On November 16, 2022 Scandion Oncology (Scandion) reported its interim report for Q3 2022 (Press release, Scandion Oncology, NOV 16, 2022, View Source;interim-report-q3-2022,c3667570 [SID1234624141]). The following is taken from the report.

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Johnny Stilou, Acting CEO & CFO, comments

"In the third quarter of 2022 we managed to raise approximately 42 MDKK net in a very difficult stock market. The raised capital will take us well into 2024."

Shares outstanding, ending
Highlights during Q3 2022

On July 4, Scandion announced final outcome of its rights issue. Through the issue, Scandion raises approximately SEK 75 million before deduction of issue related costs.
On July 26, Scandion’s rights issue was registered with the Danish Business Authority.
On August 17, Scandion announced extension of the PANTAX trial due to better-than-expected tolerability of SCO-101.
On August 19, Scandion received approvals for next parts of the CORIST trial. The development of SCO-101 will continue as planned with expansion of the CORIST trial expected to commence during the third quarter of 2022.
On August 31, Scandion announced changes to Executive Management.
On September 31, Scandion announced topline results from part 2 of the CORIST phase II trial. Data from part 2 of the trial confirm the safety and tolerability of SCO-101. The trial will continue with part 3 exploring an optimized dosing schedule, aiming to utilize the full potential of SCO-101 in this indication and combination.
Highlights after the end of the period

On October 10, Scandion initiates recruitment in part 3 of the CORIST phase II trial.
On October 28, Scandion announce results of extraordinary general meeting.
The interim report Q3 2022 is available on the Company’s website: www.scandiononcology.com.

Audiocast today, November 16 at 10:00 am CET

Today at 10:00, Scandion Oncology’s executive management will host a webcast and conference call presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on November 16, 2022, at 08.30 CET.

On November 16, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that it will present updated efficacy, immunogenicity and safety data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (ROSALIE trial) in an oral presentation at the 27th Society for Neuro-Oncology (SNO) Annual Meeting which will be held in Tampa Bay, Florida, US on November 16-20, 2022 (Press release, Enterome, NOV 16, 2022, View Source [SID1234624137]).

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Oral Presentation Details – Abstract CTIM-17

Title: EO2401 therapeutic vaccine for patients with recurrent glioblastoma: phase 1/2 ROSALIE study (NCT04116658)
Authors: D. Reardon et al.
Date: November 18, 2022, 4:35 pm EST
Location: Tampa Convention Center, Ballroom B
Presenter: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School, and Clinical Director for Dana Farber Cancer Institute
The abstract is published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, and available via this link.

About EO2401

EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It combines three microbial-derived OncoMimics peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5 and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). EO2041 is designed to trigger the immune system into recognizing these epitopes on glioblastoma cells as foreign (non-self) and eliciting a targeted memory T-cell driven cell-killing response against the tumor cells.

Promising data presented during 2022 at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), EANO and SITC (Free SITC Whitepaper)

Data confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
Addition of bevacizumab, either as a low-dose symptom driven time-limited treatment, or as a continuous treatment at the labelled US dose, to EO2401 in combination with nivolumab supported longer treatment durations and an increase in efficacy.
CD8+ T cells against at least one of the EO2401 peptides was detected in 26 out of 28 patients with some patients exhibiting up to 5% of circulating specific CD8+ T cells. Memory specific CD8+ T cells response were found as early as two weeks after the first vaccination and maintenance of a strong and stable immune response could be detected for more than 10 months.
Additional patients are to be treated with triple combination of EO2401/nivolumab/bevacizumab to support final regimen selection for further studies.
About ROSALIE

ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.

On November 16, 2022 Precision Biologics, Inc. ("Precision"), a clinical-stage immunotherapy and targeted oncology company, reported that it will present at the SITC (Free SITC Whitepaper) 37th Annual Meeting (2022) in Boston, MA (Press release, Precigen, NOV 16, 2022, View Source [SID1234623581]).

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The first poster presentation will discuss the novel target for its NEO-201 monoclonal antibody and mechanism of action for this drug including the specific O-glycan epitope recognized by NEO-201 and that NEO-201 kills target cells expressing core 1 and/or extended core 1 O-glycans through Antibody-Dependent Cellular Cytotoxicity (ADCC)

The second poster presentation will discuss the ongoing Phase 2 clinical trial being conducted at the National Cancer Institute that combines NEO-201 with Pembrolizumab in patients with treatment refractory solid tumors. The study is enrolling patients at the National Cancer Institute, Bethesda, MD, with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancers, Endometrial Cancer and Cervical Cancer, who have already been treated with checkpoint inhibitor therapy (including prior Keytruda). (View Source)

Posters will be presented in person at the at the Boston Convention and Exhibition Center on Thursday November 10th, 2022.

On November 15, 2022 NextCure and LegoChem Biosciences reported a collaboration and co-development agreement focused on generating a B7-H4 antibody drug conjugate (ADC) and options for two additional targets (Press release, NextCure, NOV 15, 2022, View Source [SID1234638589]). The B7-H4 ADC will utilize NextCure’s B7-H4 antibody and LCB’s ConjuAllTM ADC technology.

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Under the terms of the agreement, both parties will equally share the costs to develop the molecules and profits on commercialized products. The parties will utilize their respective product development capabilities to generate the B7-H4 ADC and advance it to the clinic. In addition, there are options for the parties to nominate two additional targets for ADC development beyond B7-H4.

"We are excited to work with LCB, and apply ConjuAllTM, a leading ADC technology, to add a new treatment modality to our B7-H4 program," said Timothy Mayer, NextCure’s Chief Operating Officer. "We remain committed to developing novel immunomedicines using multiple modalities to address the significant unmet needs of cancer patients not adequately addressed by available therapies."

"The initiation of this collaboration with NextCure represents another important milestone for LCB as we continue to build our ADC pipeline and seek to demonstrate the potential of our ADC platform in a wide range of different tumors," said Yong-Zu Kim, LCB’s Chief Executive Officer. "B7-H4 ADC would potentially offer a first-in-class opportunity for a target expressed on a broad range of tumor types, and I look forward to progress in early stage studies."

On November 15, 2022 Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, reported that it has entered into definitive agreements for a private placement of its securities for gross proceeds of approximately $18.9 million, prior to deducting placement agent commissions and estimated offering expenses (Press release, OncoGenex Pharmaceuticals, NOV 15, 2022, View Source [SID1234624241]).

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The private placement will be for up to 4,093,141 units at a price of $4.625 per unit, with each unit consisting of two shares of common stock and one warrant to purchase one share of common stock. The private placement was priced at $2.3125 per common share, an 8.6% premium to the closing price of the Company’s common stock the day prior to entering into the subscription agreements, including a one-half warrant per share. The private placement is expected to close on or about November 18, 2022, subject to customary closing conditions. The warrants will have an initial per share exercise price of $4.50. All warrants will be exercisable beginning on the six-month anniversary of the closing of the offering and will have a seven-year term. The Company intends to use the proceeds from the private placement to fund clinical research and development, and for general working capital. It estimates that the net proceeds, plus its existing financial resources, are sufficient to fund operations into late 2023.

The private placement includes a new life sciences focused investment fund, participation from Achieve management, as well as new and existing investors. Lake Street Capital Markets, LLC is acting as the exclusive placement agent in connection with this offering.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state’s securities laws, and are being issued and sold in reliance on Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. The securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Achieve has agreed to file a registration statement to register the resale of the shares of common stock included in the units and underlying the warrants within 60 days of the closing of the offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.