On November 17, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that, as part of its ongoing collaboration with STORM Therapeutics ("STORM"), the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, STORM has selected STC-15 as a first-in-class development candidate (Press release, Evotec, NOV 17, 2020, View Source;announcements/press-releases/p/evotec-and-storm-therapeutics-leverage-indigo-platform-to-progress-oncology-project-towards-clinical-studies-5998 [SID1234571192]). STORM will now use INDiGO, Evotec’s unique integrated, accelerated IND-enabling platform, to progress STC-15 towards an IND application in 2021.

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STORM discovered STC-15, an orally bioavailable, small molecule inhibitor of the enzyme METTL3 targeting modulation of RNA epigenetics, an entirely new mechanism of action, to treat acute myeloid leukaemia ("AML") and other solid and haematological cancers with the support from Evotec’s pre-clinical drug discovery engine.

STORM leads the global field of RNA modulation having demonstrated in vivo proof of concept activity of the first RNA methyltransferase inhibitor in relevant animal models for myeloid and solid tumours. METTL3 is one of two programmes from the STORM platform that have already shown in vivo activity.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "The relationship with STORM goes from strength to strength and is a great example of Evotec’s ability to support the exploration of novel and exciting biology to maximise innovation, but also execute efficiently with rapid and seamless integration from target through to IND."

Dr Keith Blundy, Chief Executive Officer of STORM Therapeutics, added: "STC 15 was identified with support from Evotec and is a highly potent and selective METTL3 inhibitor that is effective in leukaemia cells refractory to chemotherapy treatment. This patient population will be incorporated into the initial clinical trials aiming to accelerate clinical proof of concept for patients with limited other options in addition to exploring combinations with standard of care. STORM’s vision is to become the world’s first company to deliver a disease-modifying agent that works by targeting RNA-modulating enzymes. Evotec has enabled us to rapidly and successfully progress our work resulting in a first-in-class development candidate, with more to follow."

On November 17, 2020 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the "Company") (Paris:NANO), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that the United States Food and Drug Administration (FDA) has provided ‘Safe to Proceed’ notifications for two additional trials in its ongoing clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) (Press release, Nanobiotix, NOV 17, 2020, View Source [SID1234571172]). These trials were co-developed with Nanobiotix and MD Anderson is the sponsor and executor.

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Significant Unmet Needs and Opportunity in Cancer Immunotherapy

Cancer immunotherapies such as immune checkpoint inhibitors (ICIs) have shown promising clinical outcomes over the past two decades; and are often used for patients with advanced cancers once other therapies have reached the end of their effectiveness. However, the vast majority of patients only receive a temporary benefit or no benefit from ICIs, as they either develop resistance to the treatment during the course of therapy or are non-responsive to the treatment altogether (only 15%-20% of patients respond, according to published data). These barriers present a significant unmet need to improve the efficacy ICIs and expand their potentially curative benefits to more patients with advanced cancers.

Combining ICIs with radiation therapy is emerging as a valuable strategy to "prime" an immune response and thereby increase the response rate, however the efficacy of radiation therapy is limited by toxicities related to the exposure of healthy tissues.

NBTXR3 is injected one time, directly into solid tumors. The product candidate is designed to increase the energy deposit from radiation therapy within the target tumor and subsequently increase the tumor-killing effect without increasing toxicity in surrounding healthy tissue. Pre-clinical and clinical data also suggest that NBTXR3 activated by radiation therapy can prime the immune system, creating an anti-tumor immune response that produces both local and systemic effects.

A Phase II Study of NBTXR3 Activated by Radiation and Combined with Pembrolizumab for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Limited PD-L1 Expression or Refractory to PD-1 Blockade

This MD Anderson trial is an open label, two cohort, non-randomized phase II study. The primary objective of the study is to evaluate tumor response of NBTXR3 activated by radiation therapy in combination with pembrolizumab in patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

The population includes patients with inoperable R/M HNSCC of the oropharynx, oral cavity, hypopharynx, larynx or neck. Patients could be anti-PD-1/L1 naïve or refractory. Up to 60 patients may be treated, with up to 40 in the first cohort and up to 20 in the second cohort. The first cohort will include anti-PD-1/L1 naïve patients with a combined positive score (CPS) between greater than or equal to 1% and less than 20%. The second cohort will include anti-PD-1/L1 refractory patients irrespective of PD-L1 expression.

A Phase II Study of Reirradiation with NBTXR3 in Patients with Inoperable Locoregional Recurrent Head and Neck Squamous Cell Carcinoma

This MD Anderson trial is an open label, two cohort, non-randomized phase II study. The primary objectives of the study are: (i) to estimate progression-free survival (PFS) and the early clinical benefit in patients treated with NBTXR3 activated by SBRT re-irradiation, with concurrent pembrolizumab; (ii) to assess the safety profile and estimate the early clinical benefit of NBTXR3 activated by a reduced dose of IMRT or IMPT re-irradiation with concurrent pembrolizumab.

The population includes patients with inoperable, locoregional recurrent head and neck squamous cell carcinoma (HNSCC) or second primary HNSCC, previously treated with definitive radiation therapy and without radiographic evidence of metastases. Patients could be anti-PD-1/L1 naïve or non-responders. Up to 80 patients may be treated, with up to 60 in the SBRT cohort and up to 20 in the IMRT/IMPT cohort.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class radioenhancer composed of functionalized hafnium oxide nanoparticles that is administered via one-time intra-tumoral injection and activated by radiation therapy. The primary mode of action (MoA) of NBTXR3 is designed to generate increased cellular destruction when activated by radiation therapy without increasing damage to healthy tissues. Subsequently, this cellular destruction also triggers an adaptive immune response.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. In February 2020, the United States Food and Drug Administration granted the regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

Nanobiotix is also running an Immuno-Oncology development program. The Company has launched a Phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets) from any primary cancer eligible for anti-PD-1 therapy.

Other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company is also engaged in a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to further expand the NBTXR3 development program.

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.

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."

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.