On September 5, 2024 HanX Biopharmaceuticals reported that the first Phase 2 clinical trial of HX009 in combination therapy received approval from the National Medical Products Administration (NMPA) (Press release, HanX Biopharmaceuticals, SEP 5, 2024, View Source [SID1234655961]). This application, which met the relevant drug registration requirements, approved the Phase 2 clinical trial of HX009 in combination therapy for biliary tract cancer (BTC).

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HX009 is a clinical-stage investigational anti-PD-1 and anti-CD47 bifunctional large molecule cancer immunotherapy independently developed by Hans-Itai. Two Phase I single-agent dose-escalation trials in solid tumors have been successfully completed in Australia and China. Phase I monotherapy data demonstrated a favorable safety and tolerability profile, with single-agent anti-tumor efficacy observed in multiple indications, including biliary tract malignancies. Existing data support advancement into Phase II and combination trials. The company currently plans to conduct multicenter Phase II trials in multiple clinical indications.

Dr. Lei Zhang, Chief Medical Officer of Hans Ait, said: "We are very pleased that HX009 has received its first clinical approval for combination use from the National Medical Products Administration. Although the application of immunotherapy (including PD-1/PD-L/CTLA4 antibodies, etc.) has improved the survival prognosis of BTC patients to a certain extent, some patients still lack response to immunotherapy and suffer from immunotherapy resistance. In the Phase I clinical trial, we have observed that HX009 monotherapy can induce objective remission of biliary tract malignancies, suggesting the therapeutic potential of HX009 in this indication. We look forward to rapidly advancing this clinical trial and providing new treatment options for patients as soon as possible."

On September 5, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 Cantor Global Healthcare Conference on Wednesday, September 18, 2024, at 10:20 a.m. ET (Press release, Agios Pharmaceuticals, SEP 5, 2024, View Source [SID1234646365]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

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.

On September 4, 2024 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Fortress Biotech, SEP 4, 2024, View Source [SID1234646350]). The presentation will be available for on-demand viewing by conference attendees starting on September 9, 2024, at 7:00 a.m. ET. The Company will also attend one-on-one meetings during the conference.

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On September 4, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported that the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA (isatuximab-irfc) (Press release, ALX Oncology, SEP 4, 2024, View Source [SID1234646335]). Evorpacept is ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated Fc domain and SARCLISA is Sanofi’s approved CD38 monoclonal antibody in patients with relapsed or refractory multiple myeloma (RRMM).

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SARCLISA binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. CD38 is highly and uniformly expressed on the surface of MM cells and after first-line treatment, some relapsed or recurred patients have shown resistance to CD38 agents. CD47 expression increases as multiple myeloma progresses, suggesting that evorpacept may have the potential to re-sensitize tumors to CD38 treatment or overcome anti-CD38 resistance. This novel therapeutic combination has demonstrated synergistic anti-tumor activity in preclinical models.

"Multiple myeloma remains an incurable hematologic malignancy for which there is significant need for innovation in new treatment modalities to improve the clinical management of this disease," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer at ALX Oncology. "We are excited by the potential for the therapeutic combination being evaluated in the UMBRELLA study, in collaboration with Sanofi, to improve patient outcomes. This trial also reinforces the significant potential of evorpacept to deepen anti-cancer activity while maintaining a strong safety profile in combination with a range of therapeutic regimens used to treat both hematologic and solid cancers."

Under the terms of the agreement, Sanofi will conduct the multicenter, randomized, open-label, controlled, parallel-group UMBRELLA phase 1/2 clinical study (NCT04643002) to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM. Part 1 of the study is designed to evaluate the dosing of evorpacept in combination with standard doses of SARCLISA and dexamethasone to identify a recommended evorpacept dose. Part 2 is designed to investigate the efficacy and safety of this three-drug combination in an expanded population of patients with RRMM. ALX Oncology will supply evorpacept and Sanofi will conduct the clinical trial. ALX Oncology owns worldwide commercial rights to evorpacept.

"Our current experience with SARCLISA suggests it may prove to be an excellent combination partner for novel agents in development," said Peter C. Adamson, M.D., Global Head of Oncology Development at Sanofi. "Therefore, we are pleased to share we have started to enroll patients on this arm of our umbrella study. The partnership with ALX Oncology is part of our strategic approach of exploring potentially synergistic combinations to address therapeutic challenges in patients with relapsed or refractory multiple myeloma."

About multiple myeloma
Multiple myeloma (MM) is the second most common hematologic malignancy, with more than 185,000 new diagnoses of MM worldwide annually (Globocan) and over 35,000 new diagnoses in the United States each year (American Cancer Society). Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.