A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy

This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

Start Date20 Apr 2017

Sponsor / Collaborator

Rainier Therapeutics, Inc.

NCT02925533 / TerminatedPhase 1IIT

A Phase 1B Study of B-701 in Combination With Pembrolizumab in Relapsed or Refractory Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

This research study is studying a combination of two experimental drugs as a possible treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder Cancer that got worse while on treatment with standard therapy.
The following interventions will be involved in this study:
B-701
Pembrolizumab

Start Date14 Dec 2016

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT02401542 / TerminatedPhase 1/2

A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy

This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

Start Date01 Jun 2015

Sponsor / Collaborator

Rainier Therapeutics, Inc.

100 Clinical Results associated with Rainier Therapeutics, Inc.

0 Patents (Medical) associated with Rainier Therapeutics, Inc.

Literatures (Medical) associated with Rainier Therapeutics, Inc.

20 May 2019·Journal of Clinical Oncology

Interim analysis of the fierce-21 phase 2 (P2) study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Author: Pang, S ; Mellado, Begona ; Currie, Graeme ; Vaishampayan, Ulka N. ; Vogl, Florian D. ; Pal, Sumanta K. ; Urun, Yuksul ; Necchi, Andrea ; Abella, Esteban ; Castellano, Daniel E. ; Park, Se Hoon

4547 Background: Patients (pts) with mUC with FGFR3 mutations who have failed platinum-based chemotherapy have a poor prognosis. Their response to immune checkpoint inhibitors appears diminished 10% or less compared to WT pts. 20% of mUC pts harbor FGFR3 mutations or fusions (M/F). Vofatamab is a fully human monoclonal antibody against FGFR3 that blocks activation of the wildtype and genetically activated receptor. FIERCE-21 is a Phase 1b/2 study designed to evaluate vofatamab monotherapy (VFM) or in combination with docetaxel (VFD). Methods: The P2 expansion enrolled mUC pts with FGFR3 M/F+ tumor (identified with FoundationONE CDx™), who failed ≥ 1 prior line of chemotherapy (including prior taxane for pts receiving VFM) or recurred ≤ 12 months of (neo)adjuvant chemotherapy. Pts had measurable disease and ECOG ≤ 1. Treatment consisted of vofatamab at 25 mg/kg alone and in combination with docetaxel at 75 mg/m2 q3w. Efficacy was assessed by investigators (RECIST 1.1). Primary objectives were safety and objective response-rate (ORR). Results: In the P2, 21 pts each received VFM and VFD. 57% of VFD pts had received at least 2, and 71% of VFM at least 3 prior lines of therapy. Best response to prior therapy was PD for 67% of VFD and 38% of VFM. The safety profile is consistent with previously reported data. TEAEs occurring in > 20% of pts were decreased appetite, diarrhea, pyrexia, asthenia, anemia, dyspnea, and fatigue. Most common vofatamab-related TEAEs in > 10% of pts were asthenia, diarrhea, decreased appetite and rash; all were Grade 1 or 2. In VFM, only 1 pt had a grade 3 TEAE and no pt discontinued treatment due to an AE. There were no cases of hyperphosphatemia, ocular or nail toxicity; 1 pt reported grade 2 skin toxicity. For pts receiving VM, median age was 70 yrs, ECOG 1 = 67%, Hgb < 10 g/dL 5%, liver metastases 19%. Responses have been seen in 7 pts to date including those receiving both VFM and VFD. Conclusions: Vofatamab both alone and combined with D in a q3w schedule are well tolerated with a low frequency of grade 3 TEAEs. Both VFM and VFD have demonstrated efficacy in terms of ORR. PFS/OS and DOR data will be presented at 7+ months for VFD and 9+ months for VFM. Clinical trial information: NCT02401542.

20 May 2019·Journal of Clinical Oncology

FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.

Author: Andric, Zoran Gojko ; Tupikowski, Krzysztof ; Kelly, William Kevin ; Vaena, Daniel A. ; Abella, Esteban ; Siefker-Radtke, Arlene O. ; Curigliano, Giuseppe ; Rezazadeh Kalebasty, Arash ; Lugowska, Iwona ; Currie, Graeme

4511 Background: Patients (pts) with mUC who have failed platinum-based chemotherapy have a poor prognosis. Reported response rates to immune checkpoint inhibitors (ICI) are approximately 20%. 20% of pts with mUC harbor FGFR3 mutations or fusions (M/F), which may result in lower sensitivity to ICI. V (B-701) is a fully human monoclonal antibody against FGFR3 that blocks activation of both the wildtype and genetically activated receptor. This is a Phase 1b/2 study designed to evaluate V monotherapy window followed in combination of V with P(VP) (NCT03123055). Methods: This trial enrolled mUC pts with failure to ≥ 1 prior line of chemotherapy or recurrence ≤ 12 months of (neo)adjuvant chemotherapy, measurable disease and ECOG <2. Treatment consisted of v at 25 mg/kg alone for 2 week monotherapy window followed by combination with P 200 mg q3w.during the V window paired tumor biopsy were obtained. Efficacy was assessed by investigators (RECIST 1.1). Primary objectives were safety and activity [ORR]). Results: 35 pts have received treatment (Ph1b:8, WT:20, M/F+: 7). WT patients were unselected for PD-1 status, predominately male (55%) white (95%), all had received at least 1 line of prior chemo and 60% had Bellmunt scores of > 1. The safety profile is consistent with previously reported data for P. TEAE occurring in >20% of patients were nausea, anemia, diarrhea and fatigue. Six WT patients (30%) had responses (4 confirmed responses, 1 unconfirmed), and an additional patient with an iRECIST response. Responses occurred at a median of 3.5 months. At 4+ months of follow up, 13(65%) remain on treatment @ a median of 8 cycles (range: 1-13). At 5+ months the median PFS has not been reached. Conclusions: VP combination therapy is well tolerated with an encouraging ORR and prolonged PFS in the WT cohort; greater than one would anticipate from P alone based upon historical data. We will be reporting 9+ month preliminary PFS/OS and updated OOR/DOR data. Clinical trial information: NCT03123055.

01 Mar 2019·Journal of Clinical Oncology

Fierce-21: Phase II study of vofatmab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Author: Currie, Graeme ; Abella-Dominicis, Esteban ; Pal, Sumanta K. ; Vaishampayan, Ulka N. ; Urun, Yuksul ; Necchi, Andrea ; Mellado, B ; Park, Se Hoon ; Castellano, Daniel E. ; Pang, S

409 Background: Patients (pts) with mUC who have failed platinum-based chemotherapy have a poor prognosis. About 20% of them usually respond to immune checkpoint inhibitors (ICI). Also, 20% of pts with mUC harbor FGFR3 mutations or fusions (M/F), and this feature may be associated with lower sensitivity to ICI. Vofatamab (B-701) is a fully human monoclonal antibody against FGFR3 that blocks activation of the wildtype and genetically activated receptor. FIERCE-21 is a Phase 1b/2 study designed to evaluate vofatamab monotherapy (VM) or in combination with docetaxel (VD). Methods: The study consists of a P 1b lead-in (P1b with VD), previously reported followed by P2 expansion cohort in FGFR3 M/F+ pts (identified with the FoundationONE CDx™ assay on archival samples). The study enrolled mUC pts with failure to ≥ 1 line prior chemotherapy (including prior taxane treatment) or ≤12 months of (neo)adjuvant chemotherapy, measurable disease and ECOG ≤ 1. Treatment consisted of vofatamab at 25 mg/kg alone (VM) and in combination with D (VD) at 75 mg/m2 q3w. Efficacy was assessed by investigators (RECIST 1.1). Primary objectives were safety and activity (objective response-rate [ORR]). Results: 55 pts have received treatment. In the Ph 2 study, 21 pts received VM, 15 pts received VD. 35% of pts were included as 2nd line therapy, 65% in 3rd or later line of treatment. For pts receiving VD, safety was consistent with Ph 1B data. For pts receiving VM, median age was 67 yrs, ECOG 1 = 71.4%, Hgb < 10 gm/dL 13%, liver metastases 19%, ≥ 2 prior regimens 57%, (best response to prior therapy PD 31%). TEAEs occurring in ≥5% patients were asthenia (19%), diarrhea (9.5%), flushing 14%, chills (9.5%), hypotension (9.5%), decreased appetite (19%) and creatinine increased (9.5%). The majority of TEAS were grade 1 and 2. Only 1 patient on MF had a grade 3 TEAE and only 1 patient discontinued treatment due to an AE. The ORR have been seen in 7 pts to date including those receiving both VM and VD. Conclusions: Vofatamab both alone and combined with D in an every 3-week schedule are well tolerated with a low frequency of grade 3 TEAEs. Both VM and VD have demonstrated efficacy in terms of ORR, and mature results with PFS data will be presented. Clinical trial information: NCT02401542.

News (Medical) associated with Rainier Therapeutics, Inc.

04 Mar 2024

·www.prnewswire.com

Convergent Therapeutics Appoints Scott Myers as Chairman of its Board of Directors

CAMBRIDGE, Mass., March 4, 2024 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for prostate and other cancers, today announced the appointment of Scott Myers as Chairman of its Board of Directors. Mr. Myers previously served as President and Chief Executive Officer of Viridian in 2023, and prior to that, he was the Chief Executive Officer of AMAG Technology, purchased by Covis Pharmaceuticals, SA in November of 2020. Prior to 2020, Mr. Myers served as both Chairman and Chief Executive Officer of Rainier Therapeutics, a private, clinical-stage biotechnology company focused on metastatic bladder cancer that was purchased by Fusion Pharmaceuticals in March of 2020. Prior to joining Rainier, Mr. Myers served as Chief Executive Officer, President and as a director of Cascadian Therapeutics Inc. prior to its acquisition by Seattle Genetics in March of 2018. Mr. Myers also served as Chief Executive Officer of Aerocrine AB, a medical device company from 2011 to 2015 prior to its acquisition by Circassia. "Speaking on behalf of Convergent's Board of Directors and our leadership team, I am delighted that Scott agreed to join our Board as Chair," said Dr. Philip Kantoff, Co-Founder and CEO of Convergent. "Scott brings an enormous amount of experience and expertise as both a Chief Executive Officer, as well as a board member and chair in numerous life science companies." Mr. Myers currently serves as the Chairman of the Board of Dynavax Technologies, a commercial stage vaccine company. Mr. Myers also serves as Chairman of the Board of Directors of Ironshore Pharmaceuticals, a private, commercial stage ADHD company. About Convergent Therapeutics, Inc. Convergent Therapeutics Inc. is a clinical-stage biotechnology company focused on developing next-generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology was developed by Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine, and licensed to Convergent by Cornell University. CONV01-α, a monoclonal antibody conjugated to actinium-225 (Ac-225), a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV01-α is that once bound to PSMA, it becomes internalized, delivering its powerful radioactive payload directly into prostate cancer cells while minimizing damage to surrounding healthy tissue. CONV01-α has the potential to be the first Ac-225 radioantibody approved for use in prostate cancer treatment. For more information, please visit and follow us on Twitter and LinkedIn. SOURCE Convergent Therapeutics

VaccineExecutive ChangeRadiation TherapyAcquisition

31 Jul 2023

·www.globenewswire.com

Immutep Quarterly Activities Report Q4 FY23

Media Release Late-stage & registrational trial progress: TACTI-004 Phase III - Positive feedback received from US FDA for planned registrational trial in 1st line non-small cell lung cancer (1L NSCLC)TACTI-003 Phase IIb – Randomised study in 1st line head & neck squamous cell carcinoma (1L HNSCC) has reached ~91% patient recruitment and top-line results expected in H2 of CY2023AIPAC-003 Phase II/III - First patient dosed in metastatic breast cancer trial Positive eftilagimod alpha (efti) clinical results in TACTI-002 and INSIGHT-003 trials: TACTI-002 Phase II evaluating efti + KEYTRUDA® (pembrolizumab) led to excellent initial Overall Survival (OS) benefit of 25 months in 1L NSCLC patients with >1% PD-L1 TPS; more mature data in H2 of CY2023Final results in 2L HNSCC from TACTI-002 presented at ASCO 2023 showed promising response rates, overall survival, and durable responses including a Complete Response in patient with negative PD-L1INSIGHT-003 Phase I evaluating efti + KEYTRUDA® + doublet chemo achieved 67% response rate and 91% disease control rate in 1L NSCLC, despite 81% of patients having low or negative PD-L1 expression Efti trial expansion: INSIGHT-005 - Regulatory approval to commence the investigator-initiated trial in urothelial carcinomaEFTISARC-NEO - Investigator-initiated trial commenced in soft tissue sarcoma Well financed: Strong cash position of $123.4m, following A$80m capital raise for registrational and late-stage trials of efti and potentially a first-in-human trial for IMP761; extends cash runway to early CY2026 SYDNEY, AUSTRALIA, July 31, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for its fiscal fourth quarter ended 30 June 2023 (Q4 FY23). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-002 (KEYNOTE-PN798) Phase II clinical trial evaluating efti + KEYTRUDA® (pembrolizumab): 1st line Non-Small Cell Lung Cancer (1L NSCLC) Meaningful long-term survival was reported in from Immutep’s TACTI-002 (Two ACTive Immunotherapies) trial in May. An initial median Overall Survival (mOS) of 25 months was achieved in 1L NSCLC patients with >1% PD-L1 TPS (Tumour Proportion Score), a key area of focus for future clinical development with FDA Fast Track designation granted for efti and pembrolizumab in this patient population. Encouragingly, the initial mOS of 25.0 months for this chemo-free combination exceeds the reported rates for patients with the same PD-L1 TPS of >1% from registration trials of anti-PD-1 monotherapy (16.4-month mOS) and combinations of anti-PD-1 with chemotherapy (15.8-to-23.3-month mOS) or with anti-CTLA-4 (17.1-month mOS). Based on the robust initial results, the trial’s Data Monitoring Committee recommended extending OS follow-up data collection to show mature 3-year and potentially 5-year rates. More mature OS data and additional efficacy and safety results will be presented at a major medical conference in H2 CY2023. 2nd Line Head and Neck Squamous Cell Carcinoma (2L HNSCC) Immutep reported positive final TACTI-002 data in 2L HNSCC patients in a poster presentation at the ASCO 2023 Annual Meeting in June. Deep and durable responses were seen from efti plus pembrolizumab regardless of patients’ PD-L1 expression levels (measured by Combined Positive Score or CPS). Encouragingly, median Duration of Response had not been reached (meaning the response is still ongoing) despite a long median follow up of 39 months, providing continued evidence of the durable responses efti helps drive. Notably, one long-lasting Complete Response occurred in a patient with negative PD-L1 expression, who wouldn’t typically be expected to respond to PD-L1 monotherapy. Efti plus pembrolizumab led to an encouraging overall response rate (ORR) of 29.7% and Complete Response (CR) rate of 13.5% in 2L HNSCC patients. Responses were seen across all PD-L1 subgroups. A promising ORR of 38.5% & 60%, median Overall Survival (mOS) of 12.6 & 15.5 months, and 12-month Overall Survival (OS) rate of 52.0% & 66.7%, were seen in patients with a PD-L1 CPS of ≥1 and a PD-L1 CPS ≥20, respectively. The results from the chemo-free IO-IO combination of efti plus pembrolizumab in 2L HNSCC patients with a PD-L1 CPS ≥1 compare favourably to reported results from a registrational trial of anti-PD-1 monotherapy in the same patient population, which showed a 17.3% ORR, mOS of 8.7 months, 12-month OS rate of 40%, a CR rate of 2%, and mDoR of 18.4 months.1 TACTI-003 – Phase IIb clinical trial in 1st line HNSCCImmutep’s ongoing TACTI-003 trial is evaluating efti in combination with pembrolizumab in the 1st line setting in HNSCC. The trial has reached ~91% patient recruitment, and Immutep is on track to report top-line results from TACTI-003 in H2 of CY2023. TACTI-004 Phase III registrational trial in 1st line NSCLC In May, Immutep received positive feedback from the US Food and Drug Administration (FDA), which is supportive of a registrational trial to evaluate efti in combination with an anti-PD-1 for the treatment of 1L NSCLC. Among the items discussed at the meeting were the toxicological package and general aspects of the trial design, including statistics and potential patient population with a focus on 1st line NSCLC patients with a Tumor Proportion Score (TPS) PD-L1 of >1% for which efti plus pembrolizumab has already received Fast Track designation. The Company is advancing its preparations for the trial. AIPAC-003 – Integrated Phase II/III trial in Metastatic Breast Cancer Immutep enrolled and safely dosed the first patient in its integrated Phase II/III AIPAC-003 trial in May. Recruitment has continued with 12 clinical sites now actively recruiting patients, and the trial currently has 3 patients enrolled in the open-label lead-in portion of the trial. This lead-in portion of 6 to 12 patients dosed at 90mg efti will be followed by a randomized (1:1) portion of the Phase II consisting of up to 58 evaluable patients who will receive 30mg efti or 90mg efti to determine the optimal biological dose in combination with paclitaxel. INSIGHT-003 – Phase I in 1st line NSCLCImmutep reported new encouraging clinical data in 1L NSCLC patients in May from the INSIGHT-003 trial, an investigator-initiated Phase I trial conducted by the Frankfurt Institute of Clinical Cancer Research IKF as part of the investigator-initiated INSIGHT platform of studies. The new data showed the therapy is well tolerated and promising initial efficacy signals were observed including a 67% response rate and 91% disease control rate in metastatic 1st line non-small cell lung cancer patients, despite 81% of patients having low or negative PD-L1 expression. INSIGHT-005 – Phase I trial in Urothelial CarcinomaRegulatory approval was received from the Paul-Ehrlich-Institut (“PEI”), German Federal Institute for Vaccines and Biomedicines, to initiate INSIGHT-005 in May. This study is an investigator-initiated trial, open-label Phase I trial evaluating the safety and efficacy of efti in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma which is being conducted by Frankfurt Institute of Clinical Cancer Research IKF as part of the investigator-initiated INSIGHT platform. EFTISARC-NEO - Phase II Trial in Soft Tissue Sarcoma The investigator-initiated study, EFTISARC-NEO, was initiated by the Maria Skłodowska-Curie National Research Institute of Oncology in April. The study is an open-label Phase II trial evaluating efti in combination with radiotherapy and pembrolizumab in up to 40 soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting and is the first time efti will be studied in neoadjuvant, non-metastatic cancer setting. The first patient has been enrolled and safely dosed in July 2023. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASEIn May, Immutep appointed a clinical research organisation to conduct its GLP toxicology study evaluating the safety and toxicity of IMP761, Immutep's proprietary preclinical candidate and the world’s first LAG-3 agonist for autoimmune diseases. This study is a key step before the commencement of first-in-human trials to treat the underlying cause of multiple autoimmune diseases. INTELLECTUAL PROPERTYImmutep was granted three patents during the quarter. A new patent was granted by the US Patent Office protecting Immutep’s intellectual property for treating cancer by administering efti and a PD-1 pathway inhibitor, specifically BMS-936559, durvalumab, atezolizumab or avelumab. The US Patent Office also granted a new patent for composition-of-matter claims covering Immutep’s pre-clinical immunosuppressive product candidate, IMP761, which is designed to target the root cause of autoimmune diseases by directly silencing self-antigen-specific effector T cells. Finally, the Japan Patent Office granted a new patent protecting Immutep’s intellectual property for a potency assay for release testing of efti which is used in the commercial-scale (2,000L) manufacturing process for efti. This new Japanese patent follows the grant of a similar patents in Australia and South Korea in 2023 and 2022 respectively. CORPORATE OVERVIEW Financing CompletedDuring the quarter, Immutep completed a fully underwritten pro rata accelerated non-renounceable entitlement offer (Entitlement Offer) and a placement to institutional investors (Placement) to raise a total amount of A$80 million. The funds raised extends Immutep’s cash runway to early CY2026 and will support its registrational and late-stage trials of efti and ongoing expansion of its clinical pipeline including potentially a first-in-human trial for IMP761. Immutep was pleased to have very strong support from its existing shareholders and welcomed new healthcare-focussed and specialist funds to its register. Board ChangesIn April, Immutep was pleased to appoint highly experienced corporate lawyer, Lis Boyce to its Board as Non-Executive Director. Ms Boyce is currently a partner at Piper Alderman. She has extensive involvement in the Life Sciences and Healthcare sectors and is currently deputy chair of AusBiotech’s AusMedtech Advisory Group and a member of AusBiotech’s NSW Leadership Committee. Ms Boyce replaces Lucy Turnbull who resigned from the Board at the same time. Senior LeadershipThe Company appointed Florian D. Vogl, M.D., Ph.D., MSc, as Chief Medical Officer (CMO) in May. Dr Vogl brings over a decade of experience in the biopharmaceutical industry to the role, with extensive clinical development expertise in the field of oncology. Prior to Immutep, Dr. Vogl held senior management roles in Europe and the United States, including CMO of Cellestia Biotech, Head of Clinical Development Europe at Rainier Therapeutics, Senior Global Medical Leader, Oncology Development at Novartis, and Early Development Leader, Oncology Pipeline at Amgen. He assumed the CMO role from Frédéric Triebel, M.D., Ph.D., who is now primarily focused on his responsibilities as CSO and as a member of Immutep’s Board of Directors. FINANCIAL SUMMARYImmutep’s financial performance over the final quarter (Q4 FY23) continues to reflect prudent cash management as well as investment into its clinical trial program for efti, as aligned with its strategy. Following its financing completed in June, Immutep is fully funded for its current and expanded clinical program through to early CY2026. Cash receipts from customers Q4 FY23 were $16k, compared to $30k in Q3 FY23. The net cash used in G&A activities in the quarter was $1.61 million, compared to $1.12 million in Q3 FY23. The increase is mainly due to the prepayment of certain G&A expenses, including insurance premiums. Payments to Related Parties, for the quarter includes $282k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. The net cash used in R&D activities in the quarter was $5.41 million, compared to $11.52 million in Q3 FY23. The decrease in cash used for the quarter was mainly due to reduced manufacturing activities in the current quarter and the prepayment of clinical trial expenses in the previous quarter. Total net cash outflows used in operating activities in the quarter was $8.35 million compared to $14.17 million in Q3 FY23. The company completed a capital raising of $80m in June 2023, which consisted of a placement and institutional component of the Entitlement Offer of approximately $68m and a retail Entitlement Offer component of approximately $12m. Net cash inflow from financing activities for the quarter was $76.2m. Immutep’s cash and cash equivalent balance as at 30 June 2023 was approximately $123.4 million. Immutep will continue to manage its strong cash balance carefully as it pursues its overall development strategy for efti and IMP761. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Ezra E W Cohen et al., Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study; The Lancet 2019. http://dx.doi.org.libproxy1.nus.edu.sg/10.1016/S0140-6736(18)31999-8 About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to market for patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

Clinical ResultPhase 2Phase 1Phase 3Executive Change

28 Apr 2023

·www.fiercebiotech.com

Chutes & Ladders—BMS CEO set to leave after 8-year run

None Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week. BMS CEO retiring in November Bristol Myers Squibb Bristol Myers Squibb came in hot with one heck of a Thursday news bomb, announcing that CEO Giovanni Caforio, M.D., plans to retire in November after eight years at the helm. He’ll be replaced by newly named Chief Operating Officer Chris Boerner. Caforio’s exit comes as the seventh-largest pharmaceutical by 2022 revenue braces for the loss of exclusivity on three commercial blockbusters, including blood thinner Eliquis and cancer treatments Revlimid and Opdivo. All three are slated for patent expiration this decade. Under Caforio’s leadership, BMS has launched 12 new medicines, and revenue has tripled. Five of the new launches were first-in-class medicines across different disease areas. Last year alone, the company had three new product launches, including TYK2 inhibitor Sotyktu for patients with plaque psoriasis. Boerner was promoted to commercial chief in 2018, and, shortly thereafter, BMS scooped up Celgene for a whopping $74 billion. He was first hired to lead U.S. commercial efforts in 2015 after years at Seagen. As part of the transition announcement, BMS named Boerner COO effective immediately, calling on Adam Lenkowsky, SVP and head of major markets, to be the new commercial chief. Fierce Pharma AbbVie is no Waystar Royco, but plots CEO succession plan AbbVie As far as we at Fierce Biotech know, there’s no lineage of Gonzalez family members lining up to take the helm of AbbVie. But, for the first time, the company teased a succession plan for CEO Rick Gonzalez as he finishes a decade as CEO. Gonzalez said during the company’s first-quarter earnings call that he’s had many conversations with the board about a succession plan, though any handing off of the corporate baton will wait until at least 2024. Gonzalez says his first priority is guiding AbbVie through one of the most significant patent losses in pharmaceutical history, as biosimilars for Humira enter the fold. Revenue for Humira fell by more than 25% in the first quarter, evidence of how quickly Humira’s reign is ending. Gonzalez said that he’s “willing to stay in any capacity that [the board] would desire,” evidence that he’s in no rush to depart. News of his looming, albeit time-devoid, departure comes just one quarter after Gonzalez teased potentially ambitious M&A plans. The Chicago-based pharma then shed a $2 billion dealmaking cap that had been in place since the purchase of Allergan, with Gonzalez telling investors at the time that they should expect AbbVie to act if the right M&A opportunity presented itself. Fierce Pharma French pharma Ipsen taps new chief medical officer Ipsen French pharma Ipsen has landed on a new clinical chief, tapping Sandra Silvestri, M.D., Ph.D., to be chief medical officer and head of global medical affairs, patient safety and patient affairs. Silvestri jumps from fellow European pharma Sanofi, where she was most recently SVP and chief medical officer of the general medicines unit. It’s but the latest high-profile departure from Sanofi after R&D chief John Reed, M.D., Ph.D., left for the same role at Johnson & Johnson. Ipsen said that current Chief Medical Officer Steven Hildemann, M.D., Ph.D., will leave to pursue other opportunities. Prior to joining Sanofi in 2015, Silvestri spent more than nine years at Lilly, risking the medical affairs ranks before being named senior medical director of Italy, south and central east Europe. She spent years as an endocrinologist in Italy before jumping to industry in 2005. Silvestri’s first order of business will be seeing Ipsen’s rare disease med palovaratone through the finish line after U.S. regulators said they’d take another look at it. The med’s topsy-turvy regulatory process resulted in a end-of-year rejection, but Ipsen has supplied additional data that it hopes can push it over the finish line following a second review. The FDA has set a a mid-August deadline to decide whether to approve palovarotene. Release > Alongside a $53 million series E fundraise, Antiva Biosciences’ CEO Gail Maderis will shift to chair of the board. Kristine Ball, who most recently helmed Soteria Biotherapeutics as CEO, is set to take the head job at Antiva. Fierce Biotech > BrainStorm Cell Therapeutics is tapping Kirk Taylor, M.D., to serve as EVP and chief medical officer starting May 1. Taylor joins from Merck KGaA’s EMD Serono and has held past roles at Verastem Oncology, Finch Therapeutics, Biogen, Pfizer and Sanofi-Genzyme. Release > Giuseppe Ciaramella- and John Maraganore-founded Orbital Therapeutics has looped in $270 million and two new executives. Niru Subramanian joins from Rheos Medicine and will serve as chief operating officer, while Jonathan Piazza joins from Silverback Therapeutics and will take on the role of chief financial officer. Fierce Biotech > After laying off 95% of its staff in January, Finch Therapeutics’ CEO Mark Smith, Ph.D., is stepping down May 15, with Matthew Blischak exiting Roivant Sciences to take the reins. Lance Thibault is also stepping on as chief financial officer, while Marc Blaustein is set to leave his role as chief operating officer and principal financial officer. Release > Athenex has brought on Nick Campbell to serve as chief restructuring officer and continue the process of reviewing strategic alternatives amid an FDA clinical hold from the FDA. Campbell is the founder and managing partner of Meru, a firm focused on helping companies identify and address operational, organizational and financial matters. Release > Israel biotech Can-Fite has tapped its current Chief Financial Officer Motti Farbstein to double up as both CFO and CEO. Farbstein takes the place of Cab-Fite’s scientific founder Pnina Fishman, Ph.D., who will continue to serve as chief scientific officer and take on the role as executive chair of the board. Release > Seagen’s R&D president Roger Dansey, M.D., has joined the board of cancer company Kronos Bio. Dansey has extensive experience in oncology drug development, clocking in time at Merck, Gilead and Amgen as well. Release > Zevra Therapeutics CEO Richard Pascoe has been booted from the company’s board after a shareholder’s vote this week. The rare disease biotech, formerly called KemPharm, replaced two other board members with new incomers as well. Release > Australian biotech Immutep has selected Florian Vogl, M.D., Ph.D., to serve as chief medical officer, starting May 1. Most recently, Vogl was CMO of Cellestia Biotech and has held previous leadership roles at Rainier Therapeutics, Novartis and Amgen. Release > Kent Bondensgaard and John “Lippy” Lippincott have hopped aboard Alloy Therapeutics’ team, set to serve as SVP of antibody discovery services and SVP of therapeutic discovery strategies, respectively. Bondensgaard joins from Kiniksa Pharmaceuticals and has nearly 15 years of experience at Novo Nordisk, while Lippincott has worked across AlivaMab, Ablexis, LakePharma and Pfizer. Release > Epsilogen is expanding, bringing on Nick Robbins-Cherry as chief financial officer, Andrew Calam as VP of clinical operations and Elizabeth Hardaker as VP of biology. Most recently, Robbins-Cherry worked at Ixaka, while Calam had been at Syneos Health and Hardaker was at AstraZeneca. Release > FogPharma President and CEO Mathai Mammen, M.D., Ph.D., has joined private equity firm General Atlantic as a senior adviser. Before joining FogPharma earlier this month, Mammen was EVP of pharmaceuticals and R&D for Johnson & Johnson. Release

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