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.

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.

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

On January 11, 2021 Myeloid Therapeutics, Inc., a company harnessing and reprogramming myeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, reported the signing of a clinical and commercial licensing agreement (Press release, Myeloid Therapeutics, JAN 11, 2021, View Source [SID1234573860]).

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Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

Myeloid’s ATAK platform leverages the unique power of myeloid cells to help patients fighting cancers that, until now, have been very difficult to treat. By targeting myeloid cells, the technology allows for diverse applications and Myeloid’s pipeline expansion is ongoing.

"We are very excited to be working with MaxCyte, an established leader in cell engineering. This agreement provides long-term access to MaxCyte’s unique electroporation technology platform, representing an important enabling step in the continued clinical advancement of targeted cell-based therapies, for patients with few if no options," said Daniel Getts, PhD, CEO of Myeloid. "The ease of use and integration of MaxCyte instruments into our workflow allows us to envision rapid-same-day turnaround of cell treatments for patients presenting with aggressive tumors."

Doug Doerfler, President & CEO of MaxCyte, said: "We are proud to support Myeloid’s work and are excited about the company’s novel approach to engineering and harnessing the innate capabilities of the myeloid cell. This agreement represents an important achievement for MaxCyte as it expands the use of our next-generation technology platform to support engineering in novel cell types. Myeloid’s ATAK technology is being developed for several critical applications in cancer."

MaxCyte’s ExPERT instrument portfolio represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

On January 11, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported that the company has entered into a research collaboration agreement with LegoChem Biosciences Inc. (KOSDAQ: 141080ks), a biopharmaceutical company focusing on the research and development of ADCs (Antibody-Drug Conjugates) in South Korea (Press release, PharmAbcine, JAN 11, 2021, View Source [SID1234573859]).

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Under the agreement, PharmAbcine will provide PMC-403, a preclinical pipeline, to LCB so LCB can conduct a combination research using PMC-403 and LCB’s proprietary ADC. This preclinical study will allow both parties to evaluate the efficacy of the combination therapy in solid tumors.

Dr. Yong Zu Kim. CEO & President of LegoChem said "Currently, our company is widening the development areas such as monoclone antibody-ADC, which is being mainly developed, as well as bispecific antibody-ADC and combination therapy with various drugs. With this agreement, we will try to secure an additional high value-added pipeline by confirming the possibility of combination therapy with our ADC candidates and PharmAbcine’s drug"

"We are excited about this agreement with LegoChem Biosciences, a global leader in ADC. We have been emphasizing wide application of PMC-403 to potential partners and investors in recent months," said Dr. Jin-San Yoo, CEO of PharmAbcine. "This agreement marks an important milestone in exploring the full potential of PMC-403."

PMC-403, a Tie2-activating antibody, is a next generation therapeutic antibody that regulates the formation of functional blood vessels. It is expected to induce normalization of leaky blood vessels formed around tumor mass in a ligand-independent manner. It has demonstrated its anti-tumor effect in a mouse model for colon cancer, corroborated by the improvement in immune cell infiltration and delivery of anti-cancer agents to a tumor site when administered as a single agent or as a combination therapy regimen.

PMC-403 also stabilizes and repairs damaged blood vessels in non-oncology indications. PharmAbcine is currently developing PMC-403 for ophthalmology indications such as AMD (Age-related Macular Degeneration).