1stOncology™: Cancer Intelligence Service – Page 8507 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Syros to Present New Data from Phase 1 Clinical Trial of SY-5609 in Oral Presentation at ESMO Congress 2021

On September 13, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new data from the dose-escalation portion of the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, at the ESMO (Free ESMO Whitepaper) Congress 2021, taking place virtually September 16-21, 2021 (Press release, Syros Pharmaceuticals, SEP 13, 2021, View Source [SID1234587611]). The oral presentation will include safety, tolerability, and initial clinical activity data for SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.

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

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

Schedule Your 30 min Free Demo!

In separate poster presentations, Syros will present new preclinical data evaluating the antitumor and pharmacodynamic activity of intermittent dosing regimens for SY-5609 in ovarian cancer models, as well as new preclinical data evaluating antitumor activity of SY-5609 as a single agent and in combination with chemotherapy in KRAS-mutant models.

The abstracts for the two poster presentations are now available online on the ESMO (Free ESMO Whitepaper) conference website at: View Source, and the presentations will become available for on-demand viewing starting September 16 at 08:30 CEST (September 16 at 2:30 a.m. ET). The abstract for the oral presentation on the Phase 1 dose-escalation data will remain embargoed until September 17 at 00:05 CEST (September 16 at 6:05 p.m. ET).

Details of the oral presentation are as follows:

Presentation Title: Tolerability and Preliminary Clinical Activity of SY-5609, a Highly Potent and Selective Oral CDK7 Inhibitor, in Patients with Advanced Solid Tumors
Session Date & Time: Monday, September 20, 17:30-18:30 CEST (11:30-12:30 p.m. ET)
Presentation Time: 17:55-18:00 CEST (11:55-12:00 p.m. ET)
Session Title: Mini Oral Session: Developmental Therapeutics
Presenter: Manish Sharma, M.D., START Midwest
Abstract Number: 518MO

Details of the poster presentations are as follows:

Presentation Title: Preclinical Evaluation of Intermittent Dosing Regimens on Antitumor and PD Activity of SY-5609, a Potent and Selective Oral CDK7 Inhibitor, in Ovarian Cancer Xenografts
Abstract Number: 14P
Presentation Title: SY-5609, a Highly Potent and Selective Oral CDK7 inhibitor, Exhibits Robust Antitumor Activity in Preclinical Models of KRAS Mutant Cancers as a Single Agent and in Combination with Chemotherapy
Abstract Number: 13P

Conference Call Information

Syros will host a conference call on Monday, September 20, 2021 at 4:00 p.m. ET to discuss the new clinical and preclinical data for SY-5609, which will be presented at the ESMO (Free ESMO Whitepaper) Congress 2021.

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international) and refer to conference ID 4648345. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the conference call.

ProMIS Neurosciences to Participate in H.C. Wainwright & Co. 23rd Annual Investment Conference

On September 13, 2021 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its participation in H.C. Wainwright & Co., 23rd Annual Investment Conference being held virtually September 13-15 2021 (Press release, ProMIS Neurosciences, SEP 13, 2021, https://promisneurosciences.com/news/promis-neurosciences-to-participate-in-h-c-wainwright-co-23rd-annual-investment-conference/ [SID1234587609]).

ProMIS Executive Chairman, Eugene Williams, will provide an update on the company with special focus on PMN310, ProMIS’ lead antibody for Alzheimer’s disease (AD), as well as an overview of the Company’s unique, proprietary technology platform and ProMIS’ expanding portfolio of antibody therapeutic candidates targeting in addition to AD, amyotrophic lateral sclerosis (ALS), Parkinson’s disease (PD) and beyond. A narrated version of the slide deck presented at the conference is available on the ProMIS website by clicking on the following link:

HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma

On September 13, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that the Center for Drug Evaluation of China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma ("FL"), a subtype of non-Hodgkin’s lymphoma ("NHL") (Press release, Hutchison China MediTech, SEP 13, 2021, View Source [SID1234587608]).

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients’ unmet needs more quickly.

Christian Hogg, CEO of HUTCHMED, said, "The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor. There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO (Free ESMO Whitepaper) Congress next week and are continuing to accelerate global development of this novel therapy."

Updated preliminary results from the ongoing Phase Ib expansion study in China will be presented as a Proffered Paper at the 2021 ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress on September 20, 2021. To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics ("PK"), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In April 2021, HUTCHMED initiated a Phase II registration study in China for amdizalisib in approximately 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma ("MZL"). The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.

Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL (NCT03786926).

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered a promising target for drugs that aim to treat certain hematologic cancers.

FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively1,2,3. Patients with relapsed or refractory FL do not have curative treatment options and have a high unmet need for optimal therapeutic options.

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s PK properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED currently retains all rights to amdizalisib worldwide.

Greenwich LifeSciences to Present at H.C. Wainwright 23rd Annual Global Investment Conference

On September 13, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021 (Press release, Greenwich LifeSciences, SEP 13, 2021, View Source [SID1234587607]).

CEO Snehal Patel will make a presentation that will be available on demand beginning on September 13th to conference attendees. In addition, the Company will be participating in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

H.C. Wainwright 23rd Annual Global Investment Conference

H.C. Wainwright’s Global Investment Conference will include leading industry keynote speakers and presenting companies, investor one-on-one meetings, networking opportunities with attendees, and an evening of entertainment. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

Labcorp Completes Acquisition of Myriad Autoimmune’s Vectra Testing Business

On September 13, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has closed its acquisition of select operating assets and intellectual property (IP) from Myriad Genetics’ autoimmune business unit, including the Vectra rheumatoid arthritis (RA) assay (Press release, LabCorp, SEP 13, 2021, View Source [SID1234587606]).

Earlier this year, Labcorp entered into a definitive agreement to acquire Myriad’s Vectra test, related IP and other RA assets, bolstering its scientific leadership in rheumatology. Specific terms of the transaction were not disclosed.