On May 11, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its revenue and cash position for the three-month period ending March 31, 2021.

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"This quarter, we have continued to execute against our strategy, successfully progressing the lacutamab TELLOMAK trial in the mycosis fungoides cohort while also advancing our first NK cell engager with our partner, Sanofi," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As we continue to advance our business, we look forward to delivering additional data read-outs from these programs this year, as well as leveraging our strong R&D competencies to lead the next wave of scientific innovation at Innate."

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

In February 2021, the Company announced lacutamab showed a positive early signal in the KIR3DL2-expressing mycosis fungoides cohort (‘cohort 2’) of the TELLOMAK clinical trial. This cohort reached the pre-determined number of responses needed to advance to stage 2 earlier than anticipated. The Company plans to present this preliminary data as an oral presentation at the 16th International Conference on Malignant Lymphoma, Lugano (16-ICML) being held virtually between June 18-22, 2021.
The Company expects to initiate its Phase 1b trial evaluating lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed/refractory peripheral t-cell lymphoma (PTCL) by mid-2021. In addition, the Lymphoma Study Association (LYSA) will initiate 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 PTCL patients in the second half of 2021.
IPH6101 (NKp46-based NK cell engager), partnered with Sanofi:

Progress was made in the NKCE collaboration with Sanofi, resulting in the decision announced in January 2021 that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate.
In January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
The Company will share an update on its NKCE platform at the Federation of Clinical Immunology Societies (FOCIS) meeting being held virtually between June 8-11, 2021.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Company expects to publish data this year from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN.

Avdoralimab in COVID-19 (anti-C5aR1 antibody):

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), has completed enrollment and is ongoing for patient follow-up and data analysis. More information on this study can be found at clinical trials.gov.

Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €181.7 million as of March 31, 2021. At the same date, financial liabilities amounted to €18.5 million.

During the first quarter of the year 2021, a €7.0m milestone payment was received from Sanofi in February 2021. This milestone followed the decision taken by Sanofi to advance IPH6101/SAR443579 into investigational new drug (IND)-enabling studies.

Revenues for the first three months of 2021 amounted to €4.5 million (€19.3 million for the same period in 2020). For the three-month period, ended March 31, 2021, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca and Sanofi. (Press release, Innate Pharma, MAY 11, 2021, View Source [SID1234579639])

On May 11, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from clinical trials of 19 approved and investigational medicines across 20 cancer types will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held 4-8 June, 2021 (Press release, Hoffmann-La Roche, MAY 11, 2021, View Source [SID1234579638]). A total of 132 abstracts that include a Roche medicine will be presented at this year’s meeting. These data advance oncology by showing the importance of making patient-centric treatment decisions and providing tailored medical care based on specific cancer types.

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"We will be presenting data from across our diverse oncology portfolio that has the potential to help more people living with many types of cancers," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We are particularly excited about our compelling immunotherapy data in lung cancer, which may provide new hope for patients with earlier stage disease."

Focusing on earlier treatment and targeted lung cancer care
Positive results from the phase III IMpower010 study will be presented that show Tecentriq (atezolizumab) improved disease-free survival (DFS) in people with resectable early-stage non-small cell lung cancer (NSCLC) compared to best supportive care – a first in cancer immunotherapy. This advance is significant, as half of all people with early stage lung cancer today still experience a recurrence following surgery; therefore, treating lung cancer early, before it has spread, can provide the best opportunity for a cure. Additionally, updated data for Gavreto (pralsetinib) in patients with advanced RET fusion-positive NSCLC, including in patients who are treatment naïve, will be reported. These data highlight the need for early RET fusion-positive testing to identify candidates who may benefit from treatment with Gavreto.

Exploring personalised cancer care for more patients
Roche will present several studies that take tumour-agnostic approaches to clinical development, and in breast cancer, that may benefit people with rare and common tumours alike. These studies bring together next-generation sequencing, targeted therapies and patient-centric clinical trial design that show how personalised treatment plans are helping to evolve the way people are treated. The phase II ALPHA-T study, made possible through a collaboration with Foundation Medicine and Science37, is pioneering a decentralised approach to clinical trial design which enables patients to participate from their own homes while remaining under the care of their oncologist. The phase II TAPISTRY study, a platform umbrella trial, will pair patients with immunotherapy, targeted therapy or treatment combinations based on distinct tumor biology characteristics. The similarly designed phase II MyTACTIC study is enrolling a diverse population of patients to direct them to appropriately targeted treatments based on the results of comprehensive genomic profiling.

With our research we are contributing to the body of evidence in hormone receptor (HR)-positive breast cancer, the most prevalent type of all breast cancers. For giredestrant, a third generation oral selective oestrogen receptor degrader (SERD), we will present data further supporting the tolerable safety profile and single agent clinical activity, as well as pharmacodynamics data from studies in HR-positive early and metastatic breast cancer.

Defining new solutions for patients with difficult-to-treat blood cancer
New and updated data in non-Hodgkin lymphoma (NHL) will be shared, including data from the T-cell engaging CD20xCD3 bispecific antibody development programme. Glofitamab and mosunetuzumab are both T-cell engaging CD20xCD3 bispecific antibodies that are being studied as single agents or in combination with other Roche therapies. Together, they may offer a new immunotherapy based approach to tackle a range of blood cancers. In addition, data exploring novel combinations with mosunetuzumab and Polivy (polatuzumab vedotin), an antibody drug conjugate, will also be featured. These data demonstrate how Roche continues to seek new solutions for people living with a range of malignant blood disorders, where treatment options are still limited and both relapse and treatment resistance are common.

Furthermore, Roche’s data showcase a commitment to health equity through medicine delivery approaches that reduce treatment time and cost, trial designs that help remove barriers to clinical trial participation, pioneering cancer immunotherapy to improve outcomes for earlier disease stages, and a focus on inclusivity through developing tumour-specific therapies and therapy combinations based on specific characteristics of each person’s disease.

For more details on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2021 scientific programme, and to learn more about how Roche is harnessing the latest innovations to accelerate progress in cancer care, join the Roche virtual analyst event from 4:00 – 5:30 pm CEST on Tuesday, 8 June. Further details are available here.

Keep up to date with ASCO (Free ASCO Whitepaper) news and updates by using the hashtag #ASCO21 and follow Roche on Twitter via @Roche and LinkedIn.

Overview of key presentations featuring Roche medicines

Medicine Abstract title Abstract number
Lung cancer
Alecensa Final OS analysis from the phase III J-ALEX study of alectinib (ALC) versus crizotinib (CRZ) in Japanese ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC). 9022
Gavreto Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial. 9089
Tecentriq IMpower010: Primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). 8500
Tecentriq Artificial intelligence (AI)–powered pathologic response (PathR) assessment of resection specimens after neoadjuvant atezolizumab in patients with non-small cell lung cancer: Results from the LCMC3 study. 106
Tecentriq Pooled analyses of immune-related adverse events (irAEs) and efficacy from the phase 3 trials IMpower130, IMpower132, and IMpower150. 9002
Tecentriq CONTACT-01: A phase III, randomised study of atezolizumab plus cabozantinib versus docetaxel in patients with metastatic non-small cell lung cancer (mNSCLC) previously treated with PD-L1/PD-1 inhibitors and platinum-containing chemotherapy. TPS9134
Tecentriq Clinicogenomic real-world data analysis of patients (pts) with KRAS G12C-mutant advanced non-small cell lung cancer (aNSCLC) from the natural history cohort of the Blood First Assay Screening Trial (BFAST). 9023
Tecentriq Real-world treatment patterns in stages IA-IIIB non-small cell lung cancer. e20528
Blood cancer
Gazyva

Obinutuzumab short-duration infusion (SDI) in previously untreated advanced follicular lymphoma: Results from the end of induction analysis of the phase IV GAZELLE study. 7545
Glofitamab Glofitamab step-up dosing (SUD): Complete response rates in updated efficacy data in heavily pretreated relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) patients (pts).

7519
Mosunetuzumab Promising tolerability and efficacy results from dose-escalation in an ongoing phase Ib/II study of mosunetuzumab (M) with polatuzumab vedotin (Pola) in patients (pts) with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (B-NHL). 7520
Polivy Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. 7512
Venclexta/
Venclyxto Measurable residual disease response in acute myeloid leukemia treated with venetoclax and azacitidine. 7018
Breast cancer
Giredestrant acelERA Breast Cancer (BC): Phase II study evaluating efficacy and safety of giredestrant (GDC-9545) versus physician’s choice of endocrine monotherapy in patients (pts) with oestrogen receptor-positive, HER2-negative (ER+/HER2-) locally advanced or metastatic breast cancer (LA/mBC). TPS1100
Giredestrant persevERA Breast Cancer (BC): Phase III study evaluating the efficacy and safety of giredestrant (GDC-9545) + palbociclib versus letrozole + palbociclib in patients (pts) with oestrogen-receptor-positive, HER2-negative locally advanced or metastatic BC (ER+/HER2– LA/mBC). TPS1103
Giredestrant Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with oestrogen receptor-positive (ER+), HER2-negative locally advanced/metastatic breast cancer (LA/mBC). 1017
Giredestrant Evaluation of pharmacodynamic (PD) and biologic activity in a preoperative window-of-opportunity (WOO) study of giredestrant (GDC-9545) in postmenopausal patients (pts) with oestrogen receptor-positive, HER2-negative (ER+/HER2–) operable breast cancer (BC). 577
Kadcyla Safety of trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive locally advanced or metastatic breast cancer (mBC): Final results from KAMILLA Cohorts 1 (global) and 2 (Asia). 1039
Phesgo Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States. 544
Tecentriq The tumour microenvironment (TME) and atezolizumab + nab-paclitaxel (A+nP) activity in metastatic triple-negative breast cancer (mTNBC): IMpassion130. 1006

Colon cancer
Tecentriq Phase Ib/II open-label, randomised evaluation of atezolizumab (atezo) + Imprime PGG (Imprime) + bevacizumab (bev) vs regorafenib (rego) in MORPHEUS: Microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). 3559
Liver cancer
Tecentriq IMbrave150: Exploratory analysis to examine the association between treatment response and overall survival (OS) in patients (pts) with unresectable hepatocellular carcinoma (HCC) treated with atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor).

4071
Tecentriq IMbrave150: Exploratory efficacy and safety results of hepatocellular carcinoma (HCC) patients (pts) with main trunk and/or contralateral portal vein invasion (Vp4) treated with atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in a global Ph III study. 4073
Personalised healthcare and health equity
Association of electronic-health record (EHR)-derived race with BRCA testing in patients (pts) with breast cancer (BC) with similar genetic ancestry (GA) in a clinicogenomic database (CGDB). 6524
Racial, ethnic, and socioeconomic disparities in treatment outcomes in patients (pts) with diffuse large B-cell lymphoma (DLBCL): A U.S. real-world study using a de-identified electronic health record (EHR)-derived database.

e18514
Tumour agnostic
Alecensa Alpha-T: An innovative decentralised (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumours in a histology-agnostic setting. TPS3155
Gavreto Clinical activity and safety of the RET inhibitor pralsetinib in patients with RET fusion-positive solid tumours: Update from the ARROW trial 3079
Rozlytrek,
Alecensa,
Tecentriq,
Ipatasertib,
Kadcyla,
Inavolisib Tumour-agnostic precision immuno-oncology and somatic targeting rationale for you (TAPISTRY): a novel platform umbrella trial. TPS3154
Rozlytrek,
Inavolisib,
Ipatasertib,
Tecentriq,
Kadcyla,
Perjeta,
Herceptin A study evaluating targeted therapies in participants who have advanced solid tumours with genomic alterations or protein expression patterns predictive of response (MyTACTIC). TPS1588

Blueprint Medicines and Roche are co-developing Gavreto (pralsetinib) globally, excluding Greater China.* Blueprint Medicines and Genentech, a wholly-owned member of the Roche Group, are commercialising Gavreto in the US and Roche has exclusive commercialisation rights for Gavreto outside of the US, excluding Greater China.*

Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan. CStone Pharmaceuticals retains all rights to the development and commercialisation of Gavreto in Greater China under its existing collaboration with Blueprint Medicines.

All trademarks used or mentioned in this release are protected by law. Blueprint Medicines, Gavreto and associated logos are trademarks of Blueprint Medicines Corporation.

On May 10, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that interim clinical data, including a confirmed partial response (PR), from its ongoing Phase 1a/1b monotherapy study of CUE-101 as second-line treatment for patients with HPV+ R/M HNSCC (Press release, Cue Biopharma, MAY 10, 2021, View Source [SID1234608280]). To date, CUE-101 has demonstrated a favorable tolerability profile in a monotherapy dose escalation trial and continues to generate encouraging emerging data pertaining to its pharmacokinetic (PK) and pharmacodynamic (PD) profiles, as well as clinical anti-tumor activity.

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"We are very excited by the partial response observed in this patient, since it demonstrates single-agent activity of CUE-101, so rarely seen in mono-immunotherapy treatments," said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "Based on recent clinical observations, we have delivered CUE-101 to patients at tolerated doses, achieving a confirmed PR as well as stable disease (SD) in several patients while still in the dose escalation portion of the trial. This provides evidence that CUE-101 is an active agent with promising potential for HPV+ HNSCC patients. This is bolstered by the supporting pharmacodynamic data in which we have observed activation of disease-specific T cells and NK cells in the blood of our treated patients. We look forward to initiating the expansion phase of the Phase 1 trial which may provide a potential path forward for a registration-directed clinical trial for CUE-101 as a monotherapy for HPV+ R/M HNSCC."

Key interim analysis of patient data from the ongoing open-label Phase 1a/1b study include:

Confirmed PR in one patient and SD in five patients, all confirmed by RECIST criteria, in the dose escalation phase of the study to date, providing early signs of potential single-agent activity of CUE-101.
Demonstrated evidence of both tumor-specific CD8+ T cell expansion as well as dose-dependent increases in NK cells in patients.
Observed immune cell infiltration and tumor cell necrosis in patient tumor biopsies after CUE-101 treatment, supporting CUE-101’s mechanism of action at engaging and modulating targeted T cells within the patient’s body.
Dose-proportional PK profile and comparable drug exposure levels in patients receiving repeated dosing cycles, consistent with a lack of drug-clearing anti-drug antibodies.
No maximum tolerated dose (MTD) observed in patients dosed with up to 8 mg/kg of CUE-101.
Dan Passeri, chief executive officer of Cue Biopharma added, "Receiving early confirmation of clinical activity of CUE-101 as a monotherapy in this challenging patient population is an important validation of the potential of the CUE-101 program for oncology, as well as for our follow-on programs such as CUE-102, from the IL2-based CUE-100 series. This confirmed PR provides valuable proof of concept of the Immuno-STAT platform to activate and expand disease specific T cells and NK cells as a method to treat other cancers. We anticipate a number of important milestones throughout this year with the potential of further data to inform CUE-101’s clinical application. These milestones include, the potential selection of a recommended Phase 2 dose of CUE-101 by mid-2021 for further development as a single-agent treatment for HPV+ 2L+ head and neck squamous cell carcinoma; our plans to report initial Phase 1 results from the combination study of CUE-101 with pembrolizumab in the second half of 2021; and our plans to initiate a Phase 2 neoadjuvant study to evaluate the effects of CUE-101 on the tumor microenvironment, which is also expected to start in the second half of 2021."

Conference Call
Cue Biopharma will discuss these new data points during its first quarter business update call and webcast on May 17 at 4:30 p.m. ET. Please check the Events page of the Investor and Media section of the Company’s website at www.cuebiopharma.com for details. A live and archived version of the webcast will be available for 30 days after the call.

About the CUE-101 Clinical Trial
The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. Based on translational data from the trial, a maximum tolerated dose (MTD) or recommended Phase 2 dose will be determined. The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On May 10, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported that it will report its fiscal 2021 third quarter financial results before market open on Monday, May 17, 2021 (Press release, iBioPharma, MAY 10, 2021, View Source [SID1234585483]). iBio management will host a webcast and conference call at 8:00 a.m. Eastern Time to discuss the results and provide a corporate update.

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The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 3085726.

On May 10, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM RI (50ml) liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, MAY 10, 2021, View Source [SID1234584740]).

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The application is based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYMRTD administered by 10-minute intravenous infusion.

"We are pleased that the RI application has been submitted ahead of schedule, which will enable patients and providers alike to reap the benefits of this formulation. We believe we can get close to peak income of $20-$25 million as early as next year from the RTD and RI products. This is an important extension of the bendamustine franchise, and we value the relationship with Symbio," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

TREAKISYM RI has the advantage of reducing infusion time to 10 minutes (from the current 60 minutes), eliminating the need for manual reconstitution and significantly reducing preparation time, benefitting both patients and healthcare providers.