On November 4, 2024 Lomond Therapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, reported the completion of a reverse merger transaction with Venetian-1 Acquisition Corp. and the closing of a $44 million private placement financing (Press release, Lomond Therapeutics, NOV 4, 2024, View Source [SID1234647679]). Following the reverse merger, Venetian-1 Acquisition Corp. changed its name to Lomond Therapeutics Holdings, Inc. ("Lomond Therapeutics" or the "Company"), and will continue the historic and innovative business of Lomond Therapeutics, Inc.

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"This transaction provides the resources necessary to advance our potentially best-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development," said Iain Dukes, M.A. D.Phil., co-founder and chief executive officer at Lomond Therapeutics. "Lomonitinib is currently being evaluated in a Phase 1b clinical trial in patients with mutated FLT3 relapsed refractory AML – an area of important unmet need and will shortly commence recruitment of CLL and selected lymphoma patients to evaluate lonitoclax, a potentially first-in-class oral targeted selective B-cell lymphoma-2 ("BCL-2-2") inhibitor."

The Company announced that current investors, OrbiMed and Torrey Pines Investment have participated in the placement alongside new investors led by Deerfield Management Company, American Financial Group, Heights Capital and others.

Previous members of Lomond Therapeutics, Inc.’s board of directors, Carl L. Gordon Ph.D., CFA, Iain Dukes M.A., D.Phil., Nikolay Savchuk Ph.D., and Eddie Wang Rodriguez J.D., will continue as directors of the Company.

The offering was exempt from registration under Section 4(a)(2) of the United States Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated by the U.S. Securities and Exchange Commission ("SEC") thereunder. The Common Stock in the offering was sold to "accredited investors," as defined in Regulation D, and was conducted on a "reasonable best efforts" basis.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Raymond James and Wedbush & Co. acted as the placement agents and Venetian-1 Acquisition Corp. was formed by Montrose Capital, which sponsored the transaction.

On November 4, 2024 Shasqi, Inc. ("Shasqi") a biotech company using in-vivo click chemistry to enable pre-targeting for ADCs and radioisotopes, reported that Founder and CEO, José M. Mejía Oneto, MD, PhD, and VP of Research, Travis Biechele, PhD will both be presenting sessions at the 15th World ADC San Diego conference taking place in San Diego, between November 4-7th (Press release, Shasqi, NOV 4, 2024, View Source [SID1234647678]).

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Shasqi will also be presenting posters at the World ADC conference, as well as at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place in Houston, between November 8-10th.

The presentations and posters will share data from Shasqi’s novel Click Activated Protodrugs Against Cancer (CAPAC) technology, a pre-targeting approach using in-vivo click chemistry to enable preferential drug exposure in tumors versus normal tissues. This can be used to improve the therapeutic index of potent cytotoxic drugs or radioisotopes.

"99% of the ADC dose is catabolically eliminated in normal tissues leading to active payload exposure and toxicity. I am eager to discuss what we can do as a field to reduce some of the target-independent toxicities seen with the ADC platform. Shasqi’s pre-targeting approach is a potential solution to reduce payload exposure and toxicity to normal cells that applies to any payload including those from ADCs or targeted radiopharma approaches. I am excited to share data from our platform at World ADC," said VP of Research, Travis Biechele, PhD.

Shasqi is seeking to establish new and advance existing conversations with partners around the applications of their CAPAC pre-targeting technology at both World ADC and SITC (Free SITC Whitepaper).

Details on each of the sessions can be found below.

World ADC speaking session – November 4th at 10:30am PDT
Presenter: Travis Biechele, PhD.
5th Toxicity Day track
Title: Understanding the drivers of target independent toxicities associated with ADCs and solutions to overcome them

World ADC speaking session – November 6th at 12:45pm PDT
Presenter: José M. Mejía Oneto, MD, PhD.
Discovery Chemistry track
Title: Click chemistry enabled pre-targeting as a solution to target-independent ADC toxicities

World ADC Poster session – November 5th at 6:30pm PDT
Poster 1 title: Pre-targeting with in vivo click chemistry enables preferential drug exposure in tumors versus normal tissues
Poster 2 title: CEACAM5 is an ideal target for click chemistry enabled pre-targeting

SITC 39th Annual Meeting – November 9th at 9:00am CDT
Poster title: Doxorubicin-based click chemistry therapeutic activates potent cytotoxic immune responses in advanced sarcoma patients in a Phase 1/2a clinical trial
Poster Number: 624

Poster title: Attenuated MMAE therapeutic activated by click chemistry at the tumor evokes potent immune responses
Poster Number: 1278

On November 4, 2024 SimBioSys, a pioneering TechBio company at the forefront of digital precision medicine for cancer care, reported its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons across the US (Press release, SimBioSys, NOV 4, 2024, View Source [SID1234647677]). The updated TumorSight Viz now processes images with AI in a matter of minutes, integrates enhanced AI-driven tumor segmentation, enables seamless access to MRI images through direct connectivity to PACS systems, and has a first of its kind clinical decision support (CDS) feature that informs providers of evidence-based treatment options. The addition of the CDS application is designed to enhance treatment planning and optimize oncologists’ decisions for early-stage breast cancer patients’ surgery.

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With the recent FDA mandate which now requires breast density reporting for all women undergoing a mammogram, the demand for MRI as a supplementary screening tool is anticipated to rise. TumorSight Viz offers healthcare providers a powerful platform to visualize MRI data in 3D, supporting breast surgeons in tailoring treatment decisions to each patient’s unique tumor characteristics. The platform’s new CDS tool is designed to empower providers with advanced imaging insights and best practices for breast-conserving surgeries, aligning with updated NCCN guidelines promoting minimally invasive approaches when feasible and desired by patients.

"TumorSight Viz’s clinical decision support functionality provides a groundbreaking resource to assist breast surgeons and oncologists in considering the best possible approaches for each patient, fostering shared decision-making and precision care," said Dr. Freya Schnabel from NYU.

TumorSight Viz: Key Enhancements

Enhanced AI-Driven Segmentation: Utilizing AI, TumorSight Viz is designed to deliver accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.
Clinical Decision Support (CDS) Application: The new CDS application is designed to provide data-driven insights for informing breast surgeons’ planning and preparation for surgery
Direct MRI Access via PACS Systems: TumorSight Viz now supports integration with middleware software as well as direct to PACS systems, allowing automated access to MRI images for analysis within the TumorSight platform and seamless fit into the clinician workflow.
Recent NCCN guideline updates emphasize the importance of individualized, data-supported treatment planning to support breast reconstruction and oncoplastic surgery as safe and effective options for eligible patients. TumorSight Viz aligns with these recommendations by enabling volume and anatomical measurements that assist surgeons in utilizing volume displacement techniques with a goal to achieve optimal cosmetic and functional outcomes. With the new CDS capability, surgeons are now better equipped with output measurements from TumorSight Viz that are aligned with standard of care guidelines to help plan lumpectomies more precisely, supporting both effective tumor removal and preservation of breast appearance.

A Game-Changer in Breast Cancer Care

Breast cancer affects more than 300,000 patients in the U.S. annually, many of whom now stand to benefit from SimBioSys’s enhanced TumorSight platform. By combining advanced AI-driven visualizations with CDS tools, TumorSight Viz is designed to provide surgeons, together with their patients, greater confidence in their treatment decisions.

"This second FDA clearance represents a significant milestone in our mission to redefine precision medicine for cancer," said Barry Rosen, MD, Chief Medical Officer at SimBioSys. "TumorSight Viz’s latest capabilities elevate the standard of breast cancer care by allowing surgeons to make more informed choices, moving closer to an era of precision surgery that reduces variation and supports breast conservation when desired by the patient."

TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer.

About TumorSight Viz:
TumorSight Viz provides clinicians with 3D spatial visualizations of breast cancer using standard-of-care medical imaging (DCE MRI). Clear 3D "digital twin" renderings automatically display the tumor in the context of auto-segmented anatomical structures and provide key metrics used to inform the treatment planning process in conjunction with patient history and standard of care testing. TumorSight Viz received its original 510(k) FDA clearance in December 2023. Learn more about TumorSight Viz at View Source

On November 4, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia’s blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM (Press release, Kazia Therapeutics, NOV 4, 2024, View Source [SID1234647676]).

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In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data including secondary endpoints from the paxalisib arm of the GBM-AGILE study is expected to be presented at a scientific meeting later this year.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Updated corporate presentation
Today, the Company also announced that it has updated its corporate presentation, which now incorporates preliminary data from the GBM AGILE Phase II/III clinical trial evaluating paxalisib versus the standard of care for the treatment of in patients with glioblastoma. The updated presentation can be found at View Source

Participation in Upcoming and Recent Medical and Investor Conferences

The company plans on attending the following medical conferences in the fourth quarter of 2024:

Society for Neuro-Oncology 29th Annual Meeting and Education Day, November 21-24, 2024, in Houston, TX
San Antonio Breast Cancer Symposium, December 10-13, 2024, in San Antonio, TX
These events provide Kazia with the opportunity to engage with key stakeholders and share the Company’s vision to make a difference in the lives of patients by developing innovative cancer treatments. Kazia looks forward to meeting with investors in person at these events and invites discussion regarding partnering and investment opportunities.

Over the last several months, the Company has also participated and presented at a number of medical and investor conferences, including:

H C Wainwright 26th Annual Global Investment Conference from Sep. 9-11, 2024
15th Biennial AACR (Free AACR Whitepaper) Ovarian Cancer Research Symposium, Sep. 20 – 21, 2024
Oppenheimer Oncology Summit, in collaboration with MD Anderson Cancer Center, Sep. 26, 2024
American Society for Radiation Oncology Annual Meeting, Sep. 29 – Oct. 1, 2024
Deerfield CEO Conference, Oct. 8-9, 2024
Maxim Group’s 2024 Healthcare Virtual Summit, Fireside Chat, Oct. 15, 2024

On November 4, 2024 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that it will present Phase 1 results for the clinical study of OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody that rescues innate and adaptive immune responses from LILRB2 mediated immune suppression (Press release, OncoResponse, NOV 4, 2024, View Source [SID1234647675]). The Phase 1 study results will be presented as a late-breaker poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024), taking place in Houston, Texas, November 8-10, 2024.

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Details are as follows:

Title (Late-Breaking Abstract): Phase 1 results of OR502, an antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in subjects with advanced cancers

Abstract Number: 1464
Details: Saturday, November 9, George R. Brown Convention Center

Title: Adaptive design elements in a Ph 1-2 study of OR502, a novel antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in response to evolving Ph 1 data and changing regulatory environment

Abstract Number: 680
Details: Saturday, November 9, George R. Brown Convention Center

OncoResponse poster presentations from SITC (Free SITC Whitepaper) are available on the Publications page of the Company website following their respective sessions.