On November 15, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and an update on its cash position at the end of September 2021 (Press release, ERYtech Pharma, NOV 15, 2021, View Source [SID1234595692]).

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"While the outcome of our TRYbeCA-1 trial in second-line pancreatic cancer did not achieve its primary endpoint of overall survival, we remain encouraged by the observed improvement of overall survival in a subset of patients treated with FOLFIRI and will continue analyzing the sizeable TRYbeCA-1 data set in order to distill the reasons for this disappointing outcome," said Gil Beyen, CEO of ERYTECH. "We are also encouraged by the progress we are making towards seeking an approval for eryaspase for the treatment of ALL patients who experienced hypersensitivities to pegylated asparaginase. The dialogue with the FDA is continuing and we are hopeful we can submit our first BLA around year end. We were pleased with the granting of the Fast Track designation for this high unmet need indication in July."

Business Highlights

Path to BLA in hypersensitive ALL, based on results of NOPHO-sponsored Phase 2 trial

The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

Eryaspase in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

The Company continued its interactions with the U.S. Food and Drug Administration (FDA) regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June after which the Company confirmed its intention to submit a BLA subject to successful completion of remaining activities.
In July, the Company announced that the FDA had granted eryaspase Fast Track designation for the treatment of ALL patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.
Subject to review of remaining information requests, the Company intends to submit a BLA around year-end.

TRYbeCA-1, pivotal Phase 3 clinical trial in second-line advanced pancreatic cancer

As reported in late October, the Phase 3 TRYbeCA-1 trial did not meet the primary efficacy endpoint of overall survival (OS). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months, compared to 6.7 months for chemotherapy alone, with an OS hazard ratio (HR) of 0.92 in the intent-to-treat (ITT) population (p-value 0.375).

The prespecified subgroup of patients treated with eryaspase and FOLFIRI, an irinotecan-based chemotherapy, demonstrated a nominal increase in median OS of 2.3 months, from 5.7 to 8 months (HR = 0.77; per protocol population), which the Company believes merits further investigation.
Patients treated with eryaspase demonstrated improved disease control compared to patients treated with chemotherapy only. Other secondary endpoints showed nominal improvement.
The safety profile of eryaspase was consistent with earlier clinical trials results and safety reviews.

Final data are being analyzed and will be presented at an upcoming medical conference.

rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer

rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.

Patient enrollment started in January 2021, and the first dose cohort (75 U/kg) of three patients was enrolled by the end of February. No dose-limiting toxicity (DLT) was observed, and the trial was escalated to the next dosing cohort (100 U/kg).
After review of the safety data in the first two dose cohorts, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the maximum tolerated dose (MTD) was determined at a dose of 100 U/kg eryaspase.
Additionally, all six patients evaluated for response achieved disease control; three patients with objective response and three with stable disease.

The trial will continue enrolling up to approximately 18 patients. Reporting of final data is expected in the first half of 2022.

TRYbeCA-2, randomized Phase 2 clinical trial in triple-negative breast cancer (TNBC)

The TRYbeCA-2 trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC. Target enrollment is approximately 64 patients. The primary end point of the trial is objective response rate.

Following the disappointing results of eryaspase in combination with a gemcitabine-based chemotherapy in the TRYbeCA-1 trial in second-line pancreatic cancer, the Company has, in consultation with the trial’s Steering Committee, decided to stop further enrollment in the TRYbeCA-2 trial.

The results of the patients enrolled in the TRYbeCA-2 trial to date are expected to be reported in the first half of 2022.

Process to review strategic options and partnering alternatives launched

The Company launched a process and appointed a specialized advisor to evaluate its strategic and partnering alternatives, including for the further development and commercialization of eryaspase. Gil Beyen, the CEO of ERYTECH, will lead these partnering efforts and take on the role of acting Chief Business Officer (CBO), as Jean-Sebastien Cleiftie, current CBO of ERYTECH will leave the Company at the end of this month.

Update on Q3 2021 Cash Position

As of September 30, 2021, ERYTECH had cash and cash equivalents totaling €38.0 million (approximately $43.9 million), compared with €44.4 million as of December 31, 2020 and €46.3 million on June 30, 2021. The €6.5 million decrease in cash position during the first nine months of 2021 was the result of a €7.8 million net cash utilization, which was mostly comprised of a €46.2 million net cash utilization in operating activities, €0.3 million used for investing activities and €38.8 million generated in financing activities, while the variation of the U.S. dollar against the euro led to a €1.3 million positive currency exchange impact.

Financing activities in the first nine months of 2021 included a $8 million placement in the United States through the Company’s at-the-market (ATM) equity financing program for net proceeds of €6.4 million, a $30 million Registered Direct offering for net proceeds of €22.4 million, and the drawdown of four tranches under the convertible notes (OCABSA) financing agreement signed with Alpha Blue Ocean, for net proceeds of €11.4 million.

At the date of this press release, nine OCABSA tranches have been called since the initiation of the program in June 2020. During the last 12 months, the OCABSA converted notes, together with the shares issued under the ATM program, have resulted in the issuance of 4,690,904 new shares and 235,690 warrants, representing 17.6% of the Company’s outstanding share capital.

The Company believes that its current cash position can fund its planned operating expenses and current programs into the second quarter of 2022. Further, the Company has engaged in cash preservation measures and believes that these measures, together with further utilization of the OCABSA agreement, subject to the regulatory limit of 20% dilution, could extend its cash horizon into the third quarter of 2022. The Company is currently exploring potential financing and partnering options to further extend its cash horizon beyond key 2022 development milestones.

The release on October 25, 2021 of the TRYbeCA-1 Phase 3 trial in pancreatic cancer, which did not meet its primary endpoint, is considered a triggering event for impairment analysis, which will require the Company to test tangible and intangible assets for possible impairment. The Company is therefore not in a position to announce full financial results for the third quarter of 2021 until current uncertainties on business assumptions are clarified. The Company will conduct an impairment analysis in light of its new business situation, which may potentially lead to an impairment of some of its assets.

Key News Flow and Milestones Expected Over the Next 12 Months

Planned BLA submission of eryaspase in hypersensitive ALL (around year end 2021)
Results from the Phase 1 rESPECT Trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (1H 2022)
Presentation of full dataset of TRYbeCA-1 trial at a medical meeting (1H 2022)
Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (1H 2022)
Third Quarter 2021 Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, November 16, 2021 at 8:30am EST / 2:30 pm CET to discuss the recent business and financial updates. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link:

View Source (Conference ID : 6425429)

Once registered, participants will receive a unique access code and the call number details to join the teleconference.

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 6425429#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

Financial Calendar 2021

Business Update and Financial Highlights for the Fourth Quarter and Full Year 2021: March 11, 2022 (after U.S. market close), followed by a conference call & webcast on March 14, 2022 (2:30pm CET/8:30am ET)

ERYTECH plans on attending the following upcoming investor conferences:

Jefferies 2021 Global Healthcare Conference, November 16-19, London
LifeSci Partners 11th Annual Corporate Access Event, January 5-7, 2022
H.C. Wainwright, BioConnect Conference, January 10-13, 2022
JPMorgan HealthCare Conference, January 10-13, 2022, San Francisco

On November 15, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that it will be presenting positive results from a Phase 2a clinical study of the company’s lead drug candidate, STP705, for treatment of squamous cell skin cancer in situ (nonmelanoma skin cancer) at the 2021 TIDES Europe event (Press release, Sirnaomics, NOV 15, 2021, View Source [SID1234595670]). The hybrid conference is taking place digitally and in person at the Sheraton Brussels Airport Hotel in Belgium from November 15-17, 2021.

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Title: Novel Dual Targeting siRNA Therapeutic Offers Innovative Solution for Derm-Oncology Treatment
Presenter: David Evans, PhD., Sirnaomics Chief Scientific Officer
Presentation Overview: Clinical trial results showing STP705, used to target TGF-β1 and COX-2 siRNAs for the treatment of nonmelanoma skin cancer, has demonstrated rates of histological clearance that rival surgical excision combined with improved cosmetic appearance.
Time/Date: November 16, 2021 at 16:30; available on demand after the presentation to TIDES delegates

About STP705

Sirnaomics’ product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including for the treatment treatments of cholangiocarcinoma and other solid liver tumors, nonmelanoma skin cancer and hypertrophic scar, and Keloid scarring. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma, primary sclerosing cholangitis, and hepatocellular carcinoma. A Phase 2a study of STP705 for treatment of squamous cell skin cancer (isSCC) in adult patients demonstrated positive efficacy and safety results, with 76% of all patients (19/25) achieving complete histologically clearance and the two optimal dosing ranges achieving 90% histological clearance of tumor cell in the lesion. No significant or serious adverse events, including no significant cutaneous skin reactions, were reported in the study, and the company was able to define a clear therapeutic window in advance of later stage studies.

On November 15, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, reported financial results for the third quarter of 2021 and recent corporate updates (Press release, Ensysce Biosciences, NOV 15, 2021, View Source [SID1234595667]).

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"In the third quarter, we successfully completed our convertible note financing of $15 million that provided us with the necessary proceeds to continue our advancement of our lead clinical trial programs," said Dr. Lynn Kirkpatrick, CEO of Ensysce. "As previously announced, we commenced our second study of our TAAP opioid, PF614, in early September, and through this study, we aim to demonstrate the correlation between PF614 to Oxycontin, and how Ensysce can begin to make this solution readily available for public use. Additionally, we appointed Dr. Linda Pestano as our Chief Development Officer. Linda’s extensive expertise in the preclinical drug development area makes her a perfect addition to our team as we work towards commercializing our next-generation opioid products."

Dr. Kirkpatrick concluded, "We’re continuing to develop the next generation of innovative solutions to combat the potential for opioid abuse, and we’re pleased with our progress to date. We believe we have the necessary resources and bandwidth to continue to progress on our important mission."

Program Updates

TAAP – opioid abuse deterrent program:

On September 7, 2021, Ensysce enrolled the first cohort of subjects in a clinical study PF614-102 entitled "A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects."
This study builds on the results of the initial Phase 1 study and is designed to help us understand how PF614 compares to currently available commercial products.
Other Business Highlights

Ensysce completed a $15 million convertible note financing, receiving the second tranche of $10 million on November 5, 2021 after receiving the first tranche of $5 million on September 24, 2021.
Total gross proceeds from the convertible note financing will be used for general working capital purposes, allowing for advancement of lead clinical trial programs including the completion of the PF614-102 bioequivalence study, as well as continuing the clinical development of the overdose protection platform with our lead product PF614-MPAR.
Third Quarter 2021 Financial Results

Cash – Cash and cash equivalents were $6.8 million as of September 30, 2021. On November 5, 2021, Ensysce received additional funding of $10 million under the convertible note financing.
Federal Grants – Funding under federal grants was $1.2 million for the third quarter of 2021 compared to $0.8 million for the third quarter of 2020. The increase is attributable to increased clinical development activity with our PF614-MPAR overdose protection product.
R&D Expenses – Research and development expenses were $1.7 million for the third quarter of 2021 compared to $0.9 million for the same period in 2020. The increase primarily resulted from increased clinical development activity with our PF614 abuse protection product and combination product PF614-MPAR for overdose protection.
G&A Expenses – General and administrative expenses were $16.4 million for the third quarter of 2021 compared to $0.3 million for the third quarter of 2020. The increase was primarily a result of $11.6 million of non-cash expenses for warrants issued under a December 2020 share subscription facility following the Company’s listing on Nasdaq in July 2021 and $2.3 million of non-cash expenses related to equity for consultants.
Net Loss – Net loss for the third quarter of 2021 was $17.2 million compared to net income of $1.6 million for the same period in 2020.

On November 15, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported that new data has been published in poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2021 which took place from 10-14 November 2021 in the US (Press release, Immutep, NOV 15, 2021, View Source [SID1234595666]). The new data relates to the Company’s Phase IIb AIPAC trial and Part C of its Phase II TACTI-002 study (also designated KEYNOTE-798). In addition, a poster presentation of the trial design of the Company’s new randomised Phase IIb study in 1st line HNSCC was also presented at SITC (Free SITC Whitepaper).

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All three poster presentations relate to Immutep’s lead candidate efti and are available on the Company’s website: View Source New data which is shown in addition to the data from the abstracts released on 9 November 2021 is summarised below.

Immutep will present data from the posters in a global webcast for investors on Wednesday, 17 November 2021 at 8.00 am AEDT / Tuesday, 16 November 2021 at 4.00 pm EST. Details are below.

PHASE IIB AIPAC POSTER PRESENTATION

In addition to the final OS data announced on 10 November 2021, Immutep reports new Quality of Life (QoL) data from AIPAC. QoL is a secondary endpoint of the study. In the total trial population, a statistically significant QoL preservation was observed in the first 6 months in the efti group of patients who were treated with efti in combination with paclitaxel. This compares favourably to the comparator group (paclitaxel and placebo) where a significant deterioration in these measures were reported at 6 months (see Figure 1). QoL is generally very important for patient compliance and forms part of reimbursement discussions after any potential marketing approval.

Figure 1. Quality of Life at 3 and 6 months of treatment (Global Health Status / QoL QLQC30-B23)2

As previously announced, the AIPAC trial demonstrates a statistically significant and clinically meaningful OS benefit in now three prespecified (prior to unblinding) patient subgroups. A majority of patients fall into at least one of the patient subgroups and therefore derive a statistically significant benefit (Table 1).

Patients under the age of 65 years (representing 66.7% of patients in the efti group) reported a median OS of 22.3 months compared to 14.8 months in the comparator group, indicating an absolute survival benefit of +7.5 months (HR = 0.66; p = 0.017) favoring the efti group (see Figure 2).

Patients with a low monocyte count (< 0.25/nl) at the commencement of the study (representing 21.9% of patients in the efti group) reported a median OS of 32.5 months compared to 12.9 months in the comparator group, indicating an absolute survival benefit of +19.6 months (HR = 0.44; p = 0.008) favoring the efti group.

Patients with a more proliferating tumor cell type expressing more neo-antigens (i.e. leading to more immunogenicity), characterised as luminal B (representing 48.8% of patients in the efti group) reported a median OS of 16.8 months compared to 12.6 months in the comparator group, indicating an absolute survival benefit of +4.2 months (HR = 0.67; p = 0.049) favoring the efti group.

Figure 2. Kaplan-Meier curve for OS in patients < 65 years of age

Table 1 – Overall Survival in key patient subgroups at final analysis at 72.5% of events in the overall population

Group % of patients in efti group Efti group /

Comparator group Median OS

(months) Absolute OS benefit from efti
Total Population

100

%

Efti + paclitaxel 20.4 +2.9 months
HR = 0.88
p = 0.197

Placebo + paclitaxel 17.5
< 65 years old

66.7

%

Efti + paclitaxel 22.3 +7.5 months
HR = 0.66
p = 0.017

Placebo + paclitaxel 14.8
Low monocytes
< 0.25/nl

21.9

%

Efti + paclitaxel 32.5 +19.6 months
HR = 0.44
p = 0.008

Placebo + paclitaxel 12.9
Luminal B

48.8

%

Efti + paclitaxel 16.8 +4.2 months
HR = 0.67
p = 0.049

Placebo + paclitaxel 12.6
Pleasingly, these results have improved since interim data were reported at the San Antonio Breast Cancer Symposium (SABCS) in December 2020. A comparison is provided in Table 2.

Table 2 – Comparison of interim Overall Survival data and final Overall Survival data

Group Interim data

(SABCS 20) Final data

(SITC 21) Median OS improvement [months]
Total Population +2.7 months
HR = 0.83
p = 0.14 +2.9 months
HR = 0.88
p = 0.197 +0.2
< 65 years old +7.1 months
HR = 0.62
p = 0.012 +7.5 months
HR = 0.66
p = 0.017 +0.4
Low monocytes
< 0.25/nl +9.4 months
HR = 0.47
p = 0.02 +19.6 months
HR = 0.44
p = 0.008 +10.2
Luminal B +3.8 months
HR = 0.69
p = 0.077 +4.2 months
HR = 0.67
p = 0.049 +0.4
In addition, as briefly reported on 10 November 2021, immune monitoring studies showed an increase in peripheral CD8 T cells in patients from the efti group of the total population (N=36/31 comparator group/efti group).1 This increase is statistically significant and is also significantly correlated with improved OS, demonstrating strong proof-of-concept. New data and graphs are provided below (see Figures 3 & 4).

Immutep CEO, Marc Voigt commented: "The combination of the OS data in the prespecified subgroups, immune monitoring data and Quality of Life data, which were all statistically significant, give us confidence as we move forward with the development of efti in various late-stage settings. The results here are particularly noteworthy because Her2-HR+ metastatic breast cancer is not a particularly immunogenic tumour and so does not always respond to treatment with modern immunotherapies such as anti-PD-1 therapy. Indeed, we have seen across our various studies that efti, with its unique mechanism of action, has the potential to benefit many cancer patients, including those with more limited treatment options."

PHASE II TACTI-002 POSTER PRESENTATION

Immutep’s TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 183 patients with non-small cell lung cancer (NSCLC) in 1st and 2nd line (Parts A and B, respectively) or 2nd line head and neck squamous cell carcinoma (HNSCC, Part C). The results announced today relate to Part C only.

Immutep CSO and CMO, Dr Frederic Triebel said: "It is encouraging to see deep and durable responses in low PD-L1 expressing patients who may not typically respond to anti-PD-1 therapy when given on its own. When given in combination with efti, we are seeing an ORR of about 30%. Results from TACTI-002 demonstrate an encouraging ORR combined with a durable response and good safety. This was key to securing Fast Track Designation with the US FDA in April this year."

Key Findings 2nd line HNSCC – Part C

ORR of 29.7% (11/37) per iRECIST in patients unselected for PD-L1 on an intention-to-treat basis and 35.5% (11/31) in evaluable patients
13.5% of patients (5/37) reporting a Complete Response, indicating deep responses
Median duration of response is not yet reached and none of the patients with a confirmed response progressed within 9 months
5 patients still under therapy and 1 patient completed 2 years of therapy
ORR in patients in the PD-L1 ≥ 1 (N = 27) and PD-L1 ≥ 20 (N = 14) subgroups is 40.7% and 64.3%, respectively

Table 3 – TACTI-002 Interim ORR Results for Part C (data cut-off date: 4 August 2021)

Part C
2nd line HNSCC3
Tumour Response
Best Overall Response (BOR) per iRECIST Stage 1 & 2
N (%)
Total N=37
Complete Response (CR) 5 (13.5)
Partial Response (PR) 6 (16.2)
Stable Disease (SD) 3 (8.1)
Progressive Disease (PD) 17 (45.9)
Not Evaluable 6 (16.2)
Disease Control Rate (DCR) 14 (37.8)
Objective Response Rate (ORR) 11 (29.7)
ORR in evaluable pts (N=31) 11 (35.5)
Conclusion: The more mature data from 2nd line HNSCC patients continues to be encouraging, including when compared to historical studies with checkpoint inhibitor monotherapy in comparable patient groups. These results are supportive of Immutep’s randomised Phase IIb TACTI-003 study in the 1st line HNSCC indication conducted in collaboration with MSD. The trial design for the new TACTI-003 study is outlined below.

Safety (data cut-off date 16 April 2021)
The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.

Next Results
Further data from TACTI-002 are planned to be reported in H1 of calendar year 2022.

PHASE II TACTI-003 POSTER PRESENTATION

TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled, trial enrolling approximately 154 patients with 1st line HNSCC.

Patients will be enrolled into two cohorts (see Figure 5):

Cohort A (approximately 130 patients) will evaluate the safety and efficacy of efti in combination with MSD’s KEYTRUDA (pembrolizumab), compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive tumours (CPS ≥ 1).

Cohort B (up to 24 patients) is an experimental arm which will determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumours (CPS < 1).

Figure 5. TACTI-003 trial design

Pembrolizumab will be given at a dose of 400 mg via intravenous infusion on day 1 of each 6-week treatment cycle (maximum of 18 infusions). Efti will be subcutaneously injected at a dose of 30 mg every 2 weeks for the first 6 months (4 cycles) and thereafter at a dose of 30 mg every 3 weeks for up to 2 years in total.

The primary endpoint of the study is ORR according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS). The TACTI-003 study is open for patient recruitment in the US and Ukraine, with further clinical sites expected to be opened in the coming months.

GLOBAL WEBCAST
Date & Time: 8.00 am AEDT (Sydney) Wednesday 17 November 2021

4.00 pm EST (New York) Tuesday 16 November 2021

10.00 pm CET (Berlin) Tuesday 16 November 2021

Register: View Source

Questions: Investors are invited to submit questions in advance via [email protected].

A replay of the webcast will also be available at www.immutep.com from the day after the event.

About AIPAC
Active Immunotherapy Paclitaxel (AIPAC) is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb clinical trial in HER2-negative/HR positive metastatic breast cancer.

The study is evaluating the combination of efti with paclitaxel chemotherapy. 227 HER2-negative/HR positive metastatic breast cancer patients are randomised 1:1 to a chemo-immunotherapy arm (efti plus paclitaxel) or to a comparator arm (placebo plus paclitaxel). Patients receive weekly paclitaxel at days 1, 8 and 15, with either efti or placebo injected subcutaneously on days 2 and 16 of each 4-week cycle, repeated for 6 cycles. Thereafter, patients pass over to the maintenance phase with efti alone.

For more information regarding the AIPAC trial, visit clinicaltrials.gov (identifier: NCT02614833) and View Source

About TACTI-002
TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, the UK and US.

Patients participate in one of the following:
• Part A – first line non-small cell lung cancer (NSCLC), PD-X naive
• Part B – second line NSCLC, PD-X refractory
• Part C – second line head and neck squamous cell carcinoma (HNSCC), PD-X naive

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ≥ 50% (Tumour Proportion Score or TPS) and in HNSCC: < 1, 1-19 and ≥ 20 (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall less responsive.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier:
NCT03625323).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About TACTI-003
TACTI-003 is a Phase IIb clinical trial in first line head and neck squamous cell carcinoma (HNSCC) in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA, known as "MSD" outside the United States and Canada. It will evaluate efti in combination with MSD’s KEYTRUDA (pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS ≥ 1) tumours. It will be a randomised, controlled clinical study in approximately 154 first line HNSCC patients and will take place across Australia, Europe and the US in up to 35 clinical sites.

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in first line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ≥ 1) tumours (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumours (CPS < 1) (cohort B). According to the current plans, about 130 patients in cohort A will be randomised 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.

The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS).

On November 15, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported its virtual participation in the following conferences (Press release, Lexicon Pharmaceuticals, NOV 15, 2021, View Source [SID1234595665]):

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Jefferies London Healthcare Conference, taking place November 16-19, 2021
Piper Sandler 33rd Annual Healthcare Conference, taking place on November 30-December 2, 2021
Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation for the Jefferies conference which will be available on-demand beginning at 3:00 am ET/8:00 am GMT on Thursday, November 18, 2021.

Lexicon’s executive management will participate in a fireside chat for the Piper Sandler conference which will be available on-demand beginning at 10:00 am ET on Monday, November 22, 2021.

Recordings of both webcasts will be available in the "Events" section of the Lexicon website at www.lexpharma.com for two weeks following the original on-demand date.