On December 27, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has received approval from the University of Miami to enroll patients for its first in human clinical trial of HT-001 (Press release, Hoth Therapeutics, DEC 27, 2023, View Source [SID1234638809]).

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This First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi). This clinical trial is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at clinicaltrials.gov.

"We are very pleased to have received approval for our FIH clinical trial," said Hoth Therapeutics Chief Executive Officer, Robb Knie. "We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001. Coupled with approval at Washington University of St. Louis and MD Anderson Cancer Center, University of Miami will be our third site approved to host our trial and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments. I look forward to updating our investors and patients on this ongoing trial in the first quarter of 2024."

On December 27, 2023 TAE Life Sciences reported that it is set to unveil significant strides in its innovative drug development at the esteemed Biotech Showcase, taking place in parallel to the 42nd annual J.P. Morgan Healthcare Conference (JPM) (Press release, TAE Life Sciences, DEC 27, 2023, View Source [SID1234638808]).

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At the event, Rob Hill, Chief Executive Officer of TAE Life Sciences, will unveil groundbreaking insights derived from recent studies on BTS, the company’s proprietary boronated drug designed for Boron Neutron Capture Therapy (BNCT). Mr. Hill’s presentation will delve into pivotal findings, shedding light on the potential of BTS to revolutionize the treatment landscape for cancer patients. This development holds significant promise for BNCT—a highly precise and targeted radiation therapy applicable to various cancer types. The study results not only contribute to advancing medical knowledge but also open new avenues for enhancing the effectiveness of cancer treatment through cutting-edge applications.

Moreover, Hill will shed light on TAE’s patent-pending Fc-engineered antibodies, heralding a new era in site-specific conjugation and reduced effector function. These antibodies, meticulously engineered with mutations in the CH2 domain, enable precise site-specific conjugation while silencing the Fc region. This breakthrough technology holds immense promise for both Antibody Boron Conjugates (ABC) for BNCT applications and Antibody Drug Conjugates (ADC), presenting a versatile approach in the landscape of oncology therapeutics.

"Our commitment to pioneering advancements in antibody therapies is underscored by our latest breakthroughs in BTS and Fc-engineered antibodies," stated Rob Hill, CEO of TAE Life Sciences. "We’re excited about the potential impact these developments hold for targeted cancer treatments, offering new possibilities for precision medicine."

Details about Rob Hill’s presentation at Biotech Showcase 2024:

Date: January 8, 2024
Time: 2:45 PM
Location: Biotech Showcase 2024; Hilton San Francisco, Yosemite C (Ballroom Level)
TAE Life Sciences invites interested stakeholders and investors to attend Rob’s presentation to gain deeper insights into these transformative developments and explore potential collaborations.

To schedule a meeting with Rob Hill at Biotech Showcase or JPM, please contact Anna Theriault at [email protected].

For more information about TAE Life Sciences, BTS, engineered antibody drugs, and Alphabeam BNCT system, please visit www.taelifesciences.com.

On December 27, 2023 PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, reported that management will be presenting at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024, at 1:30 PM PT (4:30 PM ET) in San Francisco, California (Press release, Pacific Biotech, DEC 27, 2023, View Source [SID1234638807]).

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A live webcast of the event can be accessed at the company’s investors page at investor.pacificbiosciences.com. A replay of the webcast will be available for at least 30 days following the event.

On December 27, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Xuanzhu Biopharma, reported that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection (brand name: TYVYT) with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China (Press release, Innovent Biologics, DEC 27, 2023, View Source [SID1234638806]).

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Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial. Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors.

TYVYT (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China. It has been approved and included in the national reimbursement drug list (NRDL) for seven indications. It is also the only PD-1 inhibitor for the first-line treatment of five high-incidence cancer types in the NRDL.

KM-501 is designed by Mebs-Ig (antibody-edited bispecific antibody) platform with independent intellectual property rights to target dual-antibody ADC with two different domains of HER2. It is suitable for the treatment of locally advanced/metastatic solid tumors with HER2 positive / expression, amplification or mutation, including related advanced tumors with low HER2 expression. The IND was approved by the NMPA in March this year, and it is currently in the phase I dose escalation study. Pre-clinical studies showed that KM-501 was better than control-drugs DS-8201 and Herceptin in terms of endocytosis rate, internalization rate and in vitro inhibitory activity; KM-501 was better than DS-8201 in tumor models with high and low expression of HER2.

Combining a PD-1 inhibitor and an ADC candidate represents a new direction for the development of cancer therapy in terms of potentially improving the effect of immunotherapy and overcoming potential drug resistance. The PD-1 immunotherapy can release the suppressed state of T cells while the ADC drug can achieve the anti-tumor killing effect through cytotoxic payload, thus bringing in synergistic tumor inhibition effect.

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to collaborate with Xuanzhu Biopharma to explore the synergistic anti-tumor effects of the combination therapy of sintilimab and a novel ADC candidate. The leading position and clinical value of sintilimab as a backbone immunotherapy are further strengthened. In light of the synergistic mechanism of two novel medicines, we hope to bring new treatment options for cancer patients in the future. "

Dr. Xiaodong Zhu, General Manager of Xuanzhu Bio, stated: " The collaboration with Innovent is an important milestone for KM-501 in the development and commercialization strategy. We look forward to new opportunities for KM-501 in combo with sintilimab so as to potentially improve patient benefit and overcome tumor resistance."

About KM-501

KM-501 is designed by Mebs-Ig (antibody-edited bispecific antibody) platform with independent intellectual property rights to target dual-antibody ADC with two different domains of HER2. It is suitable for the treatment of locally advanced/metastatic solid tumors with HER2 positive / expression, amplification or mutation, including related advanced tumors with low HER2 expression. The IND was approved by the NMPA in March this year, and it is currently in the phase I dose escalation study. Pre-clinical studies showed that KM-501 was better than control-drugs DS-8201 and Herceptin in terms of endocytosis rate, internalization rate and in vitro inhibitory activity; KM-501 was better than DS-8201 in tumor models with high and low expression of HER2.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[i].

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope of TYVYT (sintilimab injection) include:

For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Besides, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.

On December 27, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, reported follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo) in patients with refractory/relapsed malignant pleural mesothelioma (MPM) (Press release, Sellas Life Sciences, DEC 27, 2023, View Source [SID1234638805]).

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As previously reported, ten patients were enrolled in the clinical study and nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response. All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional analyses for the correlation of immune response and survival benefit were performed. Immune response was defined as a measurable increase in activated Wilms Tumor 1 (WT1) specific T cells, both CD8 T+ cells (killer T cells) and CD4+ T cells (regulatory T cells).

Of the 10 evaluable patients, eight were male and two were female, with a median age of 69 years. Sixty percent entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients). All patients had MPM epithelioid and/or sarcomatoid variant, a tumor that universally expresses WT1, one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy.

The key clinical efficacy and immune response study outcomes are as follows:

70.3 weeks (17.6 months) median overall survival (OS) was achieved in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all 10 patients (nine patients with combination therapy and one GPS-only patient).
Median OS for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months). OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40% of patients).
The median OS among patients who did not have an immune response to GPS was 9.0 months; the median OS for patients who had an immune response to GPS was 27.8 months, more than three times longer median OS (208.3% increase). Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS. Three patients had both CD4+ and CD8+ immune responses (33.3%).
Among patients who had a full immune response (both CD4+ and CD8+) to GPS, two patients achieved an objective response (66.7%), while among the patients who did not have an immune response to GPS one patient achieved an objective response (14.3%).
11.9 weeks median progression-free survival (PFS) was observed for all patients.
The disease control rate (DCR) was 30% with three patients achieving stable disease per RECIST criteria with a tumor volume decrease of up to 17%. DCR is the sum of the overall response rate and rate of stable disease.
Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS commented: "We are excited that in a bulky, measurable disease setting, such as in this relapsed/refractory advanced mesothelioma study, we have observed yet again strong GPS-specific immune responses which appear to be correlated with significant survival benefit in patients when combined with checkpoint inhibitors, a more than 200% survival benefit. As we had hypothesized in the past, this increase in survival appears to be consistent with long-term immunity-mediated antitumor effect with our immunotherapy combination as we had seen in other studies with GPS, and, importantly, the positive survival outcomes seen in this study are accompanied with a safety profile which is similar to that of the checkpoint inhibitor alone. We believe that these observed survival benefits in the active disease setting further confirm the strong biological effect of GPS in even the most challenging settings where GPS seems to contribute to stopping the progression of extremely aggressive cancers and demonstrates its utility as a potentially effective combination therapy."

About Malignant Pleural Mesothelioma (MPM)

With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both OS and PFS, especially for those patients with the sarcomatoid variant who show a median OS of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and OS in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, the median OS is reported to be approximately 7.0 months.