On August 3, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported that Ipsen, SA ("Ipsen") has issued its primary analysis of the results of its Phase 3 trial of Onivyde (irinotecan liposomal injection) as a treatment of second line small cell lung cancer (SCLC) (Press release, Merrimack, AUG 3, 2022, View Source [SID1234617382]). The press release indicates that the "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

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"We will continue to monitor updates from Ipsen regarding the SCLC program," said Gary Crocker, Chairman and CEO of Merrimack Pharmaceuticals. "Ipsen also reported in its recent H1 2022 financial results update provided on July 29, 2022, that it expects to publicly report its top line data from its continuing Phase 3 study of Onivyde in first line pancreatic ductal adenocarcinoma before the end of 2022.

On August 3, 2022 College of American Pathologists reported A new College of American Pathologists (CAP) evidence-based guideline is among the first to address testing based less on the cancer type or tumor origin and more on the methodology and status of a biomarker—in this case, microsatellite testing and deficient mismatch repair process assessment (Press release, College of American Pathologists, AUG 3, 2022, View Source [SID1234617419]).

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The "Mismatch Repair (MMR) and Microsatellite Instability (MSI) Testing for Immune Checkpoint Inhibitor Therapy" guideline provides clarity for pathologists and oncologists to improve the evaluation of patients with colorectal, endometrial, gastroesophageal, small bowel, and certain other cancers who may be eligible for immunotherapies known as immune checkpoint inhibitors.

Published today in an early online release in Archives of Pathology & Laboratory Medicine, the guideline also breaks new ground with recommendations on the role of tumor mutational burden in MMR testing and the evaluation for Lynch Syndrome, a hereditary cancer syndrome that may be unexpectedly detected in the work-up of these patients with advanced cancers. The CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and the patient advocacy group Fight Colorectal Cancer (Fight CRC).

"We’ve seen that patients whose cancers had high levels of MSI or defective MMR can respond well to immune checkpoint inhibitor therapy, and now we have objective guidance to assess that status across a range of cancer types," explains pathologist Russell Broaddus, MD, PhD, FCAP, who led the expert panel to develop the guideline.

Dr. Broaddus noted that when the FDA approved immunotherapy treatment for patients with MSI-high or MMR-deficient tumor status, regardless of cancer type, it did not detail how to test for that status. The new CAP guideline helps to fill that gap, providing oncologists, pathologists, and laboratories of all sizes with objective, evidence-based recommendations to efficiently deploy specific assays and accurately identify patients eligible for treatment.

With six recommendations and three good practice statements, the guideline provides data and details regarding the efficacy and utility of specific testing modalities across applicable cancer types, including MMR by immunohistochemistry, MSI by polymerase chain reaction, and MSI by next generation sequencing, for patients being treated with immune checkpoint inhibitors. In addition, the guideline identifies gaps in our current knowledge base, which, when addressed, may represent opportunities to help improve the methodological approach for identifying the patients with advanced cancers who are most likely to respond to this therapeutic approach.

To ensure patients receive more effective testing with consistent, high-quality results, and expert interpretations, the CAP provides free, open access tools and resources with each evidence-based guideline to help clinical and laboratory teams adopt the recommendations. MMR-MSI guideline resources are downloadable on cap.org.

On August 3, 2022 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 that it will provide business updates and report financial results for the second quarter ended June 30, 2022 on Monday, August 8, 2022 and will host a conference call and webcast at 4:30 p.m. Eastern Time that afternoon (Press release, Mersana Therapeutics, AUG 3, 2022, View Source [SID1234617337]). Members of management will also be presenting at two upcoming conferences. Details are as follows:

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Mersana Second Quarter 2022 Conference Call
Format: Webcast and Call
Date/Time: Monday, August 8, 2022, at 4:30 p.m. Eastern Time

2022 Wedbush PacGrow Healthcare Virtual Conference
Format: Panel
Panel Name: ADCs – Take Me to Your Tumor
Date/Time: Wednesday, August 10, 2022, at 2:20 p.m. Eastern Time

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Webinar
Format: Panel
Panel Name: Targeted Systemic Delivery of Innate Immune Activators: A Deep Dive in Targets for Cancer IO
Date/Time: Friday, August 26, 2022, at 11:00 a.m. Eastern Time

To access Mersana’s second quarter conference call live, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 4656534. Live webcasts of all the presentations above will be accessible via the Investors & Media section of the Mersana website at www.mersana.com, and webcast replays of the second quarter conference call and Wedbush panel will be available in the same location for approximately 90 days following the live events.

On August 3, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter of 2022 and recent corporate updates (Press release, Mirati, AUG 3, 2022, View Source [SID1234617383]).

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"Mirati continues to advance the development of a broad portfolio of targeted oncology medicines," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "We are progressing toward the potential launch of adagrasib for patients with previously treated non-small cell lung cancer harboring a KRASG12C mutation in the U.S. this year. In addition, we have submitted a Marketing Authorization Application to the European Medicines Agency, bringing us one step closer to expanding the potential availability of adagrasib in the European Union. We continue to progress our sitravatinib and MRTX0902 clinical programs, which strengthen our targeted oncology portfolio. Our financial position remains strong, enabling continued investment and advancement of our extensive oncology pipeline."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

Presented full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with previously treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These results were published concurrently in the New England Journal of Medicine. (View Release)
Presented late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. (View Release)
Submitted a Marketing Authorization Application to the European Medicines Agency for adagrasib for the treatment of patients with previously treated NSCLC harboring a KRASG12C mutation. (View Release)
Sitravatinib (Potent TAM receptor inhibitor)

Anticipated to achieve the number of events needed to trigger an interim analysis of overall survival in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the fourth quarter of 2022.
MRTX0902 (Potent SOS1 inhibitor)

Submitted an Investigational New Drug (IND) application to the U.S. FDA to evaluate MRTX0902, a selective SOS1 inhibitor, which shifts KRAS into its inactivated state resulting in significantly increased activity of adagrasib and other KRAS inhibitors in preclinical models and may improve clinical efficacy of adagrasib in patients with KRAS G12C mutations. The Company expects to initiate a Phase 1/2 clinical study by year-end 2022.
Recent Corporate Updates

Announced the appointment of Laurie Stelzer as Chief Financial Officer. (View Release)
Second Quarter 2022 Financial Results

Cash, cash equivalents, and short-term investments of approximately $1.2 billion as of June 30, 2022
Research and development expenses for the second quarter 2022 were $128.3 million, compared to $134.6 million for the same period in 2021. The decrease was primarily related to a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program, offset by increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio. Research and development expenses for the six months ended June 30, 2022 were $259.3 million, compared to $238.6 million for the same period in 2021. The increase was primarily related to increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio, offset by a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program. The Company recognized research and development-related share-based compensation expenses of $22.8 million during the second quarter of 2022, compared to $16.5 million for the same period in 2021, and $49.1 million during the six months ended June 30, 2022, compared to $31.0 million for the same period in 2021.
General and administrative expenses for the second quarter of 2022 were $54.2 million, compared to $29.6 million for the same period in 2021. General and administrative expenses for the six months ended June 30, 2022 were $108.2 million, compared to $58.0 million for the same period in 2021. The increases were primarily due to an increase in commercial readiness costs, including increases in headcount-related costs, as we prepare for a potential product launch. The Company recognized general and administrative-related share-based compensation expenses of $15.9 million in the second quarter of 2022, compared to $11.5 million for the same period in 2021, and $32.5 million during the six months ended June 30, 2022, compared to $21.7 million for the same period in 2021.
Net loss for the second quarter of 2022 was $176.4 million, or $3.18 per share basic and diluted, compared to a net loss of $166.4 million, or $3.23 per share basic and diluted for the same period in 2021. Net loss for the six months ended June 30, 2022 was $364.8 million, or $6.57 per share basic and diluted, compared to a net loss of $302.1 million, or $5.91 per share basic and diluted for the same period in 2021.
Conference Call Information

There will be a conference call on August 3, 2022 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the second quarter of 2022 and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 877-502-9276, confirmation code: 1791105.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

On August 3, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that the Company’s second quarter 2022 financial results will be released after market close on Tuesday, August 9, 2022 (Press release, ChemoCentryx, AUG 3, 2022, View Source [SID1234617400]). ChemoCentryx executive management will host a conference call and webcast beginning at 5:00 p.m. Eastern Time on August 9, 2022 to discuss these results and to answer questions.

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To participate by telephone, please dial (800) 715-9871 (Domestic) or (646) 307-1963 (International). The conference ID number is 9726781. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.