On November 17, 2020 xCures Inc. reported that it is launching xACCESS – a new registration module for their AI-assisted clinical study platform (Press release, xCures, NOV 17, 2020, View Source [SID1234571196]). The module is used to enroll cancer patients and empower them, and their physicians, to make informed decisions and learn about access to treatment programs. The xCures platform uses a Master Observational Registry to efficiently run a wide variety of oncology studies and decentralized trials, prospectively generating real-world evidence.

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"xACCESS is xCures’ first patient-centric technology module, onboarding patients directly to our sponsored studies and partner programs," stated Mika Newton, xCures’ CEO. "This is an important milestone on our journey to make the cancer treatment ecosystem work better for patients and facilitating access to the best treatment options."

The xACCESS registration module enables rapid scaling by eliminating bottlenecks in eConsenting and acquiring medical records, providing benefits to patients, physicians, partners, payers, sponsors, and investors. The resulting Real-World Evidence (RWE) supports the assessment of safety, efficacy, and utility of investigational and approved cancer therapies.

The xACCESS module will be used for all clinical studies and programs available on the xCures platform, including the recently announced Compassionate Use program for ulixertinib (BVD-523), currently enrolling patients with MAPK pathway aberrant cancer.

On November 17, 2020 Targovax ASA, reported that members of the management team will present the company at Bryan Garnier & Co Virtual European Healthcare Conference today, Tuesday 17 November (Press release, Targovax, NOV 17, 2020, View Source [SID1234571195]).

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The presentation will be available to download at www.targovax.com after the event.

On November 17, 2020 Hutchison China MediTech Limited ("Chi-Med" or the "Company") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$30 per American Depositary Share ("ADS") via a private placement to Canada Pension Plan Investment Board ("CPP Investments") (Press release, Hutchison China MediTech, NOV 17, 2020, https://www.chi-med.com/us100-million-equity-investment-by-cpp-investments/ [SID1234571193]).

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Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "We are very pleased to welcome CPP Investments as a shareholder. CPP Investments’ focus on building long-term value and its experience in healthcare investing make it an important global strategic partner to Chi-Med. We look forward to building on the partnership as we work, during the next six months, to launch both surufatinib and savolitinib in China, subject to approval, as well as submit our first U.S. NDA on surufatinib."

Mr. Agus Tandiono, Managing Director and Head of Fundamental Equities Asia at CPP Investments, said, "This placement aligns with CPP Investments’ focus on providing strategic, long-term capital to industry leading companies where we can participate in the future success of the business and help create greater value through ongoing partnership. We look forward to supporting Chi-Med’s work on innovation in oncology treatment."

Chi-Med will receive all proceeds from this private placement of the equivalent of 3,333,334 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation
Chi-Med has agreed to issue 16,666,670 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by CPP Investments. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. CPP Investments has the right to appoint an observer and a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. GMT on November 26, 2020.

Following admission of the Shares to trading on AIM, the issued share capital of Chi-Med will consist of 727,702,215 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 727,702,215 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 727,702,215 ordinary shares were converted in their entirety, they would be equivalent to 145,540,443 Nasdaq-traded ADSs (each equating to five ordinary shares).

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.