On May 11, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Consumer Self-Care Products, reported financial results from continuing operations for the first quarter of fiscal year 2021 ended April 3, 2021 (Press release, Perrigo Company, MAY 11, 2021, View Source [SID1234579640]). The Consumer Self-Care Americas ("CSCA") segment, the Consumer Self-Care International ("CSCI") segment and Corporate are included in results from continuing operations. Financial results from the generic Rx pharmaceuticals business are reported as discontinued operations. All comparisons are against the prior-year fiscal first quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Two years ago, we began our journey to transform Perrigo from a healthcare to a consumer self-care company and with the actions taken this quarter, that transformation is now nearly complete. On March 1, 2021, we announced the divestment of our generic Rx business, our tenth transaction over the last two years, essentially completing our portfolio reconfiguration. We have made the necessary investments in infrastructure, capabilities, talent and capacity, and as a result have restored Perrigo to growth, all while weathering the storm of a horrific global pandemic. From where I sit, Perrigo is re-born."

Kessler further noted, "The reported declines in the first quarter were distorted by consumer pantry loading in the year ago quarter and by a historically weak cough/cold season this year, both of which were the result of COVID-19. Our business remains strong, even during this volatile environment, as evidenced by Perrigo’s first quarter 2021 two-year reported and organic compound annual growth rates, compared to the pre-COVID first quarter of 2019. Additionally, Perrigo’s first quarter performance results were in line with our expectations. Looking ahead to the rest of the year, we are encouraged to see the recent increases in retail store foot traffic, more people traveling again, and children returning to school in the fall. Further, according to leading sources, the 2021-2022 cough/cold season is expected to be more normal. That, in combination with Perrigo’s durable business fundamentals, strong pipeline of new product launches, productivity improvements in progress and e-commerce leadership, provides us confidence in our ability to deliver a strong second half and is why we are reaffirming our ‘3/5/7’ growth guidance for 2021."

Kessler concluded, "Perrigo is now a pure-play consumer self-care company that is on-trend and growing. When the Rx deal closes, we will have approximately $2 billion in cash to support the growth of the business and strengthen our balance sheet. We believe this represents a significant value creation opportunity, as Perrigo’s forward price-to-earnings multiple continues to trade at a significant discount to our CPG peers with similar growth profiles. I am more excited than ever about the future of Perrigo and am grateful to all of our teams around the world who have helped to transform Perrigo."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Given the difficulty in comparing first quarter 2021 net sales results to the first quarter of 2020 due to the pandemic-related pantry load and subsequent destock in the second quarter of 2020, two-year compound annual growth rates (CAGRs) are provided below, offering further insight into underlying growth trends.

First Quarter 2021 Financial Highlights From Continuing Operations

Perrigo first quarter net sales were $1.01 billion, a decrease of 6.8%, due primarily to the pandemic-related pantry load benefit in the prior year quarter and the negative impact from the very low incidence of cough/cold related illness this year. On a two-year CAGR basis, net sales grew 4.1%, including a negative 4.5 percentage points impact from cough/cold, while organic(1) growth declined 0.4%, including a negative 4.1 percentage points impact from the weak cough/cold season.
CSCA first quarter net sales of $641 million were 8.6% lower compared to the prior year quarter, with organic growth down 11.8%; CSCI first quarter net sales of $370 million were 3.4% lower versus the prior year quarter, with organic growth down 9.1%.
Reported diluted earnings per share ("EPS") for the first quarter of 2021 was $0.02 per diluted share as compared to EPS of $0.42 in the prior year quarter.
Adjusted diluted EPS, which excludes certain costs required to operate the RX business until the sale closes(2), for the first quarter of 2021 decreased 25.4% to $0.50 per diluted share as compared to $0.67 per diluted share in the prior year quarter. The prior year quarter benefited from an estimated $0.16 per diluted share from the pandemic-related pantry load, while the current year quarter was negatively impacted by an estimated $0.14 per diluted share from the weak cough/cold season.
(1) See attached Appendix for details. Organic net sales growth excludes the effects of acquisitions and divestitures and the impact of currency.

(2) In addition to other non-GAAP adjustments as described in the attached appendix, adjusted profit measures, including adjusted EPS and adjusted operating income, exclude from both periods certain costs, which are reported in GAAP continuing operations but were previously allocated to the RX business. On a go-forward basis, such costs will either be covered by the transition services agreement or eliminated following closing. Accordingly, as described below under "Non-GAAP Adjustments", we do not believe such operational costs are representative of the future expenses of our continuing operations. See the attached Appendix for additional details.

First Quarter 2021 Perrigo Results From Continuing Operations

Perrigo net sales for the first quarter were $1.01 billion, a decrease of $73 million or 6.8%, including positive impacts of 3.0 percentage points and 2.3 percentage points from acquisitions and favorable currency movements, respectively, offset by a negative impact of 1.2 percentage points from divestitures. Organic net sales declined 10.9%, including the estimated pandemic-related pantry load benefit in the prior year quarter of 6.8 percentage points and the estimated negative impact from the very low incidence of cough/cold related illness this year of 6.4 percentage points.

On a two-year CAGR basis, net sales grew 4.1%, including a negative 4.5 percentage points impact from the very low incidence of cough/cold related illness this year. Organic net sales declined 0.4%, including a negative 4.1 percentage points impact from the weak cough/cold season.

Net sales in the quarter were driven by 1) $32 million from the acquisitions of Dr. Fresh and Eastern European dermatology brands, 2) organic growth of $25 million, excluding the estimated impacts from the pandemic-related pantry load benefit in the prior year and the very low incidence of cough/cold related illness this year, and 3) $25 million in net favorable currency movements. These gains were more than offset by 1) the estimated impact from the pandemic-related pantry load benefit in the prior year of $73 million, 2) the estimated impact from the very low incidence of cough/cold related illness this year of $68 million, and 3) $14 million from divested businesses.

First quarter reported operating income was $51 million in 2021 and $86 million in 2020. Adjusted operating income was $118 million in 2021 and $151 million in 2020, a decrease of $33 million or 21.6%. Results were impacted by lower net sales volumes leading to lower gross profit, divestitures, and higher operating expenses including R&D investments. These factors were partially offset by lower advertising and promotion expenditures, acquisitions and positive pricing.

Reported net income was $3 million, or $0.02 per diluted share, versus net income of $58 million, or $0.42 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2021 adjusted net income was $67 million, or $0.50 per diluted share, versus $92 million, or $0.67 per diluted share, for the same period last year. Adjusted EPS was lower as positive impacts from growth in certain base business categories, lower advertising and promotion expenditures, acquisitions and savings from Project Momentum were more than offset by the estimated pandemic-related pantry load benefit in the prior year quarter of $0.16 per diluted share, the estimated negative impact from the very low incidence of cough/cold related illness this year of $0.14 per diluted share, and divested businesses of $0.03 per diluted share.

First Quarter 2021 Business Segment Results From Continuing Operations

Consumer Self-Care Americas Segment

CSCA first quarter net sales of $641 million were 8.6%, or $60 million, lower than the prior year, including a positive 3.4 percentage points impact from the Dr. Fresh acquisition. Organic net sales decreased 11.8%, including the estimated pandemic-related pantry load benefit in the prior year quarter of 7.1 percentage points and the estimated negative impact from the very low incidence of cough/cold related illness this year of 5.0 percentage points.

On a two-year CAGR basis, net sales grew 4.9%, including a negative 3.6 percentage points impact due to the very low incidence of cough/cold related illness this year. Organic net sales grew 0.8%, including a negative 3.3 percentage points impact from the weak cough/cold season.

OTC net sales in the quarter were driven by 1) strong e-commerce growth as consumers continued shifting purchases to online where Perrigo has greater market share than in-store, which more than offset lower in-store purchases as measured by IRI MULO, 2) double-digit percentage growth in the branded OTC product portfolio led by Prevacid and ScarAway, and 3) higher net sales in the Digestive Health category, due primarily to favorable consumer conversion to Perrigo OTC products and incremental new product sales from Esomeprazole Mini, and in the Skin & Personal Hygiene category, due primarily to higher demand in the minoxidil franchise. More than offsetting these drivers were the pandemic-related pantry load benefit in the prior year quarter and the very low incidence of cough/cold related illness this year, which impacted the Upper Respiratory and Pain & Sleep Aids categories.

Perrigo omnichannel POS (point of sale) declined 18.7% for the 13-weeks ending March 21, 2021, compared to an estimated decline in total store brand OTC omnichannel POS data of 19.8%, leading to a Perrigo share gain from store brand competitors of 27 basis points. Perrigo’s share of total OTC on an omnichannel basis was stable in categories that declined an estimated 19.1% in the categories in which Perrigo competes.

Net sales in the Oral Self-Care category were driven by the Dr. Fresh acquisition, strong growth in e-commerce net sales, which doubled compared to the prior year quarter, and new products. These drivers were partially offset by soft demand for travel-related oral care products related to COVID-19 and lower customer inventory compared to the prior year due to timing of orders.

In the Nutrition category, net sales growth in e-commerce and contract manufacturing were more than offset by the pandemic-related pantry load benefit in the prior year quarter and an increase in governmental benefits that led to a decline in store brand market share.

Reported operating income for CSCA was $96 million. Adjusted operating income decreased $26 million to $111 million due primarily to 1) gross profit flow-through on lower net sales, 2) higher input costs on certain products and unfavorable plant overhead absorption due primarily to lower production volumes compared to the prior year pandemic-related pantry load benefit, and 3) higher operating expenses, including R&D investments. These factors were partially offset by favorable product mix.

Consumer Self-Care International Segment

CSCI net sales of $370 million decreased $13 million, or 3.4%, including a positive 6.8 percentage points impact from favorable currency movements, a positive 2.3 percentage points impact from acquisitions and a negative 3.5 percentage points impact from divestitures. Organic net sales were 9.1% lower, including the estimated 9.0 percentage points negative impact from the very low incidence of cough/cold related illness this year and the estimated pandemic-related pantry load benefit in the prior year quarter of 6.2 percentage points.

On a two-year CAGR basis, CSCI net sales grew 2.6%, including a negative 6.1 percentage points impact due to the very low incidence of cough/cold related illness this year. Organic net sales declined 2.9%, including a negative 5.5 percentage points impact from the weak cough/cold season.

Net sales in the quarter were driven by 1) new products, including line extensions in the ACO dermatology product line and in the Davitamon and Granufink VMS (Vitamins, Minerals and Supplements) product lines, 2) positive pricing, 3) the acquisition of three Eastern European OTC Dermatology Brands, 4) higher net sales in the Pain & Sleep Aids category, and 5) $26 million in favorable currency movements. These drivers were more than offset by 1) the very low incidence of cough/cold related illness this year, which impacted the Upper Respiratory category, 2) comparison to the pandemic-related pantry load benefit in the prior year quarter, 3) lower demand for anti-parasite products within the Skincare & Personal Hygiene category due primarily to COVID-19 related school closings and limited travel, and 4) divested businesses of $14 million.

Reported operating income was $17 million. Adjusted operating income decreased $4 million to $60 million due primarily to gross profit flow-through on lower net sales and the impact from divested businesses. These factors were partially offset by lower advertising and promotion spend, greater operational efficiencies and favorable currency movements.

U.S. Licensing Agreement with Burt’s Bees

Perrigo announced today the existence of a licensing agreement with Burt’s Bees to offer a comprehensive, innovative line of organic baby formulas and nature-based remedies for kids under the Burt’s Bees brand. This partnership combines Perrigo’s R&D, regulatory, and sales and marketing capabilities with Burt’s Bees leading trusted and distinctive brand and deep understanding of the efficacy of nature-based ingredients to care for baby and mom, to create innovative organic and nature-based remedies.

Fiscal 2021 Outlook From Continuing Operations

The Company reaffirmed its fiscal 2021 outlook and expects to deliver 3% organic net sales growth, 5% adjusted operating income growth and 7% adjusted diluted EPS growth, translating into an adjusted diluted EPS range of $2.50 to $2.70.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2021 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

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.