1stOncology™: Cancer Intelligence Service – Page 8254 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Innate Pharma Presents Preliminary Data from TELLOMAK Trial Showing Clinical Response for Lacutamab in Mycosis Fungoides

On June 22, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported preliminary data from the mycosis fungoides (MF) cohort of the Phase 2 TELLOMAK clinical trial, evaluating lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, in an oral presentation at the 16th International Conference on Malignant Lymphoma (16-ICML) (Press release, Innate Pharma, JUN 22, 2021, View Source [SID1234584215]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Lacutamab demonstrated clinical responses in patients with MF that express KIR3DL2 (cohort 2), reaching the pre-determined threshold to advance to stage 2.1

As of the May 10, 2021 data cutoff, in the KIR3DL2-expressing cohort (n=17), complete (n=1), partial (n=3) and unconfirmed partial (n=2) global responses were observed. Following the data cutoff, the two unconfirmed partial responses have been confirmed.

When evaluating responses in the skin, one patient had a complete response, eight patients had a partial response and two patients had an unconfirmed partial response. Out of seven patients with blood involvement, four had a complete response in the blood, and out of eight patients with lymph node involvement, one had a partial response. Following the data cutoff, the two unconfirmed partial responses in the skin have been confirmed.

All patients (n=19) in the KIR3DL2-non-expressing cohort (Cohort 3) have been recruited. The threshold of responses needed to advance to stage 2 has not been reached, and follow up is ongoing.

"We are pleased by the response demonstrated to date in patients with mycosis fungoides that express KIR3DL2, which has enabled us to advance this cohort earlier than expected," said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma. "These data confirm our initial hypothesis that lacutamab may benefit patients with KIR3DL2-expressing T-cell lymphomas, and support our data-driven approach in pursuit of a new standard of care in this population. Looking ahead, we continue to enroll patients in both the mycosis fungoides and Sézary syndrome cohorts of our TELLOMAK study. In addition, we plan to initiate our peripheral T-cell lymphoma program for lacutamab, with our Phase 1b monotherapy study expected to start mid-year and an investigator-sponsored combination study expected in the second half of this year."

In line with previous observations, lacutamab demonstrated a favorable safety profile in MF. Grades 1-2 treatment-related adverse events (AE) were observed, with one patient (out of 36) experiencing a grade 3 AE. No relevant skin toxicities were observed.

"Mycosis fungoides, and cutaneous T-cell lymphomas more broadly, are associated with poor clinical outcomes, particularly at advanced stages," said Pr. Martine Bagot, Head of the Dermatology Department, Saint Louis Hospital, Paris, and a study investigator. "The clinical responses and favorable safety profile observed in the TELLOMAK study are quite encouraging so far. I am particularly pleased by the preliminary skin responses, as relapsed/refractory patients are in need of new treatment options that can improve their quality of life, and slow disease progression. I look forward to seeing more data from lacutamab as this trial progresses with the enrollment of additional patients in this cohort."

Innate will provide additional information on these results tomorrow, June 23, 2021, in an investor event scheduled for 2:00 p.m. CEST / 8:00 a.m. EDT. Details to access the live event are available in the investors section of Innate’s website, where a replay of the webcast will also be archived for 90 days following the event.

About Lacutamab:

Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

About TELLOMAK:

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab.
Cohort 2: lacutamab being evaluated as a single agent in up to approximately 50 patients with MF that express KIR3DL2, as determined at baseline.
Cohort 3: lacutamab being evaluated as a single agent in up to approximately 38 patients with MF that do not express KIR3DL2, as determined at baseline.
The MF cohorts follow a Simon 2-stage design that will terminate early if treatment is considered futile. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.

The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, quality of life and adverse events.

Global response in cutaneous lymphoma is measured by the guidelines published by Olsen et. al in the Journal of Clinical Oncology in 2011.2

Immutep completes a A$60 million placement to expand its clinical development and manufacturing program into late-stage settings

On June 22, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or Company), reported that it has received commitments for a A$60 million two-tranche private placement of new ordinary shares (New Shares) to professional, institutional and sophisticated investors (Placement) (Press release, Immutep, JUN 22, 2021, View Source [SID1234584214]).

The first tranche of the Placement will be completed without shareholder approval. The second tranche of the Placement is subject to shareholders approval.

Use of Funds

The Company will use the proceeds received from the Placement to fund the expansion of its clinical programs and to commence the process characterisation and process validation for efti commercial manufacturing (2,000 litre scale). The proceeds received from the Placement will also be used for the offering costs and working capital purposes.

Placement

The Placement will involve the issue of New Shares at an issue price of A$0.52 per New Share (representing a 12.9% discount to the volume weighted average price (VWAP) of the Company’s ordinary shares as traded on ASX over the 30 days up to and including June 16, 2021). The New Shares issued under the Placement will rank equally with existing Immutep ordinary shares on issue with effect from their date of issue.

Settlement of the first tranche of the Placement is expected to occur on June 25, 2021, with the issuance of New Shares expected to occur on June 28, 2021.

Assuming Shareholder Approval is obtained for the completion of the second tranche of the Placement, settlement is expected to occur on July 29, 2021, with the issuance of New Shares expected to occur on July 30, 2021.

Share Purchase Plan

Following completion of the issue of the first tranche of the Placement, Immutep will conduct an offer of New Shares under a non-underwritten share purchase plan (SPP) to existing shareholders in the Company with a registered address in Australia and New Zealand as at 7.00pm (Sydney, Australia time) on June 18, 2021.

The SPP will provide each Eligible Shareholder with the opportunity to apply for up to A$30,000 of New Shares at the price payable per New Share in the Placement. The SPP is targeting to raise approximately A$5 million. The SPP is expected to close at 5.00pm (Sydney, Australia time) on July 22, 2021.

Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic for MSI-High Tumors

On June 22, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 21, 2021, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for both a human anti-human PD-1 monoclonal antibody, Opdivo [generic name: nivolumab (genetical recombination)] and a humanized anti-human PD-1 monoclonal antibody, Keytruda [generic name: pembrolizumab (genetical recombination)] for the treatment of patients with microsatellite instability high (MSI-High) tumors (Press release, Chugai, JUN 22, 2021, View Source [SID1234584213]).

"High microsatellite instability has been identified in tumors in various organs, and immune-checkpoint inhibitors can be a therapeutic option. FoundationOne CDx Cancer Genomic Profile is characterized by the ability to comprehensively capture information on individual gene alterations, as well as the ability to detect microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "Through testing with FoundationOne CDx Cancer Genomic Profile, we will contribute to ensuring as many patients as possible to have access to optimal treatments."

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with MSI-High unresectable advanced or recurrent colorectal cancer that have progressed following chemotherapy who may benefit from nivolumab. It will also be used to identify patients with microsatellite instability (MSI-H) solid tumors that have advanced or relapsed after chemotherapy (limited to use when difficult to treat with standard of care), who may benefit from pembrolizumab.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About Microsatellite instability high (MSI-High)
The genome contains several short strings of DNA (deoxyribonucleic acid) called microsatellites that are repeated many times. High-frequency microsatellite instability (MSI-High) is an abnormal number of microsatellite repeats1). Abnormal microsatellites do not lead to cancer, but tissues that show MSI-High are thought to be more likely to develop cancer. MSI-High has been found in patients with cancer of various organs, including endometrial, gastric, small intestine, colorectal, ovarian, renal pelvis/ureteral, prostate, and breast cancers2, 3). MSI-High is also a hallmark of people with Lynch syndrome who are born with genomic alterations that predispose them to developing cancer3).

Trademarks used or mentioned in this release are protected by laws.

[Reference]

Nojadeh, J.N. et al.: Microsatellite instability in colorectal cancer. EXCLI J. 17: 159-168, 2018.
Japan Society of Cancer Therapy/Japanese Society of Clinical Oncology: Guidelines for Transversal Genomic Practice in Organs in Adult and Pediatric Advanced Solid Tumors, Second Edition, October 2019
Colorectal Cancer Study Group: Hereditary Colorectal Cancer Guidelines 2020 Version

Anavex Life Sciences Announces $50 Million Registered Direct Offering

On June 22, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that it has entered into a definitive purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock a registered direct offering (Press release, Anavex Life Sciences, JUN 22, 2021, View Source [SID1234584212]). The registered direct offering is expected to close on or about June 24, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $50 million before deducting placement agent fees and other offering expenses. Anavex currently intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above are being offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

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

Targovax receives Fast Track designation for ONCOS-102 in melanoma

On June 22, 2021 Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, reported that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA (Press release, Targovax, JUN 22, 2021, View Source [SID1234584210]).

The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses. Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma. This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track designation in malignant pleural mesothelioma.

The FDA Fast Track designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast Track products have high likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application for rolling review to shorten the approval timeline.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said: "Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need. Fast Track simplifies and expedites the regulatory interactions and review process, and further supports the rationale for initiating a Phase 2 trial to target accelerated approval for ONCOS-102 in PD-1-refractory advanced melanoma".