On January 6, 2023 Synthekine Inc., an engineered cytokine therapeutics company, reported the closing of a $100 million Series C financing led by The Column Group, with participation from both new and existing investors. Debanjan Ray, Synthekine’s chief executive officer, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference at 1:30 p.m. PT on Tuesday, January 10 (Press release, Synthekine, JAN 6, 2023, View Source [SID1234625992]).

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"Synthekine has made significant progress since our founding in 2019. We have advanced our alpha/beta-biased IL-2 partial agonist, STK-012, into the clinic, developed a novel cytokine approach to empower CAR-Ts and other adoptive cell therapies, matured our three distinct cytokine engineering platforms, and secured our first pharmaceutical partnership through a deal with Merck," said Ray. "We are thankful for the support from these elite healthcare investors, which enables us to pursue our bold vision of advancing novel cytokine science to benefit patients with debilitating cancers and inflammatory diseases."

Proceeds of the financing will be used to advance Synthekine’s differentiated therapeutic pipeline, led by its alpha/beta-biased IL-2 partial agonist, STK-012, which is currently in a Phase 1 clinical trial. In addition, it will support upcoming clinical studies of its orthogonal IL-2 and CD19 CAR-T combination therapy, STK-009 + SYNCAR-001, which the company anticipates to begin early this year.

Funds will also be used to progress the company’s IL-12 partial agonist program, which is currently in IND-enabling studies. IL-12 is a potent cytokine with potential for the treatment of cancer, but administration of unmodified forms of the cytokine have been limited by a narrow therapeutic window, including life-threatening toxicities in patients. Preclinical data for Synthekine’s IL-12 partial agonist program demonstrates potent anti-tumor efficacy in mouse models while avoiding induction of systemic toxicity. In addition, funds will also be used to advance toward clinical investigation its orthogonal IL-2 system with a GPC3 CAR-T therapy. Preclinical data for this program, the company’s first cell therapy program for solid tumors, were presented at AACR (Free AACR Whitepaper) 2022.

On January 6, 2023 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 41st Annual J.P. Morgan Healthcare Conference (Press release, Orca Bio, JAN 6, 2023, View Source [SID1234625991]).

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The company presentation will take place on Monday, January 9, 2023, at 7:30 a.m. PST at the Westin St. Francis in the Mission Bay Room on the 32nd Floor.

On January 6, 2023 Cellenkos Inc, a clinical stage biotechnology company focused on the development of allogeneic, off-the-shelf, T regulatory cell therapies targeting inflammatory disorders and autoimmune diseases, reported that the first patient was dosed in the Phase 1b LIMBER-TREG108 study evaluating CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib (Press release, Cellenkos, JAN 6, 2023, View Source [SID1234625990]). CK0804 is a novel allogeneic, CXCR4 enriched, T regulatory cell therapy product that utilizes Cellenkos’ proprietary CRANE technology to generate disease specific products.

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The LIMBER-TREG108 trial (NCT05423691) is part of a development collaboration between Cellenkos and Incyte.

"This is an exciting milestone for our company. The initiation of this study of CK0804 as on add on therapy to ruxolitinib is an important achievement that brings us closer to delivering a potential new treatment which may have a life-changing impact for myelofibrosis patients who have less than optimal response to treatment with ruxolitinib," said Tara Sadeghi, Chief Operating Officer of Cellenkos Inc., "Myelofibrosis patients who do not respond to ruxolitinib have limited treatment options and can progress to leukemia. This experimental immunotherapy treatment in combination with the standard of care may represent a new hope for the patients with myelofibrosis potentially enhancing the efficacy of current JAK inhibitor therapy while also offering possible immune modulation and restoration of impacted hematopoiesis."

LIMBER-TREG108 is a multicenter study at The University of Texas MD Anderson Cancer Center, The University of Columbia Hospital and University of California, Davis. The study is led by principal investigator Lucia Masarova, M.D., Assistant Professor of Leukemia at MD Anderson. This Phase 1b study will evaluate the safety, pharmacodynamics and immunogenicity of intravenous CK0804, administered monthly for up to 6 doses. The study will consist of 2 phases: an open-label safety run-in of 9 patients (Stage 1) and an expansion cohort of 15 additional patients (Stage 2).

"We are pleased that the first patient first dose milestone in the LIMBER-TREG108 study – one of several studies in our LIMBER clinical program evaluating multiple monotherapy and combination strategies to improve and expand treatments for patients with MPNs – has been achieved. We look forward to the results of the study, and to continuing our partnership toward important scientific advances for these patients," said Ekaterine Asatiani, M.D., Division Vice President and Head of Early Development at Incyte.

About Myelofibrosis

Myelofibrosis is a rare, chronic and progressive blood cancer that is part of a group of diseases known as myeloproliferative neoplasms. In myelofibrosis, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, as well as symptoms such as fatigue, itching and night sweats, which can severely impact a patient’s quality of life. About 16,000 to 18,500 people in the U.S. are living with myelofibrosis1. Patients who have had a suboptimal response to the standard of care treatment have limited options and a poor prognosis.

About CK0804

CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos’ proprietary CRANE process. Multiple doses of CK0804 can be manufactured from a single umbilical cord blood unit, where the final cryopreserved product is readily available for use. No requirement for HLA matching to the patients makes CK0804 an ideal therapy that can be infused intravenously, in the outpatient setting.

About Ruxolitinib (Jakafi )

Ruxolitinib (Jakafi) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older2.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

On Januray 6, 2023 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that Bristol Myers Squibb exercised its option to enter into an exclusive license for a sixth TriNKET Immunotherapy drug candidate, that will bring the total drug candidates licensed by Bristol Myers Squibb to seven including Dragonfly’s novel IL12 cytokine DF6002/BMS-986415 (Press release, Dragonfly Therapeutics, JAN 6, 2023, View Source [SID1234625989]). Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets. Today’s announcement marks the first TriNKET opt-in outside of oncology.

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"We are delighted that our research collaboration initiated with Dragonfly in July 2020 on multiple sclerosis and neuro-inflammation has rapidly produced novel TriNKET drug candidate molecules that may provide new treatment options for patients with neurological diseases" said Richard Hargreaves, Senior Vice President, Neuroscience, Bristol Myers Squibb.

"We believe this opt-in decision by Bristol Myers Squibb further validates our drug discovery platform," said Bill Haney, Dragonfly’s CEO. "The ongoing clinical trials of six Dragonfly-developed drugs including our wholly owned solid tumor targeting TriNKETs DF1001 (HER2), now in Phase 2, DF9001 (EGFR), and our BMS-partnered novel IL12 cytokine, underscore the breadth of Dragonfly’s portfolio of innovative therapeutics, and potential to help patients with hematological cancers, solid tumor cancers, autoimmune diseases, and neurological conditions."

On January 6, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the China National Medical Products Administration (NMPA) has approved the Company’s Clinical Trial Application (CTA) for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics (Press release, CASI Pharmaceuticals, JAN 6, 2023, View Source [SID1234625988]). CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy. The Phase 1 development program is expected to start in 2023.

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Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, "This is exciting news for CASI, as we are now a step closer to make CB-5339 available to patients and healthcare providers across Greater China. CB-5339 represents a promising new agent for selectively targeting VCP/p97 in cancers and is a complementary addition to our growing portfolio of approved and investigational therapies for hematology oncology indications. CASI is responsible for the conduct of the clinical trials in China and will initiate the studies as soon as possible."

About CB-5339 (VCP/p97 inhibitor)

CB-5339 is an oral second-generation, small molecule VCP/p97 inhibitor, and is currently being evaluated by Cleave Therapeutics in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (NCT04402541).

VCP/p97 inhibitors exploit molecular features that define cancer cell growth and metabolism. VCP/p97 plays a critical role in protein homeostasis processes such as endoplasmic reticulum associated degradation (ERAD) and chromatin-associated degradation (CAD), as well as the DNA damage response (DDR). These key cellular stress pathways are known to represent sensitivities critical to cancer cell survival. Cellular stress provides an attractive means of targeting non-oncogene addiction as a way to combat tumor heterogeneity and emerging resistance to targeted therapies. Such an approach has the added benefit of broad applicability, not dependent on a single driver mutation and potential efficacy across cancer types.