On May 11, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported the dosing of the first patient in its part 2 of phase I (phase Ib/IIa) clinical study of its next-generation anti-CTLA-4 antibody, where Australian patients with metastatic or advanced melanoma, hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC) and other type of tumors will be enrolled (study no. 4003.1) (Press release, Harbour BioMed, MAY 11, 2021, View Source [SID1234579731]). The objective of this study is to evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 as a single agent in multiple solid tumor types. The part 1 of phase I trial study results have been submitted to European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper).

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As Harbour BioMed’s next-generation anti-CTLA-4 antibody, HBM4003 is currently in an open label, multicenter global trial for patients with advanced solid tumors. The part 1 study was focused on dose escalation, and phase Ib/IIa study is to proceed to dose expansion to further explore the anti-tumor activities of HBM4003 in multiple solid tumor types.

"In our previous study, we observed a case of good tumor shrinkage in a man with metastatic liver cancer," said Professor Paul de Souza from St George Private Hospital (Australia). "I look forward to this new stage of the study, which will allow us to recruit more patients with particular cancers that may benefit from this treatment."

"HBM4003 has shown strong anti-tumor activity and great safety in its phase 1 clinical studies," Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed said. "We will continue to accelerate the global development of HBM4003 for multiple tumor types, so that we can help cancer patients around the world to live better and longer lives."

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

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 11, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the 2021 RBC Capital Markets Healthcare Conference at 10:55 a.m. Eastern Time on Tuesday May 18, 2021 (Press release, Neurocrine Biosciences, MAY 11, 2021, View Source [SID1234579667]). Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On May 11, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the quarter ended March 31, 2021, and provided an update on the company (Press release, Schrodinger, MAY 11, 2021, View Source [SID1234579682]).

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"We had strong execution across multiple facets of our business during the quarter," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We are continuing to advance our internal drug discovery pipeline and recently selected a development candidate for our MALT1 inhibitor program. Progress on our internal programs, coupled with our collaborators’ successes with molecules we’ve helped discover, are powerful examples that our platform and approach generates high-quality development candidates. We look forward to seeing the full impact of our technology as pharmaceutical, biotechnology and materials companies adopt our platform on a larger scale."

Today the company announced an expanded collaboration with AstraZeneca to deploy Schrödinger’s computational platform to help accelerate drug discovery. The collaboration is an expansion of the agreement announced in September 2019, which was a pilot project across an initial small number of programs. Under the expanded agreement, AstraZeneca will fully deploy Schrödinger’s platform across all its structurally-enabled small molecule discovery programs.

First Quarter 2021 Financial Results

Revenue was $32.1 million for the first quarter of 2021, a 23 percent increase compared to the first quarter of 2020.
Software revenue was $26.3 million for the first quarter of 2021, an 11 percent increase compared to the first quarter of 2020.
Drug discovery revenue was $5.8 million for the first quarter of 2021, compared to $2.4 million in the first quarter of 2020.
Gross profit was $16.2 million in the first quarter of 2021, up three percent over the first quarter in 2020. Software gross margin was 78 percent in the first quarter of 2021, compared to 83 percent for the same period in the prior year.
Operating expenses for the first quarter of 2021 were $40.1 million, compared to $27.4 million in the first quarter of 2020.
Other income, which included losses on equity investments, changes in fair value of such investments and interest income, was $23.5 million in the first quarter of 2021 compared to a loss of $2.4 million for the first quarter of 2020. Other income for the first quarter of 2021 included a $24.8 million non-cash gain from the change in fair value of Schrödinger’s equity stake in Morphic Therapeutic. Additionally, in the first quarter of 2021, Schrödinger sold its equity stake in Relay Therapeutics, Inc. for cash proceeds of $15.7 million, which resulted in a non-cash loss of $1.8 million as a result of the fair value based on the share price of the Relay Therapeutics common stock at the sales date.
Net loss, after adjusting for non-controlling interests, was $0.0 million for the first quarter of 2021, compared to a net loss of $13.8 million in the first quarter of 2020.
Recent Business Highlights

Continued revenue growth and strategic execution

Reported 23 percent total revenue growth in the first quarter of 2021, driven by significant increase in drug discovery revenue in addition to continued uptake of Schrödinger’s core technologies including FEP+ and its enterprise solution, LiveDesign, as well as growth in new customers.
Ended the first quarter of 2021 with cash, cash equivalents, restricted cash and marketable securities of $649.0 million, compared to $643.2 million as of December 31, 2020.
Progressed internal pipeline

Selected a development candidate for the company’s MALT1 inhibitor program. Targeting MALT1 is emerging as a potential therapeutic strategy to treat certain relapsed or resistant B-cell lymphomas and chronic lymphocytic leukemia.
Continued to advance multiple programs toward IND-enabling studies; subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission to the FDA expected in the first half of next year.
Presented preclinical data on the company’s CDC7 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting. The data showed that Schrödinger’s picomolar CDC7 inhibitors were highly selective and inhibited tumor cell growth alone and in combination with several approved and investigational cancer treatments.
Advanced discovery efforts to allow addition of new programs to the company’s internal pipeline in 2021.
Continued investment in Schrödinger’s computational platform

Formed a strategic partnership with NVIDIA to further optimize Schrödinger’s software platform for the NVIDIA DGX SuperPODTM, an enterprise system that can be scaled to enable any organization to reach supercomputing speed and power. Optimizing Schrödinger’s platform for the NVIDIA GPU framework is designed to give customers access to an all-in-one supercomputing solution for in silico drug and materials discovery.
Further expanded the domain of applicability for Schrödinger’s software platform. Recently published research provided rationale for applying Schrödinger’s free energy calculation technology, FEP+, to ion channels using structures generated by cryo-electron microscopy (cryo-EM). The company’s scientists also published research describing a highly accurate method to predict the binding modes of small molecule inhibitors binding to protein targets with flexible binding sites, which have historically been challenging targets for structure-based drug design. Additionally, Schrödinger scientists co-authored a white paper describing how recent advances in protein production and cryo-EM can rapidly facilitate the structural enablement of drug targets.
Full-Year 2021 Financial Outlook

As of May 11, 2021, Schrödinger continues to expect total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ending December 31, 2021. Additional details are as follows:

Software revenue growth is expected to be higher in the second half of the year with the majority of second half growth in the fourth quarter of 2021.
Drug discovery revenue is expected to be highly variable quarter to quarter based on the timing of potential milestones related to collaborative agreements.
Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company expects operating expense growth to be higher than the 42% annual growth rate reported in 2020 and expects software gross margin to be lower than the 81% reported in 2020.
Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its first quarter financial results on Tuesday, May 11, 2021, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 3297222. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website following the event.

On May 11, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer of Merus, will participate in a fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18 at 8:00 a.m. ET (Press release, Merus, MAY 11, 2021, View Source [SID1234579698]).

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The live webcast of the presentation will be available on the Investors page of the Company’s website. An archived presentation will be available on the Merus website for a limited time.