On November 19, 2022 MonTa Biosciences reported that the company has transitioned from a preclinical to a Clinical stage Biotech company (Press release, MonTa Biosciences, NOV 19, 2020, View Source [SID1234618638]). MonTa has today filed our first Clinical Trial Application in Europe and look forward to start treatment of the first patient with our lead candidate MBS8, in Q1, 2021. We will start the dose-escalation part of the study with two Danish sites and later expand into additional European sites. The trail will include MBS8 dosed in monotherapy and focus on safety, biomarkers and effect on tumor development. MBS8 is a novel TLR7 agonist formulated in micelles that show a strong antitumor activity, superior to other TLR7 agonists due to a different Mode of Action involving immediate migration of innate immune cells into tumor tissue and killing of tumor cells within hours. The Phase I trial is designed with two stages, stage I with a dose escalation phase and stage II with an expansion phase at the recommended phase 2 dose level.

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On November 19, 2020 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported that the company has extended the term of the research program under its existing 2017 research collaboration and license agreement with Merck toward developing a clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease (Press release, Cue Biopharma, NOV 19, 2020, View Source [SID1234608288]).

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"We are very pleased with the progress to date in our ongoing strategic collaboration with Merck," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "Extending the research term of our agreement based on promising preclinical data with a goal of identifying a clinical candidate underscores the significant potential of our therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) platform and CUE-300 series in the treatment of debilitating autoimmune diseases."

Under the terms of the extension, Cue Biopharma will receive additional financial research support to further study and develop promising preclinical biologics with the objective of identifying clinical candidates.

Cue Biopharma entered into an exclusive patent license and research collaboration agreement with Merck in November 2017 to develop biologics for the treatment of selected autoimmune diseases. For further information regarding the amendment, please refer to the Current Report on Form 8-K to be filed by Cue Biopharma with the SEC on November 19, 2020.

About Immuno-STAT
Immuno-STAT biologics are being designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drug candidates is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On November 19, 2020 MercachemSyncom reported that it will change its name and operate under the registered trade name of Symeres (Press release, Mercachem, NOV 19, 2020, View Source [SID1234584204]).

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The new name reflects the strategic evolution of the company, with the growth of integrated drug discovery and development services, which complement the company’s strong reputation in synthetic discovery and development chemistry. Recent examples of this evolution include the acquisition of ADME-Tox provider Admescope in November 2020 and strategic alliances integrating our services with high-quality CROs in the fields of in vitro biology, biophysics, and structural biology.

The name Symeres (derived from Sy-ncom Me-rcachem res-research) and accompanying tagline "making molecules matter" are derived from the experience and success of the Syncom and Mercachem legacy organizations and their core strengths in innovative research.

Dr. Eelco Ebbers, CEO of Symeres, added, "The evolution of MercachemSyncom into Symeres is representative of the continuing expansion of the organization and our move into integrated solutions for drug discovery and development services, alongside our strong chemistry-centric services. The most recent example being our acquisition of Admescope. We look forward to continuing our journey with our clients around the world under our new identity, without forgetting the core values of quality, integrity, transparency, and innovation that got us to where we are today."

On November 19, 2020 Scandion Oncology A/S ("Scandion Oncology" or "the Company")reported the Interim Report for the period 1 January – 30 September 2020 (Press release, Scandion Oncology, NOV 19, 2020, View Source;30-september-2020,c3240006 [SID1234574540]). The Interim Report is available on the Company’s website (www.scandiononcology.com). Below is a summary of the report.

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Reporting period July 2020 – September 2020

Net sales amounted to DKK 0 (0).
Operating profit was -4.90 m DKK (-7.03).
Cash and bank assets amounted to 7.50 m DKK (18.03).
Result per share was DKK -0.20 (-0.33).
Reporting period January 2020 – September 2020

Net sales amounted to DKK 0 (0).
Operating profit was -13.68 m DKK (-14,23).
Result per share was DKK -0.58 (-0.63).
Equity ratio was 64% (91).
Highlights during the third quarter

On July 3rd, Scandion Oncology announced that its Chairman of the Board, Dr. Peter Høngaard Andersen, had bought an additional 6,000 shares in Scandion Oncology, resulting in a total holding of 37,839 shares in the Company.
On July 11th, Scandion Oncology announced that the results from the four SCO-101 Phase I clinical trials had been published in the international peer-reviewed journal "Basic & Clinical Pharmacology & Toxicology". The publication can be found on www.scandiononcology.com.
On July 31st, Scandion Oncology reported on data from the first patient from cohort I of the first part of the clinical phase II study enrolling chemotherapy resistant colorectal cancer patients treated with SCO-101 and chemotherapy (FOLFIRI). All patients had completed at least one treatment cycle (14 days). The main result was that 150 mg daily oral SCO-101 potentiates the effects of chemotherapy (FOLFIRI). Based on the data from this first cohort of patients, the Data Safety Monitoring Board recommended to include three additional patients at 150 mg SCO-101 to get more details on the interactions between SCO-101 and FOLFIRI.
On August 1st, Scandion Oncology announced that Saniona had reduced its ownership stake in Scandion Oncology A/S to below 10%. Saniona, together with Nils Brünner and Jan Stenvang initially founded Scandion Oncology A/S in 2017. After the last capital raise in June 2019, Saniona owned approximately 18% of Scandion Oncology.
On August 20th, Scandion Oncology reported that the next evaluable cancer patient at the 8 weeks CT-scanning showed stable disease in the patient’s liver metastases, which are used to measure disease activity, but a metastatic lesion had appeared in the lung of this patient. According to the clinical protocol this patient will be discontinued.
On September 10th, Scandion Oncology announced the beginning of the exercise period for the warrants of series TO 1 that were issued in connection with the issue of units in June 2019. The exercise period ran until October 1st, 2020. A full exercise of all warrants would allocate approximately SEK 12.4 million (before costs).
On September 16th, Scandion Oncology appointed Bo Rode Hansen as new President & CEO and co-founder Nils Brünner as new CSO in order to strengthen executive leadership, and secure corporate- and pipeline development towards upcoming value inflection points for Scandion Oncology.
On September 28th, Scandion Oncology announced that the Company had received final approval from the Danish Medicines Agency and Ethical Committee to initiate a clinical trial with the drug candidate SCO-101 in combination with first line chemotherapy in patients with inoperable or metastatic pancreatic cancer. This was the second clinical trial with SCO-101 that will commence in 2020. Results from this trial are expected in Q2-Q3, 2021.
On September 29th, Scandion Oncology announced that its management team and its Board of Directors had all exercised their Scandion Oncology A/S warrants of series TO 1.
Highlights after the period

On October 1st, Scandion Oncology held the Extraordinary General Meeting. The General Meeting decided that Scandion Oncology will establish an incentive program by issuance of up to 214,338 warrants to the board of directors at Scandion Oncology. It was also decided that the Company will establish an incentive program by issuance of up to 1,286,026 warrants to the CEO and the employees of Scandion Oncology. All decisions were taken with the required majority and in accordance with the notice of the Extraordinary General Meeting.
On October 3rd, Scandion Oncology announced that it had been selected to present the Company for the MATWIN Board and investors. The MATWIN program is installed by the French Government as a collaboration with Pharma companies, investors, and patient advocacy groups to accelerate development of future oncology treatments.
On October 6th, Scandion Oncology received approximately 12.3 MSEK through a warrant exercise that ended on October 1st. A total of 2,371,455 TO 1 were exercised to a subscription rate of approximately 99.6 percent. This secures capital for the continual clinical development of SCO-101.
On October 7th, Scandion Oncology announced a modified timeline for the clinical Phase II colorectal cancer study and the dose range finding study for pancreatic cancer study. The first part (dose range finding) of the ongoing colorectal cancer study was expected to be finalized in Q4 2020 and is now expected to be finalized in Q2 2021. The first part (dose range finding) of the upcoming pancreatic cancer study was expected to be initiated in Q2 2020 and is now expected to be initiated in Q4 2020. The timelines are modified due to COVID-19 and the pandemics’ effects on hospital resources and the general health care systems.
On October 9th, Scandion Oncology announced that the share capital increase from the exercise of warrants of series TO 1 had been registered at the Danish Companies Registration Office.
On October 28th, Scandion Oncology announced that its second clinical study with SCO-101 has been initiated. This Phase Ib study enrols metastatic pancreatic cancer patients who will receive SCO-101 together with 1st line standard chemotherapy (Nab-paclitaxel plus gemcitabine) in cohorts of three. The endpoints of this study are safety and efficacy, and the results are expected to be released Q2-Q3, 2021.
On November 13th, Scandion Oncology held the Extraordinary General Meeting. The general meeting resolved to authorize the Board of Directors during the period until 13 November 2025 to increase the Company’s share capital in one or more issues of new shares with pre-emptive rights for the Company’s existing shareholders by up to a nominal amount of DKK 1,574,641.6560. The proposal is adopted with the required majority and in accordance with the notice of the Extraordinary General Meeting.
On November 16th, Scandion Oncology announced that the Board of Directors had, pursuant to the authorization granted by the extraordinary general meeting on 13 November 2020, resolved on a fully guaranteed new share issue of 10,711,848 shares with preferential rights for the Company’s existing shareholders (the "Rights Issue"). The subscription price in the Rights Issue is SEK 22 per share. The Company will receive SEK 235,660,656 prior to deduction of transaction costs related to the Rights Issue. The full terms and conditions of the Rights Issue and information about the Company will be included in a prospectus expected to be published on the Company’s website around 24 November 2020.
Live webcast tomorrow, 20 November at 10:00 am CET

Scandion Oncology A/S will be hosting a live webcast on 20 November at 10:00 – 10:20 CET to present results of the first nine months in 2020. Participants will be President & CEO, Bo Rode Hansen, CSO, Nils Brünner and CFO, Carit Jacques Andersen. Link to the webcast will be posted at View Source later today.

On November 19, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported positive new interim data from its ongoing ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, PLUS THERAPEUTICS, NOV 19, 2020, View Source [SID1234572301]). These results were presented in an electronic poster entitled, "Safety and Feasibility of Rhenium-186 Nanoliposomes (RNL) in Recurrent GBM: the ReSPECT Phase 1 Trial," at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is taking place virtually November 19-21, 2020.

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The interim data set shows that intratumoral RNL can successfully deliver up to fifteen times the absorbed dose of radiation administered by standard external beam radiation therapy (EBRT) without significant toxicity. These data support progression to the ReSPECT trial’s sixth dose escalation cohort.

"The results we have seen thus far from ReSPECT are encouraging and support the continued development of RNL as a potential new option for recurrent GBM patients," said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the study. "With limited therapeutic options for these patients, we remain committed to advancing this clinical program to further investigate the therapeutic potential of RNL."

"Treatment for glioblastoma remains a significant challenge as current therapies have exhibited limited efficacy," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "RNL’s novel design allows the drug to be targeted directly into the tumor using a small catheter and enabling greater control of radiation dosing. These encouraging data reinforce RNL’s potential to deliver targeted high-dose radiation in a safe, effective, and convenient manner."

Key R esults from the I nterim A nalysis

All 15 patients in the first five of six planned cohorts have completed treatment.
RNL treatment volume and radiation dose increased successfully from 0.66 milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi, respectively.
Cohort 5 patients received an RNL average absorbed radiation dose of 423 Gray (Gy).
RNL has been well-tolerated, and no dose-limiting toxicity has been observed despite markedly higher absorbed doses of radiation compared to EBRT.
Most adverse events (AEs) were considered causally unrelated to RNL except scalp discomfort, which was considered related to the surgical procedure. Neither the incidence nor severity of AEs appeared to increase with increasing doses of RNL.
Four serious adverse events (SAEs) were reported, none of the SAEs were considered causally related to RNL.
Median survival duration in patients that previously received bevacizumab (n=7) was 4.8 months, while median and mean survival durations in patients that were bevacizumab-naïve (n=8) are currently 11.0 months (range 3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with four patients still alive.
Two patients survived greater than 30 months after therapy with RNL.
The sixth dose escalation cohort of the ReSPECT trial is underway and one patient has thus far been treated. The sixth cohort is expected to fully enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration (FDA) granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webinar details

The Company will host a webinar today, Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data. In addition, a patient with recurrent GBM from the ReSPECT trial will provide their treatment experience with RNL.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.