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Alpine Immune Sciences to Collaborate with Merck on Immuno-Oncology Study to Evaluate ALPN-202 in Combination with KEYTRUDA® (pembrolizumab)

On June 30, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported a clinical trial collaboration and supply agreement with Merck (Press release, Alpine Immune Sciences, JUN 30, 2021, View Source [SID1234584500]). This collaboration will evaluate the safety and efficacy of Alpine’s ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The clinical trial, NEON-2, began dosing study participants in June 2021.

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"We are extremely pleased to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Stanford Peng, M.D., Ph.D., President and Head of R&D of Alpine. "Our prior preclinical studies demonstrated that the combination of ALPN-202 and a PD-1 inhibitor can be particularly advantageous, and this collaboration will greatly enable our ability to pursue this opportunity in the clinic. This study, in conjunction with NEON-1, ALPN-202’s ongoing first-in-human monotherapy trial, will provide insights across a broad spectrum of cancers and lines of therapy."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a monotherapy study of ALPN-202 in patients with advanced malignancies, and NEON-2 (NCT04920383), a study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, are currently enrolling.

Panbela Increases Previously Announced Bought Deal Offering of Common Stock to $10.0 Million

On June 30, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA) (the "Company" or "Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3,333,334 shares of common stock of the Company at a price to the public of $3.00 per share, less underwriting discounts and commissions (Press release, Panbela Therapeutics, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=panbela-increases-previously-announced-bought-deal-offering-of-common-stock-to-10-million [SID1234584498]). The closing of the public offering is expected to occur on or about July 2, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has granted to the underwriter a 30-day option to purchase up to an additional 500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The gross proceeds of the offering are expected to be approximately $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Panbela and assuming no exercise of the option to purchase additional shares. The Company intends to use the net proceeds of the offering for the continued clinical development of its initial product candidate SBP-101 and for working capital and other general corporate purposes.

The shares of common stock described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255751) filed with the Securities and Exchange Commission ("SEC") and declared effective on May 11, 2021. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

Oncolytics Biotech® to Present at the Ladenburg Thalmann Healthcare Conference

On June 30, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will present a corporate overview at the Ladenburg Thalmann Healthcare Conference, which is taking place virtually from July 13-14, 2021 (Press release, Oncolytics Biotech, JUN 30, 2021, View Source [SID1234584497]). Presentation details are listed below .

Oncolytics Biotech Inc.

Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, July 14, 2021
Time: 4:30 p.m. Eastern Daylight Time
Webcast Link: Please click here

The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Ladenburg Thalmann representative or email [email protected].

A live webcast of the presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for 90 days.

Cantrixil positive Phase I trial data published in the journal Cancers

On June 30, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that the results from a Phase I open-label study (NCT02903771) of the investigational drug candidate Cantrixil (TRX-E-002-1) have been published in Cancers, a peer-reviewed, open access journal of oncology (Press release, Oasmia, JUN 30, 2021, View Source [SID1234584496]).

The paper entitled ‘Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results’ can be accessed online at the following link: View Source

Oasmia acquired the exclusive global development rights for the Cantrixil ovarian cancer program from Kazia Therapeutics Ltd earlier this year. Top-line data from the Phase I study previously reported by Kazia Therapeutics Ltd in December 2020 and presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021 confirmed that the Phase I study met its primary endpoints, establishing clinical proof of concept.

The study was conducted at sites in the USA and Australia under the leadership of clinical trial’s Principal Investigator, Jermaine Coward, Associate Professor, ICON Cancer Centre, located in Brisbane, Australia. The study aimed to define the maximum tolerated dose, tolerability, and antitumor activity of Cantrixil when administered via an intraperitoneal (IP) port. Cantrixil was well tolerated even in patients with heavily pre-treated disease.

The study demonstrates the potential for prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy with IP-administered Cantrixil.

Dr. Heidi B. Ramstad, CMO of Oasmia, commented: "These data are encouraging and has demonstrated the potential for prolonged survival in some patients with advanced ovarian cancer. By inducing ovarian cancer stem cell death and sensitizing cancer cells to standard chemotherapy, Cantrixil may improve survival outcomes in this patient population. Ovarian cancer remains one of the most aggressive cancers and are proven difficult to treat in advanced stages. We look forward to the forthcoming Phase 2 trial investigating Cantrixil in combination with first-line chemotherapy with an aim to improve survival rates in ovarian cancer."

Alligator Bioscience AB and Scandion Oncology A/S present promising preclinical data

On June 30, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) and Scandion Oncology (Nasdaq Stockholm: SCOL) reported that promising preclinical data from their ongoing collaboration exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology’s drug candidate SCO-101 and Alligator Bioscience’s candidate drug mitazalimab.

The collaboration explores the anti-tumor efficacy of the CD40 antibody mitazalimab in combination with SCO-101 as an addition to chemotherapy (FOLFIRINOX) in chemotherapy-resistant preclinical tumor models. The hypothesis is that SCO-101 will revert chemotherapy resistance and thereby facilitate a strengthening of the anti-tumor effects of mitazalimab.

The combination of mitazalimab and FOLFIRINOX demonstrates a strong anti-tumor response in FOLFIRINOX resistant cancer cells. Importantly, the current data indicate that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. The studies are still ongoing and further monitored for anti-tumor effects and survival.

The data further validate the potential of mitazalimab in combination with standard of care chemotherapy such as FOLFIRINOX.

"We are pleased to see that the preliminary results strengthen and expand the preclinical efficacy data for mitazalimab, by demonstrating synergy with FOLFIRINOX even in tumors resistant to chemotherapy. This bodes well for our OPTIMIZE-1 phase II study where we are assessing the efficacy of mitazalimab in combination with FOLFIRINOX in pancreatic cancer. Once we have the full data we will evaluate the possibility of testing of the triple combination in clinical trials," said Søren Bregenholt, CEO of Alligator Bioscience.

The data support the basic concept that SCO-101 in combination with chemotherapy and immuno-oncology is well tolerated and has a very potent anti-tumor effect in vivo on drug resistant cancer cells.

"The very first set of in-vivo data is encouraging. The studies will continue to draw the final conclusions, but this first assessment is supporting our hypothesis and opens for a novel opportunity in our R&D strategy. We are pleased that the collaboration with Alligator Bioscience has enabled us to explore the potential of SCO-101 in the setting of immuno-oncology and are committed to explore the potential of SCO-101 in immuno-oncology further," said Bo Rode Hansen, CEO of Scandion Oncology.