On September 5, 2024 Akeso, Inc. (9926.HK) reported that it will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO (Free ESMO Whitepaper) Congress 2024 from September 13th to 17th (CEST) (Press release, Akeso Biopharma, SEP 5, 2024, View Source [SID1234646383]). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies.

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Notably, ivonescimab’s clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, the Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. Stay tuned for additional updates!

Details of the Presentations:

Colorectal Cancer
Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC)

Key Study Findings:
For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC.

Session Type: Mini Oral Session
Number: 514MO
Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST)
Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital
Triple-Negative Breast Cancer
Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC)

Key Study Findings:
Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies.

Session Type: Mini Oral Session
Number: 347MO
Presentation Time: Monday, 16 September 08:30-08:35 (CEST)
Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital
Head And Neck Squamous Cell Carcinoma
Abstract Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)

Key Study Findings:
PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024.

Session Type: Poster Session
Number: 876P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study

Session Type: Poster Session
Number: 866P
Presentation Time: Saturday, 14 September 2024 (CEST)
Hepatocellular Carcinoma
Abstract Title: Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC)

Session Type: Proffered Paper Session
Number: LBA40
Presentation Time: Friday,13 September 16:55-17:05 (CEST)
Gynecological Oncology
Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy

Session Type: Poster Session
Number: 732P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China

Session Type: Poster Session
Number: 727P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial

Session Type: Poster Session
Number: 760P
Presentation Time: Saturday, 14 September 2024(CEST)
Nasopharyngeal Carcinoma
Abstract Title: Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial

Session Type: Poster Session
Number: 893P
Presentation Time: Saturday, 14 September 2024(CEST)
Biliary Tract Cancer
Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial

Session Type: Poster Session
Number: 52P
Presentation Time: Monday, 16 September 2024 (CEST)
Gastric Cancer
Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial

Session Type: Poster Session
Number: 1455P
Presentation Time: Monday, 16 September 2024(CEST)
Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients

Session Type: Poster Session
Number: 1473TiP
Presentation Time: Monday, 16 September 2024 (CEST)
Esophageal Squamous Cell Carcinoma
Abstract Title: Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial

Session Type: Poster Session
Number: 1446P
Presentation Time: Monday, 16 September 2024 (CEST)

On September 5, 2024 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, reported that Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder, will present at H.C. Wainwright’s 26th Annual Global Investment Conference being held at the Lotte New York Palace Hotel in New York City on September 9-11, 2024 (Press release, Celularity, SEP 5, 2024, https://celularity.com/celularity-to-present-at-h-c-wainwrights-26th-annual-global-investment-conference/ [SID1234646368]).

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H.C. Wainwright 26th Annual Global Investment Conference
Date: Monday, September 9, 2024
Time: 12:30 p.m. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Robert J. Hariri, M.D., Ph.D., Founder, Chairman & CEO

Celularity will also participate in one-on-one investor meetings at the conference. To obtain more information on the conference, or schedule an investor meeting with Dr. Hariri, please contact your H.C. Wainwright representative or KCSA Strategic Communications at [email protected].

A replay of this presentation will be available on the Company’s website at View Source for at least 90 days following the date of the presentation.

On September 5, 2024 Tempo Therapeutics, Inc. ("Tempo"), a leading innovator in tissue engineering and regenerative medicine, reported the dosing of the first patients in a clinical trial of TT101 (the MOSAIC Trial), the company’s lead pipeline candidate for tissue regeneration based on its proprietary MAP technology (Press release, Tempo Therapeutics, SEP 5, 2024, View Source [SID1234646384]). TT101 is a first-in-class, flowable and integrative scaffold that has demonstrated non-immunogenic and regenerative tissue responses in large animal studies of soft tissue repair. Based on these compelling preclinical data, TT101 is now being tested in humans to evaluate safety and gather additional information on its ability to potentially regrow large volumes of surgically removed tissue while allowing patients to avoid the formation of disfiguring scars that currently require further intervention.

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"Enrolling patients in this first clinical trial is a significant milestone for Tempo representing many years of hard work and innovation in bringing the MAP technology from the bench to the bedside," said Westbrook Weaver, PhD, Tempo’s Chief Executive Officer and company co-founder. "I am immensely proud of our great team of scientists, engineers, and physicians at Tempo, as well as our investors and partners that have all come together to bring this first-in-class technology to human trials for the first time."

The open label, randomized, first-in-human trial is evaluating the safety of TT101 when applied to acute surgical oncology resection sites in the skin after the resection of Basal Cell Carcinomas (BCC) or Squamous Cell Carcinomas (SCC), frequently addressed with Mohs surgery. BCCs and SCCs affect over 5 million patients every year in the United States alone. A significant number of these patients require surgical resection that exposes bone, muscle, or fascia. The recovery of these surgical sites is challenging, costly, and requires continued intervention that can interfere with secondary cancer therapy and negatively affect patient outcomes, especially in those patients also undergoing immunosuppressive treatments or in an immunocompromised state. The Company believes that TT101 and MAP technology have the potential to revolutionize treatment outcomes for surgical oncology patients with complex surgical sites, addressing a large unmet medical need for rapid tissue healing in complex surgical sites.

About MAP Technology:

The Microporous Annealed Particle (MAP) technology is a first-in-class volumetric flowable porous scaffolding for regenerative medicine. The MAP technology enables Tempo to repurpose established hydrogel polymer components with strong safety profiles by assembling them into a hyper-porous, flowable scaffold format. MAP-based products immediately allow tissue ingrowth and integration upon application. Tissue implants using MAP technology are able to evade the typical inflammatory and scar-forming Foreign Body Response (FBR) and instead promote a regenerative immune response that leads to accelerated formation of vascularized tissue volume. Unlike normal biology and current available products, MAP drives tissue reformation without requiring patient inflammation, unlocking new biological pathways for building tissue inside patients without delivering cells or biologic therapy.

On September 5, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Cidara Therapeutics, SEP 5, 2024, https://www.cidara.com/news/cidara-to-present-at-the-h-c-wainwright-26th-annual-global-investment-conference/ [SID1234646369]).

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Presentation details are as follows:

Event: H.C. Wainwright 26th Annual Global Conference
Date: Monday, September 9, 2024
Time: 7:00 am ET
Webcast: View Source

Cidara’s presentation will be available on-demand from the above date/time in the investors section on the Company’s website at www.cidara.com. The replay of the presentation will be available for 90 days.

On September 5, 2024 NextPoint Therapeutics, a clinical-stage biotechnology company developing a new class of precision immuno-oncology and tumor-directed therapeutics targeting the novel B7-H7 axis, reported that it has unveiled NPX372, a novel T cell engager (Press release, NextPoint Therapeutics, SEP 5, 2024, View Source [SID1234646385]). NPX372 further expands NextPoint’s multi-modal focus on the emerging B7-H7 axis in cancer therapy.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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B7-H7, also known as HHLA2, is an emerging immunomodulatory receptor upregulated in various solid tumor types, including colorectal carcinoma, non-small cell lung cancer, renal cell carcinoma, prostate cancer, and many others. Notably, this receptor is induced independently of PD-L1 or other B7 family members. Unlike other B7 family proteins that are expressed across a wide range of cell types, B7-H7 is primarily found on the epithelial cells of tumors, making it a unique and potentially specific target for tumor-directed therapies.

"T cell engagers have shown immense potential, but to date their application in solid tumors has remained a formidable challenge. NPX372 represents a significant advancement, aiming to redirect T cell-mediated immunity with high specificity by modulating key biological components, potentially offering more effective monotherapy treatment options for a range of solid tumors," said Tatiana Novobrantseva, PhD, Chief Scientific Officer of NextPoint Therapeutics.

NPX372 is a CD3 bispecific antibody with unique capabilities to redirect T cell-mediated cytotoxicity toward B7-H7-positive tumors. In addition to CD3 engagement, this antibody interacts with the B7-H7 immune axis to achieve added potency. Preclinical data highlight NPX372’s potent anti-tumor responses and a favorable safety profile at clinically relevant doses with no indication of cytokine release syndrome. This asset is part of NextPoint’s diverse portfolio of immunotherapies designed to target various tumor types. NextPoint is rapidly advancing the Investigational New Drug (IND) application for NPX372.

"NPX372 represents a significant advancement in our pursuit of precision immunotherapy," said Ivan Cheung, CEO of NextPoint Therapeutics. "As part of our ongoing immune checkpoint clinical programs, NPX267 and NPX887, we have developed a clinical biomarker for B7-H7 expression, which allows us to selectively target patients across various tumor types who may benefit from a potent T cell engager such as NPX372. This precision medicine approach allows us to potentially address solid tumors expressing B7-H7, tailoring treatments to those who will respond best. Our deep knowledge of B7-H7 biology drives our leadership in advancing innovative, transformative treatments that can make a meaningful difference in the lives of cancer patients."