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Theratechnologies Reports Second Quarter 2023 Financial Results and Business Updates

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Wednesday, July 12, 2023
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For the second quarter of fiscal 2023, net sales of EGRIFTA SV® were $10,853,000 compared to $11,416,000 in the second quarter of fiscal 2022, representing a decrease of 4.9% year-over-year.

Key Points: 
  • For the second quarter of fiscal 2023, net sales of EGRIFTA SV® were $10,853,000 compared to $11,416,000 in the second quarter of fiscal 2022, representing a decrease of 4.9% year-over-year.
  • Trogarzo® net sales in the second quarter of fiscal 2023 amounted to $6,696,000 compared to $7,852,000 for the same quarter of 2022, representing a decrease of 14.7% year-over-year.
  • We ended the second quarter of fiscal 2023 with $25,369,000 in cash, bonds and money market funds.
  • In the second quarter of fiscal 2023, changes in operating assets and liabilities had a positive impact on cash flow of $4,643,000 (2022-positive impact of $10,701,000).

PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

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Wednesday, June 14, 2023
Biologics license application, Biotechnology, ICI, Progression-free survival, PDSB, Infection, RECIST, OS, Cancer, Clinical trial, BOR, Head, PFS, Stage 2, ASCO, Investigational New Drug, CD8, American Society of Clinical Oncology, Patient, Annual general meeting, HPV, CD4, FDA, Pembrolizumab, BLA, Society, IND, Safety, Disease, Medical imaging, Pharmaceutical industry

The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023 .

Key Points: 
  • The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023 .
  • Additional patients in the trial have yet to undergo imaging evaluation.
  • Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1.
  • In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in the third quarter of 2023.

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Wednesday, May 31, 2023
Cervical cancer, Interim, US Foods, OTS, Precigen, Progression-free survival, SC, DCR, CMC, RECIST, BOR, Infection, Immunotherapy, Doctor of Philosophy, PFS, ASCO, Investigational New Drug, American Society of Clinical Oncology, Patient, Annual general meeting, HPV, Trial of the century, Infrared spectroscopy correlation table, Secondary, FDA, Pembrolizumab, Abstract, IND, Society, ORR, Food, Safety, Pharmaceutical industry

The Phase 2 randomized, open-label, two-arm, multicenter study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab versus pembrolizumab monotherapy in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant.

Key Points: 
  • The Phase 2 randomized, open-label, two-arm, multicenter study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab versus pembrolizumab monotherapy in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant.
  • The study will enroll approximately 46 patients who previously have been treated with pembrolizumab for recurrent or metastatic disease.
  • In the Phase 1 study, PRGN-2009 was evaluated as a monotherapy (N=6) and in combination with a checkpoint inhibitor (N=11) in patients with recurrent or metastatic human papillomavirus (HPV)-associated cancers.
  • Patients in the Phase 2 study will be randomized 1:1 to the combination of PRGN-2009 and pembrolizumab (cohort 1) or pembrolizumab monotherapy (cohort 2).

Theratechnologies to Present Preliminary Safety and Efficacy Data from Phase 1 Trial of Sudocetaxel Zendusortide in Heavily Pretreated Cancer Patients at ASCO 2023

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Thursday, May 25, 2023
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Based on the results presented at ASCO, Theratechnologies is engaged with the U.S. Food and Drug Administration (FDA) to amend the protocol of the Phase 1 clinical trial of sudocetaxel zendusortide.

Key Points: 
  • Based on the results presented at ASCO, Theratechnologies is engaged with the U.S. Food and Drug Administration (FDA) to amend the protocol of the Phase 1 clinical trial of sudocetaxel zendusortide.
  • The amendments are designed to improve the therapeutic window and allow for more prolonged therapy with sudocetaxel zendusortide, reflecting changes in patient selection and evaluation of alternative dosing regimens.
  • “The early efficacy data for our lead peptide-drug conjugate, sudocetaxel zendusortide, confirm that it rapidly internalizes and hyper-targets delivery of cytotoxic payload directly into cancer cells,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.
  • The starting dose of 30 mg/m2 every 3 weeks (Q3W) was selected based on sudocetaxel zendusortide preclinical data.

eFFECTOR Therapeutics Reports Positive Data Updates from Phase 2 Expansion Cohorts Evaluating Zotatifin in Patients with ER+ Metastatic Breast Cancer at the ASCO 2023 Annual Meeting

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Thursday, May 25, 2023
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SOLANA BEACH and REDWOOD CITY, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (“STRIs”) for the treatment of cancer, today announced positive interim data updates from a Phase 2 expansion cohort evaluating zotatifin combined with fulvestrant and abemaciclib (ZFA triplet) in patients with ER+ metastatic breast cancer (mBC). These data, as well as initial data from further dose escalation, will be presented as a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6 in Chicago, IL by Ezra Rosen, M.D. from Memorial Sloan Kettering Cancer Center (MSK). The Company will host a virtual investor call on Sunday, June 4, 2023, at 6:30 PM CT / 7:30 PM ET to discuss the data and clinical progress. Sarat Chandarlapaty, M.D., Ph.D. of MSK will join the call to discuss the unmet medical need and current treatment landscape for patients with ER+ mBC.

Key Points: 
  • New interim data were presented on the fully enrolled expansion cohort of patients (n=20) who received the ZFA triplet with zotatifin dosed at 0.07 mg/kg on Days 1 and 8 of 21-day cycles.
  • Patients were heavily pre-treated, having received a median of four prior lines of therapy for metastatic disease.
  • Five out of 19 (26%) RECIST-evaluable patients achieved a partial response (PR), including four confirmed and one unconfirmed.
  • Zotatifin has been generally well tolerated in dose escalation cohorts, with no dose limiting toxicities or serious adverse events observed.

Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME

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Tuesday, May 2, 2023
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These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203.

Key Points: 
  • These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203.
  • No dose-dependent increase of CRS was observed across Phase 1a and Phase 1b Cohort A (N=38 patients infused with IMA203 in total).
  • Clinical activity for IMA203 TCR-T monotherapy in Phase 1b Cohort A: IMA203 monotherapy demonstrates a high rate of deep objective responses with ongoing durability of more than 9 months after treatment in some patients.
  • Immatics will host a conference call today, May 2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data.

Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR NK Cell Programs for Multiple Myeloma at 2022 ASH Annual Meeting

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Saturday, December 10, 2022
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SAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today presented interim clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT576 for patients with relapsed / refractory multiple myeloma (r/r MM) at the 64th American Society of Hematology Annual Meeting and Exposition. The off-the-shelf product candidate, which is derived from a clonal master engineered induced pluripotent stem cell (iPSC) line, incorporates a chimeric antigen receptor (CAR) targeting B-cell maturation antigen (BCMA) as well as a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor to maximize antibody-dependent cellular cytotoxicity (ADCC) and enable dual-antigen targeting of myeloma cells through combination with monoclonal antibody (mAb) therapy. Preclinical data published last month in the journal Nature Communications (Cichocki et al. 2022, 13:7341) demonstrated that single-dose administration of FT576 was effective at controlling tumor growth in vivo, with deeper and more sustained anti-tumor activity observed through multi-dose administration of FT576 as well as in combination with the CD38-targeted monoclonal antibody daratumumab.

Key Points: 
  • Grade 3 or greater treatment-emergent AEs (TEAEs) not related to FT576 primarily included hematologic cytopenias associated with conditioning chemotherapy.
  • Administration of three doses of FT555 as monotherapy further improved tumor clearance and showed superior activity compared to single-dose primary CAR T cells.
  • Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.
  • Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer.

Loxo@Lilly Presents Updated Pirtobrutinib Data from the Phase 1/2 BRUIN Clinical Trial at the 2022 American Society of Hematology Annual Meeting

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Monday, December 12, 2022
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INDIANAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Loxo@Lilly, the oncology unit of Eli Lilly and Company (NYSE: LLY), today announced updated clinical data from the pirtobrutinib global Phase 1/2 BRUIN trial in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Richter transformation (RT), and Waldenström macroglobulinemia (WM). Pirtobrutinib is an investigational, highly selective, reversible (non-covalent) inhibitor of Bruton's tyrosine kinase (BTK). These data are featured in oral and poster presentations at the 2022 American Society of Hematology (ASH) Annual Meeting. 

Key Points: 
  • These data are featured in oral and poster presentations at the 2022 American Society of Hematology (ASH) Annual Meeting.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib monotherapy in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • The BRUIN trial includes one of the largest prospective cohorts of BTK inhibitor pre-treated CLL/SLL patients ever studied.
  • The trial includes a Phase 1 dose-escalation phase, a Phase 1b combination arm, and a Phase 2 dose-expansion phase.

NCI/NIH Award $2 Million to Immunicom to Initiate Clinical Trial Evaluating Breakthrough Immunopheresis® LW-02 Molecular Subtractive Therapy in Refractory ER+/Her2- Breast Cancer

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Tuesday, June 14, 2022
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View the full release here: https://www.businesswire.com/news/home/20220614005928/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220614005928/en/
    Immunicom's LW-02 molecular ligand-capture column (Photo: Business Wire)
    We are honored to receive this grant from the NCI/NIH recognizing the potential of Immunopheresis therapy.
  • This clinical trial is a monumental step for Immunicom to address unmet needs for patients with difficult-to-treat cancers, said Principal Investigator Dr. Robert Segal, Immunicoms Chief Medical Officer.
  • In a process like dialysis, Immunopheresis therapy removes sTNF-R1/2 from plasma, helping kickstart endogenous TNF- response to cancer without toxicities that increase the risk of side effects.
  • Immunicom is headquartered in San Diego, CA, with operations in Houston, TX, Philadelphia, PA, Krakow, Poland, and Istanbul, Turkey.

Gracell Biotechnologies Presents Updated Clinical Data for BCMA/CD19 Dual-targeting FasTCAR GC012F in RRMM at EHA2022 Congress, Highlighting 100% MRD Negativity Rate in All Treated Patients

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Sunday, June 12, 2022
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SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, June 12, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the updated clinical data from a multicenter study evaluating GC012F, the Company's autologous CAR-T therapeutic candidate dual-targeting B-cell maturation antigen (BCMA) and CD19, for the treatment of relapsed/refractory multiple myeloma (RRMM). Gracell shared the data at the European Hematology Association 2022 Hybrid Congress (EHA2022 Congress), held from June 9-12 in Vienna, Austria.

Key Points: 
  • Gracell shared the data at the European Hematology Association 2022 Hybrid Congress (EHA2022 Congress), held from June 9-12 in Vienna, Austria.
  • "The updated data of the final dataset of 29 treated patients underscore the deep responses achieved with GC012F, including a 100% MRD negativity rate in all patients treated," commented Dr. Martina Sersch, Chief Medical Officer of Gracell.
  • In addition, we presented at EHA the first-in-human data of GC012F in B-NHL, a potential second indication.
  • We look forward to continuing developing this lead asset and providing a new treatment option to the patients with high unmet needs."