On January 26, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that David E. Anderson, Ph.D, VBI’s Chief Scientific Officer, will present an overview of VBI-1901, the Company’s cancer immunotherapeutic for the treatment of glioblastoma (GBM), at B. Riley’s Oncology Investor Conference (Press release, VBI Vaccines, JAN 26, 2022, View Source [SID1234607395]). During his presentation, Dr. Anderson will highlight data from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients.

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Presentation Details

Event: B. Riley Securities 2022 Oncology Investor Conference
Date: Friday, January 28, 2022
Time: 1:30-2:00 PM ET
Webcast: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

On January 26, 2022 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) upon learning from the trial sponsor, Pancreatic Cancer Action Network (PanCAN), that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC (Press release, TYME, JAN 26, 2022, View Source [SID1234607413]). Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.

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The Precision Promise trial is an adaptive randomized Phase 2/3 trial in mPDAC for patients treated in both first-line and second-line therapies. SM-88 (racemetyrosine) with MPS (10 mg methoxsalen, 50 mg phenytoin, and 0.5 mg sirolimus) was the first therapy to join this trial and was being studied as a standalone monotherapy in second-line patients versus control arms of standard of care regimens of either Gemcitabine and Abraxane or modified FOLFIRINOX.

"Given pancreatic cancer’s high mortality rate, we wanted to make a difference in the lives of these patients. Our team understood that many efforts before us have failed, but based on SM-88’s prior activity and safety profile, we were hopeful we could provide an effective new option for those fighting against this devastating disease," said Richie Cunningham, Chief Executive Officer of TYME. "I want to express my sincerest appreciation to the patients, their loved ones, the researchers, and the principal investigators involved in this trial, as well as thank PanCAN and Precision Promise for their passionate dedication to exploring new treatment options for pancreatic cancer patients."

"Given our prior promising results with SM-88 plus MPS in a subset of patients in second-line pancreatic cancer1, we are disappointed that we couldn’t make an impact in this very difficult to treat population. We will work with PanCAN and Precision Promise leadership to further analyze the data with the SM-88 arm, as it becomes available," said Dr. Jan M. Van Tornout, MD, MSC, Acting Chief Medical Officer of TYME.

TYME remains committed to advancing its current pipeline and the continued research and development of SM-88.

On January 26, 2022 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), a clinical-stage oncology-focused cell therapy company, reported that highlighted recent operational and corporate updates (Press release, Ziopharm, JAN 26, 2022, View Source [SID1234607432]). The Company also announced that it has changed its name to Alaunos Therapeutics, Inc. ("Alaunos" or the "Company").

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"We are very pleased to announce that our Phase 1/2 TCR-T library trial is now open for enrollment at MD Anderson Cancer Center. This first of its kind study, enabled by our versatile non-viral Sleeping Beauty technology, will allow us to efficiently target six solid tumor indications within this single clinical trial. In addition, our R&D efforts continue to bear fruit and we amended our IND to include four additional TCRs to the study. This further increases the number of eligible patients who could benefit from our therapies, and we look forward to dosing the first patient in this study within the first half of this year. Lastly, to support our clinical development, we have successfully opened our cGMP manufacturing facility and we are now able to manufacture our autologous cell therapy products in-house," commented Kevin S. Boyle, Sr., Chief Executive Officer.

"Over the course of 2022, the team will continue to work diligently with an execution mindset to deliver results. In addition to translating groundbreaking science into meaningful clinical progress we will work to advance our membrane bound IL-15 program with IND enabling studies. Our name change to Alaunos Therapeutics reflects the completion of our transition to a TCR-T focused company and embodies our mission of developing novel therapies for cancer patients," concluded Mr. Boyle.

Operational Updates

Phase 1/2 TCR-T Library Program Open for Enrollment: Alaunos’ phase 1/2 clinical trial is evaluating library TCR-T shared hotspot neoantigens using the Company’s Sleeping Beauty transposon/transposase technology. The Company added four additional T-cell receptors (TCRs) to its library, further increasing the number of eligible patients for the clinical trial. The study being conducted at MD Anderson Cancer Center is an open label, dose escalation study that will enroll patients who have a matched HLA and hotspot mutation that is a targeted by one of the 10 TCRs from the Alaunos library. The trial will evaluate 10 unique TCRs targeting KRAS, TP53 and EGFR mutations in patients across a broad range of solid tumors that include non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers, all in a single trial. The Phase 1 primary endpoint is maximum tolerated dose or recommended phase 2 dose. The Company expects to dose the first patient in the first half of 2022 and to provide an interim data update later this year. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735.

In-House cGMP Manufacturing Facility Operational: Alaunos completed the qualification of its state-of-the-art good manufacturing practice (cGMP) TCR manufacturing facility near the Texas Medical Center in Houston. The facility is staffed by Alaunos personnel and is fully operational for the manufacture and release of clinical product.

hunTR (human neoantigen T-cell Receptor) Platform for TCR Discovery: Alaunos’ TCR hunting process, hunTR, enables the rapid identification of new and proprietary TCRs from CD4+ and CD8+ T cells to further expand the Company’s growing TCR-T library. The platform can evaluate thousands of single T cells simultaneously using state-of-the-art bioinformatics and next generation sequencing to identify TCRs specific for neoantigens that arise from hotspot mutations. The proprietary high-throughput TCR screening process permits rapid functional validation of TCRs. Newly discovered neoantigen-specific TCRs will then undergo further development required to potentially qualify the TCR for inclusion in the Company’s TCR library and clinical evaluation.
Corporate Updates

Name Change to Alaunos Therapeutics, Inc.: The name Alaunos originates from the Celtic mythological god of healing, reflecting the Company’s commitment to developing therapies for cancer patients. The Company will trade on The Nasdaq Stock Market under the new ticker symbol "TCRT", to be effective at market open on January 27, 2022. In conjunction with the corporate name change, the Company has launched a new website, www.alaunos.com, which contains information about the Company and its innovative TCR-T platform.

Closure of Boston, MA Location: To streamline operations, the Company has closed its Boston office. Alaunos will be headquartered in Houston.

On January 26, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the initiation of the company’s global Phase 2 clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, which is referred to as the ASPIRE trial (Press release, Panbela Therapeutics, JAN 26, 2022, View Source [SID1234607396]).

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Arvind Chaudhry MD, PhD, Principal Investigator at Summit Cancer Centers in Spokane, Washington was the first clinical site activated, with approximately 60 additional sites expected to be activated in 2022. Panbela has commenced screening for eligible patients, with enrollment expected to complete in approximately 12 months.

The ASPIRE trial is designed as a randomized double-blind placebo-controlled trial, with a primary endpoint of overall survival. The design includes a futility analysis after 104 progression-free survival events. Panbela is seeking to conduct the trial at leading cancer centers in the United States, Europe, and the Asia-Pacific region.

"Pancreatic cancer is one of the most common causes of cancer deaths in the United States and represents a significant unmet medical need, as is underscored by SBP-101’s Fast Track and Orphan Drug designations," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "We are enthusiastic about having initiated the ASPIRE global randomized Phase 2 trial. Given the rigor of the trial design, we expect the resulting data to support our registration effort."

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On January 26, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the pricing of an upsized underwritten public offering of 4,074,075 shares of its common stock and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock pursuant to its existing shelf registration statement (Press release, Sierra Oncology, JAN 26, 2022, View Source [SID1234607414]). The shares of common stock are being offered at a public offering price of $27.00 per share and the pre-funded warrants are being offered at a public offering price of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The expected gross proceeds to Sierra Oncology from the offering is approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Sierra Oncology has granted to the underwriters a 30-day option to purchase up to 750,000 of additional shares of its common stock at the public offering price less underwriting discounts and commissions. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. All of the securities are being offered by Sierra Oncology. The offering is expected to close on or about January 31, 2022, subject to customary closing conditions.

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Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the SEC on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.