On May 15, 2023 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, reported strategic, financial, and operational updates for the quarter ended March 31, 2023 (Press release, NightHawk Biosciences, MAY 15, 2023, View Source [SID1234631734]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We continue to invest in and advance our research and biomanufacturing efforts, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities. We are making steady progress and look forward to providing further updates."

2023 Financial Results

For the three months ended March 31, 2023 we recognized $0.1 million of revenue from a licensing agreement with Shattuck Labs and $0.7 million of revenue from Scorpius biomanufacturing services. For the three months ended March 31, 2022 we recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant. The decrease in grant revenue in the current-year period is due to the fact that we have recognized all $15.2 million of CPRIT grant revenue. As of March 31, 2023, we had a grants receivable balance of $1.5 million for the final CPRIT tranche, and received those funds in April 2023. . We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expenses increased approximately 79.5% to $7.0 million for the three months ended March 31, 2023 compared to $3.9 million for the three months ended March 31, 2022. The components of R&D expense are as follows: HS-110 expense decreased $0.1 million primarily due to a decrease in consultants and contract labor expense; HS-130 expense decreased to $0 from $0.5 million due to the deprioritization of the oncology assets; PTX-35 expense increased by $0.3 million primarily due to the expensing of prepaid expenses associated with the discontinued clinical trials and development of the product candidate in the third quarter of 2022;
ANTHIM (obiltoxaximab) was not acquired until the second quarter of 2022 and the 2023 expense primarily relates to fill finish; other programs expense increased by $0.4 million primarily due to increase in laboratory supplies expense related to preclinical R&D expenses and the operations of the CDMO facility; Unallocated research expenses increased by $2.7 million primarily due to increased personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects;
Cost of revenues were $0.6 million for the three months ended March 31, 2023. These expenses primarily reflect direct cost of labor, overhead and material costs for Scorpius biomanufacturing services. There was no cost of revenues for the three months ended March 31, 2022 as the Scorpius facility was not operational.
Selling, general and administrative expenses were $6.8 million and $3.8 million for the three months ended March 31, 2023 and 2022, respectively. The increase was primarily due to an increase of $1.9 million for consulting and other professional expenses to manage the business and increased personnel costs of $1.0 million, and to a lesser extent, an increase in rent expense of $0.3 million, offset by a decrease in stock-based compensation expense of $0.1 million.
Net loss attributable to NightHawk Biosciences was approximately $12.8 million, or ($0.49) per basic and diluted share, for the three months ended March 31, 2023, compared to approximately $8.1 million, or ($0.32) per basic and diluted share, for the three months ended March 31, 2022.
As of March 31, 2023, the Company had approximately $28.6 million in cash, cash equivalents, and short-term investments.
About ANTHIM

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

Indications and Usage

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS

Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS

The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.

To see the complete prescribing information for ANTHIM, click here.

On May 15, 2023 NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, reported financial results for the first quarter 2023 (Press release, NexImmune, MAY 15, 2023, View Source [SID1234631733]).

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"This is an exciting time for NexImmune, as we remain focused on progressing the development of novel approaches in the field of immunotherapy," said Kristi Jones, NexImmune’s CEO. "Interest in antigen specific approaches for oncology, autoimmune disorders and infectious diseases has never been higher. We believe our AIM INJ direct injectable nanoparticle platform offers a unique and powerful solution to direct a multi-antigen specific T cell response in a scalable "off the shelf" approach across these disease areas. We continue to move our INJ "off the shelf" lead program forward in oncology and are encouraged by our conversations with the FDA."

"I am also pleased that our NEXI-001 phase 1 clinical data in cell therapy has been accepted for presentation at ASCO (Free ASCO Whitepaper) and I look forward to reviewing this data, as well as the preclinical data across oncology, autoimmune and infectious disease areas for our "off the shelf" injectable this year."
"We remain confident in the potential therapeutic benefit of our AIM platform-based product candidates and their ability to significantly impact the emerging, rapidly moving field of antigen specific immuno-oncology therapies, novel IO/IO combinations, autoimmune disorders and virally-driven diseases."
Select First Quarter 2023 Clinical and Business Highlights
Clinical and Preclinical Updates
AIM INJ, Injectable "Off-the-shelf" Antigen-Specific Immunotherapy, and Other Preclinical Research
•Initiated multiple preclinical studies to evaluate as a monotherapy and in combination with a checkpoint inhibitor to support the Company’s oncology program
•Continue to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Herold in partnership with JDRF
•Poster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma models
•Publication in Frontiers in Medicine highlighted the potential ability of NexImmune’s AIM platform to treat viral diseases
•Announced research collaboration with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, with an initial focus on multiple sclerosis
•Announced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center
•Continued work in other areas of autoimmune diseases; including vitiligo, multiple sclerosis, pemphigus, HTLV-1-associated myelopathy and others.

NEXI-001 Relapsed Refractory AML Post Allo-HSCT
•Full enrollment and dosing of the final safety cohort of NEXI-001 completed
•Plan to announce data at ASCO (Free ASCO Whitepaper) 2023
•Continued to explore opportunities to advance NEXI-001 with potential collaborators and investigators
NEXI-003 HPV-Related Cancers
•Continued to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality.
Select First Quarter 2023 Financial Highlights
Cash and cash equivalents for the Company as of March 31, 2023 were $22.3 million compared to $34.6 million at December 31, 2022. Based upon current operating plans, NexImmune expects that its existing cash and cash equivalents will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.

Research and development expenses were $6.1 million in the first quarter of 2023, compared to $10.4 million for the same period in the prior year. The decrease of $4.3 million was due primarily to the completion of preclinical manufacturing work and the pausing of the clinical trials.

General and administrative expenses were $3.7 million, compared to $4.6 million for the same period in the prior year. The decrease was primarily due to decreases in personnel-related expenses and in legal and other administrative fees expenses.
Net loss, according to generally accepted accounting principles in the U.S. GAAP, was $9.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.37. This compares to a net loss of $15.0 million, or a basic and diluted GAAP net loss per share of $0.66, for the same period in the prior year.

On May 15, 2023 Nerviano Medical Sciences Srl, a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that a poster, describing the currently enrolling phase II part of the trial MPSA-153-001, will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting which will be held June 2-6, 2023 at the McCormick Place, Chicago, IL (Press release, Nerviano Medical Sciences, MAY 15, 2023, View Source [SID1234631732]).

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Title: "Phase II study on safety and efficacy of NMS-01940153E, an MPS1 inhibitor with first-in-class potential, in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy"

Session Category: Trials in Progress (TIP); Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number: TPS4185

Date and Time: Monday, June 5, 2023, 8:00 AM-11:00 AM (CDT)

link: 20230515 MPS1 2023 ASCO (Free ASCO Whitepaper) poster_PressRelease

On May 15, 2023 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies ("ETBs"), to create novel therapies with potent differentiated mechanisms of action for cancer, reported financial results and business updates for the first quarter of 2023 (Press release, Molecular Templates, MAY 15, 2023, View Source [SID1234631731]).

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Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM, stated, "ETBs represent a novel platform with unique biology for the treatment of patients with disease that has progressed on available therapy. We continue to see an acceptable tolerability profile with these molecules and monotherapy activity."

Company Highlights

Clinical data for each program has demonstrated novel mechanisms of action, unique pharmacodynamic ("PD") effects, and single agent activity in heavily relapsed / refractory patients across immuno-oncology, hematologic, and solid tumor indications.
To date, no instances of capillary leak syndrome or other manifestations of innate immunity have been observed with any next-generation ETB.
MT-6402 Phase I dose escalation continues at 100 mcg/kg. As of May 2023, patients with r/r tumors expressing PD-L1 have been treated across six dose escalation cohorts: 16 mcg/kg, 24 mcg/kg, 32 mcg/kg, 42 mcg/kg, 63 mcg/kg and 83 mcg/kg with clearance of immune cells in a PD-L1 targeted fashion and increases in cytokines associated with T-cell activation.
A MT-6402 patient in cohort 5 (63 mcg/kg) with metastatic squamous cell nasopharynx carcinoma with disease progression after radiation therapy, chemotherapy, and pembrolizumab had a Partial Response ("PR") (RECIST) with a 63% reduction in the index lesion after cycle 2. The PR was confirmed after cycle 4 with a 66% reduction, and the patient remains on treatment and in a response in cycle 7. This patient’s tumor had 2% PD-L1 expression and the patient is not HLA-A*02, suggesting the response is due to T-cell activation through the clearance of PD-L1+ immune cells. The patient showed a >250% increase in CD8/CD4 T-cell ratios.
An IND for MT-8421 was accepted on March 8, 2023, with the first-in-human phase I study anticipated to begin by mid-year 2023. MT-8421 targets CTLA-4-expressing Tregs in the TME for elimination without affecting Tregs in the periphery.
In April 2023, the FDA placed the Phase I study for MT-0169 on a partial clinical hold based on previously disclosed cardiac AEs noted in two patients dosed at 50 mcg/kg that prompted the dose reduction to 5 mcg/kg last year. Current study participants may continue treatment. MTEM has submitted its response to the partial hold to the FDA and anticipates feedback from the agency by the end of May. No cardiotoxicity was seen in patients treated at 5 mcg/kg or 10 mcg/kg; one patient treated at 5 mcg/kg remains in a stringent Complete Response at cycle 9.
MTEM retains Stifel, Nicolaus & Company, Incorporated to assist in exploring strategic and financing alternatives.
MT-6402 (PD-L1-targeting ETB with Antigen Seeding Technology)

MT-6402 was designed to activate T-cells through direct cell-kill of immunosuppressive PD-L1+ immune cells.
In addition, MT-6402 can deliver and induce the presentation of an MHC class I CMV antigen on tumor cells (antigen seeding mechanism of action) for pre-existing CD8 T-cell recognition and destruction in HLA-A*02/CMV+ patients with high PD-L1 expression on their tumors.
MT-6402 continues to demonstrate PD effects and monotherapy activity in heavily pre-treated checkpoint therapy experienced patients.
Dose escalation continues in the MT-6402 phase I study in relapsed/refractory solid tumor patients with PD-L1-expressing tumors and/or PD-L1 expressing immune cells in the TME. Highlights from the on-going Phase I study:
As of May 2023, patients have been treated across six dose escalation cohorts of 16 mcg/kg, 24 mcg/kg, 32 mcg/kg, 42 mcg/kg, 63 mcg/kg and 83 mcg/kg in the MT-6402 study of patients with relapsed/refractory tumors that express PD-L1. Dose escalation continues with patients being recruited at 100 mcg/kg.
We continue to observe pharmacodynamic ("PD") effects including the depletion of PD-L1+ monocytes, MDSCs, PD-L1+ dendritic cells, as well as T cell activation.
One patient in cohort 5 (63 mcg/kg) with metastatic squamous cell nasopharynx carcinoma with disease progression after radiation therapy, chemotherapy, and pembrolizumab had a Partial Response ("PR") (RECIST) with a 63% reduction in the index lesion after cycle 2. The patient remains in a confirmed response at cycle 7.
Treatment-related AEs including immune-related AEs have been largely restricted to grade 1-2.
Two Phase I dose expansion cohorts are planned for 2023 including for patients with high PD-L1 tumor expression and for patients with low PD-L1 tumor expression.
MT-8421 (CTLA-4 ETB)

MT-8421 was designed to target CTLA-4 in a wholly distinct manner from the current monoclonal antibody approaches. MT-8421 was designed to preferentially destroy high CTLA-4-expressing Tregs in the TME relative to peripheral Tregs which are lower CTLA-4 expressing, through an enzymatic ribosomal direct cell-kill mechanism independent of the TME.
MT-8421 was also designed to avoid CTLA-4 blockade in the periphery, the major mechanism of antibody-mediated autoimmune toxicity.
The IND for MT-8421 was filed in February 2023 and accepted in March 2023.
The first-in-human Phase 1 study is expected to start by mid-year 2023.
MT-8421 and MT-6402 represent a unique approach to immuno-oncology based on dismantling the TME through direct cell-kill of tumor and immune cells.
MT-0169 (CD38 ETB)

MT-0169 was designed to destroy CD38+ tumor cells through internalization of CD38 and cell destruction via a novel mechanism of action (enzymatic ribosomal destruction and immunogenic cell death).
In April 2023, the FDA placed the Phase I study for MT-0169 on a partial clinical hold based on previously disclosed cardiac AEs noted in two patients dosed at 50 mcg/kg that prompted the dose reduction to 5 mcg/kg last year. MTEM has submitted its response to the partial hold to the FDA and anticipates feedback from the agency by the end of May.
A stringent Complete Response was seen in a patient with extramedullary IgA myeloma treated at 5 mcg/kg. The patient had a marked reduction in IgA serum protein, conversion from immunofixation positive to negative, and resolution of uptake on bone scan of skeletal lesions. The patient’s disease was quad-agent refractory including CD38-targeting, proteosome inhibitor, IMiD, and a BCMA bispecific antibody. The patient continues on study in Cycle 9.
Research and Collaboration

MTEM continues to expand and develop its unique approach to oncology targets in its collaboration with Bristol Myers Squibb.
Key Milestones for 2023

Accelerating enrollment across clinical programs
Initiation of first-in-human Phase I study for MT-8421 mid-year
Advancement of Bristol Myers Squibb research collaboration across multiple targets
MTEM expects to provide periodic updates on MT-6402, MT-8421, and MT-0169 throughout 2023.
Conferences

MTEM presented an abstract, "Engineered Toxin Bodies (ETBs): Clinical stage immunotoxins with a safer and differentiated profile", Monday, April 17, 2023, 1:30pm – 5pm ET (Section 13, Poster Board No 29, No. 2661)), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting which took place at the Orange County Convention Center in Orlando, FL from April 14 – 19, 2023. The abstract is visible in the presentations section of the corporate website.
MTEM will present a poster on updated clinical data on MT-6402 (ETB targeting PD-L1), June 3, 2023, at the 2023 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place at McCormick Place in Chicago, Illinois and virtually from June 2 – 6, 2023. The poster will be visible in the presentations section of the corporate website. One-on-one meetings may be scheduled by directly contacting Molecular Templates.
MTEM will participate at the BIO International conference taking place at the Boston Convention and Exhibition Center in Boston, MA from June 5 – 8, 2023. One-on-one meetings may be scheduled by directly contacting Molecular Templates.
MTEM will present a virtual fireside chat Wednesday, June 7, 2023, at the Jefferies Healthcare Conference taking place at the Marriott Marquis in New York, NY from June 7 – 9, 2023. The presentation will be accessible via the corporate website. One-on-one meetings may be scheduled by directly contacting Molecular Templates.
Financial Results

The net income attributable to common shareholders for the first quarter of 2023 was $10.8 million, or $0.19 per basic and diluted share. This compares with a net loss attributable to common shareholders of ($21.6) million, or ($0.38) per basic and diluted share, for the same period in 2022.

Revenues for the first quarter of 2023 were $36.6 million, compared to $8.5 million for the same period in 2022. Revenues for the first quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb and grant revenue from CPRIT.

Total research and development expenses for the first quarter of 2023 were $19.0 million, compared with $21.5 million for the same period in 2022. Total general and administrative expenses for the first quarter of 2023 were $5.8 million, compared with $7.6 million for the same period in 2022.

On March 29, 2023, we implemented a strategic reprioritization and corresponding reduction in workforce, designed to focus on the clinical development programs for MT-6402, MT-8421 and MT-0169, and preclinical activities related to our collaboration with Bristol Myers Squibb Company ("Bristol Myers Squibb") (the "Restructuring"). The Restructuring reduced our current workforce by approximately 50%, resulted in the cessation of our MT-5111 clinical development program, and focused the majority of our pre-clinical efforts around activities related to the Bristol Myers Squibb collaboration. We incurred approximately $0.3 million in expenses related to the Restructuring in the first quarter of 2023 and estimate that we will incur an aggregate of approximately $0.4 million of costs in connection with the reduction in workforce related to severance pay and other related termination benefits. We expect the remaining costs associated with the Restructuring to be incurred during the second quarter of 2023.

As of March 31, 2023, MTEM’s cash and investments totaled $41.7 million, including borrowings of $35.0 million under its K2 Loan and Security Agreement whose scheduled maturity date for repayment is June 1, 2024, subject to continued compliance with the financial covenant and solvency requirements therein. MTEM is currently in compliance with such covenant and requirements and expects to continue to be in compliance with the financial covenant and the solvency requirements late into the third quarter of 2023. Any default of the financial covenant or solvency requirements would potentially trigger accelerated repayment. Subject to MTEM’s continued compliance with the K2 Loan and Security Agreement, MTEM anticipates a cash runway into the first quarter of 2024.

Process to Explore Strategic Alternatives

MTEM has an ongoing process to explore a range of strategic and financing alternatives to maximize shareholder value. In addition to continuing to explore any available financing alternatives to maintain continued compliance with the covenants and restrictions under the K2 Loan and Security Agreement as described above and to lengthen its cash runway, MTEM’s process will also focus on identifying and evaluating any other strategic alternatives, including potentially the sale of all, or part, of the Company, or a merger. MTEM has retained the investment bank Stifel, Nicolaus & Company, Incorporated to act as a strategic advisor for this process. There can be no assurance that this strategic review process will result in the completion of any transaction. MTEM has not set a timetable for completion of this strategic review process.

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