Curis Doses First Patient in Phase 1 Study of CA-4948 in Combination with Ibrutinib in Patients with Relapsed or Refractory Hematologic Malignancies

On February 9, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory (R/R) hematologic malignancies (Press release, Curis, FEB 9, 2021, View Source [SID1234574785]).

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"In dosing the first patient in this Phase 1 study evaluating CA-4948 and ibrutinib, we are taking a highly anticipated step forward in bringing a potent oral therapeutic regimen to patients with relapsed or refractory hematologic malignancies," said James Dentzer, President and Chief Executive Officer of Curis. "BTK inhibitors are an approved category of therapies for patients with various lymphatic cancers yet they only target one of the two main pathways activating NF-κB in B-cell malignancies. CA-4948 targets the other main NF-κB-activating pathway by shutting down signaling through the Myddosome. We have shown highly encouraging increased tumor-reducing activity when combining both covalent and non-covalent BTK inhibitors with CA-4948 in preclinical models."

Mr. Dentzer continued, "We observed single-agent activity in the non-Hodgkin’s lymphoma (NHL) monotherapy study, with the majority of patients treated at 300mg twice daily experiencing at least some reduction in tumor volume. We coordinated with our trial partners to amend the protocol of our existing study to include combination therapy starting at a previously demonstrated therapeutic dose. This will allow us to leverage the clinical sites and staff currently active in our monotherapy study and should save significant time and resources as we advance through the clinic."

"Given the profile CA-4948 has demonstrated in existing studies, it is a promising candidate for combination with a proven BTK inhibitor such as ibrutinib," said Dr. Erel Joffe, M.D., Assistant Attending with the Lymphoma Service at Memorial Sloan Ketting Cancer Center and a lead investigator on the study. "We believe there may be important synergies given that IRAK4 controls the critical TLR pathway that is parallel and complementary to the BTK pathway and that both of these pathways are primary and independent oncogenic activators of NF-κB in lymphoma and leukemia. Effective dual targeting of both independent pathways that drive excessive B-cell proliferation via NF-κB could potentially provide significantly improved outcomes over either treatment in a monotherapy setting."

About the CA-4948+ibrutinib Phase 1 Combination Study

The Phase 1 trial is a two-part, multicenter, open-label, dose escalation and expansion study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, clinical activity, and biomarker correlations of CA-4948 and ibrutinib patients with relapsed or refractory hematologic malignancies. Part 1 of the study is a dose escalation using a 3+3 design. Approximately 18 patients will be enrolled in Part 1 and will receive a starting dose of 200mg CA-4948 BID with subsequent escalation to 300mg BID, both of which have been observed to be safe and effective in the NHL monotherapy study, combined with ibrutinib doses appropriate for their respective NHL subtype. The primary endpoints of Part 1 will be safety and tolerability, maximum tolerated dose, and the recommended Phase 2 dose. Secondary objectives will be pharmacokinetics and preliminary efficacy. Exploratory objectives will include biomarker correlations, such as MYD88-L265P mutations and IRAK4 pathway and NFκB inhibition.

Part 2 of the study will enroll patients across an expansion basket of four cohorts: marginal zone lymphoma (MZL), ABC-DLBCL, primary central nervous system lymphoma (PCNSL), and NHL with adaptive ibrutinib resistance. An interim futility analysis will be conducted after approximately 15-20 patients are enrolled in each cohort. Primary endpoints of Part 2 will be complete response or objective response rate and duration of response compared to historical controls. Secondary objectives will be safety and tolerability, progression-free survival, and population PK sampling for CA-4948. Exploratory objectives will include response correlation with biomarkers including MYD88-L265P or other genetic mutations, gene expressions, cell of origin, IRAK4 signaling, and resistance.

RedHill Biopharma to Present at SVB Leerink Global Healthcare and BIO CEO & Investor Conferences

On February 9, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will present at the following virtual conferences in February (Press release, RedHill Biopharma, FEB 9, 2021, View Source [SID1234574776]):

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SVB Leerink 10th Annual Global Healthcare Conference (Feb 22-26, 2021)
Presentation and Q&A: Thursday, February 25, 8:40 am ET
Speaker: Dror Ben-Asher, Chief Executive Officer

BIO CEO & Investor Digital Conference (Feb 16-18, 2021)
Presentation: Available on-demand from February 16
Speaker: Guy Goldberg, Chief Business Officer

Incyte Reports 2020 Fourth Quarter and Year-End Financial Results, Provides 2021 Financial Guidance and Updates on Key Clinical Programs

On February 9, 2021 Incyte (Nasdaq: INCY) reported 2020 fourth quarter and full year financial results, and provides a status update on the Company’s development portfolio (Press release, Incyte, FEB 9, 2021, View Source [SID1234574775]).

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"Our team achieved many important accomplishments in the past year. Revenue growth was strong, driven by demand for Jakafi (ruxolitinib), and the launches of Monjuvi (tafasitamab-cxix) and Pemazyre (pemigatinib) continue to gain momentum. During 2020, we also announced positive results across multiple late-stage programs, including the pivotal trials of ruxolitinib in chronic GVHD, ruxolitinib cream in atopic dermatitis, parsaclisib in NHL, and retifanlimab in SCAC," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "During 2021, we expect regulatory decisions on seven applications seeking approval, including four in the U.S, two in Europe and one in Japan, and we are working towards the potential U.S. launch of ruxolitinib cream, which we expect to be approved by the FDA in the middle of the year."

Portfolio Updates

MPNs and GVHD – key highlights

Our LIMBER development program, to improve patient outcomes in MPNs and GHVD, is progressing well.

The two Phase 3 trials of ruxolitinib in combination with parsaclisib are both underway, evaluating the combination versus monotherapy ruxolitinib as a first-line therapy for patients with myelofibrosis (MF) (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304).

Monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are underway, and are expected to lead to proof-of-concept combination trials of both agents with ruxolitinib in patients with myelofibrosis. A monotherapy trial of itacitinib (JAK1) in patients previously treated with ruxolitinib is ongoing.

In December 2020, Incyte and Cellenkos announced a development collaboration to investigate the combination of ruxolitinib and CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis. In addition, Incyte obtained an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.

The sNDA seeking approval of Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) has been submitted, based on data from the successful results of the REACH3 trial, which were presented at ASH (Free ASH Whitepaper) 2020.

Indication and status

Once-a-day ruxolitinib
(JAK1/JAK2)

Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies

ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)

Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313)

Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304)

ruxolitinib + INCB57643
(JAK1/JAK2 + BET)

Myelofibrosis: Phase 2 in preparation

ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)

Myelofibrosis: Phase 2 in preparation

itacitinib
(JAK1)

Myelofibrosis: Phase 2 (low platelets)

ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)

Myelofibrosis: PoC in preparation

ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD2: sNDA submitted

itacitinib
(JAK1)

Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)

Development collaboration with Cellenkos
Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis
Other Hematology/Oncology – key highlights

Momentum is strong behind the U.S. launch of Monjuvi (tafasitamab-cxix), with good uptake in both academic and community settings and illustrated by the market share gained in the first several months since launch.

The Phase 3 inMIND trial evaluating tafasitamab plus lenalidomide and rituximab (R-squared) versus R-squared in patients with relapsed or refractory follicular or marginal zone lymphoma is open for recruitment, and the Phase 3 frontMIND trial of tafasitamab plus lenalidomide and R-CHOP versus R-CHOP as a first-line treatment in patients with DLBCL is expected to open in the coming months.

The U.S. launch of Pemazyre (pemigatinib) has been successful and, in January, Incyte announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.

In December 2020, data from three ongoing Phase 2 studies evaluating parsaclisib for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas were presented at ASH (Free ASH Whitepaper) 2020. Data from the CITADEL program are expected to form the basis of an NDA seeking FDA approval of parsaclisib, which is expected to be submitted in the second half of 2021.

In January 2021, Incyte announced that the FDA had accepted for Priority Review its Biologics License Application (BLA) for retifanlimab as a treatment for previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy. The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with advanced SCAC who have progressed following standard platinum-based chemotherapy; the Phase 3 POD1UM-303 trial in patients with SCAC is underway.

Indication and status

pemigatinib
(FGFR1/2/3)

CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); J-NDA under review

8p11 MPN: Phase 2 (FIGHT-203)

Tumor agnostic: Phase 2 (FIGHT-207)

tafasitamab

(CD19)1

r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review

1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND) in preparation

r/r FL and r/r MZL: Phase 3 (inMIND) open for recruitment

r/r B-cell malignancies: PoC with parsaclisib (PI3Kδ) in preparation

r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2

parsaclisib
(PI3Kδ)

r/r follicular lymphoma: Phase 2 (CITADEL-203)

r/r marginal zone lymphoma: Phase 2 (CITADEL-204)

r/r mantle cell lymphoma: Phase 2 (CITADEL-205)

retifanlimab
(PD-1)3

SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303); BLA under review

MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)

Merkel cell carcinoma: Phase 2 (POD1UM-201)

NSCLC: Phase 3 (POD1UM-304)

CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma

Development of tafasitamab in collaboration with MorphoSys
Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab.
retifanlimab licensed from MacroGenics
Incyte’s emerging clinical candidates in hematology/oncology include INCB86550, the first in a series of selective oral inhibitors of PD-L1; INCB81776, a dual AXL/MER inhibitor; INCB106385, an adenosine (A2A/A2B) inhibitor and, via a collaboration with Merus, MCLA-145, a PD-L1xCD137 bispecific antibody.

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

As planned, the NDA seeking approval of ruxolitinib cream as a treatment for patients with atopic dermatitis was submitted to the FDA late in the fourth quarter of 2020, including use of the previously acquired priority review voucher (PRV). The use of the PRV is expected to accelerate the time to an FDA decision.

Recruitment has been completed in both Phase 3 trials in the TRuE-V development program evaluating ruxolitinib cream as a treatment for patients with vitiligo, and topline results are expected to be announced in the first half of 2021. If successful, data from TRuE-V are expected to form the basis of an sNDA seeking approval of ruxolitinib cream as a treatment for patients with vitiligo, which would be submitted as soon as practicable after the FDA decision on the atopic dermatitis NDA.

Indication and status

ruxolitinib cream
(JAK1/JAK2)

Atopic dermatitis: NDA submitted

Vitiligo: Phase 3 (TRuE-V1, TRuE-V2; recruitment complete in both trials)

INCB54707
(JAK1)

Hidradenitis suppurativa: Phase 2b

parsaclisib
(PI3Kδ)

Autoimmune hemolytic anemia: Phase 2

INCB00928
(ALK2)

Fibrodysplasia ossificans progressiva: Phase 2 in preparation

Partnered – key highlights

In December 2020, Incyte and Lilly announced that Olumiant had been approved in Japan as a treatment of patients with atopic dermatitis who have inadequate response to conventional therapies.

Indication and status

baricitinib
(JAK1/JAK2)1

Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan

Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)

capmatinib
(MET)2

NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan

Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis
Worldwide rights to capmatinib licensed to Novartis
Potential therapies for patients with COVID-19

In November 2020, Incyte and Lilly announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

In December 2020, the New England Journal of Medicine published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results supported the EUA issued by the FDA.

Status

ruxolitinib
(JAK1/JAK2)

COVID-19 associated cytokine storm: Phase 3 (369-DEVENT)

baricitinib
(JAK1/JAK2)1

Hospitalized patients with COVID-19: Phase 3 (COV-BARRIER)

Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis
2020 Fourth Quarter and Year-End Financial Results

The financial measures presented in this press release for the quarter and year ended December 31, 2020 and 2019 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Product and Royalty Revenues Product and royalty revenues for the quarter and year ended December 31, 2020 increased 17% and 18%, respectively, over the prior year comparative periods primarily as a result of increases in Jakafi net product revenues, the launch of Pemazyre and higher product royalty revenues from Jakavi and Olumiant. Jakafi net product revenues for the quarter and year ended December 31, 2020 increased 11% and 15%, respectively, over the prior year comparative periods, primarily driven by growth in patient demand across all indications.

1. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2. Non-GAAP research and development expenses exclude the cost of stock-based compensation.
3. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.
4. Non-GAAP change in fair value of acquisition-related contingent consideration is null.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended December 31, 2020 increased 30% and 32%, respectively, compared to the same period in 2019 primarily due to our 55% share of the global and U.S. specific development costs for tafasitamab, product supply related costs to support the potential launch of ruxolitinib cream as a treatment for atopic dermatitis in 2021 and an increase in upfront and milestone payments under our collaborative agreements. Excluding the $42 million impact of product supply costs and the upfront and milestone payments, research and development expense for the quarter ended December 31, 2020 increased approximately 17% compared to the same period in 2019.

For the year ended December 31, 2020, GAAP and Non-GAAP research and development expense increased 92% and 101%, respectively, compared to the year ended December 31, 2019 primarily due to higher upfront and milestone payments under our collaborative agreements which includes upfront consideration of $805 million related to our collaborative agreement with MorphoSys, $120 million of expense related to the purchase of an FDA priority review voucher ("PRV") utilized to accelerate the FDA review of ruxolitinib cream in atopic dermatitis, our 55% share of the global and U.S. specific development costs for tafasitamab, and product supply costs to support the potential launch of ruxolitinib cream. Excluding the $1.02 billion impact of upfront consideration and milestone payments, purchase of the PRV and product supply related costs, research and development expense for the year ended December 31, 2020 increased approximately 4% compared with the prior year period.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended December 31, 2020 increased 23% and 24%, respectively, compared to the same period in 2019, primarily due to the timing of certain expenses. GAAP and Non-GAAP selling, general and administrative expenses for the year ended December 31, 2020 increased 10% compared to the year ended December 31, 2019 primarily due to an increase in sales and marketing spend to support the commercialization of Pemazyre in the US and to prepare for the potential launch of ruxolitinib cream in the U.S. and pemigatinib and tafasitamab in the EU.

Other Financial Information

Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended December 31, 2020 increased compared to the same period in 2019, due to the growth in total revenues exceeding the growth in operating expenses. For the year ended December 31, 2020, Incyte recorded an operating loss compared to operating income for the same period in 2019, on both a GAAP and Non-GAAP basis, primarily due to upfront consideration related to our collaboration with MorphoSys and expense related to the PRV, partially offset by the growth in product and royalty revenues.

Cash, cash equivalents and marketable securities position As of December 31, 2020 and 2019, cash, cash equivalents and marketable securities totaled $1.8 billion and $2.1 billion, respectively. The decrease is primarily due to the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the PRV, partially offset by the cash flow generated in 2020.

2021 Financial Guidance

Due to the continuing growth and diversification of Incyte’s commercial product portfolio, 2021 net product revenue guidance is being provided for Jakafi and in total for other Hematology/Oncology products, which currently include Iclusig in Europe and Pemazyre in the U.S. Guidance does not include revenue from any potential new product launches. However, GAAP and Non-GAAP selling, general and administrative expense guidance for 2021 includes costs to support the potential launches of ruxolitinib cream as a treatment for atopic dermatitis in the U.S., pemigatinib as a treatment for cholangiocarcinoma in the EU and Japan, and tafasitamab as a treatment for DLBCL in the EU. The 2021 financial guidance does not include the impact of any potential future strategic transactions.

(1) Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
(2) Adjusted to exclude the estimated cost of stock-based compensation.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13715042.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13715042.

The conference call will also be webcast; the livestream and the replay can be accessed at investor.incyte.com.

Innate Pharma Advances Lacutamab Clinical Development Program

On February 9, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported new clinical developments for its first-in-class, proprietary investigational asset, lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas (Press release, Innate Pharma, FEB 9, 2021, View Source [SID1234574774]). This includes advancement of the KIR3DL2-expressing mycosis fungoides (MF) cohort (cohort 2) to Stage 2 in the TELLOMAK study, as well as the initiation of the peripheral T-cell lymphoma (PTCL) clinical program.

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Mycosis Fungoides: Advancing TELLOMAK Cohort 2 to Stage 2
In TELLOMAK, an open-label, multi-cohort, Phase 2 trial, lacutamab demonstrated a positive early signal in cohort 2. This cohort reached the pre-determined number of responses needed to advance to stage 2, allowing the Company to recruit additional patients. The Company plans to present this preliminary data at a scientific meeting in 2021.

Recruitment is ongoing in cohort 3, evaluating lacutamab as a monotherapy in KIR3DL2 non-expressing MF patients.

Peripheral T-Cell Lymphoma: Introducing a Data-Driven Clinical Strategy
The Company reported plans to initiate two parallel clinical trials to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory PTCL. Together these trials offer a data-driven strategy to identify potential opportunities for lacutamab in the relapsed setting, and potential expansion into earlier lines of therapy for PTCL in the future.

Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.

Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) will launch an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
"Lacutamab is our priority clinical asset, and we are pleased to share important progress of this program. The early signal seen in the KIR3DL2-expressing mycosis fungoides patient population is encouraging and moves us past the pre-determined threshold for the cohort earlier than anticipated," said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer Innate Pharma. "In addition, our PTCL trials announced today demonstrate our strategy to first explore lacutamab’s potential in the relapsed/refractory setting, then potentially in earlier lines of treatment. Partnering with LYSA will provide invaluable expertise given their track record in advancing therapeutics for the lymphoma community."

"Relapsed PTCL patients are in need of alternative, effective options and we are pleased to partner with Innate Pharma on this important study," said Franck Morschhauser, Professor of Hematology in Lille (France) and President of LYSA. "KIR3DL2 represents a meaningful target, as it is expressed in up to 50% of PTCL across subtypes. Through our global network and deep expertise in lymphoma, we believe this study will help us better understand the potential for lacutamab to help these patients."

To learn more about these updates, join Innate’s executive leadership team, as well as Pierluigi Porcu, M.D., Professor of Medical Oncology, Dermatology and Cutaneous Biology and Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation at Jefferson University Hospital and principal investigator of Innate’s Phase 2 TELLOMAK study, and Olivier Hermine, M.D., Professor of Hematology at the University of Paris Descartes, Director, Division of Adult Hematology at Hôpital Universitaire Necker Enfants Malades and principal investigator of the LYSA Phase 2 KILT study for a virtual presentation today.

Webcast and conference call will be held today at 2:00 p.m. CET / 8:00 a.m. ET

Access to live webcast: View Source

Participants may also join via telephone by registering in advance of the event at View Source Upon registration, participants will be
provided with dial-in numbers, a direct event passcode and a unique registrant id that they
may use 10 minutes prior to the event start to access the call.

This information can also be found on the Investors section of the Innate Pharma website,
www.innate-pharma.com. A replay of the webcast will be available on the Company website
for 90 days following the event.

About Lacutamab:

Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which 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 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 advanced T-cell lymphomas (TCL) in the United States and Europe. TELLOMAK is expected to recruit up to 150 patients, with lacutamab evaluated:

As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab.
As a single agent in approximately 90 patients with mycosis fungoides (MF) who have received at least two systemic therapies.
In patients with MF, the study is designed to evaluate the benefit of lacutamab according to KIR3DL2 expression. The study comprises two cohorts in MF, testing lacutamab in KIR3DL2 expressing and non-expressing patients determined at baseline. These 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 response rate. Key secondary endpoints are progression-free survival, duration of response, quality of life and adverse events.

About Lacutamab in PTCL:

Two clinical trials will investigate lacutamab in KIR3DL2-expressing PTCL patients who have received at least one prior systemic therapy. Lacutamab is being evaluated:

In a multi-center, Phase 1b clinical trial as a single agent in approximately 20 relapsed patients expressing KIR3DL2. The trial is designed to evaluate safety, as well as characterize clinical outcomes, pharmacokinetics and immunogenicity of lacutamab alone in PTCL. Further expansion will be determined based on preliminary efficacy signals.
In a multi-center, randomized Phase 2 trial in combination with GEMOX in relapsed/refractory patients expressing KIR3DL2. This study will include approximately 60 patients. The combination trial, KILT (anti-KIR in T-Cell Lymphoma), is being conducted by the Lymphoma Study Association (LYSA) and its operational organization Lymphoma Academic Research Organisation (LYSARC); it will evaluate the efficacy and safety of lacutamab in combination with chemotherapy GEMOX in prescreened patients, with progression-free survival as the primary endpoint.

TUMAGNOSTIC – Phase 1 clinical trial

On February 9, 2021 Convert Pharmaceuticals, a Belgian biotech company developing anti-cancer therapeutics, reported that it has obtained very promising pre-clinical results with CP-506 drug, a new and improved Hypoxia Activated Prodrug (Press release, Convert Pharmaceuticals, FEB 9, 2021, View Source [SID1234574773]). The company is finalising its Clinical Trial Application to obtain regulatory approval for the launch of its tumor agnostic Phase I Clinical Trial in 2021. This will be a first in human dose escalation study to determine the safety, pharmacokinetics, pharmacodynamics and phase 2 recommended dose. At the same time, we will check for the first indication of antitumor effect in humans.
CP-506 will be tested in both monotherapy, with patient selection based on validated biomarkers, as well as in combination with standard treatments such as immune checkpoint inhibitors.

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We expect that by 2024 we will have completed the study with results that prompt us to continue the clinical development of CP-506 as the first antitumor drug from the HAP class.