PCI Biotech: European patent for treatment of bile duct cancer with the fimaCHEM technology

On November 16, 2020 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, reported that the European Patent Office (EPO) has informed the company that a new European patent has been granted (Press release, PCI Biotech, NOV 16, 2020, View Source [SID1234585149]). The European patent covers the intended use of fimaChem in combination with gemcitabine for the treatment of cholangiocarcinoma (bile duct cancer).

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Per Walday, CEO, comments: We are very happy to see this patent granted in Europe, which provides an extended protection of the intended use of fimaChem lasting several years beyond the potential market exclusivity offered by the orphan designation. Our full focus is now on the successful delivery of the global pivotal RELEASE study.

Today’s announced European patent secure protection until 2037. The patent application is still pending in US and key Asian markets.

Champions Oncology Announces the Launch of Lumin Bioinformatics, Its New Oncology Data-Driven SaaS Program

On November 16, 2020 Champions Oncology, Inc. (NASDAQ:CSBR), a leading global oncology technology solutions provider that is transforming drug discovery through innovative pharmacology, biomarker and data platforms, reported the launch of its new proprietary SaaS program known as Lumin Bioinformatics (Press release, Champions Oncology, NOV 16, 2020, View Source [SID1234574975]). By leveraging Champions’ large cancer dataset, which is unique for its substantial depth of characterization, combined with many other published cancer datasets, Lumin provides users with a vast database of tumor characterization that can be used for computational research. The software, which is purchased as a yearly subscription, also provides sophisticated analytic tools that are utilized to interrogate the data for associations between molecular and various phenotypic features, including thousands of drug responses, clinical annotations, prior treatment histories, and genetic dependencies. Insights developed using Lumin can provide the basis for biomarker hypotheses, reveal potential mechanisms of therapeutic resistance, and guide the direction of additional preclinical evaluations.

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Ronnie Morris, MD, President and CEO, said "The launch of Lumin Bioinformatics is an exciting step forward in our strategy to deploy the unique dataset that we have established over the past decade. Our data is distinct in its depth of characterization, providing a powerful foundation for computational analyses. Lumin harnesses this power and facilitates access to it for a deeper understanding of therapeutic programs and tumor cell biology. We’re excited to see how it can impact the direction of our customers’ research programs."

"Lumin Bioinformatics overcomes many of the computational challenges our customers experience", said Michael Ritchie, PhD, MBA, Chief Commercial Officer at Champions Oncology. "Most of the biopharma organizations we work with do not have large bioinformatic teams, nor access to such a robust dataset. Lumin fills these gaps by making extremely complex computational analyses accessible to a broader audience."

The Board of Directors of Scandion Oncology has resolved on a fully guaranteed rights issue of approximately SEK 236 million

On November 16, 2020 The Board of Directors in Scandion Oncology A/S ("Scandion Oncology" or the "Company") reported that pursuant to the authorization granted by the extraordinary general meeting on 13 November 2020, resolved on a fully guaranteed new share issue of 10,711,848 shares with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Scandion Oncology, NOV 16, 2020, View Source,c3237586 [SID1234574539]). The subscription price in the Rights Issue is SEK 22 per share. The Company will receive SEK 235,660,656 prior to deduction of transaction costs related to the Rights Issue.

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The information in this press release is not intended for publication, public release or distribution, directly or indirectly, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa or any other jurisdiction where such publication or distribution would violate applicable laws or regulations. See the section "Important information" at the end of this press release.

The proceeds from the Rights Issue will primarily be used to finance continued clinical development of SCO-101.
Existing shareholders in the Company receive one subscription right for each share held as of the record date, 24 November 2020. Two subscription rights entitle the holder to subscribe for one new share in the Rights Issue.
Subscription in the Rights Issue may occur under the period as of 26 November – 10 December 2020.
For existing shareholders not participating in the Rights Issue, a dilution effect corresponding to 33.3 per cent of the total number of shares and votes in the Company following the Rights Issue will arise.
Certain of the Company’s shareholders, board members and management have undertaken to subscribe new shares, amounting to approximately SEK 4.4 million, equivalent to approximately 2 percent of the Rights Issue. In addition, the Company has received subscription commitments (without commitment fee) amounting to approximately SEK 29 million from external professional investors and guarantee commitments amounting to approximately SEK 202.3 million from certain external guarantors, together corresponding to approximately 98 percent of the Rights Issue. Consequently, the Rights Issue is fully guaranteed.

"With the proceeds from this rights issue we will continue the development of Scandion Oncology into a significant clinical stage cancer drug resistance company. We are at the threshold of bringing SCO-101 to proof of concept in drug resistant cancer patients, and we see a large and growing potential to strengthen our pipeline further preventing resistance not only in colorectal cancer, but also in pancreatic cancer and other cancers. SCO-101 is the first of its kind, and will bring a solution to a huge and growing problem for patients – overcoming cancer drug resistance," says Bo Rode Hansen, President & CEO, Scandion Oncology A/S.

Background and reasons

Scandion Oncology is a clinical phase II biotechnology company addressing cancer drug resistance as a complement to existing anti-cancer therapies by developing first-in-class, oral add-on drugs. Used as a combination therapy, the Company’s products have the potential to quickly reach peak sales in addition to potentially offering better response rates and increased survival time with improved quality of life. The lead candidate, SCO-101, is currently in clinical phase II. The drug has a multimodal mechanism of action, targeting well-documented, key cancer drug resistance mechanisms, which are common among a wide variety of cancer indications. The Company is targeting cancer drug resistance in various treatment modalities including, chemotherapy, anti-hormonal therapy, and immuno-oncology. Initially, the Company is targeting colorectal-, pancreatic-, and breast cancer.

On 1 October 2020, Scandion Oncology appointed Bo Rode Hansen as new President and CEO and co-founder Nils Brünner as new CSO to strengthen executive leadership in order to bring the Company to the next level of its corporate, scientific and commercial phase.

Targeting well-known cancer drug resistance mechanisms enables the Company to develop a broad pipeline that address several indications:

SCO-101 is currently in phase II trial in combination with standard market-leading chemotherapy (FOLFIRI) to evaluate safety and efficacy of the combination treatment in late-stage metastatic colorectal cancer patients with acquired FOLFIRI resistance. Data from part 1 of the trial is expected in Q2 2021.
In October 2020, Scandion Oncology initiated phase Ib (dose-range finding) with SCO-101 in combination with first line chemotherapy (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer. Results are expected in Q2-Q3 2021.
In addition, Scandion Oncology’s biomarker strategy includes a personalized treatment approach with SCO-101, which is enabled through the development of predictive biomarkers where the biomarker assays are expected to be validated in Q2 2021.
The second clinical drug, SCO-201, is undergoing preclinical profiling to be prepared for human trial.
During 2020, Scandion Oncology has reached several important milestones. The positive data from the first patients made it possible for the Company to attract Bo Rode Hansen, a seasoned top executive and life science entrepreneur, as President and CEO. Scandion Oncology is now on the path towards value inflecting milestones, aiming to increase benefit of patients and create shareholder value. The Company will use the proceeds from the Rights Issue to further create shareholder value and to bring Scandion Oncology’s candidates towards commercialization.

Use of proceeds

The net proceeds of approximately SEK 200 million from the Rights Issue are intended to finance the following activities:

Approximately 60% will be used for continued development of SCO-101, including drug production and clinical trials.
Approximately 10% will fund pre-clinical development of SCO-201 and explorations og additional indications of SCO-101.
Approximately 30% will support general company activities.
Rights Issue

The Board of Directors of the Company has today, 16 November 2020, pursuant to the authorization granted by the extraordinary general meeting held on 13 November 2020, resolved on a new share issue of up to a maximum of 10,711,848 shares with preferential rights for the Company’s existing shareholders in proportion to their shareholdings as of the record date 24 November 2020.

Holders of shares, which on the record date of 24 November 2020 are entered in the share register held by Euroclear Sweden AB, have the preferential right to shares in the Rights Issue. One existing share gives right to one subscription right and two subscription rights entitle the holder to subscribe for one new share in the Rights Issue at a subscription price of SEK 22 per share.

The Company will receive SEK 235,660,656 before deduction of transaction costs related to the Rights Issue.

The Rights Issue will result in an increase of the share capital of DKK 787,320.8280. Following the Rights Issue, the number of shares in Scandion Oncology will amount to 32,135,544 and the share capital will amount to DKK 2,361,962.4840. For existing shareholders not participating in the Rights Issue, a dilution effect corresponding to approximately 33.3 percent of the total number of shares and votes in the Company following the Rights Issue will arise. Shareholders who choose not to participate in the Rights Issue may sell their subscription rights.

The last day of trading in Scandion Oncology’s shares, including the right to receive subscription rights in the Rights Issue, is 20 November 2020. The first day of trading in Scandion Oncology’s shares without the right to receive subscription rights in the Rights Issue is 23 November 2020. Subscription of shares with subscription rights shall be by cash payment during the period from 26 November – 10 December 2020. Subscription of shares without subscription rights shall be made on a special subscription list during the period from 26 November – 10 December 2020. Payment for remaining shares subscribed without subscription rights shall be made in cash no later than two banking days following the issue of the settlement note, which indicates notification of allocation.

Allotment of remaining shares subscribed for without subscription rights

In the event that all shares are not subscribed for with subscription rights before the expiry of the subscription period, the remaining shares will, without compensation to the holders of unexercised subscription rights, be allotted to such existing shareholders and qualified investors having made binding undertakings to subscribe for remaining shares without subscription rights. In case of oversubscription of the remaining shares, the remaining shares will be allocated according to apportionment keys determined by the Board of Directors.

Prospectus

The full terms and conditions of the Rights Issue and information about the Company will be included in a prospectus expected to be published on the Company’s website around 24 November 2020. In Denmark, the offering is carried out without a prospectus pursuant to applicable exemptions.

Subscription undertakings and guarantees

Certain of the Company’s shareholders, board members and management have undertaken to subscribe new shares, amounting to approximately SEK 4.4 million, equivalent to approximately 2 percent of the Rights Issue. In addition, the Company has received subscription commitments amounting to approximately SEK 29 million from external professional investors and guarantee commitments amounting to approximately SEK 202.3 million from certain external guarantors, together corresponding to approximately 98 percent of the Rights Issue. Consequently, the Rights Issue is fully guaranteed.

A guarantee commission will be paid for the guarantee commitments, based on current market conditions, of nine (9) percent of the guaranteed amount in cash consideration. No consideration is to be paid for the subscription commitments that have been entered into. These subscription and guarantee commitments are not secured through bank guarantees, restricted funds, pledged assets or similar arrangements. Further information on the parties who have entered into guarantee commitments will be presented in the prospectus that will be released before the commencement of the subscription period.

Preliminary timetable for the Rights Issue

Last day of trading in shares including right to receive subscription rights: 2020-11-20
First day of trading in shares excluding right to receive subscription rights: 2020-11-23
Record date for participation in the Rights Issue: 2020-11-24
Prospectus announced and published on the Company’s web page: 2020-11-24
Subscription period: 26 November – 10 December 2020
Trading in subscription rights: 26 November – 8 December 2020
Trading in BTA’s ends: 3 December 2020 until the Danish Business Authority has registered the Rights Issue and BTA are converted to shares.
Announcement of final outcome in the Rights Issue: Around 15 December 2020.
Trading in new shares commences: Following registration of the new shares at the Danish Business Authority, the newly issued shares will be admitted to trading on Spotlight. Such trading is expected to commence around 11 January 2021.
Lock-up undertakings

The Board of Directors and executive management of Scandion Oncology have signed so-called lock-up undertakings towards Vator Securities AB, which means that they commit to retain their holdings of shares and/or other securities in the Company for a period of 180 days calculated from the first day of trading of the new shares in the Rights Issue. The lock-up undertaking does also apply to shares subscribed for in the Rights Issue.

Advisors

Vator Securities is financial adviser and Advokatfirman Schjødt (as to Swedish law) and Plesner Advokatpartnerselskab (as to Danish law) are legal advisers to the Company in connection with the Rights Issue.

This information is information that Scandion Oncology is obliged to publish in accordance to the EU Market Abuse Regulation. The information was provided by the contact person above for publication on 16 November 2020.

Atara Biotherapeutics to Participate at Two Upcoming Investor Conferences

On November 16, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease, reported that Company management will participate at two upcoming virtual conferences (Press release, Atara Biotherapeutics, NOV 16, 2020, View Source [SID1234574477]).

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Stifel 2020 Virtual Healthcare Conference
Wednesday, November 18, 2020 at 4:40 p.m. EST
Fireside Chat with Pascal Touchon, President and Chief Executive Officer

Evercore ISI 3rd Annual Virtual HealthCONx Conference
Wednesday, December 2, 2020 at 8:50 a.m. EST
Fireside Chat with Pascal Touchon and Jakob Dupont, Global Head of Research and Development

Live video webcasts of both presentations will be available by visiting the Investor Events and Presentations section of atarabio.com. Archived replays will be available on the Company’s website for approximately 14 days following the live webcasts.

Entry into a Material Definitive Agreement

On November 16, 2020, Medgenics Medical Israel Ltd. ("Medgenics"), a subsidiary of Cerecor Inc. (the "Company"), reported that it entered into a sixth amendment to that certain Sponsored Research Agreement, dated as of November 12, 2014, by and between Medgenics and Children’s Hospital of Philadelphia ("CHOP") (as amended, the "SRA") and a sixth amendment to that certain License Agreement, dated as of November 12, 2014, by and between Medgenics and CHOP (as amended, the "License Agreement"), which modified the term of the SRA and certain of Medgenics’ exclusive rights under the License Agreement (collectively, the "Amendments") (Filing, 8-K, Cerecor, NOV 16, 2020, View Source [SID1234573111]). Pursuant to the amended SRA, the term of the SRA is extended to January 15, 2021, and may be extended for additional terms ending on each of June 30, 2021, 2022 and 2023, if the Company provides written notice to CHOP of such extension, and a commitment to fund at set amounts, by January 15, 2021 (for the January 16, 2021 to June 30, 2021 term), March 30, 2021 (for the July 1, 2021 to June 30, 2022 term) and March 20, 2022 (for the July 1, 2022 to June 30, 2023 term). Pursuant to the amended License Agreement, the Company has the option to extend the term during which it is granted certain exclusive rights under the License Agreement to match the then-current term of the SRA. In addition, the License Agreement was amended to adjust the field in which Medgenics has exclusive rights and clarify payment obligations of Medgenics to CHOP in respect of the Company’s anti-LIGHT monoclonal antibody, CERC-002. Pursuant to the terms of the Amendments, the Company is obligated to pay to CHOP (i) $125,000 within ten days of entry into the Amendments, (ii) $1,500,000 for sponsored research during each of the periods July 1, 2020 through January 15, 2021 and January 15, 2021 through June 30, 2021, (iii) $3,000,000 for each of the periods July 1, 2021 through June 30, 2022 and July 1, 2022 through June 30, 2023 and (iv) $125,000 under the License Agreement each time that the Company exercises its extension option.

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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

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