On January 16, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL siRNA gene silencing technology to make the body’s immune cells more effective in killing cancer cells, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 610,000 shares of its common stock at a purchase price of $3.00 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, JAN 16, 2025, View Source [SID1234649758]). In addition, in a concurrent private placement, the Company will issue short-term unregistered warrants to purchase up to an aggregate of 1,220,000 shares of common stock. The short-term warrants will have an exercise price of $3.00 per share, will be exercisable upon issuance and expire twenty-four months following the date of issuance. The closing of the offering is expected to occur on or about January 17, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be $1.83 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the short-term warrants issued in the private placement or the shares of common stock underlying such short-term warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279557) filed with the Securities and Exchange Commission ("SEC") on May 20, 2024 and became effective on July 1, 2024. The registered direct offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

The short-term warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the short-term warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the short-term warrants and underlying shares of common stock 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 of the Securities Act and such applicable state securities laws.

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 the registration or qualification under the securities laws of any such state or jurisdiction.

On January 16, 2025 Peptomyc SL, a clinical-stage biotech company focused on developing new mini-protein therapeutics targeting MYC, the most dysregulated oncogene in human cancer, reported the approval of a Phase 2 trial of OMO-103, the Company’s lead candidate, in pediatric and adult patients with advanced osteosarcoma (Press release, Peptomyc, JAN 16, 2025, View Source [SID1234649757]).

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This investigator-initiated trial conducted by the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, is sponsored by the Osteosarcoma Institute (OSI; View Source), whose mission is to dramatically increase treatment options and survival rates in osteosarcoma patients through identifying and funding the most promising and breakthrough osteosarcoma clinical trials and science. Dr. Lee Helman, Director of the OSI, commented that MYC amplification/overexpression occurs in a subset of patients with osteosarcoma and there is mounting evidence that this may be associated with a poor outcome. We are grateful for the opportunity to support a study evaluating the use of a MYC inhibitor in collaboration with VHIO and Peptomyc." The OSI is a science-driven organization whose strategy is guided by its active and engaged Strategic Advisory Board (SAB) of preeminent physicians and other researchers from academia and industry. We would like to acknowledge OSI SAB members William Tap, MD; Katherine Janeway, MD, MMSc; Brian Crompton, MD, Lara Davis, MD, and Chand Khanna, DVM, PhD for their expert contributions to the development of this clinical trial.

"We are extremely grateful to the OSI and VHIO for this study and we are thrilled to expand our OMO-103 clinical program with the initiation of a third clinical trial for this candidate, underscoring OMO-103’s potential versatility across a broad range of solid tumors," commented Dr. Laura Soucek, Chief Executive Officer of Peptomyc. "Patients with advanced osteosarcoma, a rare type of bone cancer affecting predominantly children, adolescents, and young adults have an extremely poor prognosis, highlighting the need for novel treatment regimens to combat this highly aggressive disease. With MYC representing a bad prognostic for osteosarcoma patients – potentially resulting in resistance to standard of care treatment – we believe that inhibiting MYC could have a significant anti-tumor effect in this dismal disease."

Dr. Claudia Morales Valverde, Senior Researcher of the Genitourinary, Central Nervous System (CNS) Tumors, Sarcoma and Cancer of Unknown Primary Site Group at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona and Principal Investigator of the trial said, "This is the first use of a MYC inhibitor in osteosarcoma patients and we are eager to conduct this seminal study at the Vall d’Hebron University Hospital. MYC is especially amplified in osteosarcomas and our study will include at least 30% of patients below the age of 18, highlighting the importance of pediatric, adolescent, and adult specialists’ collaboration."

Dr. Manuela Niewel, Chief Medical Officer of Peptomyc, added, "I am really excited to test OMO-103 in this underserved patient population and hopefully make a change in their disease outcome. "

The Phase 2 trial (OSTEOMYC) aims at evaluating the safety and clinical activity, pharmacodynamics, and pharmacokinetics of OMO-103 in advanced osteosarcoma. The primary efficacy endpoint is progression-free survival (PFS) at 16 weeks per RECIST criteria. Secondary endpoints include Overall Response Rate (ORR) per RECIST and overall survival. The trial is enrolling patients at Vall d’Hebron University Hospital in Barcelona, Spain. More information about the trial is available at:

View Source

About Osteosarcoma

Osteosarcoma, while rare, is the most common type of bone cancer and is often associated with a high degree of malignancy, early metastasis, rapid progression, and poor prognosis. This cancer occurs primarily in children, adolescents, and young adults ranging from 10 to 30 years of age. The risk of diagnosis decreases in adulthood but rises again in older adults, usually over the age of 60. Approximately 3 new cases/million population are diagnosed each year. Treatment typically includes surgery and chemotherapy, with chemotherapy administered before and after surgery to help lower the risk of relapse. Even though curative therapy is available for the primary tumor, long-term outcomes for osteosarcoma patients continue to be impacted by metastatic progression and few improvements have been achieved in the last 40 years.

About MYC

MYC is the most dysregulated oncogene in human cancer, controlling multiple transcriptional programs associated to most hallmarks of cancers, including increased proliferation, metastatic potential, immune suppression, and resistance to treatment.

About OMO-103

OMO-103 is a first-in-class and best-in-class mini-protein against MYC. It has successfully been tested in a Phase Ia study in all-comers solid tumors and is currently in a Phase Ib study in metastatic pancreatic ductal adenocarcinoma (mPDAC) patients in combination with standard of care chemotherapy.

On January 16, 2025 GT Medical Technologies, Inc. (GT MedTech), a medical device company with a corporate purpose of improving the lives of patients with brain tumors, reported the company has completed a $37 million first close of a Series D financing round (Press release, GT Medical Technologies, JAN 16, 2025, View Source [SID1234649756]).

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The financing was led by Evidity Health Capital, alongside new investor Accelmed Partners. Also participating were existing investors MVM Partners, Gilde Healthcare and Medtech Venture Partners. The funds will accelerate the completion of the ROADS clinical study that is focused on GammaTile for newly diagnosed brain metastases, and the GESTALT clinical trial for patients with newly diagnosed glioblastomas (GBMs). In addition, the funds will support the continued commercialization of GammaTile, the Company’s FDA cleared bioresorbable radiotherapy implant for the treatment of brain tumors.

In conjunction with the financing, Adam Lessler, MD, Partner at Evidity Health Capital, and Camilo Rico, Vice President at Accelmed Partners, will join GT MedTech’s Board of Directors.

"Since 2019, doctors across the country have chosen GammaTile as a proven treatment for patients with operable brain tumors," said Per Langoe, Chief Executive Officer at GT MedTech. "With the support of Evidity and Accelmed, we are well-positioned to expand the availability of GammaTile and advance our ongoing clinical studies to continue transforming brain tumor treatment."

By delivering tile-based radiation therapy directly into the surgical cavity at the time of tumor removal, GammaTile provides immediate, localized treatment. This approach targets remaining cancer cells when they are at their lowest levels to help prevent regrowth while minimizing radiation exposure to healthy brain tissue.

"The Series D financing round underscores the confidence investors have in GammaTile Therapy and our vision to innovate brain tumor care," added Sandeep Yadav, Chief Financial Officer of GT MedTech. "We are thrilled to welcome Adam and Camilo to our Board of Directors as we enter this next phase of growth."

Dr. Lessler stated, "GammaTile’s unique combination of surgical precision and immediate, targeted radiation represents a transformative leap in oncology care. We are proud to partner with GT MedTech to bring this life-changing technology to more patients."

Mr. Rico shared, "Accelmed is excited to support GT MedTech as it accelerates the adoption of GammaTile Therapy. GT MedTech complements our strategy of partnering with innovative companies and management teams with a strong commitment to advance life changing therapies."

On January 16, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX (Press release, Alligator Bioscience, JAN 16, 2025, View Source [SID1234649755]).

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A recent Type C CMC interaction with the FDA in December 2024 reinforced feedback received from the PEI in July 2024, confirming that the completed and planned CMC work through early 2025 enables the Phase 3 development of mitazalimab. With this feedback, Alligator initiated manufacturing of mitazalimab to be used in the Phase 3 study, and thus remains on track for initiation of Phase 3 clinical activities during 2025.

"This regulatory feedback from both the FDA and PEI demonstrates the robustness of our CMC development strategy and validates the significant progress we’ve made in advancing mitazalimab towards Phase 3" said Søren Bregenholt, CEO of Alligator Bioscience. "We are confident in our ability to continue to execute on our timeline and bring mitazalimab one step closer to addressing the urgent unmet need for patients with metastatic pancreatic cancer."

PHYRAGO Represents the First and Only Improved Version of SPRYCEL That Can Be Safely Co-administered With Gastric Acid-Reducing Agents

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On January 15, 2025 Handa Pharmaceuticals, Inc. ("Handa") (6620.TWO) announced that its U.S. subsidiary, Handa Therapeutics, LLC (the "Company"), has acquired PHYRAGO (dasatinib) tablets, a U.S. Food and Drug Administration ("FDA") approved chronic myeloid leukemia treatment that was developed by Nanocopoeia, LLC (Press release, Nanocopoeia, JAN 15, 2025, View Source [SID1234650016]). PHYRAGO is the first and only dasatinib product that can be co-administered with gastric acid-reducing agents. An estimated one-third of patients who require SPRYCEL treatment may also take gastric acid-reducing agents1, which can reduce dasatinib’s drug exposure by more than 40% when taken with a proton pump inhibitor and more than 60% when taken with an H2 receptor antagonist2.

PHYRAGO was granted Orphan-Drug Designation and has received three (3) years of data exclusivity that will expire December 5, 2026. Should PHYRAGO be granted Orphan-Drug Exclusivity, it may be eligible for seven (7) years of exclusivity, until December 5, 2030. PHYRAGO is protected by several issued patents, including those listed in the FDA’s Approved Drugs and Therapeutic Equivalents publication (the "Orange Book") that expire January 22, 2041.

The Company is in the process of selecting a U.S. commercialization partner and expects PHYRAGO to be available to patients in Q1-2025.

PHYRAGO is indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatments.

"PHYRAGO represents a novel dasatinib formulation that delivers equivalent efficacy to SPRYCEL, with the additional benefit of allowing patients to take dasatinib with gastric acid-reducing agents", said Bill Liu, Chairman and CEO of Handa. "Unlike SPRYCEL, PHYRAGO allows concomitant use with a proton pump inhibitor or H2 receptor antagonist."

The effect of co-administration of gastric acid-reducing agents on SPRYCEL is significant. The SPRYCEL label warns that the "co-administration of SPRYCEL with a gastric acid-reducing agent may decrease the concentration of dasatinib. Decreased dasatinib concentrations may reduce efficacy. Do not administer H2 agonists or proton pump inhibitors with SPRYCEL."3

The FDA approved PHYRAGO with a label that allows co-administration with gastric acid-reducing agents, stating that "No clinically significant differences in the pharmacokinetics of PHYRAGO were observed following concomitant use with omeprazole (proton pump inhibitor) or famotidine (H2 receptor antagonist)."4 and "Avoid concomitant use of PHYRAGO with antacids. If concomitant use of an antacid cannot be avoided, administer the antacid at least 2 hours prior to or 2 hours after the dose of PHYRAGO."5

According to Bristol Myers Squibb’s annual report, net sales of SPRYCEL in 2023 totaled $1.44 billion. For full prescribing information about PHYRAGO, please visit www.phyrago.com.

Sources:

IQVIA longitudinal prescription and medical claims data, January 2013-March 2021, identified 7,419 patients receiving dasatinib treatment of which 31.8% were concomitantly prescribed a proton pump inhibitor and/or H2 receptor antagonist
SPRYCEL Prescribing Information (Rev. 7/2024), Section 12.3, Pharmacokinetics – Drug Interaction Studies – Gastric Acid Reducing Agents
SPRYCEL Prescribing Information (Rev. 7/2024), Section 7.1, Drug Interactions – Effect of Other Drugs on Dasatinib – Gastric Acid Reducing Agents
PHYRAGO Prescribing Information (Rev. 12/2024), Section 12.3, Pharmacokinetics – Drug Interaction Studies – Gastric Acid Reducing Agents
PHYRAGO Prescribing Information (Rev. 12/2024), Section 2.2, Dosage Modifications – Antacids