On January 6, 2023 Biosortia Microbiomics, the small molecule drug discovery platform and the only company practicing microbiome mining reported that it is presenting at Biotech ShowcaseTM 2023, taking place on January 9-11 in San Francisco, CA (Press release, Biosortia Pharmaceuticals, JAN 6, 2023, View Source [SID1234625996]). This year, registered attendees can view Biosortia Microbiomics’ presentation live, and with 24/7 on-demand access, attendees can also view recorded presentations at their convenience when scheduling does not allow viewing during the main event week.

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Ross Youngs, CEO, and Founder of Biosortia Microbiomics will be presenting on January 10 at 10:00 am PT at Franciscan A (ballroom level) at the event. In his session, Ross will explore the current problems with drug costs and drug discovery and educate the audience about industrial-scale microbiome mining and how it fits into the solution.

Ross will discuss how in just the past ten years, new drug costs have increased by 300% with minimal progress in finding new cures or treatments. And although small molecules are 90% of drugs on the shelf, the most sought-after drug-like small molecules can’t be obtained by indirect methods. Ross will also share how Biosortia’s technology, which is backed by the U.S. Air Force Research Laboratory, ARPA-E, DARPA and NIH are proven for obtaining nature’s drug-like small molecules, which were previously inaccessible, for treatments and cures.

"The capabilities and potential impact of Biosortia’s technology on the drug discovery industry is what motivates me and my team," says Youngs. "We’ve received incredible support through funding from major organizations that allowed us to prove the effectiveness of our technology. The next step for us is to continue raising funds in order to put the technology to work and collaborate with researchers and academia to accelerate discovery in critical life science areas."

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

"We are delighted that Biosortia Microbiomics will be joining us in San Francisco and presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

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."