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.

On January 6, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported it plans to prioritize key research and development efforts to advance EO-3021, its potential best-in-class antibody-drug conjugate (ADC) designed to target Claudin18.2, and other pipeline programs including those through its existing partnership with Caris Life Sciences (Press release, Elevation Oncology, JAN 6, 2023, View Source [SID1234625987]).

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Elevation Oncology is pausing further investment in the clinical development of seribantumab and realigning its resources to focus on advancing EO-3021 and other pipeline programs. Elevation Oncology intends to pursue further development of seribantumab only in collaboration with a partner.

In addition, the Company announced that Shawn M. Leland, PharmD, RPh, has resigned from his role as Chief Executive Officer and a member of the Board of Directors, effective immediately. The Board of Directors has appointed Joseph J. Ferra as Interim Chief Executive Officer. Mr. Ferra will remain as the Company’s Chief Financial Officer, and lead Elevation Oncology along with Valerie Malyvanh Jansen, MD, PhD, Chief Medical Officer and David Dornan, PhD, Chief Scientific Officer.

"We remain focused on developing innovative cancer therapies to treat patients with significant unmet medical needs, and in EO-3021 we believe we have a potential best-in-class asset that can target solid tumors expressing Claudin18.2 and plan to enter the clinic in the US in the second half of 2023," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "In light of our ongoing evaluation of our pipeline, we are pausing further investment in the development of seribantumab and the CRESTONE study. Additionally, we have made the difficult decision to reduce our workforce which will enable us to realign our resources towards advancing EO-3021 and additional pipeline programs. We would like to extend our deepest gratitude to the patients and their families, the investigators and study teams as well as our employees for their invaluable contributions to the CRESTONE study."

"Shawn’s dedication and leadership were instrumental in the founding and building of Elevation Oncology. On behalf of the Board of Directors, I would like to sincerely thank Shawn for his many contributions and his stewardship of the company," said Steve Elms, Chairman of the Board of Directors of Elevation Oncology. "We have the utmost confidence in Joe’s ability to lead Elevation Oncology as Interim CEO during this time of significant transition for the Company in order to realize the full potential of EO-3021, and additional pipeline programs, to benefit patients with significant unmet medical needs."

Strategic Actions Summary

EO-3021:
EO-3021 is a potential best-in-class, clinical-stage ADC designed to target Claudin18.2 and selectively deliver a cytotoxic payload directly to kill cancer cells. Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types including many gastrointestinal cancers such as gastric, gastroesophageal junction and pancreatic cancer.
Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (HKEX: 01093), is actively recruiting patients in the Phase I clinical trial of EO-3021 (SYSA1801) in China (NCT05009966).
The Investigational New Drug (IND) filing has been cleared in the US and transferred to Elevation Oncology.
Elevation Oncology plans to present preclinical proof-of-concept data of EO-3021 at a major medical conference in the first half of 2023.
Preparations are ongoing to initiate a Phase 1 clinical trial of EO-3021 in the US in the second half of 2023.

Seribantumab:

Elevation Oncology is pausing further investment in the clinical development of seribantumab and realigning resources to focus on advancing EO-3021 and other pipeline programs.
Elevation Oncology intends to pursue further clinical development of seribantumab only in collaboration with a partner. Further enrollment into the CRESTONE study will be paused, pending entering into a partnership.
Elevation Oncology plans to present additional interim data from the CRESTONE study in the first half of 2023
.
Other Pipeline Programs:

Elevation Oncology continues its research and development efforts to advance novel therapeutic drug candidates and targets, including those through its existing partnership with Caris Life Sciences.

Leadership Transition:

Shawn M. Leland, PharmD, RPh, has resigned from his role as Chief Executive Officer and member of the Board of Directors, effective immediately. Dr. Leland will serve as an advisor to the Company.
Joseph J. Ferra has been appointed Interim Chief Executive Officer and will continue in his current role as Chief Financial Officer.

Workforce Reduction:

As part of the realignment of its pipeline, Elevation Oncology’s workforce will be reduced by approximately 30% to prioritize key research and development efforts to advance EO-3021 and additional pipeline programs.

Updated Cash Runway:

As of December 31, 2022, Elevation Oncology had preliminary unaudited cash, cash equivalents and marketable securities totaling $90.3 million. The Company currently expects the pipeline prioritization and realignment of resources to extend cash runway into the fourth quarter of 2024, without giving effect to financial covenant compliance under the Company’s debt facility.

On January 6, 2023 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company"), the Biotech Royalty Aggregator, reported that the Company has granted Owen Hughes, the Company’s newly appointed Executive Chairman, two separate non-qualified stock options to purchase: (i) 100,000 shares of the Company’s common stock at an exercise price of $18.66 per share (the "First Hughes Inducement Award") and (ii) 75,000 shares of the Company’s common stock at an exercise price of $30.00 per share (the "Second Hughes Inducement Award" and together with the First Hughes Inducement Award, the "Hughes Inducement Awards") on January 3, 2023 (Press release, Xoma, JAN 6, 2023, View Source [SID1234625986]). The First Hughes Inducement Award will vest in a series of four equal installments on March 31, 2023, June 30, 2023, September 30, 2023, and December 31, 2023. The Second Hughes Inducement Award will vest in a series of 36 successive equal monthly installments measured from January 1, 2023.

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The Company also announced today it has granted Bradley Sitko, the Company’s newly appointed Chief Investment Officer, two separate non-qualified stock options to purchase: (i) 300,000 shares of the Company’s common stock at an exercise price of $18.66 per share (the "First Sitko Inducement Award") and (ii) 250,000 shares of the Company’s common stock at an exercise price of $30.00 per share (together with the First Sitko Inducement Award, the "Sitko Inducement Awards"; together with the Hughes Inducement Awards, the "Inducement Awards") on January 3, 2023. Twenty-five percent of the shares subject to each of the Sitko Inducement Awards will vest and become exercisable on January 3, 2024 (the "Initial Vesting Date"), and the balance of the shares subject to each of the Sitko Inducement Awards will vest and become exercisable in a series of 36 successive equal monthly installments thereafter on the same day of the month as the Initial Vesting Date.

The Inducement Awards are subject to the terms and conditions of the Company’s Amended and Restated 2010 Long Term Incentive and Stock Award Plan but were granted outside the plan as an inducement material to each of Mr. Hughes and Mr. Sitko entering into employment with XOMA in accordance with Nasdaq Listing Rule 5635(c)(4).

The Inducement Awards also have a ten-year term and are each subject to the terms and conditions of the stock option agreement pursuant to which each such Inducement Award was granted.