On September 30, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 4,653,036 shares of common stock in a registered direct offering at a purchase price of $0.27 per share (Press release, AIM ImmunoTech, SEP 30, 2024, View Source [SID1234646920]). In a concurrent private placement, the Company also agreed to issue unregistered Class C warrants to purchase up to an aggregate of 4,653,036 shares of common stock and, unregistered Class D warrants to purchase up to an aggregate of 4,653,036 shares of common stock. The Class C and Class D warrants will each have an exercise price of $0.28, will be exercisable six months from the date of issuance and, in the case of the Class C warrants, will expire on the eighteen-month anniversary from the initial exercise date, and in the case of the Class D warrants, will expire on the five-year anniversary from the initial exercise date.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $1.26 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, at (212) 895-3745.

The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and the shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 29, 2024 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, reported a poster presentation of the comparative clinical outcomes of patients from FUMANBA-1 study with relapsed/refractory multiple myeloma (R/R MM) who received the fully human anti-BCMA CAR-T cell therapy Equecabtagene Autoleucel (Eque-cel, Fucaso) under different lymphodepletion regimensat the 2024 International Myeloma Society (IMS) Annual Meeting (Press release, IASO Biotherapeutics, SEP 29, 2024, IASO Bio Presented Comparative Clinical Outcomes on the Optimal Lymphodepletion Prior to Infution of Equecabtagene Autoleucel（FucasoTM）in Patients with Relapsed Refractory Multiple Myeloma at 2024 IMS Annual Meeting [SID1234646909]). Results indicate that a full lymphodepletion dose can significantly improve the depth and duration of remission, prolong progression-free survival, without more treatment-related toxicity in patients.

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Abstract Number：P-094
Abstract Title: The Optimal Lymphodepletion Prior to Eque-cel in Patients with Refractory Relapsed Multiple Myeloma in FUMANBA-1 Study
Presentation Date：September 28, 2024（UTC-3)

The poster presents a post-hoc analysis of the FUMANBA-1 study which enrolled 91 subjects without prior CAR-T treatment to receive Eque-cel. The median follow-up period was 18.07 months. Of the 91 subjects, 33 underwent a lymphodepletion dose adjustment, while the remaining 58 received the standard lymphodepletion dose. Both groups had similar baseline characteristics, including age range, physical fitness scores, tumor staging, high-risk cytogenetic abnormalities, and previous lines of treatment.

The results indicate that, in terms of efficacy, the overall response rate (ORR) and stringent complete remission rate (sCR) for the standard-dose group were 100% and 82.8%, respectively, while the dose-adjusted group had rates of 97% and 78.8% .The standard-dose group also exhibited greater remission depth and better long-term prognosis, with 92.2% of patients maintaining a duration of response (DOR) exceeding one year, compared to 70.6% in the dose-adjusted group. Additionally, the median time to achieve minimal residual disease (MRD) negativity was longer in the dose-adjusted group at 22 days, compared to 15 days in the standard-dose group. The 12-month MRD negativity rate was 90.4% in the standard-dose group, significantly higher than the 63.7% observed in the dose-adjusted group (HR=3.33, P=0.0166). Regarding the 12-month progression-free survival (PFS) rate, the standard-dose group achieved 92.2% with a median PFS not yet reached, while the dose-adjusted group had a 12-month PFS of 73.5% and a median PFS of 30.28 months (HR=3.64, P=0.0032). A similar trend was noted in PFS among patients receiving a 90% dose adjustment.

In terms of safety, no significant differences in the severity and incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups. CRS (grades 1-2) occurred in 94.8% of the standard dose group and 93.9% of the dose-adjusted group, with no severe CRS (≥grade 3) in either group. Apart from one grade 2 ICANS case in the adjusted group, no ICANS (≥grade 3) occurred in either group .

Conclusions：lymphodepletion prior to CAR-T cell therapy is essential for achieving optimal CAR-T efficacy. The study further confirms that appropriate lymphodepletion regimen is crucial for effectiveness of eue-cel treatment, significantly improving treatment outcomes and prognosis. When patients can tolerate it, administering the full lymphodepletion doses, when possible, can lead to greater benefits without increasing toxicity.

The principal investigator of this study, Professor Lugui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "The lymphodepletion regimen is crucial for CAR-T cell therapy. Data from this study indicate that standardized and sufficient lymphodepletion can lead to a higher quality of remission and more ideal clearance of minimal residual disease without increasing the potential of adverse reactions. These findings provide a scientific basis to ensure the efficacy and safety of CAR-T cell therapy through optimizing regimens of lymphodepletion, which will ultimately lead to longer survival and improved quality of life for patients with R/R MM."

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, said: "We are delighted to present new finding from our FUMANBA-1 study. This study demonstrated the critical role of standard lymphodepletion in enhancing treatment outcomes and prognosis for patients.. these findings will contribute significantly to the establishment and optimization of lymphodepletion preconditioning standards in the field of CAR-T cell therapy, Our goal is to drive the standardization of industry practices, ensuring that every patient receiving CAR-T therapy benefits from a more scientific and efficient treatment plan."

About FUMANBA-1 Study

The FUMANBA-1 Study is a Phase Ib/II, single-arm, multicenter study to assess the efficacy and safety of the investigational drug Equecabtagene Autoleucel, a fully human BCMA CAR-T cell therapy, in patients with R/R MM who have received 3 or more lines of treatment.

On September 28, 2024 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported the presentation of new data at the 66th Annual Meeting of the American Society for Radiation Oncology (ASTRO), taking place September 29 – October 2, 2024, in Washington, D.C. (Press release, Naveris, SEP 28, 2024, View Source [SID1234646911]). These presentations will showcase the role of the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test, in the management of HPV-driven oropharyngeal cancers, with a focus on integration into radiation oncology practices.

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"ASTRO is the premier gathering for radiation oncology professionals, providing the perfect platform to showcase how the NavDx test is transforming the care of patients with HPV-driven cancers," said Barry M. Berger, M.D., Chief Medical Officer at Naveris. "These presentations will highlight the role of testing in personalizing treatment, enhancing real-time surveillance, and ultimately improving patient outcomes in the field of radiation oncology."

Oral Presentations:

The following presentation will be part of SS 37 – H&N 1: Envisioning the Future: Leading Edge Research in HPV-Associated Oropharyngeal Cancer on Tuesday, October 1, 2024, from 3:00 PM – 4:00 PM EDT at the Walter E. Washington Convention Center (WWCC), Room 145:

Tuesday, October 1, 2024 | 4:40 PM – 4:50 PM EDT
The Preliminary Analysis of Circulating Human Papillomavirus DNA in a Phase III Trial of Concurrent Chemoradiation (CRT) with Intensity Modulated Proton Therapy (IMPT) vs. IMRT in Oropharyngeal Squamous Cell Carcinoma
Presenting Author: Li Wang, M.D., Ph.D. | Senior Author: Steven Frank, M.D.
MD Anderson Cancer Center, Houston, TX
This large study analyzed over 1,000 blood samples and showed that the NavDx test can identify patients at risk for treatment failure earlier than imaging, demonstrating its potential as a robust biomarker to guide treatment intensity in HPV+ OPSCC.
The following educational session presentation will also incorporate a discussion of the NavDx test:

Monday, September 30, 2024 | 10:30 AM – 11:30 AM EDT | Room 151
EDU 24 – Integration of HPV ctDNA Testing into Clinical Practice for HPV+ OPSCC – Ready for Prime Time?
Moderator: John Lukens, M.D. | Speakers: David Routman, M.D., Michelle Mierzwa, M.D., Dan Faden, M.D.
University of Pennsylvania, Mayo Clinic, University of Michigan, Mass General Brigham
This educational session will explore the use of HPV ctDNA testing in clinical practice for HPV+ OPSCC, incorporating the NavDx test as part of a broader discussion on using ctDNA for treatment guidance and monitoring.
Poster Presentations:

The following posters will be part of PQA 10 – Head & Neck Cancer and Health Services Research/Global Oncology on Wednesday, October 2, 2024, from 10:30 AM – 11:45 AM EDT at WWCC, Hall C:

(3608) The Impact of Circulating Tumor Human Papillomavirus (HPV) DNA Clearance Kinetics on Disease Outcomes during Chemoradiation in Patients with HPV-Associated Oropharyngeal Cancer
Presenter: Sujith Baliga, M.D. | Senior Author: David M. Blakaj, M.D., Ph.D.
The Ohio State University, Columbus, OH
This study shows that changes in NavDx test results during treatment can predict outcomes, with rapid clearance indicating better control and persistent positivity suggesting higher risk, highlighting NavDx as a tool for adjusting radiation therapy intensity based on patient risk.
(3718) Tracking Circulating Tumor HPV DNA with Early Cessation of Radiotherapy in Oropharynx Cancer
Presenter: Zubir Rentiya, M.D., MSc | Senior Author: Charles McLaughlin, M.D.
University of Virginia, Charlottesville, VA
This study shows that using mid-treatment NavDx test results to guide early cessation of radiotherapy led to excellent outcomes, with superior progression-free survival compared to patients completing the full course of treatment.
(3639) Comparative Performance of ctHPVDNA and Imaging Surveillance for Oropharyngeal Cancer Following Radiotherapy
Presenter: Yifu Ding, M.D., Ph.D. | Senior Author: Walter A. Stokes, M.D.
Winship Cancer Institute of Emory University, Atlanta, GA
This study found that NavDx outperforms imaging in post-radiotherapy surveillance, with fewer false positives and higher specificity.
Naveris will be exhibiting at the conference at Booth #2037, where attendees can learn more about NavDx and its impact on improving care for patients with HPV-driven cancers in radiation oncology.

For more information about Naveris and NavDx, please visit www.naveris.com and www.NavDx.com.

On September 28, 2024 Kelun reported that China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen (Press release, Kelun, SEP 28, 2024, View Source [SID1234646910]). Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.

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TNBC

On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.

The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator’s choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.

Binghe Xu said, "Breast cancer is a highly prevalent malignant tumor in the world, threatening women’s lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs."

NSCLC

On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.

Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.

Prof. Wenfeng Fang said, "The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations."

CC

On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.

Professor Jing Wang said, "Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients."

EC/OC

On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.

40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).

Prof Danbo Wang said, "Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients."

With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.

On September 27, 2024 Poseida Therapeutics, Inc. (the "Company") reported new interim clinical data from its ongoing Phase 1 trial of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma ("RRMM") (Press release, Poseida Therapeutics, SEP 27, 2024, View Source [SID1234646929]).

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P-BCMA-ALLO1 is an investigational non-viral, stem cell memory T cell ("TSCM")-rich allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with RRMM. The Company is developing this investigational off-the-shelf allogeneic CAR-T cell therapy with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, "Roche") as part of a broader collaboration focused on addressing blood cancers with the Company’s TSCM-rich CAR-T platform.

Data, based on an efficacy cutoff date of September 6, 2024 and a safety cutoff date of July 31, 2024, demonstrated a 91% overall response rate ("ORR") and compelling safety results in the 23 heavily pretreated patients in Arm C, an optimized lymphodepletion arm. The new clinical data were presented on September 27, 2024 in an oral session at the 21st International Myeloma Society Annual Meeting ("IMS") in Rio de Janeiro.

The ongoing open-label, multicenter Phase 1/1b dose-escalation and expansion trial in patients with RRMM is assessing the safety and maximum tolerated dose of P-BCMA-ALLO1 (primary objective) and its anti-myeloma activity (secondary objective). As of July 31, 2024, 72 unique patients were enrolled and had at least 4 weeks of follow-up as an intent-to-treat ("ITT") population and were treated across four study arms (S, A, B and C) that included different P-BCMA-ALLO1 doses and lymphodepletion regimen combinations. Study participants were required to have received three or more prior lines of therapy, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. The trial enrolled a heavily pretreated patient population with 43% of patients having received prior B-cell maturation antigen ("BCMA")- and/or G protein-coupled receptor class C group 5 member D ("GPRC5D")-targeting therapy. Most prior BCMA therapies included autologous CAR-T and/or T-cell engagers ("TCE"). Additionally, 33% of study participants were racial minorities.

In the ITT population, 100% of patients enrolled were infused with P-BCMA-ALLO1. No patients required anti-myeloma bridging therapy or prophylaxis with steroids or tocilizumab, and there was no invasive apheresis or manufacturing wait time. The median time from enrollment to the start of study treatment was one day.

The ORR across all four study arms was 54%; 11% of patients achieved a complete response ("CR") or a stringent complete response ("sCR"), and 33% achieved a very good partial response or higher ("VGPR+"). The median duration of response ("DoR") was 232 days for study Arms A and B, including patients with six or more months of follow-up at the time of data cut-off. Expansion and persistence of the CAR-T cells in patients after infusion has been dependent upon the conditioning dose of cyclophosphamide. P-BCMA-ALLO1 levels measured in the peripheral blood and were much higher in patients in Arm C (cyclophosphamide 750 mg/m2/day) and Arm B (cyclophosphamide 1000 mg/m2/day) than in patients in Arm S (cyclophosphamide 300 mg/m2/day), and Arm A (cyclophosphamide 500 mg/m2/day). Arm C was identified as the optimized lymphodepletion arm based on cellular kinetics, safety and efficacy.

Results from 23 study participants in Arm C were highlighted in the oral session at IMS. Patients received cyclophosphamide 750 mg/m2/day and fludarabine 30 mg/m2/day and approximately 2×106 cells/kg P-BCMA-ALLO1. Some patients were treated in an outpatient setting. Arm C patient details include:

•Nearly half (48%) were age 65 or older

•All were heavily pretreated, with a median of six prior lines of anti-myeloma therapy and a maximum of 14

•62% of patients had received prior BCMA-targeting therapy

•29% had failed both a BCMA CAR-T and a bispecific TCE, and 29% had failed both a BCMA-targeting therapy and the GPRC5D-targeting TCE, talquetamab

•Approximately two-thirds of patients (62%) had high-risk disease by cytogenetics and 38% had extramedullary disease

Efficacy results, which are still evolving, for the 23 patients in Arm C showed:

•An ORR of 91%, with a 100% ORR in BCMA-naïve patients, an 86% ORR in those who had received at least one prior BCMA-targeting treatment (all had received prior CAR-T and/or TCE), and an 86% ORR in those who had received at least one prior BCMA-targeting treatment and/or talquetamab

•22% achieved a CR or an sCR

•48% achieved VGPR+

•Median DoR could not be estimated at the time of data cut-off because the current median follow-up is less than 3.5 months (for pooled arms A and B, the median DoR was more than seven months (estimated range of five-10 months), with a median time to response of only 16 days)

P-BCMA-ALLO1 was well-tolerated with key safety results from Arm C, including:

•No dose-limiting toxicities, Grade 3 or higher cytokine release syndrome ("CRS") or immune effector cell neurotoxicity syndrome ("ICANS"). The incidence of Grade 1 or 2 CRS was 39% and the incidence of Grade 1 or 2 ICANS was 13%

•The incidence of infections was 48%, including 30% that were Grade 1 or 2 and 17% that were Grade 3

•Rapid cytopenia recovery in the vast majority of cases

•No graft-vs-host disease (GvHD), hemophagocytic lymphohistiocytosis (HLH), Parkinsonism or cranial neuropathies observed

•The safety results of P-BCMA-ALLO1 in arm C have been consistent with those observed in the other three arms of the Phase 1 trial, with a total safety database, including 72 unique patients

The ongoing P-BCMA-ALLO1 Phase 1/1b trial is enrolling patients using the Arm C lymphodepletion regimen described above, across two dosing cohorts, with dose optimization ongoing in Arm C.

Roche Collaboration

Under that certain Collaboration and License Agreement, dated July 30, 2022, as amended (the "Roche Agreement"), by and between the Company and Roche, Roche did not timely exercise its option to acquire an exclusive license to the Company’s BCMA/CD19 Allo CAR T-cell therapy program for the development of hematological malignancies (the "BCMA/CD19 Program"), and, as a result, the rights held by Roche with respect to the BCMA/CD19 Program under the Roche Agreement have been deemed terminated. The Company plans to continue development of the BCMA/CD19 Program internally.