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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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."

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 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 Hansa Biopharma reported that Søren Tulstrup will participate in a Fireside chat hosted by Douglas Tsao, Managing Director and Senior Financial Analyst at H.C. Wainwright on Wednesday, September 11 at 8:00 AM EST (Press release, Hansa Biopharma, SEP 5, 2024, https://www.prnewswire.com/news-releases/hansa-biopharma-to-participate-in-hc-wainwright-26th-annual-global-investment-conference-302239226.html [SID1234646382]). Mr. Tsao’s research focuses on biopharmaceuticals and specialty pharmaceuticals. The company will cover Hansa’s clinical stage programs, recent performance and upcoming milestones.

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Hansa management will be available for meetings at the conference. If you are interested in meeting with the management team, please contact Hansa Biopharma at [email protected].

On September 5, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported that new clinical data from an ongoing Phase 1 study of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma will be presented in an oral session at the 21st International Myeloma Society (IMS) Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024 (Press release, Poseida Therapeutics, SEP 5, 2024, View Source [SID1234646381]). The Company is developing P-BCMA-ALLO1, an investigational off-the-shelf allogeneic CAR-T cell therapy enriched for stem cell memory T cells (TSCM), in partnership with Roche for the treatment of relapsed/refractory multiple myeloma.

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"Despite therapeutic advances, multiple myeloma remains an incurable hematologic cancer and relapses are common with BCMA-targeting immunotherapies, such as bispecific T-cell engagers and autologous CAR-T therapies. As a result, patient-focused, off-the-shelf therapies are needed that can provide clinical benefit to patients with relapsed or refractory disease," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "We look forward to presenting the latest data from our ongoing Phase 1 study of P-BCMA-ALLO1 and its potential as an ‘off-the-shelf’ therapy for patients at IMS. We are also pleased to announce the initiation of the Phase 1b portion of the study, which will allow us to further explore the promise of this program."

IMS Oral Presentation

Talk Title: OA – 04: A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM)
Presenting Author: Bhagirathbhai R. Dholaria, MBBS, Assistant Professor of Medicine, Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center
Session: Abstract Session 7
Presentation Date/Time: Friday, September 27, 2024, at 5:42 PM-5:54 PM local time (4:42 PM ET / 1:42 PM PT)
Room: 101 A1-A2
Company-Hosted IMS Webcast and Conference Call Information:
Poseida will host a webcast and conference call on Saturday, September 28, 2024, at 1 PM ET / 10 AM PT. The conference call can be accessed by dialing 800-225-9448 or 203-518-9708 (International) with the conference ID PSTX0928. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for approximately 90 days.

P-BCMA-ALLO1 Phase 1b Clinical Trial
The Company also announced the initiation of a Phase 1b portion of the ongoing Phase 1 clinical trial of P-BCMA-ALLO1 in patients with multiple myeloma. As a result of achieving this milestone, Poseida will receive a $20 million payment from Roche. Poseida and Roche partnered together on the P-BCMA-ALLO1 Phase 1b trial design, which incorporates process improvements and feedback from recently completed advisory board meetings with leading clinicians. Poseida will continue to have responsibility for the expanded Phase 1/1b trial, which will be funded by Roche.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH (Free ASH Whitepaper) in December 2023 support the Company’s belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.