Harbour BioMed Announces License Agreement with Windward Bio for HBM9378/SKB378, an Anti-TSLP Fully Human Antibody for Immunological Diseases

On January 10, 2025 Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, reported that the Company and Sichuan Kelun Biotech BioPharmaceutical (HKEX: 06990, "Kelun-Biotech") have entered into a license agreement with Windward Bio AG ("Windward Bio") for HBM9378/SKB378, an anti-thymic stromal lymphopoietin (TSLP) fully human monoclonal antibody co-developed by Harbour BioMed and Kelun-Biotech (Press release, Harbour BioMed, JAN 10, 2025, View Source [SID1234649606]).

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Under the terms of the agreement, Windward Bio is granted an exclusive license to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In return, Harbour BioMed and Kelun-Biotech are eligible to receive a total of up to $970 million upfront and milestone payments, as well as tiered royalties ranging from single to double digits on net sales. The $45 million upfront and near-term milestone payments include both cash payment and an equity interest in Windward Bio’s parent company. Furthermore, Harbour BioMed and Kelun-Biotech are eligible to receive additional payments if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. All payments under the license agreement shall be paid in equal amounts to Harbour BioMed and Kelun-Biotech.

In connection with the license agreement, Windward Bio announced a $200 million Series A financing round led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, along with co-investors SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.

"We are delighted to partner with Windward Bio to advance the development of HBM9378/SKB378, a promising TSLP-targeted fully human antibody with significant potential to address immunological diseases," said Dr. Jingsong Wang, Founder, Chairman & CEO of Harbour BioMed. "This collaboration demonstrates the value of our Harbour Mice technology platform and reflects our commitment to bring transformative treatments to patients worldwide."

About HBM9378/SKB378

HBM9378/SKB378 (now also known as WIN378) is a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing the global rights. It is a fully human monoclonal antibody targeting TSLP, generated from the two heavy chains and two light chains (H2L2) Harbour Mice platform. It inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor, which is a well-validated cytokine plays a key role in the development and progression of various immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD). Inhibition of this pathway has shown benefits across multiple inflammatory phenotypes. The antibody’s long half-life optimization and outstanding biophysical properties provide a favorable dosing advantage.

Prior to the execution of the license agreement, Harbour BioMed submitted an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration (NMPA) in China for HBM9378/SKB378 for the treatment of COPD in November 2024. The company has also completed a phase I clinical trial in China under an IND for the treatment of moderate-to-severe asthma.

Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)

On January 10, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) (Press release, Tyra Biosciences, JAN 10, 2025, View Source [SID1234649605]). This program will be led by newly appointed Dr. Erik Goluboff, SVP, Clinical Development of TYRA, who brings more than thirty years of experience as an academic urologic oncologist, principal investigator, practicing urologist and most recently Principal Medical Lead for GU/GI cancers at Genentech/Roche.

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TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. FGFR3 is the most frequently altered gene in NMIBC, with 60-80% of IR NMIBC showing alterations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial carcinoma (mUC).

SURF302 will be an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.

"Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options," commented Doug Warner, Chief Medical Officer of TYRA. "We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect to initiate patient dosing in the second quarter of this year, with initial three-month CR data to follow."

Dr. Goluboff joins TYRA from Genentech/Roche, where he was Principal Medical Lead for GU/GI cancers and was responsible for driving business and pipeline opportunities in those indications. Prior to Genentech/Roche, Dr. Goluboff held positions of increasing responsibility at AstraZeneca, including most recently as Global Clinical Head for IMFINZI (durvalumab) and tremelimumab for GU, GYN and tumor agnostic. Before joining industry, he held urology professorships at Columbia and Mount Sinai and managed thousands of patients from diagnosis to late line disease, medically and surgically, with bladder, prostate, and kidney cancers. He was a principal investigator for multiple clinical trials and has published over 100 peer-reviewed papers. He received his B.A. from Columbia University, an M.D. from Johns Hopkins, and an M.B.A. from NYU’s Stern School of Business. Dr. Goluboff completed his surgical internship at Johns Hopkins Hospital and his urology residency and urologic oncology fellowship at Columbia-Presbyterian Medical Center.

"For the last thirty years, I have dedicated my career to helping patients with bladder cancer as a urologic oncologist, a principal investigator running clinical trials, and as a drug developer seeking new and more effective therapies for patients with urologic cancers," added Dr. Goluboff. "I believe that TYRA-300 is the most compelling agent in development for the treatment of IR NMIBC, with a proven mechanism of action and more attractive tolerability profile than pan-FGFR inhibitors, which made joining TYRA a very exciting opportunity. I look forward to advancing TYRA-300 through the Phase 2 SURF302 study and delivering benefit to patients in need."

About Non-Muscle Invasive Bladder Cancer

In the United States, it is estimated that there are more than 730,000 people living with bladder cancer. Many of these patients have intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and experience recurrence episodes throughout the course of their disease. Treatment for IR NMIBC and disease recurrence is a surgical procedure called transurethral resection of bladder tumor (TURBT) combined with intravesical-administered chemotherapy. Repeat TURBT procedures and intravesical-administered chemotherapy can impact patients’ quality of life and overall health, leading to a significant unmet medical need for better tolerated therapeutic options. TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC.

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in metastatic urothelial cancer (mUC) and intermediate risk non-muscle invasive bladder cancer (IR NMIBC). In mUC, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. In October 2024, TYRA reported interim clinical proof-of-concept data in mUC from SURF301. TYRA has received IND clearance from the U.S. FDA to proceed with its SURF302 clinical trial in patients with IR NMIBC. In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and TYRA has received IND clearance from the U.S FDA to proceed with its BEACH301 clinical trial in children with achondroplasia.

Intensity Therapeutics Provides Business Update Highlighting Key Achievements with Lead Drug Candidate INT230-6

On January 10, 2025 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported a business update highlighting key achievements with its lead drug candidate INT230-6 (Press release, Intensity Therapeutics, JAN 10, 2025, View Source [SID1234649604]).

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Business Development

Discussions with multiple companies regarding potential strategic collaborations and licenses in various territories for INT230-6 initiated in 2024. While term sheets may be negotiated, there is no assurance that any ongoing discussions, negotiations, or due diligence processes will result in definitive agreements, partnerships, collaborations, or relationships.

Sarcoma INVINCIBLE-3

In July 2024, the Company initiated and dosed its first patient in a Phase 3 open-label, randomized study (the "INVINCIBLE-3 Study") testing INT230-6 as a monotherapy compared to the standard of care ("SOC") drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority, and Australia’s Therapeutics Goods Administration. The trial is enrolling and being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and other centers are expected to participate from these countries.

In November 2024, the Company presented INT230-6 Phase 1/2 data in a late-breaking session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS). These data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone. INVINCIBLE-3 continues recruiting with an expected enrollment of 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma.

Breast Cancer INVINCIBLE-2 and INVINCIBLE-4

In October 2024, the Company, in collaboration with the Swiss Group for Clinical Cancer Research SAKK ("SAKK") in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), announced that the first patient has been dosed in the study.

In December 2024, Phase 2 data in presurgical breast cancer from the completed INVINCIBLE-2 study along with an overview of the ongoing INVINCIBLE-4 (SAKK 66/22), was presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).

The Company’s completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed the following:

Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation.
Tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery.
Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03).
The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated.
INT230-6 patients had increases in CD4 T cells and NK cells within the tumor and associated changes in the diversity of T cell repertoire.
The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with tumors greater than two centimeters having early-stage, operable Triple Negative Breast Cancer ("TNBC"). These patients undergo standard-of-care neoadjuvant immunochemotherapy ("SOC") treatment, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen). The primary endpoint is pathological complete response ("pCR") in the primary tumor and affected lymph nodes. Patients will be randomized one to one to receive a regimen of two doses of INT230-6 followed by SOC, or SOC alone. The study is expected to enroll 54 patients in up to 16 centers in Switzerland and France.

"The data from our prior studies and trial design has allowed INT230-6 to be authorized by the leading regulatory agencies globally to move into late-stage clinical trials. INT230-6 is being tested in metastatic and pre-surgical cancers, which highlights the broad potential for our new cancer treatment," said Lewis H. Bender, President and CEO of Intensity Therapeutics, "There are many risks and hurdles in drug development and advancing programs into phase 3 trials is an important achievement and a testament that reflects the expertise and dedication of our team. We are excited that contracts exist with nearly two dozen top sarcoma-centric hospitals in our Phase 3 study and nine sites in our Phase 2 presurgical breast cancer trial with seven activated. Several sites are enrolling and continue to recruit patients for both studies. Given the potential benefit of our new drug, we are working to establish partnerships that expedite product development and ultimate market access in the US and abroad."

About Soft Tissue Sarcoma
Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mainly in the arms, legs, chest, and abdomen. There are many types of sarcomas; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), and liposarcoma. According to SEER estimates, approximately 14,500 patients have metastatic liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic disease at any one time in the US. When sarcoma is metastatic, the prognosis is poor, even with systemic chemotherapy.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer in the Presurgical Setting
Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates lower in the larger-sized tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

AKTIS ONCOLOGY TO PRESENT AT THE 43rd ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 10, 2025 Aktis Oncology, an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for large patient populations not addressed by existing platform technologies, reported that Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif (Press release, Aktis Oncology, JAN 10, 2025, View Source [SID1234649603]). Dr. Roden’s presentation will take place on Monday, January 13, 2025, at 3:30 p.m. PT.

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JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma

On January 10, 2025 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) (Press release, JW Therapeutics, JAN 10, 2025, View Source [SID1234649602]). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

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The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients.

Large B-cell lymphoma is a highly aggressive non-Hodgkin’s lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL.

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

About JWCAR029-216 Study (NCT06093841)

This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.

The study is currently ongoing. Preliminary clinical data found Carteyva providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%.