On November 22, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that new data from the ongoing Phase 1/2 GLORIA trial with NOX-A12 and radiotherapy in brain cancer (glioblastoma multiforme, GBM) were presented at the Society for Neuro-Oncology (SNO) Annual Meeting (Press release, NOXXON, NOV 22, 2021, View Source [SID1234595917]). The presentation was held by Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing GLORIA study.

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The oral presentation, entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial", included results from 9 chemotherapy refractory (MGMT promoter unmethylated) patients participating in the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of glioblastoma. Eight of 9 patients (89%) receiving NOX-A12 showed reductions in tumor size (2 patients with objective responses [>50% reduction] and 6 patients with stable disease [<50% reduction], while one patient progressed. These results compare favorably with historic patient outcomes from a matched cohort that received standard of care, where only 1 out of 13 patients (8%) showed a reduction in tumor size with an objective response and 12 patients’ tumors progressed.

Also, data from tissue analysis of a patient on NOX-A12 therapy shows [1] a significant reduction of the NOX-A12 target, CXCL12, on tumor blood vessels, [2] a significant decrease in tumor cell proliferation and [3] an increase in tumor infiltration of activated killer immune cells. Interestingly and very importantly, such benefits were observed across all available tumor tissue and not only in small subsections.

These benefits are strongly supportive of the dual mechanism of action of NOX-A12:
– inhibiting repair of blood vessels damaged by radiotherapy
– promoting of immune-response
This dual mechanism of action could prove transformational since this is not consistently observed in historical samples including patients treated with immune checkpoint inhibitors.

"The data presented by Dr. Giordano at the SNO meeting are a significant step forward in bringing NOX-A12 to glioblastoma patients. While a diagnosis of chemotherapy-resistant glioblastoma leads almost inevitably to systematic rapid progression of the disease, NOX-A12 combined with radiotherapy managed to achieve stable disease or an objective response in 8 out of the 9 patients. We very much look forward to presenting and explaining the transformational nature of these new data at our upcoming KOL event on Tuesday, November 23, when Dr. Giordano will also be available to answer questions," commented Aram Mangasarian, CEO of NOXXON.

Details of the Key Opinion Leader webinar are as follows:
Title: NOX-A12 and Radiotherapy combination: A Differentiated and Promising New Approach to Treating Brain Cancer
Presenter: Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany
Webinar time and date: November 23, 2021 at 02:00 p.m. CET (08:00 a.m. EST)
Registration: To register for the event, please click here

NOX-A12 acts via a unique mechanism of action, which was confirmed by the presented results: by removing the CXCL12 chemokine from the tumor blood vessels the revascularization of the irradiated tumor area is blocked and a significant increase in activated killer immune cell infiltration to the tumor can be seen.

More information about the GLORIA study can be found at ClinicalTrials.gov number NCT04121455.

Dr. Frank A. Giordano, is Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany. He is an expert in precision radiation therapy and intraoperative irradiation of malignant tumors and has received international recognition for his brain tumor research, including an award from the American Society of Radiation Oncology (ASTRO) and an honorary membership of the Spanish Society of Radiation Oncology (SEOR). Dr. Giordano received his medical degree from the University of Heidelberg, Germany, and did his post-doctoral training as a Peter Engelhorn fellow at the German Cancer Research Center (DKFZ). He received clinical training at the National Center for Tumor Diseases (NCT) Heidelberg and the University Medical Center Mannheim, where he served as acting chairman and director of the Department of Radiation Oncology before moving to Bonn. For many years, his research has focused on optimized radiation therapy of brain cancers to offer cancer patients personalized and even more effective treatment. As one of the few Else-Kröner-Fresenius Excellence Fellows, Dr. Giordano developed innovative therapy options that even found their way in clinical practice. He sees great potential in the combination of radiotherapy and immunomodulatory therapy.

On November 22, 2021 Lidds reported that (Press release, Lidds, NOV 22, 2021, View Source [SID1234595916])

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JANUARY – SEPTEMBER 2021

Net sales amounted to MSEK 1.2 (0.0)
Operating expenses amounted to MSEK -29,5 (-19,8)
Profit/loss before and after tax amounted to MSEK -28.4 (-19.8)
Earnings per share amounted to SEK -0.90 (-0.76)
Cash flow from operating activities amounted to MSEK -32.7 (-17.3)
Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (88%)
JULY – SEPTEMBER 2021

Net sales amounted to MSEK 0.4 (0.0)
Operating expenses amounted to MSEK -8.2 (-6.6)
Profit/loss before and after tax amounted to MSEK -7.8 (-6.6)
Earnings per share amounted to SEK -0.26 (-0.23)
Cash flow from operating activities amounted to MSEK -9.2 (-5.2)
Equity amounted to MSEK 57.4 (55.2) and the debt/equity ratio was 90% (87%)
SIGNIFICANT EVENTS DURING THE THIRD QUARTER 2021

As part of the warrants-based incentive programme 2021/2024, a total of 146,000 warrants were subscribed to, by the CEO and key personnel at LIDDS. The remaining warrants are kept by LIDDS and will be offered to future key personnel in relation to employment.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

In October, the company announced that no further patients will be enrolled in its dose escalating Phase I study (NZ-DTX-001). The primary objective of the trial was to study safety of NanoZolid-docetaxel in solid tumors.
The data collected in the trial demonstrates safety and tolerability, an active and local drug release of docetaxel over an extended period of time and signs of clinical effect in injected tumors. LIDDS plan to communicate topline results during Q4 2021.
CEO Statement

The autumn has made its entrance in Sweden and when reflecting on the progress we have made during the third quarter of this year I feel pride.

We are making good progress in our projects and in October we communicated the closing of our NZ-DTX-001 study. The scope of the study was to investigate safety and tolerability of the NanoZolid-formulated cytotoxic drug docetaxel in patients with superficial tumours which also was accomplished. We are currently closing the study and preparing for next clinical step which will be communicated in 2021 together with the top-line results from the study. This program is clearly on strategy and a good example of the value LIDDS is generating given a safety profile of docetaxel that is severely limiting its application as a systemic drug. Local intratumorally administration will improve the safety and efficacy profile of docetaxel thus allowing targeting of new types of patients.

LIDDS has previously communicated the intent to initiate a clinical investigation of our first immunoncology drug which is a TLR9 agonist. I am personally very excited about this drug given the improved behaviour of it when formulated in our technology for local administration. Since I joined LIDDS we have performed preclinical studies where we have combined the TLR9 agonist with another substance and the data looks very promising. We even see signs of immune activity in non-treated tumours in our animal studies. Given the signs of abscopal effects when combining TLR9 we have decided to go into clinical development with a combination therapy rather than a monotherapy. This change means a delay in our clinical study but given the observed data we believe the combination will generate best value for all stakeholders. I can promise you that we will do our outmost to progress this program as promptly as possible. We are all excited and looking forward to the clinical data on this specific project!

The collaboration with Johnson & Johnson is progressing according to plan and we hope to be able to expand the cooperation in the future. In parallel, we are working on validating our phase III plans for Liproca Depot. As an important step, we submitted our phase III study protocol to the European Medicines Agency (EMA) for Scientific Advise (SA) on Sep 27.

We have set a direction for the company by defining what strategic areas to focus on to reach our key targets and our Vision 2026 which is to make "LIDDS the preferred solution and partner for elegant and optimal drug delivery – enabling better health!". We are a drug delivery company and will remain so by investing in our technology and our projects, and in our people and our partnerships. The unique value of LIDDS is to deliver drugs that are both safer and more efficacious by administration of NanoZolid-formulated depots delivering a controlled and sustained local release of drugs. We will present more details regarding our strategic focus early next year.

An important strategic focus area is to secure long-term financing of LIDDS to provide resources for a sustainable growth. We are currently continuing our preparations to make the move to Nasdaq Stockholm’s main list. This is part of the long-term perspective and something we work intensively on. As senior executives need to be in place in the company for at least a quarter before being listed on the main market this has taken longer time with the entrance of myself and of the new CFO. The ambition is to make the move in first half of 2022. The requirements that are added when listing on the main market represent an opportunity to increase the quality of our work, sharpen our value propositions and becoming a more mature company.

Given our vision, strategies and plans it is important to continue to grow the organization in an efficient and sustainable way. To be successful we need the best competences onboard. I am therefore very pleased that we have now the support of Johan Harmenberg. Johan has an excellent and relevant background as Chief Medical Officer in several oncology companies. With this background I am convinced that he will contribute very positively to our growth journey.

My colleagues and I are looking forward to the rest of 2021 and to 2022 where we expect to be able to present more details about our new strategic direction and about the progresses that we make in our projects. Progresses that ultimately will make a real difference to patients.

LIDDS AB (PLC) is required to disclose this information in accordance with the EU Market Abuse Regulation. The information was submitted through the agency of the aforementioned contact, for publication on November 22, 2021 at 16.45 CET.

On November 22, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, NOV 22, 2021, View Source [SID1234595915]):

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NASDAQ 45th Investor Conference on Wednesday, December 1st at 9:30 a.m. ET
Piper Sandler 33rd Annual Virtual Healthcare Conference on Wednesday, December 1st at 2:00 p.m. ET
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for at least 30 days following the presentation.

On November 22, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will be participating in the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 29, 2021 through December 2, 2021 (Press release, Onconova, NOV 22, 2021, View Source [SID1234595914]).

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A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning today at 10:00 a.m. ET. The presentation can be viewed via the Piper Sandler presentation library on the conference site through December 2, 2021 for all registered attendees, and on the "Corporate Events and Presentations" section of the Onconova website.

The Company will also be participating in 1×1 meetings November 30, 2021 through December 2, 2021. Meetings can be requested exclusively via Piper Sandler.

On November 22, 2021 Mirati Therapeutics, Inc. (Nasdaq:MRTX), a clinical-stage targeted oncology company and Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported a non-exclusive clinical collaboration agreement to evaluate the combination of Mirati’s investigational KRASG12C inhibitor adagrasib with Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766 in KRASG12C-mutant non-small cell lung cancer (NSCLC) (Press release, Mirati, NOV 22, 2021, Mirati Therapeutics and Verastem Oncology Partner to Evaluate Adagrasib in Combination with VS-6766 in KRASG12C-Mutant Non-Small Cell Lung Cancer [SID1234595913]).

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Verastem Oncology

The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial is to determine the maximum tolerated dose and recommended Phase 2 dose for the combination of adagrasib and VS-6766 in patients with KRASG12C-mutant NSCLC. The study will also investigate the safety, tolerability and efficacy of the combination in patients who have progressed on a KRASG12C inhibitor. The trial will build on preclinical data showing deeper blockade of ERK pathway signaling resulting in enhanced anti-tumor efficacy with the combination of adagrasib and VS-6766 relative to either agent alone.

"We are pleased to collaborate with Verastem Oncology on this clinical study of VS-6766 and adagrasib. We believe the data from this trial will help to better understand how these agents, when combined, could help improve patient outcomes," said James Christensen, Ph.D., chief scientific officer, Mirati Therapeutics, Inc. "This clinical collaboration is an example of how Mirati is aggressively advancing the study of adagrasib both as a monotherapy and in rational combinations as part of its expanding development portfolio to benefit people living with difficult-to-treat cancers."

"We continue to see evidence of the differentiated potential of the dual RAF and MEK properties and favorable safety profile of VS-6766 as an ideal combination therapy in treating RAS pathway-driven cancers. We are excited to partner with Mirati Therapeutics as part of our focused and rapidly advancing development strategy," said Brian Stuglik, CEO of Verastem Oncology. "Specifically, this collaboration will provide data on the potential of VS-6766 with adagrasib to provide deeper and more durable responses in patients with KRASG12C-mutant NSCLC by overcoming downstream resistance mechanisms in the RAS pathway to address unmet needs for NSCLC patients with KRASG12C mutations."

Under the terms of the agreement, Verastem Oncology and Mirati will have joint oversight of the study.

About KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

Approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), which are the single leading cause of cancer deaths worldwide.1 KRAS mutation occurs in approximately 25% of NSCLC adenocarcinoma patients.2 Two of the most common types of KRAS mutations are G12C, which occurs in approximately 14% of patients with NSCLC adenocarcinoma, as well as G12V, which is present in approximately 7% of NSCLC adenocarcinoma.3,4 Currently, there is a high unmet need in the second-line treatment of KRAS mutant NSCLC.1,5

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life, extensive tissue distribution and is well tolerated. Adagrasib has also shown single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors with KRASG12C mutations. Adagrasib is a being evaluated in several clinical trials in combination with other anti-cancer therapies with strong scientific rationale in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.6

Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials.