On May 20, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it closed its previously announced financing for gross proceeds of $10 million (Press release, Cellectar Biosciences, MAY 20, 2019, View Source [SID1234536494]). In a registered direct offering, Cellectar issued 1,982,000 shares of common stock at an offering price of $2.50 per share.

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In a concurrent private placement, Cellectar issued to the purchasers of our common stock in the registered direct offering, Series F warrants to purchase an aggregate of 1,982,000 shares of common stock. The Series F warrants will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

In a separate concurrent private placement transaction, Cellectar sold 2,018,000 shares of common stock together with Series G warrants to purchase an aggregate of up to 2,018,000 shares of common stock. The shares of common stock and Series G warrants were priced at $2.50 per fixed combination. The warrants sold in the private placement will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

Roth Capital Partners served as sole placement agent for the transaction. After placement agent fees and estimated offering expenses payable by the company, the company expects to receive net proceeds of approximately $9.0 million.

The company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes.

The registered offering described above is being made pursuant to a Registration Statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). Copies of the prospectus supplement and accompanying base prospectus relating to the registered offering may be obtained from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder. Such common shares, warrants and common shares issuable upon exercise of such warrants have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

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

On May 20, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that it has dosed the first patient in the combination arm of its Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors (Press release, Compugen, MAY 20, 2019, View Source [SID1234536492]). The combination dose escalation arm was initiated following the determination of well-tolerated doses with no dose-limiting toxicities reported of COM701 from the monotherapy dose escalation arm of the trial. Bristol-Myers Squibb will supply Opdivo, a PD-1 inhibitor, for the combination arms of the Phase 1 study under the clinical trial collaboration announced in October 2018.

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"Our successful progression through the COM701 monotherapy dose escalation arm, enabled us to initiate the combination study with COM701 and Opdivo," stated Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, while the combination dose escalation arm is expected to finish enrolling patients later this year. As a first-in-class drug candidate against a novel drug target backed by a solid biological rationale and biomarker strategy, COM701 has generated interest in our Phase 1 study. We look forward to exploring the clinical potential of the therapy to improve response rates in patients with refractory or relapsed disease across multiple indications with the study’s investigators and our strategic partner, Bristol-Myers Squibb."

The Phase 1 study now has ten participating sites, having recently added Columbia University, MD Anderson Cancer Center, UCLA, the Cleveland Clinic and START Midwest. The primary endpoints for the study are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as monotherapy as well as in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

About the Compugen-Bristol-Myers Squibb Clinical Collaboration

In October 2018, Compugen entered into a clinical trial collaboration with Bristol-Myers Squibb to evaluate the safety and tolerability of Compugen’s COM701 in combination with Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab), in patients with advanced solid tumors. Under the terms of the collaboration agreement, Compugen will sponsor the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo in four tumor types, including non-small cell lung, ovarian, breast and endometrial cancer. The collaboration is also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and its synergistic activity with other checkpoint inhibitors demonstrated in preclinical models. In conjunction with this collaboration, Bristol-Myers Squibb made a strategic $12 million investment in Compugen.

On May 20, 2019 Strata Oncology, Inc., a precision oncology company, reported that data from its Strata Trial, a nationwide observational NGS screening protocol providing no-cost tumor sequencing and clinical trial matching for 100,000 advanced cancer patients, will be presented in a poster at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, from May 31-June 4, 2019 (Press release, Strata Oncology, MAY 20, 2019, View Source [SID1234536491]).

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"The Strata Trial enables routine genomic testing for advanced cancer patients at the Ochsner Health System, which has opened an array of options for targeted treatment, as well as enrollment in precision medicine clinical trials available at our cancer center," said Marc Matrana, MD, MSc, FACP, Director of the Ochsner Precision Cancer Therapeutics Program.

"Data from the Strata Trial support the feasibility of using a system-wide genomic testing protocol to identify patients who may be eligible for biomarker-driven trials," said Dan Rhodes, co-founder, chief executive officer, Strata Oncology. "Strata is committed to improving outcomes for patients and accelerating drug approvals through a model that integrates universal genomic sequencing for advanced cancer patients and cutting-edge clinical research."

Strata recently announced a clinical development collaboration with Arcus Biosciences, Inc. utilizing Strata’s precision drug development platform and proprietary biomarkers for the evaluation of Arcus’ clinical-stage anti-PD-1 antibody AB122.

Abstract Title: No-Cost Next Generation Sequencing of Advanced Cancer Patients within the Strata Precision Oncology Network Supports Clinical Trial Enrollment
Abstract Number: 3073
Board Number: 65
Session Information: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date/Time: Saturday June 1, 8:00 AM to 11:00 AM

On May 20, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that an abstract describing clinical data regarding their lysine-specific demethylase (LSD1) inhibitor has been selected for an oral presentation at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Amsterdam, The Netherlands from June 13-16, 2019 (Press release, Imago BioSciences, MAY 20, 2019, View Source [SID1234536489]). The abstract was published on the EHA (Free EHA Whitepaper) website.

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Title: A Phase 2A Study of the LSD1 Inhibitor IMG-7289 For the Treatment of Myelofibrosis
Abstract Number: S832
Date: Saturday, June 15
Time: 12:30-12:45 CEST
Location: Elicium 2

The abstract represents the first report of clinical data on IMG-7289. The protocol of IMG-7289-CTP-102 is an ongoing Phase 1/2a clinical trial of LSD1 inhibitor IMG-7289 in patients with high or intermediate-2 risk myelofibrosis resistant to or intolerant of approved therapy (see clinicaltrials.gov NCT03136185).

In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the Annual Congress of EHA (Free EHA Whitepaper) are embargoed from the time of submission. The terms and conditions for presentation at the Annual Congress of EHA (Free EHA Whitepaper) prohibit any additional disclosure of data or information to be presented at the Annual Congress to be made public before the presentation.

Following the Annual Congress of EHA (Free EHA Whitepaper), a summary of the presentation will be available in the "News" section of Imago’s website.

About IMG-7289

IMG-7289 is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancies models including the myeloproliferative neoplasms which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with other checkpoint agents in non-clinical models. IMG-7289 is under evaluation for the treatment of acute myeloid leukemia (see clinicaltrials.gov NCT02842827).

On May 20, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported the presentation of data from its FIERCE-22 trial where vofatamab, the company’s lead therapeutic stimulates an increase in immune cell activation in patients with metastatic bladder cancer (Press release, Rainier Therapeutics, MAY 20, 2019, View Source [SID1234536488]). The data is being presented in an oral and poster presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Bladder Cancer: Transforming the Field Special Conference.

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Researchers at John Hopkins School of Medicine and MD Anderson analyzed RNA from 22 paired biopsy samples from metastatic bladder cancer patients enrolled in Rainier’s Phase 1b / 2 FIERCE-22 trial. Patients who had progressed following platinum-based chemotherapy but had not received prior immune checkpoint inhibitor therapy were eligible to enroll. Tumor biopsies were taken pre- and post-treatment with vofatamab, and prior to the start of combination treatment with pembrolizumab. Patient biopsies were taken to understand changes to gene signatures induced with vofatamab and to correlate this with clinical outcomes.

"The unique design of the trial allowed us to evaluate the effect of FGFR3 inhibition on gene signatures," said David McConkey, Ph.D., John Hopkins School of Medicine. "Vofatamab, an FGFR3 specific antibody, significantly upregulated genes associated with inflammation in both wild-type and FGFR3 mutant tumors. This was associated with an increased response rate to the combination with pembrolizumab in these patients and was particularly marked in patients with luminal biology."

"Tumors that are immunologically ‘cold’ tend to exist in luminal bladder cancer and these patients have historically responded poorly to checkpoint inhibitors. The enhanced response rate seen suggests this combination may provide a valuable new treatment option," said Graeme Currie, Ph.D., Chief Operating Officer, Rainier Therapeutics. "We look forward to presenting interim clinical data from FIERCE-22 at the upcoming 2019 ASCO (Free ASCO Whitepaper) annual meeting."

Key Findings:

Compared to historical data with pembrolizumab, response rates with vofatamab treatment appear higher.
Vofatamab responders had upregulation of genes associated with an inflammatory response in the tumor.
Responses were enriched in the cohort with a luminal gene expression profile (also referred to as "immunologically cold").
About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy. For additional information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).