On December 15, 2020 AstraZeneca’s Imfinzi (durvalumab) reported that has been recommended for marketing authorisation in the European Union (EU) for an additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, DEC 15, 2020, View Source [SID1234572847]).

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This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and once approved, will be available to patients with locally advanced, unresectable NSCLC weighing more than 30kg.

Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from several Imfinzi clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing of 10mg/kg every two weeks already approved in locally advanced, unresectable NSCLC, and the CASPIAN Phase III trial which used fixed dosing every four weeks during maintenance treatment in ES-SCLC.

José Baselga, Executive Vice President, Oncology R&D, said: "The four-week dosing regimen will decrease the risk of exposure to infection in the healthcare setting, furthering our efforts to ensure continuity of care for cancer patients at high risk of complications during the pandemic. We look forward to offering non-small cell lung cancer patients in Europe an option that would reduce medical visits by extending dosing from two to four weeks."

Imfinzi was recently approved in the US for this dosing regimen. Imfinzi is approved in the curative-intent setting of unresectable, Stage III (locally advanced) NSCLC after CRT in the EU, US, Japan, China and many other countries, based on the PACIFIC Phase III trial. Additionally, it is approved in the EU, US, Japan and many other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial.

Stage III NSCLC

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery.1 Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised), as the majority of Stage III patients are currently treated with curative intent.1,2

Stage III NSCLC represents approximately one third of NSCLC incidence and in 2015 was estimated to affect nearly 200,000 patients in the following eight large countries: China, France, Germany, Italy, Japan, Spain, UK, and the US, with approximately 43,000 cases in the US alone.3,4 The majority of Stage III NSCLC patients are diagnosed with unresectable tumours.5 Prior to approval of Imfinzi in this setting, no new treatments beyond CRT had been available to patients for decades.6-8

Small cell lung cancer

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.9,10 About two thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.11 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.11

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, oesophageal cancer, gastric cancer, cervical cancer and other solid tumours.

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

An extensive Immuno-Oncology (IO) development programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.12 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease including potentially-curative settings (MERMAID-1, MERMAID-2, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy.

Imfinzi is also in development in the NeoCOAST, COAST and HUDSON Phase II trials in combination with potential new medicines from the early-stage pipeline including Enhertu (trastuzumab deruxtecan).

AstraZeneca’s approach to IO

IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On December 15, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) On December 7, the Company reported that received a letter from the US Food and Drug Administration (FDA) removing a partial clinical hold on Nascent’s proprietary monoclonal antibody Pritumumab (Press release, Nascent Biotech, DEC 15, 2020, View Source [SID1234572866]). This allows Nascent to commence Phase I Human Clinical Trials, effective immediately.

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Nascent CEO Sean Carrick stated, "The approval by the FDA is a major milestone in Nascent’s efforts to begin Phase 1 clinical trials. With this achievement, Nascent has advanced the asset to begin testing the antibody on humans. Receiving FDA clearance vital first step in the clinical process.

On December 15, 2020 M.S.Q. Ventures ("MSQ") reported that its client, ADC Therapeutics SA (NYSE: ADCT), has successfully entered into an agreement to jointly form a new company, Overland ADCT BioPharma (CY) Limited with Overland Pharmaceuticals, a fully integrated, biopharmaceutical company backed by Hillhouse Capital (Press release, MSQ Ventures, DEC 15, 2020, View Source [SID1234572884]).

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Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT Biopharma, in which Overland Pharmaceuticals has invested $50 million. Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. ADC Therapeutics can also earn milestone payments and royalties from the license agreement with Overland ADCT BioPharma.

"As we prepare for the potential U.S. launch of Lonca in 2021, we are delighted that Overland ADCT BioPharma will expand access to the therapy, as well as three of our other pyrrolobenzodiazepine (PBD)-based antibody drug conjugates, to address patient needs in greater China," said Chris Martin, CEO of ADC Therapeutics. "The MSQ team has been working from A to Z to help us understand China’s market, develop a plan, execute strategic objectives, and advise on this transaction. Their systematic approach and laser focus on results contributed to our success."

Ed Zhang, Co-founders of Overland Pharmaceuticals, stated, "We are excited to bring these first four candidates into Overland ADCT BioPharma’s portfolio and look forward to developing this new company into a leading oncology player in China. We are pleased to work with ADC Therapeutics, a pioneer in the field of ADCs, on this strategic venture. MSQ’s professionalism and understanding of both parties’ objectives helped to expedite this successful transaction especially during COVID-19."

As ADC Therapeutics embarks on this exciting phase of its global plan, Echo Hindle-Yang, CEO of MSQ reflected on the transaction, "This new cross-border venture is another example that even in the era of COVID-19, global innovators such as ADC Therapeutics and Overland Pharmaceuticals have joined forces. We are heartened by what this could mean for cancer patients. We congratulate both teams and look forward to more breakthroughs from them in the future."

On December 15, 2020 Scandion Oncology A/S ("Scandion" or the "Company") reported that the result of its rights issue (the "Rights Issue"), where the subscription period ended on December 10, 2020, shows that 3,600,363 shares, corresponding to approximately 34 percent of the shares offered, were subscribed for by exercise of subscription rights (Press release, Scandion Oncology, DEC 15, 2020, View Source,c3254864 [SID1234574542]). Additionally, 1,634,048 shares, corresponding to approximately 15 percent of the Right Issue, were subscribed for without use of subscription rights, of which 1,318,505 shares, corresponding to 12 percent of the Rights Issue, were subscribed for by external professional investors. The remaining part of the Rights Issue, corresponding to 5,477,437 shares or approximately 51 percent, were subscribed for by the guarantors. The Rights Issue is therefore fully subscribed and provides Scandion with proceeds amounting to approximately SEK 236 million before issue costs.

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Not for publication, distribution or announcement, directly or indirectly, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa or any other jurisdiction in which publication, distribution or announcement of this press release is unlawful or is subject to legal restrictions other than those required by Swedish law.

3,600,363 shares, corresponding to 34 percent of the Rights Issue, were subscribed for using subscription rights.
1,318,505 shares, corresponding to approximately 12 percent of the Rights Issue, were subscribed for by external professional investors.
315,543 shares, corresponding to approximately 3 percent of the Rights Issue, were subscribed for by existing shareholders and others without subscription rights.
The remaining part of the Rights Issue, corresponding to 5,477,437 shares or approximately 51 percent, were subscribed for by the guarantors.
Approximately 1.3 percent of the Rights Issue, corresponding to approximately SEK 3 million, were subscribed for by certain members of the board of directors and the management.
"I am extremely pleased to embrace the capitalization of Scandion Oncology and the strong support from our existing and new shareholders. This capital raise is a defining moment for us in our journey to make a difference for the many patients with drug resistant cancers. With this amount of new funding we are poised to deliver strong validating data for our first in class lead candidate SCO-101 and it gives Scandion Oncology the opportunity to implement our strategy to become the cancer drug resistance company" says Bo Rode Hansen, President & CEO of Scandion Oncology A/S.

Allocation of shares subscribed for without using subscription rights has been done in accordance with the principles stated in the prospectus published on 24 November 2020. Notice of allotment is made through a settlement note sent to the respective subscribers. Payment for allotted shares must be made in accordance with the instructions in the settlement note.

Following settlement and registration of the new shares with the Danish Business Authority, the Company’s share capital will increase by DKK 787,320.8280 to a total of DKK 2,361,962.4840. The number of shares in the Company will increase by 10,711,848 shares to a total of 32,135,544 shares.

Following settlement, trading in paid subscribed shares (BTA) takes place on the Spotlight Stock Market until the BTAs have been converted to ordinary shares, following registration of the new shares with the Danish Business Authority, which is expected to take place during week 52, 2020, at which point the temporary ISIN code for the BTAs will be merged with the permanent ISIN code for the Company’s shares.

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.

On September 30, 2019, STipe Therapeutics (STipe), a company founded to exploit a novel approach to the stimulator of interferon genes (STING) Pathway, a major driver of innate immunity, and regulator of tumorigenesis and autoimmune disorders, launched today with an EUR 20 million Series A financing (Press release, STipe Therapeutics, DEC 14, 2020, View Source [SID1234572788]). The round was co-led by Novo Holdings and Arix Bioscience plc who were joined by Wellington Partners Life Science V Fund and Sunstone Life Science Ventures A/S.

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STipe was spun out from the Department of Biomedicine, Aarhus University, Denmark in 2018 and is working on harnessing the immune response to target a range of tumours, both directly and in combination with other antitumoral agents. The company is developing first in class drugs targeting intracellular protein-protein interactions of the STING Pathway. STipe’s innovative technology has demonstrated that it can significantly increase the sensitivity of the innate immune system to rapidly detect even a small amount of tumour-DNA. This opens up the potential to induce a synergistic immune response alone or in combination with targeted anticancer therapies, immunotherapy or radiation. STipe has identified potential lead compounds that modulate the STING pathway in a novel way, thereby changing the tumour microenvironment and demonstrating antitumor activity preclinically.

Dr Christian Schetter, Executive Chairman of Stipe and former CEO of Rigontec:
"By assembling a group of world-renowned scientific co-founders, alongside experienced company leadership, STipe has the opportunity to revolutionise the treatment of many cancers. I am delighted to be joining the Company as Executive Chairman and look forward to working with my new colleagues to develop novel cancer therapies using our unique technology."

Dr Claus Elsborg Olesen, Chief Executive Officer of STipe commented:
"The successful financing underscores the potential of our innovative technology and product pipeline. We are grateful for the support from our new shareholders and we look forward to leveraging their extensive experience as we develop multi-product opportunities to target cancer."

Dr Jonathan Tobin, Investment Director at Arix Bioscience commented:
"We are excited about the potential of this novel angle on STING biology that has the potential to greatly enhance the efficacy and safety compared to other innate immune targeting technologies. The combination of the founders’ thorough understanding of the science with Christian Schetter’s experience and leadership in the immunotherapy space makes this a company with a great deal of potential."

Morten Graugaard Døssing, Partner at Novo Holdings added:
"The successful fundraise for STipe Therapeutics is testament to the investors’ appetite for excellent science and technology which ultimately can make a tangible difference to patients’ lives. We have been excited to work closely with STipe Therapeutics for the last three years as part of our company creation efforts and congratulate them on this important milestone.

STipe was cofounded and is led by Chief Executive Officer, Dr Claus Elsborg Olesen, a serial life-science entrepreneur in Denmark with extensive experience in founding and developing biotech companies, alongside the Chief Scientific Officer, Dr Martin Roelsgaard Jakobsen, the founding scientist, and Associate Professor at Aarhus University. In connection with the financing Dr Christian Schetter, former CEO of Rigontec, has joined the Company as Executive Chairman and will be also be joined by new Board members, Morten Graugaard Døssing of Novo Holdings, Jonathan Tobin of Arix Bioscience, Regina Hodits of Wellington Partners, and Sten Verland of Sunstone