On August 25, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported that the US Patent and Trademark Office (USPTO) will grant the company’s patent US11,103,481 directed to the use of SCO-101, on August 31, 2021 (Press release, Scandion Oncology, AUG 25, 2021, View Source,c3402649 [SID1234586871]).

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The granted patent covers combination therapy with Scandion Oncology’s first-in-class lead candidate SCO-101 and is part of the company’s patent family originating from the international application PCT/EP2017/061823. The patent claims the use of SCO-101 in combination with different anti-cancer agents across many cancer indications. The Patent Term for the US patent has been extended by 275 days, prolonging the expiry of this patent until January 2038.

"We are pleased that the USPTO has recognized the uniqueness of SCO-101 and granted this patent. This is an important milestone on our journey of developing SCO-101 and internationalizing the company. We have obtained valuable patent protection for SCO-101 in the US, one of our projected key markets, increasing the commercial potential of SCO-101 and creating value for shareholders," said Bo Rode Hansen, President and CEO.

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on August 25, 2021, at 8:30 CET

Scandion Oncology A/S is a clinical Phase II biotechnology company currently developing first-in-class, oral add-on drugs to existing market leading anti-cancer therapies. As add-on to standard anti-cancer therapies, it introduces an effective treatment approach for cancer, which is or has become resistant to cancer-fighting drugs, offering the potential for better response rates, longer survival and improved quality of life. The first-in-class lead candidate, SCO-101, is currently in clinical Phase II. The Company is targeting cancer drug resistance in various treatment modalities including chemotherapy, anti-hormonal therapy and immunotherapy. Scandion Oncology is listed on Nasdaq First North Growth Market Sweden. Ticker: SCOL.

On August 25, 2021 Novartis reported that the US Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application (NDA) for asciminib (ABL001) in chronic myeloid leukemia (CML), following its submission under the FDA’s Real-Time Oncology Review (RTOR) program. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1 (Press release, Novartis, AUG 25, 2021, View Source [SID1234586869]). This designation could shorten the FDA review period to eight months compared to the 12 months under Standard Review1.

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Priority Review granted based on positive data from the pivotal, Phase III ASCEMBL trial, where asciminib was compared to Bosulif (bosutinib)* in patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs), and data from a Phase I trial that included patients with Ph+ CML-CP harboring the T315I mutation2,3
Despite available treatments, many patients with CML remain at risk of disease progression, and sequential therapy with currently available TKIs may be associated with increased resistance and/or intolerance4-10
Asciminib, a novel investigational therapy specifically targeting the ABL myristoyl pocket – also known as a STAMP inhibitor –, is in development across multiple treatment lines for CML11-17
Novartis has previously received Orphan Drug, Fast Track and two Breakthrough Therapy designations for asciminib. Breakthrough Therapy designations were granted for asciminib for the treatment of adult patients with Ph+ CML-CP previously treated with two or more TKIs, as well as adult patients with Ph+ CML-CP harboring the T315I mutation.

On August 2, 2021 Context Therapeutics Inc. (the "Company"), a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Tyligand Bioscience, Ltd. ("Tyligand"), a leader in small molecule drug discovery and development, reported the successful completion of ONA-XR (onapristone extended release) manufacturing process optimization pursuant to the collaboration agreement entered into between the parties in March 2020 (Press release, Context Therapeutics, AUG 25, 2021, View Source [SID1234586868]).

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ONA-XR is an orally administered, potent and specific antagonist of the progesterone receptor (PR) being evaluated in the clinic for PR-positive (PR+) breast, ovarian and endometrial cancers.

In connection with this successful optimization, Context and Tyligand entered into a license agreement whereby Tyligand was granted the exclusive right and sole responsibility for the development and commercialization of ONA-XR in China, Hong Kong and Macau (the "Territory"), and Context is eligible to receive royalties on net sales of ONA-XR in the Territory. Context retains rest of world rights to commercialize ONA-XR.

"We are thrilled to announce this successful optimization work completed for ONA-XR and the execution of the license agreement with Tyligand," said Martin Lehr, CEO of Context. "This work represents another major step forward for Context’s ability to efficiently scale our manufacturing and clinical capacity to support the development and future commercialization of ONA-XR to address the unmet need in treating women with PR+ cancers."

"Onapristone has an intriguing molecular structure, and it is no small feat to achieve such a significant improvement in its manufacturing process," said Peter Wuts, PhD, a pharmaceutical veteran and Senior Advisor to Context. "It is a testament to the drive and creativity of the Tyligand team of molecule builders and the power of chemistry in making better medicines."

"Tyligand and Context share the commitment of providing effective and affordable treatment options for cancer patients globally and this milestone brings us closer to realizing our goal," said Tony Zhang, PhD, CEO of Tyligand. "ONA-XR has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and we look forward to working with Context in further developing and commercializing this excellent molecule."

On August 25, 2021 XRad Therapeutics reported that first patient dosed in Phase 1a Clinical Trial of XRD-0394 for metastatic, locally advanced or recurrent solid tumours(Press release, Aptus Clinical, AUG 25, 2021, View Source [SID1234586867])

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Aptus Clinical is providing CRO support for this study

The dosing of the first patient into US based XRad Therapeutics’ Phase 1a study of XRD-0394 in metastatic, locally advanced or recurrent solid tumours, marks a major milestone for XRad and Aptus Clinical. For XRad, XRD-0394 is their first asset to reach clinical development, whilst for Aptus this is the first study utilising their US-based CRA team. As part of Aptus’ full-service delivery capability, the US CRAs, working alongside their UK headquartered clinical operations and data management colleagues, now provide significant geographical extension to Aptus’ current experience delivering early phase oncology, cell & gene therapy and rare disease clinical trials in in the UK and EU.

This Phase 1a trial will evaluate the safety and tolerability of single ascending doses of XRD-0394 in combination with radiation therapy. The trial is being conducted at two world renowned centres of excellence: Memorial Sloan Kettering Cancer Center in New York and the Stanford Cancer Institute in Palo Alto, California. XRD-0394 is a first-in-class, oral, dual kinase inhibitor of both ataxia-telangiectasia mutated and DNA-dependent protein kinase and based on preclinical studies is designed to enhance the effectiveness of radiation therapies. Results from this trial will inform the dosing regimen for the company’s planned Phase 1b study.

Tona Gilmer, PhD, President, Chief Executive Officer and co-founder of XRad said in a statement: "We are delighted to be working with our clinical CRO partners at Aptus who are managing the delivery of this vital first study in our development programme. Successful completion will allow us to rapidly move to the next step in our clinical development"

Jonathan Lewis, co-founder and Chief Commercial Officer at Aptus Clinical commented "We are thrilled that the XRad team entrusted the clinical delivery of their first asset to Aptus. Having worked initially with members of our consulting team, recognition of the strength and depth of experience in our operational delivery organisation has been a great endorsement of our capabilities. We look forward to working alongside the XRad team to demonstrate the full benefits of this important potential addition to the cancer treatment armamentarium"

On August 25, 2021 InDex Pharmaceuticals Holding AB (publ) reported that interim report January – June 2021 (Press release, InDex Pharmaceuticals, AUG 25, 2021, View Source [SID1234586866])

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Period April – June 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –42.6 (–15.6) million
Result after tax amounted to SEK –42.6 (–15.6) million, corresponding to SEK –0.08 per share (–0.07) before and after dilution
Cash flow from operating activities amounted to SEK –53.4 (–32.8) million
Period January – June 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –51.9 (–39.6) million
Result after tax amounted to SEK –52.0 (–39.6) million, corresponding to SEK –0.11 per share (–0.17) before and after dilution
Cash flow from operating activities amounted to SEK –62.0 (–54.7) million
Cash and cash equivalents at the end of the period amounted to SEK 478.8 (70.6) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during the quarter
InDex announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer
Significant events after the quarter
InDex received first regulatory approval from the Swedish MPA to start the phase III study CONCLUDE with cobitolimod
InDex received FDA clearance to start the phase III study CONCLUDE
Other events
InDex got patent for additional DIMS compounds granted in Europe
The annual general meeting in InDex Pharmaceuticals Holding AB was held on June 3, 2021. Board members Wenche Rolfsen (also chairman), Marlene Forsell, Uli Hacksell and Lennart Hansson were re-elected. Yilmaz Mahshid and Stig Løkke Pedersen had ahead of the annual general meeting declined re-election
CEO statement
We are now close to the start of the phase III study CONCLUDE to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. It is a global clinical study which will include 440 participants and be conducted at several hundred clinics in over 30 countries. The process of applying for and obtaining approval from the relevant authorities in the participating countries is ongoing, and in July we received the first regulatory approval to start the study from the Swedish MPA and yesterday from the US FDA.

We will initiate patient recruitment when the clinics are up and running again after the summer as the healthcare situation has started to normalise. Together with our CRO we are finalising the practical preparations.

To strengthen our clinical development organisation, we have hired two new employees, Anders Bröijersén as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Both have long and broad experience of clinical development and conducting clinical studies. I am pleased that we have been able to attract two such qualified employees and welcome Anders and Johan to the team. Much of their time will be devoted to support the clinics in the study as ambassadors for InDex and the CONCLUDE study, which was a successful model for patient recruitment in our previous study CONDUCT.

In parallel with the phase III study, we will conduct a smaller clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. We have received approval from the Swedish MPA to start also this study. The purpose of the study is to evaluate the systemic uptake of cobitolimod, and the data will support future regulatory applications for market approval of cobitolimod. Previous preclinical and clinical studies have shown that the systemic uptake of cobitolimod is very limited, which likely contributes to the excellent safety profile. This is a significant advantage compared to the current systemically administered drugs for ulcerative colitis that can cause severe off-target effects.

Besides cobitolimod for ulcerative colitis, InDex has a preclinical portfolio of more than 150 DNA-based ImmunoModulatory Sequences (DIMS), of which we are testing a selected number of candidates in models of other inflammatory diseases. In April, a new European patent was granted that provides protection for 19 different DIMS substances. This patent has previously been granted in the US and Canada, and we are very pleased that also the European Patent Office confirms the novelty of our DIMS platform.

In June, we had the Annual General Meeting and although we had postponed it as much as possible, we were unfortunately not able to welcome the shareholders to a physical meeting this year either. On September 2, I will present the company at the Pareto Securities Healthcare Conference, which will be held virtually also this year.

Soon I hope we can start meeting each other in person again and I look forward to welcoming the first patient in the phase III study CONCLUDE.

Publication

This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on August 25, 2021.