On January 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), reported that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, JAN 16, 2025, View Source [SID1234649760]). Limertinib is the 14th product in Innovent’s commercial portfolio and represents a cutting-edge addition to its strong TKI franchise, offering an innovative precision therapy option to lung cancer patients.

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A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib’s robust efficacy and safety profile. Independent review committee（IRC） assessment showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%. The median progression-free survival (PFS) reached 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions (N=99), the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile aligned with other EGFR-targeting agents in its class.

Additionally, limertinib met its primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.

"Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations. Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China," said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 2b and Phase 3 clinical studies.

Dr. Hui Zhou, Senior Vice President of Innovent, stated："The approval of limertinib’s first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments. We anticipate the first-line treatment indication will benefit even more patients in the near future. As our 14th commercial product, limertinib represents an important advancement in precision medicine for lung cancer. We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC."

Mr. Jingfei Ma, CEO and Executive Director of ASK Pharm, stated: "Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in China. ASKC202, a new highly selective c-Met inhibitor, is currently undergoing clinical study in combination with limertinib to treat patients with third-generation EGFR-TKI resistance. Together with Innovent, we look forward to limertinib benefiting more Chinese lung cancer patients in the near future. The first approval of limertinib, a Class I innovative product, represents significant progress in the company’s transformation toward innovative drug research and development. "

About EGFR mutation-positive non-small-cell lung cancer (NSCLC)

Lung cancer remains one of the deadliest and most common cancers globally[i], with NSCLC accounting for about 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic disease stages that cannot be surgically resected. EGFR mutations are particularly prevalent in Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability.

About Limertinib

Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, approved by the China’s NMPA for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). A second NDA is under NMPA review for first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations.

The drug demonstrated success in a multi-center, randomized, double-blind, controlled Phase 3 clinical trial comparing its efficacy and safety of to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. With the primary endpoint met, results will be presented at upcoming academic conferences or published in academic journals.

In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China.

On January 16, 2025 IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, reported that Senaparib Capsules (派舒宁）has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy (Press release, Impact Therapeutics, JAN 16, 2025, View Source [SID1234649759]).

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Senaparib, discovered and developed by IMPACT, is a potent and novel PARP 1/2 inhibitor. Its distinctive molecular structure provides it with high in vitro and in vivo activity, exceptional target selectivity and wide safety window. The approval is based on FLAMES Study. The study is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Senaparib as monotherapy for the maintenance treatment of patients with advanced ovarian cancer who had completed first-line chemotherapy and achieved either a complete response (CR) or partial response (PR). The results of FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. [1]The results also indicated that both HRD positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer.

The top-line results of the study were initially presented as a late breaking oral presentation at ESMO (Free ESMO Whitepaper) in 2023 and presented at CSCO 2024. On May 15, 2024, the internationally renowned medical journal Nature Medicine also published the results titled "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial."[1]

Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000. According to the latest national cancer statistics released by National Cancer Center in 2024, there were 61,100 new cases of ovarian cancer and 32,600 deaths in China in 2022, making it the most lethal gynecological tumor. Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 41.8%. [2]Although ovarian cancer may be resolved after initial platinum-containing chemotherapy, most patients inevitably face recurrence, and there remains a significant unmet clinical need for treatment in the ovarian cancer patient population.

In recent years, PARP inhibitors are changing the therapeutic landscape of ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-containing chemotherapy and delaying disease recurrence.

In December 2023, IMPACT entered into a collaboration agreement with Zhongmei Huadong Pharmaceutical Co., Ltd, a subsidiary of Huadong Medicine Co., Ltd (SZ.000963) (collectively, "Huadong Medicine") for the commercialization of Senaparib. Under the collaboration agreement, Huadong Medicine receives exclusive promotion rights of Senaparib in mainland China. Huadong Medicine is deeply involved in the field of gynecological oncology. Senaparib and Huadong Medicine’s approved mirvetuximab soravtansine-gynx (ELAHERE) can provide solutions for ovarian cancer patients with different stages of the disease, sharing expert networks, research and clinical resources, promoting and developing together to form an effective and highly synergistic relationship.

Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT said:

"It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT’s in-house synthetic lethality R&D platform and the R&D execution team.

Leveraging Huadong Medicine’s extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer."

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."