On September 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sept. 13-17 (Press release, Merck & Co, SEP 4, 2024, View Source [SID1234646343]). Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO (Free ESMO Whitepaper) Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.

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"Over the past decade, data on KEYTRUDA have contributed to paradigm shifts in the treatment of some of the deadliest forms of cancer and the rewriting of medical textbooks. We are very proud that today marks ten years since KEYTRUDA received its first approval in the U.S.," said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "The compelling data for KEYTRUDA at this year’s ESMO (Free ESMO Whitepaper) are demonstrative of KEYTRUDA’s impressive journey, from 10-year survival data in unresectable or metastatic melanoma to new overall survival data in earlier stages of two types of women’s cancers. We’re also excited to show how we’re building on our leadership in oncology with data from our broad and diverse pipeline as we work toward improved outcomes for as many patients as possible."

Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy; WELIREG (belzutifan); LENVIMA (lenvatinib), in collaboration with Eisai; and LYNPARZA (olaparib), in collaboration with AstraZeneca.

Key data from Merck’s portfolio to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:

First-time overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continuing as single agent as adjuvant treatment in patients with high-risk early-stage TNBC (Presentation #LBA4; Presidential Symposium II: Practice-changing trials).
OS data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA in combination with concurrent chemoradiotherapy (CRT) as treatment for patients with high-risk locally advanced cervical cancer (Presentation #709O; Presidential Symposium I: Practice-changing trials).1
First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA plus LENVIMA in combination with transarterial chemoembolization (TACE) in patients with unresectable, non-metastatic hepatocellular carcinoma (Presentation #LBA3; Presidential Symposium I: Practice-changing trials).2
Ten-year OS data from the Phase 3 KEYNOTE-006 trial evaluating KEYTRUDA compared to ipilimumab as first-line treatment for patients with advanced melanoma (Presentation #LBA44; Mini oral session: Melanoma and other skin tumours).
OS data from the per protocol final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (Presentation #1400O; Proffered paper session 2: GI tumours, upper digestive).
Data from the per protocol final analysis of the Phase 3 LITESPARK-005 trial evaluating WELIREG as treatment for adult patients with advanced renal cell carcinoma that progressed following PD-1/L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapies (Presentation #LBA74; Proffered paper session 1: GU tumours, non-prostate).
Additionally, new data on investigational candidates from Merck’s pipeline will be presented at the Congress, including for: patritumab deruxtecan (HER3-DXd), a HER3-directed antibody-drug conjugate (ADC), and ifinatamab deruxtecan (I-DXd; also known as MK-2400) being developed in collaboration with Daiichi Sankyo; sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264), an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech; and opevesostat (also known as MK-5684/ODM-208), an investigational steroid synthesis inhibitor in collaboration with Orion.

Key data on investigational candidates from Merck’s pipeline to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:

Data from the Phase 2 ICARUS-BREAST01 trial evaluating HER3-DXd as treatment for patients with hormone-receptor (HR)-positive/HER2-negative advanced breast cancer (Presentation #340O; Proffered paper session: Breast cancer, metastatic).3
First-time data from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT as treatment for patients with previously treated advanced endometrial carcinoma and ovarian cancer (Presentation #715MO; Mini oral session 2: Gynaecological cancers).4
Findings from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA as treatment for patients with recurrent or metastatic cervical cancer (Presentation #716MO; Mini oral session 2: Gynaecological cancers).4
Details on abstracts listed above and additional key abstracts for Merck

Breast cancer

Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the Phase 3 KEYNOTE-522 study. P. Schmid.

Presentation #LBA4, Presidential Symposium II: Practice-changing trials

Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a Phase 2 Study of Patritumab Deruxtecan (HER3-DXd), in patients (pts) with HR+/HER2- advanced breast cancer (ABC). B. Pistilli.3

Presentation #340O, Proffered paper session: Breast cancer, metastatic

Intensified alkylating chemotherapy with autologous stem cell rescue (IACT) or conventional chemotherapy followed by olaparib (CCT-O) in stage III, HER2-negative, homologous recombination deficient (HRD) breast cancer (BC): Survival results of the randomized-controlled SUBITO trial. S. Linn.5

Presentation #LBA14, Mini oral session: Breast cancer, early stage

Gastrointestinal cancers

Transarterial Chemoembolization (TACE) With or Without Lenvatinib (len) + Pembrolizumab (pembro) for Intermediate-Stage Hepatocellular Carcinoma (HCC): Phase 3 LEAP-012 Study. J. Llovet.2

Presentation #LBA3, Presidential Symposium I: Practice-changing trials

Final overall survival for the Phase 3, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. S. Lonardi.

Presentation #1400O, Proffered paper session 2: GI tumours, upper digestive

Genitourinary cancers

Final analysis of the Phase 3 LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC). B. I. Rini.

Presentation #LBA74, Proffered paper session 1: GU tumours, non-prostate

Opevesostat (MK-5684/ODM-208), an oral CYP11A1 inhibitor, in metastatic castration-resistant prostate cancer (mCRPC): updated CYPIDES Phase 2 results. K. Fizazi.6

Presentation #1605P, Poster

Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab (Pembro) in Muscle-Invasive Urothelial Carcinoma (MIUC) vs Observation (Obs): Extended follow-up disease-free survival (DFS) results and metastatic (met) disease recurrence distribution. A. B. Apolo.7

Presentation #1964MO, Mini oral session: GU tumours, non-prostate

Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L) Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC). J. E. Rosenberg.8

Presentation #1968P, Poster

Preliminary Efficacy And Safety Of Disitamab Vedotin (DV) With Pembrolizumab (P) In Treatment (Tx)-Naive HER2-Expressing, Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC): RC48G001 Cohort C. M. D. Galsky.8

Presentation #1967MO, Mini oral session: GU tumours, non-prostate

Gynecologic cancers

Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: Overall survival results from the randomized, double-blind, Phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. D. Lorusso.1

Presentation #709O, Presidential Symposium I: Practice-changing trials

Safety and Efficacy of Sacituzumab Tirumotecan (sac-TMT) in Patients (pts) with Previously Treated Advanced Endometrial Carcinoma (EC) and Ovarian Cancer (OC) from a Phase 2 Study. D. Wang.4

Presentation #715MO, Mini oral session 2: Gynaecological cancers

Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT) Plus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer. X. Wu.4

Presentation #716MO, Mini oral session 2: Gynaecological cancers

Lung cancer

Neoadjuvant Pembrolizumab (pembro) or Placebo (pbo) Plus Chemotherapy and Adjuvant Pembro or Pbo for Early-Stage NSCLC: Subgroup Analyses of the Phase 3 KEYNOTE-671 Study. M. C. Garassino.

Presentation #1210P, Poster

Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. M. R. Patel. 3

Presentation #690P, Poster

Melanoma and other skin cancers

Pembrolizumab vs Ipilimumab in Advanced Melanoma: 10-Year Follow-Up of the Phase 3 KEYNOTE-006 Study. C. Robert

Presentation #LBA44, Mini oral session: Melanoma and other skin tumours

Pembrolizumab versus placebo after a complete resection of high-risk stage III melanoma: 7-year results of the EORTC 1325-MG/Keynote-054 double-blind Phase 3 trial. A. M. Eggermont.

Presentation #1095P, Poster

KEYMAKER-U02 substudy 02C: neoadjuvant pembrolizumab (pembro) and investigational agents followed by adjuvant pembro for stage IIIB-D melanoma. G. V. Long.

Presentation #1082O, Proffered paper session: Melanoma and other skin tumours

Pembrolizumab (pembro) vs placebo as adjuvant therapy for high-risk stage II melanoma: Long-term follow-up, rechallenge, and crossover in KEYNOTE-716. J. J. Luke.

Presentation #1078MO, Mini oral session: Melanoma and other skin tumours

KEYMAKER 02B: A randomized trial of pembrolizumab (pembro) alone or with investigational agents as first-line treatment for advanced melanoma. R. Dummer.

Presentation #1083P, Poster

Primary Results from TACTI-003: A Randomized Phase IIb Trial Comparing Eftilagimod Alpha (soluble LAG-3) Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with CPS ≥1. C. A. Kristensen.9

Presentation #LBA35, Proffered paper session: Head and neck cancer

1 In collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG)
2 In collaboration with Eisai
3 In collaboration with Daiichi Sankyo
4 Independent study led by Kelun-Biotech
5 In collaboration with AstraZeneca
6 In collaboration with Orion Pharma
7 Sponsored by U.S. National Cancer Institute (NCI)/led by Alliance for Clinical Trials in Oncology
8 In collaboration with Astellas/Pfizer
9 In collaboration with Immutep

On September 4, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that Arvind Sood, EVP, President of US Operations, is to participate in the upcoming investor conference, detailed below (Press release, Innate Pharma, SEP 4, 2024, View Source [SID1234646342]).

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H.C. Wainwright 26th Annual Global Investment Conference
Date: September 10, 2024 | New York, United States

On September 4, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, reported a plan to optimize its resource allocation through a pipeline prioritization and a workforce reduction of approximately 49% (Press release, In8bio, SEP 4, 2024, View Source [SID1234646341]). The Company will focus on generating robust clinical data from INB-100, the ongoing investigator-sponsored Phase 1 clinical trial of acute myeloid leukemia (AML), to further de-risk the registrational pathway and affirm the 100% one-year progression-free survival observed to date in this patient population.

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The Company will suspend its glioblastoma (GBM) development program while continuing to monitor patients in the Phase 1 INB-200 clinical trial and those enrolled in the Phase 2 INB-400 clinical trial. INB-200 has completed patient treatment with up to six repeat doses and further patient enrollment in the INB-400 trial is on hold while the Company explores potential partnership opportunities for the solid tumor program.

"The data across both of our INB-100 and INB-200 clinical programs remain positive and robust. We are committed to building upon the data for INB-100 in AML, and we are making the difficult decision to advance fewer pipeline programs, reduce our spend and focus on key milestones that can help to generate near-term interest and value creation," said William Ho, Chief Executive Officer and co-founder. "These are hard but necessary steps to enable us to continue developing these novel cellular immunotherapies that are demonstrating signs of clinical activity in difficult cancer patients. We are excited to focus on INB-100 as IN8bio and its investigators believe patient outcomes in its trial to date are surpassing that of similar leukemia patients, including those with AML undergoing haploidentical transplantation without receiving INB-100. I want to express my gratitude to all our employees, including those departing IN8bio today, for their contributions towards our mission of Cancer Zero."

Portfolio prioritization

INB-100 for AML

With additional funding, the INB-100 trial will continue to enroll patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026.

IN8bio had a Type B meeting with the FDA earlier this summer where the Company received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation.

As of August 30, 2024, 100% of AML patients remain relapse-free after receiving their dose of INB-100 after a median follow-up of 18.7 months. The previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed have since died of progression. There have been no new relapses reported since the last update.

INB-200 and INB-400

The Company has suspended patient enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it explores partnership opportunities for the program. IN8bio will continue to monitor patients previously treated in the fully enrolled INB-200 clinical trial as well as any patients that have been enrolled and are undergoing treatment in the INB-400 Phase 2 clinical trial.

Workforce Reduction

In conjunction with its pipeline prioritization, IN8bio is implementing a workforce reduction of approximately 49% of its current workforce, across all functional areas and at both its New York City and Birmingham, Alabama sites, along with cash compensation reductions implemented across the executive management team and the Company’s board of directors. IN8bio expects to incur one-time costs of approximately $0.3 million in connection with the workforce reduction, of which nearly all are cash expenditures related to severance. Such costs are expected to be incurred in the third quarter of 2024.

On September 4, 2024 Pharma Two B Ltd. ("Pharma Two B"), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson’s Disease ("PD") and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) ("Hepion"), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported the filing of a registration statement of Pharma Two B on Form F-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Hepion Pharmaceuticals, SEP 4, 2024, View Source [SID1234646340]).

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The Registration Statement contains a proxy statement/prospectus in connection with the proposed merger transaction pursuant to the definitive agreement entered into between Pharma Two B and Hepion (the "Merger Agreement", and the proposed transactions contemplated thereby, the "Proposed Transaction"). While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Pharma Two B and Hepion and the Proposed Transaction.

As announced on July 22, 2024, Pharma Two B intends to become a publicly traded company on Nasdaq through a merger transaction with Hepion.

The Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol "PHTB" and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the "Pharma Two B" name.

A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P.

Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B.

On September 4, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that management will participate in the following investor conferences in September (Press release, CytomX Therapeutics, SEP 4, 2024, View Source [SID1234646339]).

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H.C. Wainwright 26th Annual Global Investment Conference
Date: Wednesday, September 11, 2024
Formal Presentation: 12:30 p.m. ET
Location: New York, NY

2024 Cantor Global Healthcare Conference
Date: Thursday, September 19, 2024
Fireside Chat: 9:45 a.m. ET
Location: New York, NY

Live webcasts of the H.C. Wainwright presentation and Cantor fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.