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Bicycle Therapeutics LPC (BCYC)

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Bicycle Therapeutics LPC (BCYC)

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Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, called Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained to form two loops that stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches. Bicycle has a novel and proprietary phage display screening platform that we use to identify Bicycles in an efficient manner. Bicycle’s internal programs are focused on oncology indications with high unmet medical need. Its lead product candidate, BT1718, is a Bicycle Toxin Conjugate that is designed to target tumors that express MT1-MMP. BT1718 is being investigated for safety, tolerability and efficacy in an ongoing Phase I/IIa clinical trial in collaboration with, and fully funded by, the Centre for Drug Development of Cancer Research UK.

https://www.bicycletherapeutics.com/

18 miljoen aandelen en een free float van 4.5 miljoen, dus hevige koersbewegingen zijn inherent.
Voor sommige zal dit bedrijf een belletje doen rinkelen want ze werken samen met oa. Oxurion (THR-149) en Astrazeneca.

Cash op het einde van 2019: 92 miljoen $ (exclusief geld van Genentech --> 30 miljoen $)

Eind februari ging BCYC in een strategische samenwerking met Genentech van Roche, met een potentiële pay-off van 1.7 miljard $.
Entered into Strategic Collaboration with Genentech to Discover, Develop and Commercialize Novel Bicycle-based Immuno-oncology Therapies. In February 2020, Bicycle entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Bicycle will be responsible for discovery research and early preclinical development up to candidate selection. Bicycle will receive a $30 million upfront payment. The upfront payment and potential milestone payments could total up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties. None of Bicycle’s wholly owned oncology assets, including its immuno-oncology candidates, are included in the collaboration.
Door de Corona-crisis heeft dit aandeel quasi niet gereageerd op dit schitterend nieuws. Dit is mijn ogen een buitenkans. Met het oog op de situatie in de US en ook de UK, bestaat de kans dat je deze de komende weken nog goedkoop kan inslaan!

Ik heb een eerste positie aan 11.15$.

Dit is geen advies om te kopen, doe altijd uw eigen onderzoek :D !

Ik ben nieuwsgierig naar eventuele bevindingen of opmerkingen.
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NewB76
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Re: Bicycle Therapeutics LPC (BCYC)

Bericht door NewB76 »

Ze hebben drie molecules in Fase I namelijk BT1718-5528-8009 , hiervan nieuws in 2020
Een cashburn van 25 miljoen per jaar en dus 9o miljoen op de rekening
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Re: Bicycle Therapeutics LPC (BCYC)

Bericht door sLynX »

Er wordt wel zo goed als niets verhandeld vandaag.

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Re: Bicycle Therapeutics LPC (BCYC)

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BRIEF-Bicycle Therapeutics Announces Pipeline Progress Update
13:47 (07/04) - Bron: Reuters
April 7 (Reuters) - Bicycle Therapeutics PLC :
* BICYCLE THERAPEUTICS ANNOUNCES PIPELINE PROGRESS UPDATE
* BICYCLE THERAPEUTICS PLC - PHASE I DOSE ESCALATION
COMPLETED FOR
BT1718-RP2D ESTABLISHED AND PRELIMINARY SIGNS OF ANTI-TUMOR
ACTIVITY OBSERVED
* BICYCLE THERAPEUTICS PLC - DOSING COMPLETE IN SECOND
COHORT OF
PHASE I DOSE ESCALATION FOR BT5528-ALL DOSES ADMINISTERED IN
PHASE I TO DATE APPEAR TOLERABLE
* BICYCLE THERAPEUTICS - PROGRESS ACROSS PIPELINE CONTINUES
DESPITE UNCERTAINTIES ASSOCIATED WITH COVID-19
PANDEMIC-CURRENTLY
* BICYCLE THERAPEUTICS PLC - KEY 2020 EVENTS REMAIN ON TRACK

Source text for Eikon:
Further company coverage:

(Reuters.Briefs@thomsonreuters.com)
Bicycle Therapeutics Announces Pipeline Progress Update
•April 7, 2020
- Phase I dose escalation completed for BT1718—RP2D established and preliminary signs of anti-tumor activity observed, including one partial response

- Dosing complete in second cohort of Phase I dose escalation for BT5528—all doses administered in Phase I to date appear tolerable

- Significant achievements in multiple partnered programs beyond oncology

- Progress across pipeline continues despite uncertainties associated with coronavirus disease (COVID-19) pandemic—currently, key 2020 events remain on track


Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced progress updates across its wholly-owned and partnered programs in oncology and non-oncology indications.

"We and our partners have recently achieved important progress in the advancement of our pipeline that we believe could catalyze the next stage of growth for Bicycle," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Cancer Research UK has identified a recommended dose, which is within the therapeutic range predicted by preclinical models, for the Phase IIa study of BT1718, which we expect to commence this year. Our next-generation Bicycle Toxin Conjugates (BTCs), BT5528 and BT8009, are quickly progressing through respective stages of development. In addition, we believe our recently announced early discovery collaboration with Genentech will allow us to make considerable investments in expanding our portfolio of immuno-oncology assets, including our wholly-owned programs nearing late preclinical development. Beyond oncology, we continue to make progress on our partnered programs and to execute on our strategy of leveraging our collaborators’ expertise in specific therapeutic areas to advance the development of Bicycle-based medicines across a broad range of serious diseases."

Dr. Lee continued: "While we expect that the evolving COVID-19 pandemic may impact the pace of clinical development, at this time, we believe the strong progress we’ve achieved across our pipeline to date will enable us to reach our anticipated 2020 milestones as planned."

BT1718, a potential first-in-class BTC targeting key tumor antigen MT1-MMP

Cancer Research UK Completed Phase I Dose Escalation of BT1718 in Patients with Solid Tumors, Established Recommended Phase II Dose (RP2D) at 20 mg/m2. The key objectives were met in a Phase I dose escalation sponsored by Cancer Research UK and evaluating safety and tolerability of BT1718 in an unselected group of patients with advanced solid tumors. Based on study results, Cancer Research UK established an RP2D for the expansion cohorts at 20 mg/m2 administered once weekly. This recommended dose is within the efficacious dose range predicted by preclinical models, in which an equivalent dose level was associated with complete responses. With once-weekly dosing, BT1718 appeared tolerable, with manageable adverse events.

Though not a key objective of the Phase I portion of the Phase I/IIa study, preliminary signs of anti-tumor activity were observed during the dose escalation. As reported at the European Society of Medical Oncology (ESMO) 2019 Annual Congress, 13 of 24 evaluable patients (54%) had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion, with findings generally remaining consistent as the trial progressed. Today, Bicycle announced that, in addition, one patient with small cell lung cancer experienced a partial response, with a 68% reduction in a target lesion.

The Company anticipates that Cancer Research UK will initiate the Phase IIa portion of the Phase I/IIa study of BT1718 in 2020, although timing may be dependent on the ongoing COVID-19 pandemic. These expansion cohorts will include patients determined to be MT1-MMP-positive based on a prespecified tumor membrane H-score. Initially, patients will be enrolled into two expansion cohorts, one in squamous non-small cell lung cancer (NSCLC) and the other in an all-comers "basket" cohort. Depending on results from these first two cohorts, additional cohorts may be initiated.
BT5528, a BTC targeting EphA2, a potentially high-value target for which antibody-based approaches have been unsuccessful

Doses of BT5528 Administered to Date Appear Safe, Well Tolerated in Ongoing Phase I/II Trial. The second cohort of patients has completed dosing in the Phase I dose escalation portion of a Phase I/II study of BT5528 in patients with advanced solid tumors associated with EphA2 expression. Unlike previous antibody drug conjugate (ADC) programs to target EphA2, BT5528 did not show coagulopathy in preclinical studies. Initial doses of BT5528 administered in the Phase I portion of the study are estimated to deliver six to 12 times the amount of toxin that was delivered by an ADC targeting EphA2 in an unsuccessful clinical trial and, to date, BT5528 has appeared well tolerated with manageable adverse events.

The Phase I/II multi-center, open-label trial is evaluating BT5528 administered once-weekly as a single agent and in a lagging cohort in combination with nivolumab. The Phase I portion is a dose escalation study primarily designed to assess the safety and tolerability of BT5528 and to determine an RP2D. Bicycle expects the first patient in the combination arm will be dosed in 2020, subject to potential timing and other impacts of the ongoing COVID-19 pandemic.
BT8009, a Nectin-4 targeting BTC with a potentially differentiated profile to marketed ADC

Phase I/II Trial of BT8009 Currently On Track to Initiate in 2020. In preclinical studies, BT8009 demonstrated highly target-dependent and improved anti-tumor activity over comparator Nectin-4-targeting ADCs. Bicycle believes the characteristics of BT8009 may result in a favorable safety profile and could circumvent certain challenges in treating cancers believed to be associated with Nectin-4 expression that are not addressed by current ADC approaches. The Company plans to initiate a Phase I/II study of BT8009 in patients with advanced solid tumors in indications associated with Nectin-4 expression this year, subject to potential timing and other impacts of the ongoing COVID-19 pandemic.
Novel, fully synthetic Bicycle systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs™)

IND Preparation for BT7480 On Track, Enabling Potential Clinical Start in 2021. BT7480 is a novel, fully synthetic TICA that contains two Bicycles, one targeting Nectin-4 and a second agonizing CD137, that has been shown in preclinical models to rapidly penetrate tumors, effect anti-tumor activity, and facilitate immune memory. IND-enabling activities for BT7480 are ongoing and remain on track to enable the initiation of clinical development in 2021, subject to potential timing and other impacts of the ongoing COVID-19 pandemic.
Bicycle Expands IO Pipeline, Selecting BT7455 as New TICA Candidate. BT7455 is a novel, fully synthetic TICA containing two Bicycle arms, one targeting EphA2 and the other agonizing CD137. EphA2 is highly expressed in a number of tumor types of high unmet medical need. In preclinical models, BT7455 exhibits highly potent EphA2-dependent stimulation of CD137 and robust in vivo anti-tumor activity against EphA2 expressing tumors.
Cancer Research UK Advancing Preclinical Development of BT7401. BT7401 is a multivalent, systemic immune cell agonist of CD137 built from multiple CD137 monomeric Bicycles connected by stable linkers through a central hinge. In 2020, Bicycle announced a second collaboration with Cancer Research UK, in which the organization will fund and sponsor development of BT7401 through a Phase I/IIa clinical study. Preclinical development of BT7401 funded by Cancer Research UK is ongoing.
Partnered programs beyond oncology

Oxurion Preparing to Initiate Phase II Trial of Kallikrein Inhibitor Bicycle, THR-149, in Patients with Diabetic Macular Edema (DME). Positive results from the Phase I clinical trial in patients with DME evaluating the safety and tolerability of THR-149, a novel Bicycle plasma kallikrein (PKal) inhibitor, were announced in 2019. The Phase I data demonstrate that a single intravitreal injection of THR-149 resulted in increasing average improvements in best corrected visual acuity (BCVA) starting at Day 1, which were up to 7.5 letters at Day 14 and maintained through Day 90. No dose-limiting toxicities or drug-related adverse events were reported.

Oxurion is preparing to initiate a Phase II trial evaluating multiple doses of THR-149 in DME patients who respond sub-optimally to anti-VEGF therapy.
Three Target Programs Transitioned to AstraZeneca. Under the terms of the collaboration, Bicycle is responsible for identifying Bicycles for an undisclosed number of respiratory, cardiovascular and metabolic disease targets specified by AstraZeneca. Three target programs have been transitioned to AstraZeneca for subsequent optimization towards potential candidate selection. Pursuant to the collaboration agreement, AstraZeneca is responsible for further development and product commercialization, and Bicycle is eligible for over $1 billion in future R&D funding, development, regulatory and commercialization milestone payments, as well as royalties on sales of products resulting from the partnership.
Early Success in Collaboration with Dementia Discovery Fund (DDF). Bicycle, in collaboration with DDF, is developing Bicycles to modulate the activity of proteins implicated in the progression of dementia. The Company has developed Bicycles that show successful binding to a target of interest, representing the first part of the first milestone of the collaboration.
About Bicycle Therapeutics

View source version on businesswire.com: https://www.businesswire.com/news/home/ ... 005232/en/
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Re: Bicycle Therapeutics LPC (BCYC)

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BRIEF-Bicycle Therapeutics Files For Mixed Shelf Of Upto $250 Million
00:13 (06/06) - Bron: Reuters
June 5 (Reuters) - Bicycle Therapeutics PLC :
* BICYCLE THERAPEUTICS FILES FOR MIXED SHELF OF UPTO $250
MILLION
- SEC FILING

Source text: (https://bit.ly/2UeLZ4l)
Further company coverage:

((Reuters.Briefs@thomsonreuters.com;))
Koers gisteren 17.4$
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Re: Bicycle Therapeutics LPC (BCYC)

Bericht door NewB76 »

een recente voorstelling
Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET

en de volgende
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET

Quid belangstelling ?

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Re: Bicycle Therapeutics LPC (BCYC)

Bericht door And its gone! »

Nog wat bijgekocht vorige week nu gemiddeld 13.52$.

Gisteren ATH aangetikt 20$ 8-)
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Re: Bicycle Therapeutics LPC (BCYC)

Bericht door And its gone! »

BRIEF-Point72 Asset Management Reports 5.7% Passive Stake In Bicycle Therapeutics- SEC Filing
23:22 (15/09) - Bron: Reuters
Sept 15 (Reuters) - Bicycle Therapeutics PLC :
* POINT72 ASSET MANAGEMENT LP REPORTS 5.7% PASSIVE STAKE IN
BICYCLE THERAPEUTICS PLC AS OF SEPTEMBER 14 - SEC FILING

Source : (https://bit.ly/35BdqMt)
Further company coverage:

((Reuters.Briefs@thomsonreuters.com;))
BICYCLE THERAPEUTICS (BCYC)
Chemical/Pharmaceutical/Health

ISIN: US0887861088

LAATSTE
(16/09/20 - 18:02)
20,42
WIJZIGING
(1,39)
7,30%
BID
20,16
ASK
20,5
Bicycle Therapeutics to Present Trials in Progress Poster for BT8009 at the ESMO Virtual Congress 2020
September 14, 2020 06:59 AM Eastern Daylight Time
CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that a poster describing the design of the ongoing Phase I/II trial of BT8009 will be presented during an e-poster session at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 19-21, 2020. BT8009 is a second-generation Bicycle Toxin Conjugate (BTC), which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload. BT8009 targets Nectin-4, a tumor antigen observed to be overexpressed in several common tumor types and associated with poor disease prognosis.

“With our recent announcement that the first patient has been dosed in the Phase I/II trial of BT8009, we are pleased that the trial is progressing and look forward to providing an overview of its design at ESMO.”

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“We believe BT8009 represents an important addition to the landscape of potential next-generation treatments for patients with Nectin-4-positive cancers, as it could improve on Nectin-4-targeted therapies that are based on conventional modalities,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “With our recent announcement that the first patient has been dosed in the Phase I/II trial of BT8009, we are pleased that the trial is progressing and look forward to providing an overview of its design at ESMO.”

Details on Bicycle’s poster presentation at ESMO are as follows:

Poster Title: BT8009-100 Phase I/II Study of the Safety, Pharmacokinetics, & Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
Abstract #: 3716
Presentation #: 599TiP

The poster will be available on the ESMO website, as well as in the Publications section of bicycletherapeutics.com, beginning Thursday, September 17.
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