On June 16, 2020 The Lead Discovery Center GmbH (LDC) and the South Korean drug development specialist Qurient reported they have founded QLi5 Therapeutics GmbH, together with the LDC’s partners, the Max Planck Society (MPG) and Nobel laureate Robert Huber, emeritus director of the Max Planck Institute for Biochemistry (Press release, QLi5 Therapeutics, JUN 16, 2020, View Source [SID1234654542]). Dortmund based QLi5 Therapeutics licensed novel proteasome inhibitors from LDC and its partners. QLi5 Therapeutics will advance these towards preclinical and clinical development for the treatment of cancers and inflammatory and autoimmune disorders.

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The novel proteasome inhibitors were generated within a long standing and successful collaboration between the LDC and Robert Huber. Combining Huber’s vast expertise in the field of proteasome with the LDC’s drug discovery capabilities, the partners have created a portfolio of proteasome inhibitors with unique binding characteristics and favourable pharmacodynamic properties. The further development in the joint venture with Qurient is the outcome of a successful strategic partnership between Qurient, LDC and Max Planck.

"The proteasome is a real treasure chest," Robert Huber comments, "and the launch of Qli5 Therapeutics enables us to harness its potential for the treatment of many diseases. Our new generation of proteasome inhibitors is set to overcome key challenges that have so far hampered a broader application of the first generation of covalently acting proteasome inhibitors." The proteasome plays an important role in cell regulation by degrading proteins and represents a well established clinical target for the treatment of liquid tumours, in particular multiple myeloma.

"We believe the LDC’s innovative proteasome inhibitors hold exceptional potential, and we are excited to be part of QLi5 Therapeutics to jointly advance them towards preclinical and clinical testing," Kiyean Nam, CEO and CSO of Qurient adds. "We very much appreciate the LDC as long-term partner and prime source of external innovation." Over the last years, Qurient has licensed two other inhibitor projects from the LDC, targeting the kinases, Axl and CDK7 respectively. Both leads have made considerable progress since, e.g. nomination for clinical development.

"The foundation of Qli5 Therapeutics is the current peak of our trustful and long-term collaborations with Robert Huber and Qurient, our exceptionally strong and committed South Korean partner," Bert Klebl, CEO and CSO of the LDC comments. "This joint venture is wonderful step forward in our mutual relationship and it is a great opportunity to translate the potential of the proteasome complex into more tangible benefits for patients."

"Having previously licensed assets to Qurient, we are delighted to now jointly start-up a venture with Qurient. QLi5 provides excellent prospects to enable a much needed next generation of proteasome inhibitors. Bringing the company on track together with Qurient has been a swift and smooth endeavour, adds Dieter Link, Licensing manager at Max Planck Innovation GmbH.

On June 16, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR) and NorthStar Medical Radioisotopes, LLC reported a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19 (patients with SARS-CoV-2 infection) (Press release, Monopar Therapeutics, JUN 16, 2020, View Source [SID1234611968]). Monopar is a clinical-stage biopharmaceutical company and NorthStar is a commercial producer and supplier of medical radioisotopes. This collaboration combines NorthStar’s expertise in the innovative production, supply, and distribution of important medical radioisotopes with Monopar’s expertise in therapeutic drug development and its pre-IND stage humanized urokinase plasminogen activator receptor (uPAR) targeted monoclonal antibody known as MNPR-101, along with a proprietary portfolio of related monoclonal antibodies that target uPAR or its ligand uPA.

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The uPA system (comprised of the serine protease enzyme uPA and its receptor uPAR) has been demonstrated to be selectively expressed on aberrantly activated immune cells. In response to coronavirus infection, these rogue immune cells produce pro-inflammatory cytokines that can cause runaway inflammation throughout the body, commonly referred to as a cytokine storm. It is this systemic hyper-inflammatory state that is thought to be largely responsible for the severe lung injury and further multiple organ damage that contributes to poor outcomes and death in patients with severe COVID-19.

In this collaboration, Monopar and NorthStar plan to couple MNPR-101 to a therapeutic radioisotope supplied by NorthStar in order to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells. By eradicating these cells with a targeted RIT, the goal is to spare healthy cells while quickly reducing the cytokine storm and its harmful systemic effects.

"This collaboration is a powerful combination of unique scientific and technical expertise to help combat severe COVID-19," said Chandler Robinson, MD, CEO of Monopar Therapeutics. "The companies will be conducting a development program to determine if Monopar’s uPA/uPAR monoclonal antibodies can be transformed into RITs that are effective as treatments against severe COVID-19, as well as other corona viruses."

"We are pleased to work together with Monopar in the battle against COVID-19," said Stephen Merrick, CEO of NorthStar Medical Radioisotopes." Our hope is that, by joining forces, we can develop a targeted radiopharmaceutical treatment that has the ability to prevent patients with severe COVID-19 from being placed on ventilators and from dying."

"To help mitigate the cytokine storm and reduce deaths associated with COVID-19, our goal is to develop an RIT that selectively eliminates the rogue aberrantly activated immune cells that produce these cytokines," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar. "uPAR is selectively expressed on these rogue immune cells but not on healthy cells. An antibody carrying a therapeutic radioisotope could gain entry into these cells through uPAR and deliver its cytotoxic payload to kill these cells while sparing normal tissue."

"NorthStar will apply its expertise to identify and supply the optimal therapeutic radioisotope to couple with Monopar’s uPAR monoclonal antibodies," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "We will deploy the most appropriate development approaches and production technology to ensure that both development and, if successful, commercial-scale volumes of this radioisotope can be supplied in order to meet potential demand."

This targeted therapeutic approach to treating severe COVID-19 is supported by a recently published study (Rovina et al. 2020) demonstrating that soluble urokinase plasminogen activator receptor (suPAR), which is shed by aberrantly activated immune cells that make uPAR, is an early predictor of severe respiratory failure in COVID-19 and its presence increases as patients develop severe COVID-19.

On June 16, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines reported its audited preliminary results for the year ended 31 December 2019 (Press release, Midatech Pharma, JUN 16, 2020, View Source [SID1234562738]).

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Financial highlights

·Total gross revenue(1) for the year of £0.7m (2018: £1.9m, 2017: £1.0m).

·Statutory revenue(2) for 2019 of £0.3m (2018: £0.1m, 2017: £0.1m).

·Subscription, Placing and Open Offer in February 2019 raised £12.3m (net) and Registered Direct Offering in the US in October 2019 raised $2.5m (£1.8m) (net).

·Receipt of €3.6m (£3.1m) (net) non-dilutive Reindus loan and award of Guazatu loan of €1.5m.

·Provisional award of a GlioKIDS grant of €2.7m (£2.3m), subject to confirmation of Midatech’s status as an SME, to support a Phase II trial of MTX110.

·Cash and deposits at 31 December 2019 of £10.9m (2018: £2.3m, 2017: £13.2m).

·Net loss from continuing operations of £9.1m (2018: £10.4m loss, 2017: £11.7m loss) with net cash inflow in the year of £8.4m (2018: £10.9m outflow, 2017: £4.1m outflow).

·Tax credit receivable of £1.8m (2018: £1.9m, 2017: £1.2m).

1)Total gross revenue represents collaboration income from continuing operations plus grant revenue.

2Statutory Revenue represents total gross revenue, excluding grant revenue.

Operational highlights

·First substantive licensing agreement with China Medical System Holdings Ltd ("CMS") for the Group’s pipeline products for Greater China accompanied by an £8.0m strategic investment in the Company, as part of a Subscription, Placing and Open Offer executed in February 2019.

·MTX110 received orphan drug designation for malignant glioma including DIPG from the FDA.

Post period end highlights

·In January 2020, a study of subcutaneous administration of MTD201 compared with traditional intramuscular administration in healthy volunteers showed similar pharmacokinetics and bioavailability, offering the potential for a differentiated, more patient-friendly product profile.

·In March 2020, an exploratory study was initiated by Columbia University in five patients with DIPG using an alternative convection enhanced delivery system.

·Also in March 2020, following a General Meeting, the Company’s ordinary shares of £0.00005 each were consolidated on a one-for-20 basis into ordinary shares of £0.001 each. At the same meeting a resolution was passed to change the ratio of the Company’s American Depositary Receipts ("ADRs"). This will change from one ADR representing 20 Existing Ordinary Shares to one ADR representing five new ordinary shares.

·On 31 March 2020, the Company announced a wide-ranging strategic review including termination of MTD201, closure of the Company’s Bilbao operations and a re-alignment of the Board.

·On 20 April 2020, the Company announced an update to the strategic review including the appointment of an adviser and start of a ‘formal sale process’ under the Takeover Code.

·On 18 May 2020, the Company announced that it had raised gross proceeds of £4.3m (£3.8m net of expenses) in a combined UK Placing and Registered Direct Offering in the US. The combined offerings resulted in the issuance of 15.8 million new Ordinary Shares and 16.5 million new Warrants.

·On 8 June 2020, the Company received a letter sent on behalf of Secura Bio, Inc. ("Secura Bio"), dated 1 June 2020, purporting to terminate a License Agreement, dated 5 June 2017 (the "Secura License Agreement"), by and between Midatech Limited and Novartis AG, which Novartis AG subsequently transferred to Secura Bio. Pursuant to the Secura License Agreement, Midatech Limited was granted a non-exclusive worldwide, sublicenseable license to certain patents of panobinostat, the active pharmaceutical ingredient of the Company’s development product MTX110. Midatech Limited’s rights are limited to the treatment of brain cancer in humans, administered by convection-enhanced delivery. The Company plans to continue to pursue development of MTX110 and the strategic review process previously disclosed. The Company is also reviewing with its outside counsel remedies it may have if Secura Bio does not withdraw the notice and otherwise cease to interfere with its ongoing business and strategic review process, which the Company has formally requested. The Company is evaluating available actions to protect its rights under the Secura License Agreement and its assets.

Stephen Stamp, CEO and CFO commented "This has been an extremely difficult period for Midatech with the termination of in-house development of our lead programme, closure of our Bilbao operations and the loss of 47 jobs, over two-thirds of our employees. I should like to recognise the professionalism of the team in making these difficult decisions and the grace with which they have been accepted. Our focus now is to evaluate all available options for extracting maximum value from Midatech’s platform technologies."

On June 16, 2020 C4 Therapeutics, Inc. (C4T), a biotechnology company pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation, reported the closing of a $170 million financing, including $150 million in Series B equity co-led by existing investor Cobro Ventures and new investor Perceptive Advisors and $20 million in venture debt by Perceptive Advisors (Press release, C4 Therapeutics, JUN 16, 2020, View Source [SID1234562445]). Additional new equity investors in the round included Adage Capital Management, Axil Capital, Bain Capital Life Sciences, Commodore Capital, 3E Bioventures Capital, HBM Healthcare Investments, Lightchain Capital, Logos Capital, Mizuho Securities Principal Investment, Nextech, RA Capital Management, RTW Investments, Sphera Funds Management, Taiwania Capital Management, Yonjin Venture, and funds and accounts managed by T. Rowe Price Associates, Inc and Janus Henderson Investors. Existing investors also participated.

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C4T will use the proceeds to advance multiple degrader drug candidates to human proof-of-concept and to expand the Company’s capabilities. C4T has invested significantly in its TORPEDO platform, which combines a robust chemistry engine, proprietary assays, and high throughput screening with predictive modeling for accelerated, informed, and efficient discovery and design of high-quality drug candidates.

"This funding comes at a significant juncture, as our company is moving to a clinical stage. We plan on filing our first IND by the end of this year and expect to have four drug candidates in the clinic by the end of 2022. We have a deep pipeline addressing a diverse set of oncology indications that provides us with significant optionality. Protein degraders allow for more potent and durable pharmacologic responses than traditional inhibitors, and we bring a differentiated approach to this transformative modality through our proprietary TORPEDO platform," said Marc Cohen, Co-Founder, Chairman and CEO of C4 Therapeutics. "We look forward to advancing our programs with the goal of bringing new therapeutics to patients suffering from life-threatening diseases and are thrilled to have attracted top-tier life science investors to our company in this very oversubscribed round."

"C4 Therapeutics is a pioneer in this exciting and promising new protein degradation space," said Adam Stone, Chief Investment Officer of Perceptive Advisors and co-lead of this financing. "With their strong science and world class team we have no doubt that they will be able to bring powerful new therapeutics to patients and we are excited to collaborate with C4T on this important mission."

"C4T remains at the forefront of this novel modality with its proprietary platform validated by high-value strategic partnerships," added Todd Kaloudis, Managing Director at Cobro Ventures, co-lead of this round. "We are proud to support C4T in its mission to destroy disease-causing proteins and deliver breakthrough treatments for significant unmet medical needs."

Jefferies and Locust Walk served as transaction advisors to the Company in the Series B financing.

On June 16, 2020 Bonnie J Addario Lung Cancer Foundation reported that A historic milestone was reached today with the exciting announcement that the Department of Veterans Affairs (VA) and GO2 Foundation for Lung Cancer (GO2 Foundation) have established a formal partnership to advance lifesaving screening and care for our military men and women at greater risk for lung cancer (Press release, Bonnie J Addario Lung Cancer Foundation, JUN 16, 2020, View Source [SID1234561263]). One of GO2 Foundation’s core priorities is educating people at risk for lung cancer and facilitating access to early detection screenings and care that can save lives. Working to better support Veterans who are at elevated risk and incidence for lung cancer than the civilian population has been a key focus of our organization for years.

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This partnership allows GO2 Foundation to offer the VA educational and technical assistance and to collaborate on ways to improve Veterans’ access to high quality screening and care in communities where they live. This partnership will strengthen and accelerate efforts to change the reality of lung cancer for our service members. It will help break down barriers to save lives.

The announcement could not come at a better time as lung cancer advocates are gathering virtually at the 2020 Lung Cancer Voices Summit to call on Congress to increase funding for lung cancer research. As more breakthroughs are achieved, the VA-GO2 Foundation partnership picks up the baton and carries it forward to Veterans who will benefit from these life-saving endeavors.