Athenex to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will participate in the 39th annual J. P. Morgan Healthcare Conference. Johnson Lau, CEO and Board Chairman, and Daniel Lang, Senior Director, Corporate Development, will present a corporate overview at the conference (Press release, Athenex, JAN 11, 2021, View Source [SID1234573867]).

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When: Monday, January 11, 2021, at 8:40 AM ET

Where: Conference Virtual Session

A live audio webcast of the presentation and replay will be available in the "Events & Presentations" section of the Athenex website at View Source

BioInvent streamlines agreement on anti-FcγRllB antibody, BI-1206, ahead of Phase I/II data

On January 11, 2021 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported it has restructured a clinical development agreement with Cancer Research UK (CRUK), the world’s leading cancer charity, for its unique anti-FcγRIIB antibody, BI-1206 (Press release, BioInvent, JAN 11, 2021, View Source [SID1234573865]). In exchange for a one-time payment, the revised deal simplifies and reduces BioInvent’s obligations to CRUK, which provides BioInvent with more flexibility to carry out development and partnering activities with BI-1206. It follows BioInvent’s exclusive licensing agreement with CASI Pharmaceuticals for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau.

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CRUK conducted and funded a Phase I/IIa clinical trial to evaluate BI-1206 for the treatment of Non-Hodgkin Lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In parallel, BioInvent is conducting a Phase I/II trial of BI-1206 in combination with rituximab for the treatment of NHL. Given the overlap between the BioInvent and CRUK trials, CRUK decided to end the trial being conducted in the UK after the single-agent part of the study. As a result, both parties have also agreed to restructure their agreement concerning BI-1206.

The restructured agreement with CRUK releases BioInvent from obligations to pay development or commercial milestones to CRUK on BI-1206 and reduces the royalties due on net sales to low single digit levels. BioInvent will make a one-time payment of £2.5 million to CRUK.

"Our strengthened financial position gives BioInvent the means and flexibility to further advance our promising, unique anti-FcγRIIB antibody, BI-1206. By simplifying our obligations and licenses, we retain greater control and potential value from the broader development program for BI-1206 across a range of liquid and solid tumors. The data package from our UK trial added value to the clinical development of BI-1206 and I would like to thank the CRUK team for their support during the collaboration," says Martin Welschof, CEO of BioInvent.

BI-1206 is a novel mode-of-action, single inhibitory antibody that blocks the FcγRIIB receptor to unlock anti-cancer immunity in both liquid and solid tumors. BI-1206 is BioInvent’s lead drug candidate and is being investigated in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda (pembrolizumab), in solid tumors, and in a Phase I/IIa trial in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL). Early results from the Phase I open label study in NHL are expected in early 2021.

BioInvent is building a broad pipeline of cancer therapies based on the productivity of its proprietary F.I.R.S.T technology platform and n-CoDeR antibody library. The first-in-class anti-TNFR2 antibody BI-1808 is BioInvent’s third program in clinical development for the treatment of solid tumors and cutaneous T-cell lymphoma and the oncolytic virus BT-001 is the fourth, also for solid tumors.

IDEAYA Biosciences Announces Submission of IND Application for MAT2A Development Candidate IDE397 with the U.S. FDA

On January 11, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE397, a small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, for the treatment of patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion (Press release, Ideaya Biosciences, JAN 11, 2021, View Source [SID1234573864]).

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"The IDE397 IND submission is an important milestone for IDEAYA as we advance our broader synthetic lethality pipeline of potential first-in-class therapies. IDE397 was discovered through our efforts to develop a potential best-in-class MAT2A inhibitor, and we have achieved our target product profile," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences. "IDE397 is highly selective and active in the MTAP-deletion setting, which represents approximately 15% of all solid tumors, and we are excited about the potential impact IDE397 can make for these patients," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

IDEAYA Biosciences will present a program update on IDE397 and its broader synthetic lethality pipeline at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will include preclinical data demonstrating IDE397 monotherapy tumor regressions in PDX models with MTAP-deletion across several solid tumor types. IDEAYA will also present its proposed IDE397 Phase 1 clinical plan in MTAP-deleted solid tumors, including monotherapy and combination strategies, and discuss the combination rationale for IDE397 and GSK’s Type I PRMT inhibitor GSK3368715.

Synlogic Outlines Upcoming Clinical Milestones

On January 11, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported significant clinical milestones for 2021 and provided an overview of recent progress (Press release, Synlogic, JAN 11, 2021, View Source [SID1234573863]).

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"With three programs in clinical trials, multiple proof of concept opportunities, and a preclinical portfolio advancing rapidly towards the clinic, Synlogic is poised for success with a number of data readouts coming in 2021," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "2020 was a year we will not forget. Despite the external challenges, the Synlogic team moved our programs forward with grit and resilience. We enter 2021 with momentum and the opportunity to truly see the potential of novel Synthetic Biotic medicines to make a meaningful difference in patients’ lives."

Synlogic anticipates clinical proof of concept data in 2021 across two metabolic programs, SYNB1618 for the treatment of Phenylketonuria (PKU) and SYNB8802 for the treatment of Enteric Hyperoxaluria, as well as continued advancement of SYNB1891 for the treatment of solid tumors and lymphomas.

Execution Across Clinical Pipeline: Metabolic Programs

Progression of a proof of concept Phase 2 clinical trial of SYNB1618 for the treatment of Phenylketonuria (PKU)
SYNB1618 is an investigational drug composed of a Synthetic Biotic medicine designed to consume phenylalanine (Phe) in the gastrointestinal (GI) tract for the treatment of PKU in patients regardless of age or disease type.
A solid oral formulation of SYNB1618 has been shown to metabolize Phe in the GI tract in a healthy volunteer study.
The SynPheny-1 study evaluates plasma Phe lowering of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies such as Kuvan or Palynziq.
Synlogic anticipates data from SynPheny-1 will be available mid- 2021.
Progression of a Phase 1 clinical study of SYNB8802 for the treatment of Enteric Hyperoxaluria
SYNB8802 is an investigational drug composed of a Synthetic Biotic medicine designed to consume oxalate in the GI tract and lower urinary oxalate levels, potentially reducing kidney damage due to Enteric Hyperoxaluria.
In data presented at the American Society of Nephrology’s (ASN) 2020 Kidney Week, SYNB8802 was shown to reduce urinary oxalate in two animal models of Hyperoxaluria.
The Phase 1 clinical study evaluates the safety, tolerability, and potential for urinary oxalate lowering in healthy volunteers and patients.
The study has two parts: Part A is a multiple ascending dose study in healthy volunteers; Part B is a placebo controlled, cross-over design study in patients with Enteric Hyperoxaluria following Roux-n-Y gastric bypass surgery which provides an opportunity to demonstrate proof of concept.
Synlogic anticipates data from Part B of the study will be available mid-2021.
Execution Across Clinical Pipeline: Immunomodulation Programs

Advancement of SYNB1891 into combination arm dosing with PDL1 checkpoint inhibitor in ongoing Phase 1 study
SYNB1891 is an investigational drug composed of an intratumorally delivered Synthetic Biotic medicine designed to produce a STING agonist and act as a dual innate immune activator for the treatment of advanced solid tumors and lymphoma.
SYNB1891 is currently being evaluated in a Phase 1 study that has two parts:
Part A is a monotherapy arm that has enrolled four dose cohorts to date.
A maximum tolerated dose has not been reached and dose escalation continues.
Part A of the study has demonstrated target engagement and activation of the STING pathway.
Part B of the study will combine escalating dose levels of SYNB1891 with a fixed dose of the PD-L1 checkpoint inhibitor atezolizumab, to establish a recommended Phase 2 dose for the combination regimen.
Synlogic anticipates additional data from cohorts in both arms will be available in mid to late 2021.
Preclinical Roadmap

Synlogic continues to advance preclinical programs including additional effectors for immune-oncology; immune regulation targets for treatment of inflammatory bowel disease and other inflammatory disorders; and additional undisclosed rare metabolic diseases.
Further updates on these programs will be shared as they advance towards the clinic.
2020 Corporate Milestones

Synlogic strengthened leadership with the following appointments:
Synlogic appointed Dr. David Hava, Ph.D., as Chief Scientific Officer. Dr. Hava brings over a decade of senior experience in research and development to Synlogic, including deep academic expertise in pillars of synthetic biology.
Synlogic promoted Antoine ‘Tony’ Awad to Chief Operating Officer. Mr. Awad brings over 15 years of experience in the biotechnology and pharmaceutical industry with substantial experience in the development and manufacturing of novel therapeutics from pre-IND studies through global commercialization.
Synlogic appointed Michael Heffernan, seasoned entrepreneur and biopharmaceutical leader, and Dr. Michael Burgess, physician scientist and expert in translational development, to its board of directors.
Synlogic and Ginkgo Bioworks advanced their long-term strategic platform collaboration that provides expanded synthetic biology capabilities to Synlogic.
Ginkgo and Synlogic are collaborating on multiple efforts including metabolic and immunomodulation programs, and assessment of the potential application of Synthetic Biotics for vaccine development.
Synlogic ended the third quarter of 2020 with $102.0 million in cash, cash equivalents and short- and long-term investments and expects this will fund company operations through 2022 under its current plan.

Sosei Heptares to present at 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 Sosei Group Corporation ("the Company";) (TSE: 4565), reported its Chief Financial Officer, Chris Cargill, will present at the 39th Annual J.P. Morgan Healthcare Conference, which will take place virtually, on Thursday, 14 January 2021 (Press release, Sosei Heptares, JAN 11, 2021, View Source [SID1234573861]).

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The presentation will begin at 10:00 a.m. Eastern Standard Time, and will be video broadcasted live in English to registered conference attendees via the Digital Conference Book. For non-attendees, an audio link to the Company’s virtual session presentation can be accessed here. Presentation slides will be made available through the investor section of the Company’s Home Page, www.soseiheptares.com. View Source