On May 25, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported a $50 million private investment in public equity (PIPE) financing from the sale of pre-funded warrants to purchase up to 4 million shares of its common stock at a price per pre-funded warrant of $12.4999 to Redmile Group, based on the closing price per share of RAPT on May 24, 2022 (Press release, RAPT Therapeutics, MAY 25, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-private-placement-financing-50 [SID1234615023]). Gross proceeds from the PIPE financing total approximately $50 million, before deducting offering expenses. The closing of the PIPE financing is subject to customary closing conditions and is expected to close on May 27, 2022.

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The shares of common stock underlying the pre-funded warrants have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. RAPT has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 25, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a developer of treatments for rare and orphan indications, including Parkinson Disease and various cancers, reported the clearance of the Phase 2 clinical trial protocol for mesothelioma after filing the protocol to the Food and Drug Administration (Press release, Oncotelic, MAY 25, 2022, View Source [SID1234615039]). Oncotelic is initiating a Phase 2 Investigator Initiated Study (IIS) clinical trial in patients with metastatic plural mesothelioma (MPM) in collaboration with Merck who is supplying pembrolizumab for the study.

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The trial is titled M201: Phase 2 Trial of TGF-β Inhibition (OT-101) with Anti-PD-1 (pembrolizumab) in Patients with Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition. The trial is expected to enroll up to 63 patients across multiple centers in the U.S., including the center with the Principal Investigator – Melina Marmarelis, MD MSCE, Assistant Professor, Perelman School of Medicine, University of Pennsylvania, Medical Director of the University of Pennsylvania Pleural and Mesothelioma Center.

"This study encompasses a broad clinical strategy, which includes a robust and rigorous assessment of changes within the tumor microenvironment of various indications relative to pre and post therapy including the measurement of nearly 800 genes, spatial distribution of immune effector cells, expression of cytokines, phenotypic and functional changes, immunohistochemistry and deep sequencing in the hopes of better understanding the etiology and progression of malignancies and ultimately clinical benefit." noted Dr. Anthony E. Maida, Chief Clinical Officer – Translational Medicine, Oncotelic Therapeutics, Inc.

About M201

This is a phase 2, open label, non-randomized, single arm Simon’s two stage study in subjects with malignant pleural mesothelioma failing to achieve or maintain response to checkpoint inhibition. Before the efficacy assessment portion, the study will first embark a run-in dose-escalation phase to evaluate safety and tolerability of various dose of OT-101 in combination of pembrolizumab, and to determine a recommended Phase 2 dose (RP2D) of 4 days continuous i.v. infusion for every two weeks regimen. Subjects received the RP2D in the run-in dose-escalation phase will be part of the first stage of the Simon’s two-stage design for effectiveness evaluation.

A maximum of 63 subjects will be treated. Among them, a maximum of 30 subjects will be treated in the run-in dose-escalation phase to determine the MTD and RP2D. Thirty-nine subjects are required for the Simon’s two-stage assessment of efficacy: 19 subjects in the first stage, and 20 in the second stage. Subjects of the RP2D cohort in the run-in dose-escalation phase will be included in the first stage of the Simon’s two-stage assessment.

Primary Objective:

To determine whether the administration of TGF-β inhibitor (OT-101) in combination with pembrolizumab can provide improved tumor response (ORR) in MPM subjects that fail to achieve or maintain a response with anti-PD-1/PD-L1-based regimens.

Secondary Objectives:

1) To determine whether ORR induced by TGF-β inhibition combined with PD-1 blockade will result in an improved duration of response (DOR) and 6-month and 12-month Overall Survival (OS) and progression-free survival (PFS) as compared to current data with single agent pembrolizumab.

2) To evaluate the safety and tolerability of the administration of OT-101, in combination with pembrolizumab in patients with mesothelioma.

Exploratory Objective:

1) To determine whether TGF-β inhibition combined with PD-1 blockade will increase T cell infiltration, clonality in some tumors; and, the increased T cell infiltration, clonality (CD4, CD8 and Tregs) and IFN- λ signatures correlate with the reduced TBRS.

2) To determine if pretreatment TBRS signature is predictive of improved efficacy per ORR, DOR, and 6-month and 12-month overall survival OS, and progression free survival PFS.

On May 25, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that it has successfully completed the dosing of first patient in phase I trial of B7H4x4-1BB bispecific antibody HBM7008 in Australia (Press release, Harbour BioMed, MAY 25, 2022, View Source [SID1234615055]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.

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HBM7008 is generated from our unique and innovative HBICE platform, leveraging the advantages of HBM HCAb and H2L2 platforms. It targets Tumor-Associated Antigen (B7H4), mediated crosslinking T cell activation through 4-1BB. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutic. Following its global innovation and development strategy, Harbour BioMed will advance the global clinical development project of HBM7008 at full speed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency on TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On May 25, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that Lisa Anson, Chief Executive Officer, and Peter Collum, Chief Financial Officer, will be presenting in-person at the Jefferies Global Healthcare Conference in New York on Wednesday 8 June 2022 at 9:30am ET / 14:30 GMT (Press release, Redx Pharma, MAY 25, 2022, View Source [SID1234615024]). Alongside the presentation, the Company will also be available for one-to-one meetings.

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The presentation will be webcast live and can be accessed via the following link: View Source Following the event, a recording will be made available on the investor section of the Company’s website at: View Source

On May 25, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported that John Celebi, president and chief executive officer, will present at the Jefferies Healthcare Conference, being held in New York, NY and virtually, on Wednesday, June 8, 2022 at 3:00 p.m. ET (Press release, Sensei Biotherapeutics, MAY 25, 2022, View Source [SID1234615040]).

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A webcast of Sensei’s presentation will be available in the Investors section of the Sensei website. A replay of the webcast will be on the website for approximately 90 days following the event. Registration for the live webcast is available here.