On June 6, 2022 Zumutor Biologics, a next generation Tumor-Directed IO therapeutics reported that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its novel monoclonal antibody ZM008 developed to treat various locally advanced or metastatic solid tumours (Press release, Zumutor Biologics, JUN 6, 2022, View Source [SID1234616460]).

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The Company plans to initiate actions on the FDA’s recommendations and follow up with the FDA with an Investigational New Drug (IND) application by the Q3 of 2022 followed by Phase I studies.

Ms Kavitha Iyer Rodrigues Chief Executive Officer of Zumutor, commented, "We appreciate the FDA’s thoughtful guidance on the proposed chemistry, manufacturing and control (CMC), nonclinical and clinical development program of our novel monoclonal antibody ZM008. We intend to address the recommendations made by the FDA and are committed to the successful completion of the required clinical trials of ZM008 to provide an effective and safe therapy for various solid tumors."

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.