On May 25, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that initial promising data from the Archer-1 Phase 1b trial investigating Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, MAY 25, 2021, View Source [SID1234580585]).

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The preliminary results show clinical activity with seven out of seven patients achieving a response, including 5 complete responses and 2 partial responses. All responses are currently ongoing, 5 of them 2 years after Betalutin administration.

Across this patient group, Betalutin with RTX showed a very good safety profile, comparable to that of single agent Betalutin, with no dose limiting toxicities observed.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of CD37-targeted Betalutin in combination with CD20-targeted RTX in patients with relapsed/refractory FL who have received one or more prior therapies.

The starting doses of Betalutin and lilotomab were 10MBq/kg and 40mg, respectively, which was escalated to Betalutin 15MBq/kg and lilotomab 40mg in the second cohort. Following Betalutin dosing, patients received four weekly doses of RTX (375mg/m2) on days 7, 14, 21 and 28. Patients who did not progress (including CR, PR, SD) were scheduled to receive RTX maintenance for 2 years.

The primary objective of the study was to evaluate the safety and tolerability of Betalutin in combination with RTX, the secondary objective to evaluate the preliminary anti-tumour activity of combination treatment.

The rationale for Archer-1 was provided by earlier preclinical data showing Betalutin can up-regulate CD20 expression in different rituximab-sensitive NHL cell lines and act synergistically with rituximab in a rituximab-sensitive NHL animal model and, more recently, that Betalutin has the potential to counteract resistance to rituximab in non-Hodgkin’s lymphoma models.

Peter Braun, Nordic Nanovector CEO, commented: "We are encouraged by the results in this small Phase I study in second line FL patients. Both the overall safety of this combination and the preliminary signs of efficacy are promising. We look at this study as an additional building block in our overall strategy to develop Betalutin for difficult to treat hematological tumors. Our near-term focus remains very much on completing PARADIGME in 3L FL and delivering top line 3-month data by the end of 2021.

On May 25, 2021 Quest Diagnostics (NYSE:DGX) and Paige reported a collaboration designed to unlock the potential of artificial intelligence (AI) to improve and speed the diagnosis of cancer and other diseases that rely on pathologic assessment (Press release, Quest Diagnostics, MAY 25, 2021, View Source [SID1234580520]).

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The collaboration involves analysis using Paige’s proprietary machine learning expertise of pathology diagnostic data and digitized slides from Quest Diagnostics and its AmeriPath and Dermpath businesses to uncover markers of cancer and other diseases. Using these insights, the parties intend to develop new software products which, following regulatory approval, will be marketed to pathologists, oncologists and other providers to support disease diagnosis. Near term, the parties also intend to license the insights to biopharmaceutical and research organizations to aid biomarker discovery, drug research and development and companion diagnostics.

The collaboration will initially focus on solid tumor cancers, such as prostate, breast, colorectal and lung. The agreement involves shared revenue for achieving certain product and commercial milestones and, assuming regulatory approval, arrangements for Quest to use approved software products in its pathology operations as well as joint marketing and research. In addition, Quest’s pathologists will aid in defining pathology workflows for using the products to support diagnostic decision-making. Additional terms were not disclosed.

"As the leader in advanced diagnostics, we are excited to actively participate in the creation and use of new technologies that further the mission to make precision medicine clinically accessible, actionable and economical. We are energized about contributing our expertise to Paige’s computational pathology leadership to deliver insights from leading-edge technologies to improve the diagnosis of cancer and other diseases," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics.

The collaboration combines Quest’s leadership in advanced diagnostics, pathology subspecialty expertise and national scale with Paige’s leading AI-based software capabilities and proprietary data from millions of digitized pathology slides and associated therapy information. Quest and its specialty pathology businesses bring subspecialty expertise based largely from serving community cancer centers, which provide 80% of cancer care nationally, complementing insights from Paige’s academic center expertise.

"We are excited to collaborate with Quest to create new software products that can deliver faster, more accurate and more informed clinical insights to patients than what is possible today," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "Given Quest’s vast footprint in the diagnostic space this collaboration will enable us to ensure broad adoption of the clinical products and biomarkers we’re building."

Cancer diagnosis typically involves visual inspection of tumor tissue on a glass slide by a pathologist using a microscope. In contrast, AI-enabled computational pathology can identify known patterns in tissue that characterize disease as well as identify new markers, including those that are not necessarily detected by the naked eye. Because AI systems improve with exposure to new data, the data from Quest’s deep subspecialized expertise is poised to enhance Paige’s efforts to discern new insights that may improve cancer diagnosis and patient care.

Digital Pathology Use

The collaboration also aligns with Quest’s goal to expand its digital pathology network for its pathologists across the United States. The company employs widely used and cost-efficient digital technologies from different manufacturers to enable pathologists to capture and share digital images of slides with other experts to confer on findings, improving diagnosis. Paige’s software platform is interoperable across several digital systems and is designed to deploy AI-based diagnostic products into pathology workflows.

Digital pathology technologies enable pathologists to capture and share digital images of slides with experts in other locations – including in the United States and globally – to confer on findings and thereby improve diagnosis.

Quest Diagnostics is a world leader in advanced diagnostic services, including in oncology. With its AmeriPath and Dermpath specialty pathology businesses and 600 MDs and PhDs, Quest Diagnostics provides highly advanced pathology services for health systems and other providers in the United States and overseas.

On May 25, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that announced that James Dentzer, President and Chief Executive Officer of Curis, will participate in a virtual fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 3:00 p.m. ET (Press release, Curis, MAY 25, 2021, View Source [SID1234580538]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for approximately 90 days following the event.

On May 25, 2021 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported a proposed underwritten public offering in which it intends to offer and sell shares of its common stock (Press release, OncoGenex Pharmaceuticals, MAY 25, 2021, View Source [SID1234580554]). In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering. Lake Street Capital Markets, LLC is acting as the lead manager.

Achieve intends to use the proceeds from the offering to fund ongoing cytisinicline development, other clinical research and development and for working capital and general corporate purposes.

The securities are being offered by Achieve pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by calling (212) 667-8055, or by emailing [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On May 25, 2021 Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside the United States and Canada, to evaluate XTX101, Xilio’s engineered tumor-selective Fc-enhanced, anti-CTLA-4 monoclonal antibody (mAb) product candidate, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Xilio Therapeutics, MAY 25, 2021, View Source [SID1234580570]). The planned clinical trial will be conducted by Xilio and is designed to evaluate the safety and efficacy of XTX101 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.

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"We believe tumor-selective immuno-oncology has significant potential to provide meaningful treatments to patients with a number of different cancers. The clinical benefit of targeting CTLA-4 as a treatment for cancer is well-established. However, treatment with the combination of an anti-CTLA-4 mAb and PD-1 checkpoint inhibitor has been associated with challenging toxicities, preventing patients from receiving effective doses of the anti-CTLA-4 antibody," said Marty Huber, M.D., chief medical officer of Xilio Therapeutics. "XTX101 is designed to be tumor-selective and based on data observed in preclinical studies, we believe it could be an ideal CTLA-4-targeting candidate to combine with checkpoint inhibitors like KEYTRUDA. We are pleased to partner with Merck to study this combination in an effort to improve therapeutic options for people with cancer."

XTX101 is a tumor-selective anti-CTLA-4 mAb designed to pinpoint the anti-CTLA-4 effect geographically within the tumor without off-tumor peripheral effects, potentially improving the therapeutic index and overcoming the potency and tolerability limitations of other anti-CTLA-4 antibodies. In preclinical studies, XTX101 has been well-tolerated and achieved robust tumor growth inhibition, including complete responses accompanied by tumor-selective immune activation. Xilio plans to submit an investigational new drug (IND) application for XTX101 to the U.S. Food and Drug Administration (FDA) in the second quarter of 2021. Subject to FDA clearance of the IND application, Xilio expects to promptly initiate a Phase 1 clinical trial evaluating XTX101 as a monotherapy and as a combination therapy with KEYTRUDA for the treatment of solid tumors.