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.

On January 6, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported continued progress across its pipeline of target alpha therapies (TATs) and provided recent corporate highlights (Press release, Fusion Pharma, JAN 6, 2023, View Source [SID1234625985]).

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Fusion Chief Executive Officer John Valliant, Ph.D., commented, "With three Phase 1 clinical programs developing TATs as next-generation radiopharmaceuticals, Fusion is leading a wave of excitement in the radiopharmaceutical sector. Fusion is poised for an exciting year, with data from the Phase 1 study of FPI-1434 in solid tumors expressing IGF-1R expected in the second quarter. Additionally, we expect to file an investigational new drug application (IND) for FPI-2068, our first novel TAT being developed in collaboration with AstraZeneca, in the first quarter of 2023.

"While advancing our clinical programs, we’ve continued to focus on ensuring adequate actinium supply, and recently announced a new partnership with established global medical isotope supplier BWXT Medical. We are well positioned to execute on our clinical programs and continue to advance a diversified pipeline of cancer therapies generated through Fusion’s internal R&D capabilities and technologies."

Portfolio Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, from the Phase 1 study in the second quarter of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The first cohort of the Phase 1 portion of this study is designed to evaluate various doses of vofatamb ("cold antibody") to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the study. The Company anticipates providing a clinical data update in 2024.

FPI-2068

Fusion and AstraZeneca are jointly developing FPI-2068, the first novel TAT created under the companies’ multi-asset collaboration agreement. FPI-2068 utilizes Fusion’s Fast-Clear linker technology to radiolabel an AstraZeneca bispecific antibody with actinium. The investigational new drug (IND) filing is expected to be submitted in the first quarter of 2023.

On January 6, 2023 Tracon Pharmaceuticals presented its investor presentation (Presentation, Tracon Pharmaceuticals, JAN 6, 2023, View Source [SID1234625981]).

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