On October 31, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company, reported that it will present novel findings for its lead product, pepinemab, in two presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in San Diego, CA November 1-5, 2023 (Press release, Vaccinex, OCT 31, 2023, View Source [SID1234636558]). Vaccinex reports consistent findings from two independent studies demonstrating novel activity of pepinemab antibody to induce the formation of lymphoid structures in tumors that promote efficient immune responses and are known to be associated with improved outcomes to immune checkpoint inhibitors (ICI). In a pre-specified interim analysis of the Phase 2 KEYNOTE-B84 study (NCT04815720) evaluating pepinemab in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for immunotherapy of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), these structures were associated with an approximate doubling of objective responses (ORR) and progression free survival (PFS) relative to historical results with checkpoint monotherapy in patients with hard-to-treat tumors that express low levels of PD-L1 (CPS<20). Similarly, findings will be reported from a separate study with collaborators at Emory University indicating that pepinemab in combination with nivolumab and/or ipilimumab (BMS), appeared to induce tertiary lymphoid structures in tumors. Remarkably, patients receiving neoadjuvant treatment with the triple combination have not experienced tumor recurrence for more than 2 years following treatment (ongoing response in 8/8 patients) (NCT03769155).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The potential of immune checkpoint therapies to sustain cytotoxic T cells is limited by insufficient support from other immune cell interactions, including with myeloid cells and B cells. The tumor microenvironment creates barriers to efficient immune cell communication, including by expression of semaphorin 4D (SEMA4D), which binds receptors on myeloid cells to inhibit the migration and maturation of dendritic cells (DC) that are crucial for priming and expanding T cells in adaptive immune responses. Preclinical and clinical studies have previously demonstrated improved trafficking of DC and T cells and reduction of immature myeloid derived suppressor cells in tumor following treatment with pepinemab SEMA4D blocking antibody. Data from two independent studies to be presented at SITC (Free SITC Whitepaper) provide new evidence that pepinemab induces the formation of lymphoid structures within treated tumors and that this is associated with enhanced immune interactions and durable responses. These results highlight pepinemab’s novel mechanisms to overcome limitations of ICI.

"Neoadjuvant SEMA4D inhibitor pepinemab combination with nivolumab increases crosstalk between B cell and CD26hi T cell in patients with resectable stage III melanoma" will be presented by Dr. Ayana Ruffin of Emory University together with Vaccinex authors on Friday, November 3, 2023.

"Pepinemab, anti semaphorin 4D antibody, in combination with pembrolizumab induced formation of organized lymphoid aggregates and enhanced response to treatment in CPS<20 R/M HNSCC tumors (KEYNOTE-B84)" will be presented by Dr. Terrence Fisher together with Merck authors and study investigators on Saturday, November 4, 2023.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and glial cells in the brain. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.

On October 31, 2023 United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported that Patrick Poisson, Executive Vice President, Technical Operations, will provide an overview and update on the company’s business during a fireside chat session at the UBS Biopharma Conference 2023 in Miami Beach, Florida (Press release, United Therapeutics, OCT 31, 2023, View Source [SID1234636557]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The session will take place on Wednesday, November 8, 2023, from 10:00 a.m. to 10:25 a.m., Eastern Standard Time, and can be accessed via a live webcast on the United Therapeutics website at View Source An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed for 180 days.

On October 31, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (Nasdaq: THTX; TSX: TH), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has closed its previously announced public offering (the "Public Offering") of 12,500,000 common shares of the Company (the "Common Shares") at a public offering price of US$1.00 per Common Share (the "Offering Price") (Press release, Theratechnologies, OCT 31, 2023, View Source [SID1234636555]). The gross proceeds of the Public Offering are US$12,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses. Pursuant to the underwriting agreement dated October 25, 2023, the Company has also granted the underwriter a 30-day option (the "Option") to purchase up to 1,875,000 Common Shares at the Offering Price, less underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Fitzgerald & Co. acted as sole bookrunner for the Public Offering.

In connection with the Public Offering, the Company has also closed its concurrent private placement with Investissement Québec (the "Concurrent Private Placement") of 9,118,184 Common Shares and 3,381,816 fully-funded, non-voting subscription receipts, exchangeable into Common Shares on a one-for-one basis (the "Exchangeable Subscription Receipts") in lieu of Common Shares, in each case, at the Offering Price, for US$12,500,000 aggregate gross proceeds, less a capital commitment fee of 1.5% payable to Investissement Québec and Investissement Québec’s legal fees. The component of the Concurrent Private Placement in the form of Exchangeable Subscription Receipts is designed to ensure that, following completion of the Public Offering and the Concurrent Private Placement, Investissement Québec does not have beneficial ownership or control over more than 19.9% of the issued and outstanding Common Shares and therefore is not a "control person" within applicable Canadian securities laws. All securities issued in connection with the Concurrent Private Placement are subject to a four-month hold period from the closing date under applicable Canadian securities laws, in addition to such other restrictions as may apply under applicable securities laws of jurisdictions outside Canada.

The Company also entered into an investor rights agreement, pursuant to which Investissement Québec will be entitled to nominate one director to the Company’s board of directors for as long as it holds 50% of the Common Shares purchased pursuant to the Concurrent Private Placement. Copies of the subscription agreement, the exchangeable receipt agreement setting forth the terms and conditions of the Exchangeable Subscription Receipts and the investor rights agreement, when available, will be filed on SEDAR+ at www.sedarplus.ca. Summaries of the subscription agreement and the exchangeable receipt agreement and a copy of the investor rights agreement, when available, will be filed on EDGAR at www.sec.gov.

As at the date of closing, Investissement Québec beneficially owns approximately 19.9% (25.4% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares. If the Option is exercised in full, Investissement Québec will beneficially own approximately 19.1% (24.5% if the Exchangeable Subscription Receipts were to be exchanged into Common Shares) of the issued and outstanding Common Shares as of the date of closing.

The Public Offering and the Concurrent Private Placement are subject to final acceptance of the Toronto Stock Exchange.

No securities regulatory authority has either approved or disapproved the contents of this news release. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On October 31, 2023 Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, reported a fiscal year 2023 business overview (Press release, Sonnet BioTherapeutics, OCT 31, 2023, View Source [SID1234636554]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As has been our objective since the company’s founding, we are committed to innovating next generation cancer treatments of significant potential utility for patients and caregivers, alike," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "I am excited by the progress of our therapeutic pipeline, and we remain acutely focused on our business development initiatives. We continue to believe this represents a compelling value proposition for investors in the company."

Overview of Corporate Developments

In October, Sonnet completed an underwritten public offering led by existing investors for total gross proceeds of approximately $4.55 million. The company anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes. After undertaking significant cost reductions designed to fund assets with the highest estimated business development potential, cash runway is projected into the calendar year third quarter of 2024.
In August, the FDA accepted Sonnet’s IND for the SB221, the Phase 1b/2a US clinical trial of SON-1010 (IL12-FHAB) in combination with Roche’s anti-PD-L1 checkpoint inhibitor, atezolizumab. The study has been launched with several patients currently being dosed. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose. Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized comparison to show proof-of-concept (POC).
Sonnet is working to complete enrollment in the SON-080 trial in chemotherapy-induced peripheral neuropathy (CIPN) and continues to expect early safety data prior to the 2023 calendar year end.
The evaluation of SON-1010, SON-1210 and SON-1410 in combination with certain of Janssen’s proprietary cell therapy assets remains underway.

On October 31, 2023 Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based specialty pharmaceutical company reported to have have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market (Press release, Shorla Oncology, OCT 31, 2023, View Source;utm_medium=rss&utm_campaign=press-release-shorla-oncology-announces-us-acquisition-of-jylamvo-an-oncology-and-autoimmune-drug-from-therakind [SID1234636553]). The therapy has been approved by the US Food and Drug Administration (FDA).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jylamvo is an easy-to-administer, sweet tasting oral methotrexate solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation. A drug that has recently suffered shortages in other dosages forms, Jylamvo is an alternative solution offering advantages over similar drugs because it remains stable at room temperature and does not require cold chain storage. It was approved by the US FDA in 2022 and is used to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.

"We are delighted to acquire Jylamvo to provide an alternative solution for patients who may have difficulty swallowing pills," said Sharon Cunningham, chief executive officer of Shorla Oncology. "This is another key step as Shorla grows and commercializes a portfolio of late-stage assets and improves efficiencies by providing more convenient and patient friendly formulations."

The news comes shortly after Shorla announced that it has raised $35 million in Series B funding to accelerate the growth of its oncology portfolio by bringing therapies to market that will address drug shortages, and improve the preparation and application of oncology medication. This marks Shorla’s second US FDA approved product in its oncology portfolio.

"Therakind is pleased that Jylamvo will now become available to patients in the United States providing a palatable oral liquid alternative to treat a range of indications," said Susan Conroy, chief executive officer of Therakind.

"This acquisition will provide a much-needed treatment to patients in need," said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology. "It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses."