On June 6, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that senior management will participate in a fireside chat at the 2022 Jefferies Global Healthcare Conference in New York City on Wednesday, June 8, 2022 at 8:30 a.m. ET (Press release, Celldex Therapeutics, JUN 6, 2022, View Source [SID1234615708]).

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A webcast of the presentation will be available on the "Events & Presentations" (opens in a new tab)page of the "Investors & Media(opens in a new tab)" section of the Celldex website. A replay will be available for 30 days following the event.

On June 6, 2022 Yumanity Therapeutics, Inc. ("Yumanity") (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, reported it has entered into definitive agreements for two strategic transactions (Press release, Yumanity Therapeutics, JUN 6, 2022, View Source [SID1234615707]).

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The first definitive agreement is an asset purchase agreement for the sale of Yumanity’s lead clinical-stage product candidate, YTX-7739, as well as Yumanity’s unpartnered discovery-stage neuroscience product candidates and targets to Janssen Pharmaceutica NV ("Janssen"), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for $26 million in cash. In connection with the closing of the proposed transaction, Yumanity plans to distribute any remaining available cash proceeds from the sale to Yumanity stockholders via a one-time dividend, net of any amounts retained for outstanding obligations and net cash requirements associated with the proposed merger between Yumanity and Kineta, Inc. ("Kineta"). The amount of such dividend will depend on many factors and will not be determined until closer to the closing date.

Under the second definitive agreement, Kineta will become a wholly-owned subsidiary of Yumanity in an all-stock transaction, resulting in a combined publicly traded company re-named Kineta, Inc., that will focus on immuno-oncology and continue Yumanity’s ongoing research collaboration with Merck & Co. in amyotrophic lateral sclerosis and frontotemporal lobar dementia. Upon completion of the proposed merger, on a pro forma basis and based upon the number of Yumanity shares to be issued in the proposed merger, current Kineta stockholders are expected to own approximately 85% of the combined company and current Yumanity stockholders are expected to own approximately 15% of the combined company. The actual allocation will be subject to adjustment based on each company’s outstanding equity ownership and Yumanity’s net cash balance at the time of the closing of the proposed merger. The combined company expects to raise a concurrent private investment in public equity (the "PIPE financing") led by Growth & Value Development Inc.

"After evaluating Yumanity’s strategic alternatives, management and our Board of Directors believes that the proposed transactions are in the best interest of Yumanity’s stockholders," said Richard Peters, President and CEO of Yumanity. "We are excited that our lead clinical-stage neurology asset and unpartnered assets will continue to be developed and we are very enthusiastic about Kineta’s innovative oncology pipeline."

Kineta’s IND-ready, lead asset is KVA12.1, a potential best-in-class VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. KVA12.1 may be an effective immunotherapy for many types of cancer including NSCLC (lung), colorectal, renal cell carcinoma, head and neck, and ovarian. These initial target indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12.1. Kineta is also developing fully human antibodies that target CD27 and CD24. These immunotherapies are engineered to address the problems of exhausted T cells and immunologically silent tumors.

"The proposed merger with Yumanity is a unique opportunity for Kineta to build a leading public immuno-oncology focused company with a diversified pipeline of new treatments for cancer patients," said Shawn Iadonato, Ph.D., CEO of Kineta. "Kineta has demonstrated expertise in developing novel immunotherapies that will enable us to advance our lead programs towards multiple milestones over the next 18 months."

The Yumanity Board of Directors has unanimously approved both definitive agreements. The Kineta Board of Directors has unanimously approved the definitive merger agreement with Yumanity. The two transactions are expected to close in the second half of 2022, subject to customary closing conditions, including approval of both transactions by the stockholders of Yumanity.

On June 6, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported an update to its strategic priorities and the streamlining and realignment of resources to support its key value-generating indications and programs and extend its estimated cash runway into late 2024 (Press release, Vincerx Pharma, JUN 6, 2022, View Source [SID1234615685]).

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Strategic Update Summary:

Prioritizing VIP152 clinical studies to focus on:
Monotherapy in patients with high grade B-cell lymphoma characterized by translocations of MYC and BCL-2 or BCL-6 (aka double-hit diffuse large B-cell lymphoma [DLBCL])
Monotherapy in patients with high-risk chronic lymphocytic leukemia (CLL)
Combination with Bruton tyrosine kinase (BTK) inhibitor in patients with high-risk CLL
Continuing to prioritize advancement of first-in-class and potentially best-in-class bioconjugation assets
Streamlining and realigning resources to support prioritized VIP152 indications and advancement of the bioconjugation programs
Reducing full-time employees by 33%
Implementing additional cost reduction measures
Extending estimated cash runway into late 2024
Positioning company to continue executing on important clinical and preclinical milestones
"Given the unprecedented market conditions, we are making a strategic decision to focus our resources on our ongoing double-hit DLBCL and CLL clinical trials and our next-generation bioconjugation platform to deliver the greatest benefit in these patients as well as maximize value for our shareholders," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.

"The VIP152 program was designed as a signal-seeking program," added Dr. Hamdy. "Nineteen (19) patients with various MYC+ cancers have been treated. We saw stable disease in 3 patients with ovarian cancer (with one of the three patients completing cycle 6). Despite this preliminary signal in ovarian cancer, the combination of challenging market conditions and the promising VIP152 preclinical and clinical data we have seen in double-hit DLBCL and CLL patients create a compelling rationale for us to focus our efforts on these two indications."

"We continue to be excited about our preclinical bioconjugation platform—a diverse, modular platform of linkers and payloads that can be conjugated with antibodies and small molecules to create novel targeted therapeutics for a broad range of solid tumors and hematologic malignancies and remain on track to file an IND in the second half of this year for VIP236. We also remain on track to file an IND in the second half of 2023 for our initial antibody drug conjugate (ADC), VIP943. We believe our ADCs represent a paradigm-shifting technology with a proprietary and highly differentiated linker and warhead. These innovations are expected to improve efficacy and safety versus current ADCs," continued Dr. Hamdy.

To support this strategy, Vincerx also announced the streamlining and realignment of resources and the implementation of certain cost reduction measures, including a 33% reduction of full-time employees. "Reducing our staff was not an easy decision. It was the tremendous effort of our Vincerx colleagues that allowed us to execute efficiently, despite the extreme pressures of the pandemic. I want to sincerely thank every Vincerx colleague who has been impacted by this realignment. Their contributions have, without a doubt, brought us closer to achieving our goals. The realignment announced today will allow us to focus on and invest in the indications and programs we believe will generate the greatest value while reducing our operating expenses—all with the goal of achieving our anticipated key milestones for VIP152 and our bioconjugation platform," concluded Dr. Hamdy.

CLINICAL UPDATES

VIP152 (as of April 19, 2022):

VNC-152-101 study enrollment (Patients with MYC+ cancer, which included overexpression, translocation, deletion, or amplification):
High-grade lymphoma arm (n=4)
Histologies: triple-hit, double-hit, double expressor and primary mediastinal (n=1 each)
Gynecologic malignancies (n=5)
Includes 1 patient with endometrial cancer who received combination therapy of VIP152 + pembrolizumab
Triple negative breast cancer (n=2)
Tumor agnostic group (n=7)
Consists of various types of gastrointestinal cancer (n=6) and melanoma (n=1)
VNC-152-102 study enrollment:
CLL that has failed BTK inhibitor therapy, as well as venetoclax therapy (n=1)
Clinical outcomes from VNC-152-101 and VNC-152-102:
No new safety signals were identified; manageable treatment-related adverse events included neutropenia and gastrointestinal toxicity (i.e., nausea, vomiting and diarrhea); only 1 patient discontinued due to an adverse event (i.e., Grade 1 nausea)
Progressive disease was observed in 16 patients, despite evidence of tumor shrinkage in some patients including the patient with CLL who had failed BTK inhibitor and venetoclax therapy. Best response in all 19 patients has been stable disease in 3 patients with ovarian cancer as reported at the AACR (Free AACR Whitepaper) Annual Meeting in 2022.
Abstract accepted for poster presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, titled "VIP152 is a novel CDK9 inhibitor with improved selectivity, target modulation, and cardiac safety in patients with lymphoma."
Presenting author: Melanie Frigault, PhD
Abstract number: P1269
Session date and time: Friday, June 10, 2022; 16:30-17:45 CEST

Bioconjugation Platform:

Continue to advance next-generation modular bioconjugation platform, comprised of a first-in-class SMDC for solid tumors (VIP236) and two potentially best-in-class assets for hematologic malignancies (VIP943 and VIP924)
VIP236: IND filing in solid tumors expected in 2H 2022
VIP943 (anti-CD123) and VIP924 (anti-CXCR5): Manufacturing is underway and IND filing for VIP943 expected in 2H 2023 and VIP924 in 2024

On June 6, 2022 Thermo Fisher Scientific Inc., the world leader in serving science, and TransMIT GmbH Center for Mass Spectrometric Developments reported that spatial multi-omics applications in pharma and clinical labs (Press release, Lifescience Newswire, JUN 6, 2022, View Source [SID1234615684]).

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As part of the relationship, TransMIT will combine its proprietary scanning microprobe matrix-assisted laser desorption/ionization (SMALDI) MSI and 3D-surface MSI technology with the exceptional high resolution accurate mass (HRAM) power of Thermo Scientific Orbitrap MS instrumentation. TransMIT’s AP-SMALDI⁵ AF ion source coupled with Orbitrap MS technology enables spatial distribution mapping of a variety of molecules such as biomarkers, metabolites, peptides or enzymatically-digested proteins by their molecular masses. This approach can be applied to omics applications such as metabolomics, lipidomics, proteomics, glycomics and to pharmaco-kinetic studies in a variety of tissues.

"This co-marketing agreement will provide integrated solutions for mass spectrometry imaging, offering a label-free approach to map the distribution of a wide range of both known and unknown compounds directly sampled from biological tissue," said Jim Yano, senior director, life sciences mass spectrometry portfolio management, chromatography and mass spectrometry, Thermo Fisher Scientific. "Due to its high performance in spatial resolution, TransMIT’s AP-SMALDI⁵ AF ion source is the perfect match for the high mass resolution and accurate mass capabilities of the Orbitrap MS instrumentation."

Professor Bernhard Spengler, director, TransMIT Center for Mass Spectrometric Developments, said, "Our AP-SMALDI⁵ AF ion source coupled with Thermo Fisher’s Orbitrap technology create an MSI platform for high spatial resolution along with high mass resolution and mass accuracy. The AP-SMALDI-Orbitrap setup enables scanning of tissue samples or 3D objects with the pulsed laser beam of 5 μm spot size routinely without oversampling, providing a powerful solution for drug development and spatial multi-omics applications."

Announcement of the new co-marketing agreement coincides with the 70th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, being held June 5-9, 2022 where Thermo Fisher is showcasing its latest innovations in Booth 400 at the Minneapolis Convention Center, Minneapolis, Minnesota and at the Hilton Minneapolis Grand Ballrooms E, F, G.

On June 6, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the results of its Phase 2 clinical trial (Study RM-202) of rivoceranib, an orally administered tyrosine kinase inhibitor (TKI), in patients with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) (Press release, Elevar Therapeutics, JUN 6, 2022, View Source [SID1234615682]).

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As shared in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the results of Study RM-202 demonstrate the clinical effectiveness of rivoceranib for the treatment of patients with progressive R/M ACC, as indicated by substantially reduced tumor progression during the 6 months after rivoceranib treatment compared to that during the 6 months prior to rivoceranib treatment [-7.0 (-43 to 35) mm vs. 20.5 (5 to 180) mm].

The open-label study (NCT04119453) was conducted at 11 sites in the U.S. and South Korea to investigate the efficacy and safety of rivoceranib in patients with progressive R/M ACC. With 80 patients, including 53 (66.3%) based in the U.S., Study RM-202 is the largest to date involving a TKI in ACC patients.

All 80 participants demonstrated tumor progression within 6 months prior to the trial (by requirement). The study found an overall response rate (ORR) of 15.1% (a 30% reduction based on RECIST), and though not a study endpoint, the remaining 85% of patients had a reduction of tumor size.

"With every participant exhibiting a recent growing lesion upon entering this Phase 2 trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC," said Saeho Chong, chief executive officer of Elevar. "Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process."

Other Study RM-202 key findings:

52% of patients had a response according to CHOI (size or density); CHOI is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only)
CHOI for Response: >10% reduction in tumor size or >15% reduction in tumor density
Median duration of response (mDoR) of 14.9 months
Median progression-free survival (mPFS) of 9 months versus published data of a baseline of 2.8 months for R/M ACC, and disease control for ≥ 3 months in over 60% of patients, regardless of prior vascular endothelial growth factor (VEGFR) therapy
Rivoceranib adverse event profile similar to other TKIs
"There is no approved standard of care for R/M ACC, so as we investigate rivoceranib’s potential as a treatment option we remain steadfastly focused on the many patients who now have or someday will be diagnosed with this disease," said Dr. Hyunseok Kang, medical oncologist at the University of California San Francisco and the primary investigator for Study RM-202. "The positive results demonstrated in this Phase 2 trial of rivoceranib represent a vitally important step forward for them."

Rivoceranib, which has been given orphan drug designation in the U.S., is a small molecule anti-angiogenic, with more than 6,000 patients studied in multiple cancers. Elevar has worldwide commercialization rights for rivoceranib, excluding China.

About ACC

Adenoid Cystic Carcinoma (ACC) is a rare malignancy that occurs within the secretory glands, most commonly in the major and minor salivary glands of the head and neck, but also found in the breast, skin and elsewhere. It is diagnosed in about 4 of every 1 million people each year – representing a combined 3,100 annual cases in the U.S., EU and Japan – and it afflicts more than 200,000 patients throughout the world, accounting for 5 percent to 7 percent of all head and neck malignancies, according to the Adenoid Cystic Carcinoma Research Foundation. There is no approved standard of care for R/M ACC patients. A previous study showed a baseline progression-free survival (PFS) of 2.8 months for ACC (Kang EJ, et al. Clin Cancer Res. 2021;27:5272-5279).

About Rivoceranib

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib, co-developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (JHP) in China and Elevar Therapeutics globally, with the exception of China. It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy. Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma and colorectal cancer (combination with Lonsurf). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, JHP, under the brand name Aitan.