MM 111 / Merrimack, Concentra Biosciences - LARVOL DELTA

MM111 - Impact of Cochlear Implant Electrode Scala Placement on Post Operative Speech Perception (AAA 2026) - "• Upon completion, participants will be able to interpret emerging longitudinal data from a multi-center cohort. • Upon completion, participants will be able to apply evidence-based insights to guide array selection."

Mood Disorders • Otorhinolaryngology

Cancer Vaccination Induces High-Avidity T Cell Receptors Reactive to Endogenously Presented Target Antigens for Use in Future T Cell Therapies for HLA-A*03:01+ Cancer Patients (SITC 2025) - P1 | "Background FDA-approved therapies afamicel and tebentafusp target peptide antigens from MAGE-A4 and gp100, presented by HLA-A*02:01. Engineered primary CD8+ T cell expression of activation-induced markers (C) and specific lysis at varying E:T ratios (D)Abstract 340 Figure 2Request permissionsReactivity of a TCR targeting MAGE-A196-104 from patient VMM1113. Expression of activation-induced markers (A), secretion of IFNγ (B) and TNFα (C), and specific lysis at varying E:T ratios (D) by engineered primary CD8+ T cells after coculture with human cancer cell lines"

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD69 • CD8 • HLA-A • IFNG • IL2RA • MAGEA4 • TNFA • TNFRSF9

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Oncology

Merrimack: Clinical Trial Update (Merrimack) - “Adverse events reported for MM-111 in combination with anti-cancer therapies were similar to adverse events reported for the standard of care combinations; clinical activity was observed”; “Increased HER2 expression correlated with longer PFS across all patients, supporting the mechanisms of action of both trastuzumab and MM-111”; “The sensitivity and specificity of the assays developed to measure biomarkers in this Phase 1 study supports use of the assays for the analysis of samples from an ongoing randomized Phase 2 study of MM-111 in HER2+ gastro-esophageal cancer”; “Biomarker analyses of archived and newly acquired biopsy samples will be performed in the Phase 2 study to provide further insight for the role of HER2, HER3, and HRG in the response of HER2+ cancer to MM-111-containing therapy”

P1 data • Oncology

Merrimack: Clinical Trial Update (Merrimack) - “Adverse events reported for MM-111 in combination with anti-cancer therapies are similar to adverse events reported for the standard of care combinations”; “No MTD was identified for the combination of MM-111 and standard doses of lapatinib +/- trastuzumab (Arm 2), paclitaxel + trastuzumab (Arm 3), lapatinib + paclitaxel + trastuzumab (Arm 4), or docetaxel + trastuzumab (Arm 5)”; “A MTD of capecitabine (800 mg/m2) was identified in combination with the recommended dose of MM-111 (10 mg/kg) and the standard dose of cisplatin and trastuzumab (Arm 1)”; “Preliminary PK analysis showed that MM-111 PK parameters (half-life, dose-adjusted Cmax, and dose adjusted AUC) were not affected by the SOC therapies used in combination with MM-111”; “The Recommended MM-111 Phase 2 doses are 20mg/kg QW and 40mg/Q3W"

P1 data • Oncology

A study of MM-111 and paclitaxel with trastuzumab in patients HER2 positive carcinomas of the distal esophagus, gastroesophageal (GE) junction and stomach (clinicaltrials.gov) - P2, N=180 -> 120; Sponsor: Merrimack; Recruiting; Primary completion date: Jul 2014 -> Jul 2015.

Enrollment change • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Oncology

Q3 '12 Results (Merrimack) - Anticipated initiation of P2 trial for second line gastric cancer by November 2013

Anticipated new P2 trial • Breast Cancer

A study of MM-111 in patients with advanced Her2 amplified cancers (Monotherapy) (clinicaltrials.gov) - P1/2, N=73; Recruiting

Oncology

A study of MM-111 in combination with multiple treatments in patients with HER2 positive cancer (clinicaltrials.gov) - P1, N=100; Sponsor: Merrimack; Recruiting -> Active, not recruiting; Primary completion date: Jul 2013 -> Apr 2014.

Enrollment closed • Trial primary completion date • Breast Cancer • Oncology

Merrimack Pharma: Annual Report 2014 (Merrimack) - “In February 2015, we stopped enrolling patients in this clinical trial prior to full enrollment based on a recommendation from the DSMB for the clinical trial, which cited shorter PFS on the treatment arm relative to the control arm in the overall patient population. We do not expect to enroll any new patients in this clinical trial. A preliminary analysis shows that a vast majority of the patients in this clinical trial were below the threshold of heregulin levels that we believe are necessary to benefit from MM-111”

Trial termination • Esophageal Cancer • Gastric Cancer • Oncology

Merrimack Pharmaceutical's MM-111 granted Orphan drug status by FDA for treatment of advanced gastric and esophageal cancers (Merrimack Press Release) - "Merrimack Pharmaceuticals…announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted two separate orphan drug designations for its bispecific antibody, MM-111, for the treatment of esophageal cancer and for the treatment of gastric as well as gastroesophageal junction (GEJ) cancers…two orphan drug designations will potentially provide Merrimack Pharmaceuticals with 7-year marketing exclusivity for MM-111 and other benefits if the drug is approved by the FDA.”

Orphan drug • Esophageal Cancer • Gastric Cancer • Oncology

Merrimack Pharma: Bank of America Merrill Lynch Health Care Conference (Merrimack) - Anticipated presentation of P1 data for advanced HER2 positive solid tumors at ASCO (May 30-Jun 03, 2014)

Anticipated P1 data • Breast Cancer • Oncology

A study of MM-111 and paclitaxel with or without trastuzumab in patients HER2 expressing carcinomas of the distal esophagus, gastroesophageal (GE) junction and stomach (clinicaltrials.gov) - P2, N=180; Sponsor: Merrimack Pharmaceuticals; Not yet recruiting; New P2 trial.

New P2 trial • Oncology

Q2 2012 Results (Merrimack) - Anticipated data presentation of P1 combination study for breast cancer by August

Anticipated P1 data • Breast Cancer

Merrimack Pharma: ASCO 2016 (Merrimack) - "The addition of MM-111 to paclitaxel and trastuzumab did not improve PFS or OS in HER2+ GECs"; "Overall survival in the paclitaxel/trastuzumab arm was significantly better than historical controls"; "The addition of MM-111 did not clinically significantly alter the toxicity profile of paclitaxel and trastuzumab"; "Heregulin, a biomarker for MM-111 activity, was lower than anticipated in this patient population"; "Further insight is needed regarding the poor performance of the experimental arm"

P2 data • Gastric Cancer • Oncology

Merrimack Pharma: J.P. Morgan Healthcare Conference (Merrimack) - "MM-111 + Multiple Combination Regimens Phase 1 HER2+ Patients in Multiple Solid Tumors"

P1 data • Oncology

Merrimack Pharma: Annual Report 2014 (Merrimack) - Anticipated patent expiry for composition in US between 2029-2035; Anticipated patent expiry for method of use in US between 2029-2035; Anticipated patent expiry for diagnostics in US between 2029-2035; Anticipated patent expiry for a PCT application in 2033 and 2035; Anticipated patent expiry in EU and related jurisdictions between 2028-2033; Anticipated expiry of exclusively licensed patents for composition of matter in US, EU and ROW in 2023; Anticipated expiry of non-exclusively licensed patents in US, EU and Canada for composition of matter in 2016

Anticipated patent expiry • Oncology

Merrimack Pharma: Annual Report 2013 (Merrimack) - Anticipated patent expiry for composition in US between 2029-2032; Anticipated patent expiry for method of use in US between 2029-2032; Anticipated patent expiry for diagnostics in US between 2029-2032; Anticipated patent expiry for a PCT application in 2033; Anticipated patent expiry in EU and related jurisdictions between 2028-2032; Anticipated expiry of exclusively licensed patents in US, EU and other countries for composition in 2023; Anticipated expiry of non-exclusively licensed patents in US, EU and Canada for composition in 2016

Anticipated patent expiry • Oncology

Merrimack: Q2 2014 Results (Merrimack) - Anticipated presentation of P1 biomarker data for advanced HER2 positive solid tumors at ESMO (Sep 26-30, 2014)

Anticipated P1 data • Oncology

[VIRTUAL] BUDGET IMPACT ANALYSIS OF A SINGLE-INHALER TRIPLE THERAPY (TRELEGYÂ) VERSUS DUAL COMBINATION AND MULTIPLE-INHALER TRIPLE THERAPY FOR THE TREATMENT OF PATIENTS WITH COPD MODERATE TO VERY-SEVERE FROM PUBLIC HEALTH SYSTEM PERSPECTIVE IN CHILE ... (ISPOR 2020) - "OBJECTIVES : Determine the budget impact of give financial coverage to Trelegy (Fluticasone Furoate/Umeclidinium/Vilanterol in a single-inhaler triple therapy) versus Fluticasone Furoate/Vilanterol (FF/VIL), Umeclidinium/Vilanterol (UMEC/VI) and a multiple inhaler triple therapy which is Fluticasone Propionate 250mg/Salmeterol 25mg and tiotropium 18mcg (FP/SAL + TIO) in patients with COPD moderate to very-severe...The budget impact estimated for Trelegy over the five year versus FF/VIL was -MM$592.7, whilst Trelegy versus UMEC/VI and versus FP/SAL+TIO were estimated in -MM$50.7 and .MM$111.4, respectively...CONCLUSIONS : Trelegy shows a financial savings in comparison with all the interventions evaluated. Nonetheless, the financial saving is explained by the exacerbations costs and not by the drug cost."

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach (clinicaltrials.gov) - P2; N=84; Terminated; Sponsor: Merrimack Pharmaceuticals; N=120 ➔ 84; Completed ➔ Terminated; DSMB recommendation due to lack of efficacy. There were no safety signals.

Clinical • Enrollment change • Trial termination