer reagents into a Biokit in-vitro diagnostic (IVD) product (Press release, Avacta, MAR 9, 2021, View Source [SID1234576250]).

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Biokit is recognised and renowned as a Centre of Excellence with consolidated experience worldwide in research, development and manufacturing of assays and biomaterial solutions for IVD use.

The license agreement follows an extensive evaluation by Biokit of certain Affimer reagents to detect a key analyte. Under the terms of the agreement Biokit has the right to develop, manufacture and commercialise through original equipment manufacturer (OEM) partners a diagnostic immunoassay for this analyte.

Avacta will receive royalties on future sales of any products brought to market following completion of product development and regulatory approvals. Financial details of the agreement were not disclosed.

Dr Alastair Smith, Chief Executive of Avacta Group commented:

"I am delighted to have established this partnership with Biokit, a world-renowned IVD company, which further validates the Affimer reagent platform for diagnostics. Avacta’s diagnostics business model combines development of a wholly owned pipeline of products, including the SARS-CoV-2 rapid antigen test, with licensing of Affimer reagents to diagnostic development partners such as Biokit.

Biokit will develop an automated clinical assay using the Affimer reagents that Avacta has developed for them and I look forward to the successful conclusion of that development process and product launch. There is also potential for the partnership between our two companies to continue and expand to include other diagnostic targets and future Affimer-based IVDs."

Dr Marta Palicio, Innovation Director of Biokit commented:

"Biokit is very pleased to have reached this agreement with Avacta. The agreement will increase the competitiveness of our customized assay offering for our partners. Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development, incorporation of this technology into new products. We hope this is the first of many assays containing Affimer reagents which will be developed by Avacta".