On June 6, 2022 TriSalus Life Sciences, an interventional immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, reported that it will present a series of events at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting, held June 11-16, 2022, at the Boston Convention and Exhibition Center (Press release, TriSalus Life Sciences, JUN 6, 2022, View Source [SID1234615767]).

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The TriSalus clinical leadership team will be on-site to discuss the company’s FDA-cleared TriNav Infusion System as well as ongoing research with the interventional radiology (IR) community, including two presentations on new pre-clinical data that inform the company’s immunotherapeutic platform approach.

The company is pioneering an integrated platform approach that aims to overcome immunosuppression and delivery barriers by combining an investigational toll-like receptor 9 agonist, SD-101, with innovative drug delivery technology. The TriNav Infusion System utilizes the Pressure-Enabled Drug Delivery (PEDD) method of administration with SmartValve to overcome intratumoral pressure and improve delivery of therapeutic agents during outpatient interventional radiology procedures.

Additional activities, including a Monday evening reception, are highlighted below.

ON-SITE TRISALUS SPOKESPERSONS

Steven C. Katz, MD, FACS, Chief Medical Officer

David B. Jaroch, PhD, Senior Principal Scientist

Alexander Y. Kim, MD, Director of Interventional Oncology Clinical Strategies

Mikael Trollsas, PhD, Senior Vice President of Research and Development

CONFERENCE ACTIVITIES

Sunday, June 12 – Tuesday, June 14

TriNav Exhibition, Booth #605

Visit Booth #605 to see a replica of the TriNav Infusion System and learn how the device is engineered to improve tumor response, increase therapeutic delivery, and target tumors more precisely.

Sunday, June 12

Hands-on Workshop, Interventional Oncology: Embolization, 3:00 – 4:30pm ET, Exhibit Hall C

During this interactive workshop, attendees can experience what makes the TriNav Infusion System different from standard delivery approaches.

Monday, June 13

Taste of New England: An Evening Reception, Presented by TriSalus Life Sciences, 6:30-8:00pm ET

Westin Boston Seaport – Marina Ballroom II

Join the TriSalus team for an evening networking and education reception, complete with New England favorites. (Media RSVP for the event by emailing [email protected].)

Wednesday, June 15

(Scientific Sessions listed below are part of the SIR 2022 CME-accredited scientific program and not a TriSalus-sponsored activity.)

Scientific Session: IO Frontiers 2, 3:18-3:27pm ET, Room 253B

Abstract Title: Improved Delivery of a TLR-9 Agonist to Liver Tissue by Intravascular Pressure Enabled Drug Delivery (PEDD) Compared with Direct Needle Injection

Hear TriSalus Senior Principal Scientist David B. Jaroch, PhD highlight promising results from a pre-clinical study comparing local injection of labeled SD-101 into hepatic tissue versus using the PEDD method.

Scientific Session: Venous Disease and Sampling, 4:21-4:30pm ET, Room 258A

Abstract Title: Comparison of Pancreatic Tissue Uptake of Oxaliplatin Delivered by Systemic Circulation and by Pancreatic Retrograde Venous Infusion (PRVI)

TriSalus Senior Principal Scientist David B. Jaroch, PhD will present on the development of a trans-venous approach for regional treatment of pancreatic tumors, using a catheter capable of modulating pressure and flow within the organ to promote drug uptake.

On June 6, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in June (Press release, Horizon Therapeutics, JUN 6, 2022, View Source [SID1234615710]):

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Goldman Sachs 43rd Annual Global Health Care Conference

Date: Tuesday, June 14, 2022
Presentation Time: 11 a.m. ET
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for one year following the event.

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