On May 15, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2-6 (Press release, Merck & Co, MAY 15, 2023, View Source [SID1234631730]). Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA; LYNPARZA (olaparib), in collaboration with AstraZeneca; and WELIREG (belzutifan). Additionally, Merck will present data from its broad pipeline, including V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA, and MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech.

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"At this year’s ASCO (Free ASCO Whitepaper), data from our diverse portfolio and broad and expanding pipeline showcase how we continually challenge the status quo through our research to pursue meaningful advances in oncology," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "Building on our leadership with KEYTRUDA, which is now approved for 35 uses across 16 types of cancer, we will present compelling new investigational data from our expansive research program, including in earlier lines of therapy and stages of disease such as the KEYNOTE-671 study in non-small cell lung cancer, and data evaluating new combinations with KEYTRUDA."

Key data from Merck’s portfolio to be presented at ASCO (Free ASCO Whitepaper) 2023:

First-time data from the pivotal Phase 3 KEYNOTE-671 study, evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single-agent) for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) (Abstract #LBA100; The Promise of Neoadjuvant Immunotherapy Across Solid Tumors Clinical Science Symposium);
First presentation of results from the Phase 3 IND.227/KEYNOTE-483 trial in collaboration with the Canadian Cancer Trials Group (CCTG) evaluating KEYTRUDA plus chemotherapy as first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma (Abstract #LBA8505; Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session);
Final overall survival (OS) results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating KEYTRUDA plus LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC) (Abstract #4502; Genitourinary Cancer – Kidney and Bladder Oral Abstract Session);
Final distant metastasis-free survival (DMFS) data from the Phase 3 KEYNOTE-716 trial evaluating KEYTRUDA as adjuvant therapy for stage IIB and IIC melanoma (Abstract #LBA9505; Melanoma/Skin Cancers Oral Abstract Session);
Final OS results from the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA in combination with chemotherapy with or without bevacizumab, as first-line treatment for persistent, recurrent or metastatic cervical cancer (Abstract #5500; Gynecologic Cancer Oral Abstract Session), which will be featured as part of the ASCO (Free ASCO Whitepaper) press program.
Key data from Merck’s pipeline to be presented at ASCO (Free ASCO Whitepaper) 2023:

First presentation of DMFS data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating V940/mRNA-4157 in combination with KEYTRUDA as adjuvant treatment for high-risk melanoma (Abstract #LBA9503; Melanoma/Skin Cancers Oral Abstract Session);
Additional data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 evaluating minimal residual disease as a predictive biomarker of recurrence-free survival (RFS) in patients with high-risk melanoma treated with V940/mRNA-4157 in combination with KEYTRUDA (Abstract #LBA9515; Melanoma/Skin Cancers Poster Discussion Session);
Efficacy and safety data from a Phase 2 study evaluating MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate in advanced NSCLC (Abstract #9114; Lung Cancer – Non-Small Cell Metastatic Poster Session).
Merck investor event

Merck will host an Oncology Investor Event to coincide with the ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 5, 2023, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation at View Source

Details on abstracts listed above and additional key abstracts related to Merck portfolio and pipeline at ASCO (Free ASCO Whitepaper) 2023:

Central nervous system tumors

Belzutifan treatment for von Hippel-Lindau (VHL) disease–associated central nervous system (CNS) hemangioblastomas (HBs) in the phase 2 LITESPARK-004 study. O. Iliopoulos.

Abstract #2008, Central Nervous System Tumors Oral Abstract Session

Gastrointestinal cancers

Health-related quality of life (HRQoL) in the phase 3 KEYNOTE-966 study of pembrolizumab (pembro) plus gemcitabine and cisplatin (gem/cis) versus placebo plus gem/cis for advanced biliary tract cancer (BTC). C. Yoo.

Abstract #4003, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Oral Abstract Session

Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study. Y. Nakamura.*

Abstract #4007, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Oral Abstract Session

KEYNOTE-859 study of pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Outcomes in the protocol-specified PD-L1–selected populations. S. Young Rha.

Abstract #4014, Gastrointestinal Cancer –Gastroesophageal, Pancreatic, and Hepatobiliary Poster Discussion Session

Genitourinary cancers

Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma: 5-year analysis of KEYNOTE-426. B. Rini.

Abstract #LBA4501, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session

Belzutifan plus lenvatinib for patients (pts) with advanced clear cell renal cell carcinoma (ccRCC) after progression on a PD-1/L1 and VEGF inhibitor: Preliminary results of arm B5 of the phase 1/2 KEYMAKER-U03B study. L. Albiges.

Abstract #4553, Genitourinary Cancer –Kidney and Bladder Poster Session

Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). T. Hutson.**

Abstract #4502, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session

First-line lenvatinib + pembrolizumab treatment across non-clear cell renal cell carcinomas: Results of the phase 2 KEYNOTE-B61 study. C. Lee.**

Abstract #4518, Genitourinary Cancer –Kidney and Bladder Poster Discussion Session

Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up. S. Gupta.

Abstract #4505, Genitourinary Cancer –Kidney and Bladder Oral Abstract Session

Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data. T. Friedlander.***

Abstract #4568, Genitourinary Cancer –Kidney and Bladder Poster Session

Health-related quality of life (HRQoL) and pain outcomes for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone (abi) and olaparib (ola) versus (vs) abi and placebo (pbo) in the phase III PROpel trial. A. Armstrong.****

Abstract #5012, Genitourinary Cancer –Prostate, Testicular, and Penile Poster Discussion Session

Gynecologic cancers

KEYNOTE-826: Final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab + chemotherapy vs placebo + chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer. B. Monk.

Abstract #5500, Gynecologic Cancer Oral Abstract Session

Hematologic cancers

Efficacy and safety of pembrolizumab (pembro) in children and young adults with newly diagnosed classical Hodgkin lymphoma (cHL) with slow early response (SER) to front-line chemotherapy (chemo) in the phase 2, open-label, KEYNOTE-667 study. L. Vinti.

Abstract #10027, Pediatric Oncology Poster Discussion Session

Zilovertamab vedotin (MK 2140) in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Early results from the phase 2 waveLINE-004 study. M. Ozcan.

Abstract #7531, Hematologic Malignancies –Lymphoma and Chronic Lymphocytic Leukemia Poster Session

Efficacy and safety of pembrolizumab every six weeks in relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma: The phase 2 KEYNOTE-B68 trial. A. McDonald.

Abstract #7517, Hematologic Malignancies –Lymphoma and Chronic Lymphocytic Leukemia Poster Discussion Session

Lung cancer

SKB264 (TROP2-ADC) for the treatment of patients with advanced NSCLC: Efficacy and safety data from a phase 2 study. W. Fang. (Led by Kelun-Biotech)

Abstract #9114, Lung Cancer – Non-Small Cell Metastatic Poster Session

KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early stage NSCLC. H. Wakelee.

Abstract #LBA100, The Promise of Neoadjuvant Immunotherapy Across Solid Tumors Clinical Science Symposium

IND227 phase III (P3) study of cisplatin/pemetrexed (CP) with or without pembrolizumab (Pembro) in patients (pts) with malignant pleural mesothelioma (PM): A CCTG, NCIN, and IFCT trial. Q. Chu.*****

Abstract #LBA8505, Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session

Pembrolizumab vs placebo for early-stage non‒small-cell lung cancer after resection and adjuvant therapy: Subgroup analysis of patients who received adjuvant chemotherapy in the phase 3 PEARLS/KEYNOTE-091 study. K. Oselin.

Abstract #8520, Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Poster Discussion Session

Melanoma/skin cancer

Pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: Final analysis of distant metastasis-free survival in the phase 3 KEYNOTE-716 study. J. Luke.

Abstract #LBA9505, Melanoma/Skin Cancers Oral Abstract Session

Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial. A. Khattak.(Led by Moderna)

Abstract #LBA9503, Melanoma/Skin Cancers Oral Abstract Session

Minimal residual disease by circulating tumor DNA as a biomarker of recurrence free survival in resected high-risk melanoma patients treated with mRNA-4157/V940, a personalized cancer vaccine, and pembrolizumab. M. Carlino.(Led by Moderna)

Abstract #LBA9515, Melanoma/Skin Cancers Poster Discussion Session

Encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for unresectable locally advanced or metastatic BRAF V600-mutant melanoma: Results from STARBOARD safety lead-in (SLI). S. Schadendorf. (Led by Pfizer)

Abstract #9531, Melanoma/Skin Cancers Poster Session

NeoPlus: A phase II study of neoadjuvant lenvatinib and pembrolizumab in resectable mucosal melanoma. L. Mao.

Abstract #9514, Melanoma/Skin Cancers Poster Discussion Session

On May 15, 2023 Manhattan BioSolutions, Inc. ("Manhattan Bio"), an emerging biotechnology company developing new classes of precision biologics for the treatment of advanced cancers, reported that it has entered into an exclusive option agreement with the Wisconsin Alumni Research Foundation (WARF) for the innovative pan-RNA degrader technologies (pRNAD) in oncology (Press release, Manhattan BioSolutions, MAY 15, 2023, View Source [SID1234631728]). The exclusive option agreement involves the intellectual property rights to technology developed in the laboratory of Ronald T. Raines at the University of Wisconsin-Madison.

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Ronald T. Raines, Ph.D., is currently the Roger and Georges Firmenich Professor of Natural Products Chemistry at the Massachusetts Institute of Technology (MIT), an Extramural Member of the Koch Institute for Integrative Cancer Research at MIT, and an Associate Member of the Broad Institute of MIT and Harvard. Professor Raines has also joined Manhattan Bio’s Board of Directors.

The pRNAD technology is based on an engineered derivative of a naturally occurring nuclease protein involved in host defense to selectively degrade RNA in both tumors and their microenvironment. In preclinical studies, pRNAD has shown a favorable tolerability profile and potent single agent activity against a variety of cancer models such as ovarian, prostate, non-small cell lung and colon cancers. The lead drug candidate has been previously evaluated in a Phase 1 human clinical trial conducted in patients with advanced refractory solid tumors, showing promising results.

Dr Borys Shor, Chairman and CEO, Manhattan Bio, commented: "We are excited to announce this agreement and associated data acquisition, which adds potentially first-in-class clinic-ready program to our pipeline of differentiated biologics. This agent was designed to specifically target and disrupt key vulnerabilities in tumors, including their dependence on extracellular RNA and hyperactive RNA metabolic pathways. Our strategy has been to build a portfolio of world-class development candidates through a combination of in-licensing or in-house discovery. The RNAD transaction is in line with this vision."

Pending completion of the investigational new drug (IND) application process and subsequent regulatory activation of the IND, Manhattan Bio plans to initiate a phase 1b clinical trial in selected tumor indications. The company is also advancing innovative technologies capable of potentially generating multiple Investigational New Drug Applications (INDs), including novel linker/payload technologies for antibody-drug conjugates.

On May 15, 2023 Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, reported a corporate update and announces its first quarter 2023 financial results (Press release, Lipella Pharmaceuticals, MAY 15, 2023, View Source [SID1234631727]).

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Dr. Jonathan Kaufman, CEO of Lipella, said, "Lipella has had a strong start to 2023 with the release of positive top line results from our Phase 2a clinical trial evaluating the safety and efficacy of LP-10 as a treatment for hemorrhagic cystitis. The results have been presented at prestigious meetings including the 2023 Biotech Showcase and as part of a late-breaking presentation at the Annual Meeting of the American Urological Association. We expect to schedule a Type B meeting with the FDA regarding this program in the coming months.

"We were also delighted to enter a manufacturing collaboration agreement with Cook MyoSite to facilitate Chemistry, Manufacturing, and Control documentation for LP-10 in anticipation of Lipella’s forthcoming IND application."

Operational Highlights

● In March 2023, Lipella created a Scientific Advisory Board in oral health to focus on the development of LP-310, the company’s product candidate for the treatment of symptomatic oral lichen planus. The five-member board is made up of a group of highly regarded experts in oral medicine.
● In January 2023, Lipella presented successful top line results of its Phase 2a clinical trial for LP-10 in hemorrhagic cystitis at the 2023 Biotech Showcase.

Financial Highlights

● Lipella had approximately $4.0 million in cash, cash equivalents and marketable securities as of March 31, 2023.
● Net loss for the quarter ended March 31, 2023 was approximately $1.1 million.
● Investors are encouraged to read the Company’s Quarterly Report on Form 10-Q when it is filed with the Securities and Exchange Commission (the "SEC"), which will contain additional details about Lipella’s financial results as of and for the period ended March 31, 2023.

On May 15, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported its financial results for first quarter ended March 31, 2023 (Press release, Leap Therapeutics, MAY 15, 2023, View Source [SID1234631726]).

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Leap Highlights:

· Presenting new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

· Enrollment completed in Part A of the Phase 2 DeFianCe study of DKN-01 in combination with standard of care bevaiczimab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC)

· Acquired Flame Biosciences, adding FL-301, a clinical stage anti-Claudin18.2 antibody, and preclinical antibody programs targeting Claudin18.2/CD137 and GDF15 to Leap’s pipeline, along with approximately $50 million in cash.

"We continued to execute extremely well on our DKN-01 program during the first quarter of 2023 with the completion of enrollment in Part A of the DeFianCe second-line CRC study and excellent progress in enrolling our randomized, controlled Part C of the DisTinGuish first-line GEA study," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to presenting long-term follow-up data from Part A of the DisTinGuish study at ASCO (Free ASCO Whitepaper) in June, including updated response and overall survival data. With the acquisition of Flame Biosciences at the beginning of the year, we are in a strong financial position to develop our pipeline of personalized medicines for cancer patients."

DKN-01 Development Update

· Updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients to be presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. The Company will be presenting new long-term follow-up data in first-line patients with advanced GEA from Part A of the DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, IL on June 2-6, 2023. Details of the presentation are below:

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

· Announced completion of enrollment in Part A of the DeFiance Study of DKN-01 for the treatment of colorectal cancer patients. The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The study began with an initial Part A cohort that has enrolled 33 patients and is designed to expand into a 130-patient Part B randomized controlled trial. The primary objective is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to report initial data from Part A of the study in mid-2023.

Selected First Quarter 2023 Financial Results

Net Loss was $41.9 million for the first quarter 2023, compared to $10.4 million for the same period in 2022. The increase was primarily due to in-process research & development (IPR&D) expense of $29.6 million associated with the acquisition of Flame Biosciences.

Research and development expenses were $38.9 million for the first quarter 2023, compared to $7.8 million for the same period in 2022. The increase in research and development expenses was due to IPR&D expense associated with the Flame acquisition of $29.6 million, increased headcount and compensation expense of $0.8 million, increased manufacturing costs of $0.8 million, increased stock based compensation expense of $0.1 million, partially offset by decreased clinical trial costs of $0.2 million.

General and administrative expenses were $3.8 million for the first quarter 2023, compared to $2.8 million for the same period in 2022. The increase in general and administrative expenses was due to increased finance and legal fees, primarily associated with the Flame acquisition, of $0.7 million and increased headcount and compensation expense of $0.3 million.

Cash and cash equivalents totaled $102.0 million at March 31, 2023. Research and development incentive receivables totaled $2.3 million at March 31, 2023.

On May 15, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that new preclinical data on its IPH6501 tetra-specific ANKET (Antibody-based Natural Killer cell Engager Therapeutics) have been selected for oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 congress, being held 8 to 15 June 2023 in Frankfurt, Germany (Press release, Innate Pharma, MAY 15, 2023, View Source [SID1234631725]).

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ANKET is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. Innate’s latest innovation, the tetra-specific ANKET, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and the interleukin-2 receptor (via a non-alpha IL-2 variant, IL-2v) via a single molecule. By providing proliferation and activation signals targeted to NK cells, tetra-specific ANKET leverages the advantages of harnessing NK cell effector functions against cancer cells.

IPH6501, the first tetra-specific ANKET, continues toward a Phase 1 clinical trial in 2023.

Presentation details

Presentation: S258

Title: IPH6501 is a first-in-class tetraspecific antibody-based natural killer cell engager therapeutic developed for the treatment of B-cell non-Hodgkin’s lymphomas

Session: s425 Gene therapy and immunotherapy – Biology & translational research

Date and time: 10/06/2023, 11:30 – 12:45

Location: Fantasie

Speaker: Olivier Demaria, PhD, R&D Director, Science Leader at Innate Pharma