RAPT Therapeutics Announces FLX475 Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 26, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported that it will present a poster on FLX475, its lead oncology drug candidate, at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 2-6, 2023 at the McCormick Place Convention Center in Chicago, IL (Press release, RAPT Therapeutics, APR 26, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-flx475-poster-presentation-2023 [SID1234630542]).

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Presentation details:

Title: Clinical and Biological Activity of FLX475, an Oral CCR4 Antagonist, in Advanced Cancer
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday, June 3, 2023; 8:00 a.m. – 11:00 a.m. ET
Abstract Number: 2625
The abstract will be released on Thursday, May 25, 2023 at 5:00 p.m. ET on meetings.asco.org.

PharmaMar Group reports results for 1Q2023

On April 26, 2023 PharmaMar Group (MSE: PHM) reported total revenues of €34.0 million in 1Q2023, compared with €53.2 million in 1Q2022. Recurring revenues, the sum of net sales plus royalties from sales made by our partners, totaled €27.4 million compared with €45.9 million in the first quarter of 2022 (Press release, PharmaMar, APR 26, 2023, View Source [SID1234630541]). This difference is mainly due to the entry onto the European market of a generic trabectedin (Yondelis) product in the last quarter of 2022. Yondelis reported net sales of €8.1 million in the first quarter of this year, compared with €17.5 million in the same period of the previous year. The entry of the generic drug has put significant pressure on the price of Yondelis, although the change in sales measured in grams was 9% year-on-year.

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Zepzelca revenues in Europe from the early access program, mainly in France, were €5.6 million, in line with the last quarters of last year, although in the first quarter of 2022 they were €8.7 million. While the number of units sold was similar to the same period last year; there is a difference between periods due to the calculation of the adjustments resulting from the regulations governing the prices of drugs marketed through the L’autorisation d’ Access Compasionel system in France, under which Zepzelca is distributed in that territory, entailing the application of significant discounts for these drugs.

Continuing with recurring revenues, sales of raw materials to our partners, both of Yondelis and Zepzelca, amounted to €1.5 million in the first quarter of the year, compared with €7.4 million in the first quarter of 2022. This difference is temporary as our partners stocked up in previous quarters and there is a lag in purchase orders, so that this item is expected to rebound in the coming months.

Royalty income totaled €11.1 million, in line with the €11.0 million recorded during the first quarter of the same period last year. These revenues include royalties received from our partner Jazz Pharmaceuticals for Zepzelca sales in the US, which amounted to €10.2 million to March 31st (March 2022: €10.2 million). The royalties recorded for the first quarter are an estimate, as was the figure recorded in the first quarter of last year, since information on sales made by Jazz is not available at the date of publication of this report. Any discrepancies between our estimates and the final figure will be corrected in the following quarter. The real growth in royalties between the two periods was 7%, which is not reflected due to an excess in the forecast made in the royalties for the first quarter of 2022.

To the Royalties received from Jazz Pharmaceuticals must be added to the royalties on Yondelis sales received from our partners in the United States and Japan, amounting to €0.9 million in the first quarter of 2023 (€0.8 million in the same period of 2022).

Finally, non-recurring revenues, mainly consisting of those from licensing agreements, amounted to €6.5 million at March 31st, 2023, compared with €7.2 million at March 31st, 2022. In the first quarter of 2023, as well as in 2022, the revenues recorded for this item came entirely from licensing agreements related to Zepzelca.

During the first quarter of the year, R&D expenditure increased by 11% to €21.1 million, mainly as a result of the various Phase III trials, which the Company is conducting as well as the development of new molecules at earlier stages of the pipeline.

The Group recorded a net profit in this first quarter 2023 of €1.4 million, compared to €21.9m in first quarter 2022, mainly due to the drop in sales and the increase in R&D investment.

The PharmaMar Group ended the first quarter of 2023 with cash of €231.1 million and total debt of €39.8 million, which represents net cash of €191.4 million, in line with the cash position at the end of 2022.

PharmaMar’s earnings conference call for analysts and investors

PharmaMar will hold a conference call with analysts and investors on Thursday, April 27th, 2023, at 12:30 (CET).

To access this teleconference, please follow this link to register and receive conference call details:

View Source

A recording of the teleconference can be accessed on PharmaMar’s website by visiting the Events Calendar section at www.pharmamar.com.

Oncolytics Biotech® Announces Upcoming Oral Presentation on Randomized BRACELET-1 Trial in HR+/HER2- Metastatic Breast Cancer at the ASCO Annual Meeting

On April 26, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the acceptance of an abstract for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place from June 2 – 6, 2023 in Chicago, Illinois and online (Press release, Oncolytics Biotech, APR 26, 2023, View Source;metastatic-breast-cancer-at-the-asco-annual-meeting [SID1234630540]).

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"Being selected for an oral presentation at ASCO (Free ASCO Whitepaper) is an immense honor that speaks to the importance of BRACELET-1’s results to key opinion leaders and other critical stakeholders in breast cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "ASCO is widely recognized as one of the world’s premier oncology conferences, and we’re thrilled that our collaborators at PrECOG will have such a prestigious venue to present the randomized phase 2 BRACELET-1 trial."

Details on the abstract and corresponding presentation are shown below.

Title: BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab

Presentation Type: Oral

Abstract Number: 1012

Session Type: Clinical Science Symposium

Session Title: The Dr. Bernard Fisher Memorial Annual Clinical Science Symposium Supported by the Breast Cancer Research Foundation: Harnessing the Breast Cancer Immune Response

Session Date and Time: June 3, 2023 | 1:15 p.m. – 2:45 p.m. CT

The abstract will be published on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 5:00 p.m. ET on May 25, 2023.

About BRACELET-1

Additional information on the BRACELET-1 study can be found at View Source and the identifier (NCT number) NCT04215146.

Mersana Therapeutics Announces Upcoming Presentations at 2023 ASCO Annual Meeting

On April 26, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the acceptance of multiple abstracts for poster presentations at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place in Chicago from June 2-6, 2023 (Press release, Mersana Therapeutics, APR 26, 2023, View Source [SID1234630536]).

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Presentation details are as follows:

XMT-1660: A phase 1b trial of a B7-H4 targeted antibody drug conjugate (ADC) in breast, endometrial, and ovarian cancers
Abstract Number: TPS3154
Presenter: Erika Hamilton, MD, Director, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology
Session Track & Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date & Time: June 3 from 8:00-11:00 a.m. CT

Correlating expression of NaPi2b and FRa in high grade serous ovarian cancer (HGSOC)
Abstract Number: 5545
Presenter: Debra Richardson, MD, Associate Professor, Obstetrics & Gynecology and Section Chief of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT

UP-NEXT (GOG-3049/ENGOT-Ov71-NSGO-CTU): A study of upifitamab rilsodotin (UpRi), a NaPi2b-directed antibody drug conjugate (ADC), in platinum-sensitive recurrent ovarian cancer
Abstract Number: TPS5614
Presenter: Debra Richardson, MD, Associate Professor, Obstetrics & Gynecology and Section Chief of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT

UPGRADE-A: Phase 1 expansion trial of the NaPi2b-directed antibody drug conjugate (ADC) upifitamab rilsodotin (UpRi) in combination with carboplatin in patients with high-grade serous ovarian cancer (HGSOC)
Abstract Number: TPS5613
Presenter: John Hays, MD, PhD, Assistant Professor, Department of Internal Medicine, Division of Medical Oncology, The Ohio State University
Session Track & Title: Poster Session – Gynecologic Cancer
Session Date & Time: June 5 from 1:15-4:15 p.m. CT

Leap Therapeutics to Present Updated Data from Part A of the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy in Gastric Cancer Patients at the 2023 ASCO Annual Meeting

On April 26, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the Company will be presenting new long-term follow-up data in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) from Part A of the DisTinGuish study, a Phase 2 clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy, at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 2-6, 2023 (Press release, Leap Therapeutics, APR 26, 2023, View Source [SID1234630535]).

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Leap Presentation Details:

Title: A phase 2 study (DisTinGuish) of DKN-01 in combination with tislelizumab + chemotherapy as first-line (1L) therapy in patients with advanced gastric or GEJ adenocarcinoma (GEA).

Presenter: Samuel J. Klempner, Harvard Medical School

Session Type: Poster Discussion Session

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Date and Time: Monday, June 5, 2023, at 11:30 a.m. ET

Abstract Number: 4027

Poster Number: 335

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in three parts in the United States, the Republic of Korea, the United Kingdom, and Germany. Part A enrolled 25 first-line HER2- GEA cancer patients to receive DKN-01 in combination with tislelizumab and capecitabine and oxaliplatin. Part B enrolled 52 second-line GEA cancer patients whose tumors expressed high levels of DKK1 to receive DKN-01 in combination with tislelizumab. Part C is enrolling approximately 160 first-line HER2- GEA cancer patients in a randomized controlled trial of DKN-01 in combination with tislelizumab and chemotherapy compared to tislelizumab and chemotherapy.