On October 31, 2023 Kite, a Gilead Company (Nasdaq: GILD)and Epicrispr Biotechnologies ("Epic Bio"), reported the companies have entered into a research collaboration and license agreement using Epic Bio’s proprietary gene regulation platform to develop next-generation cancer cell therapies (Press release, Gilead Sciences, OCT 31, 2023, View Source [SID1234636571]). The agreement will allow Kite to leverage the licensed technology to modulate certain genes to potentially enhance CAR T-cell functionality.

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"Cell-based cancer immunotherapies have reshaped modern cancer care, but we have still only scratched the surface of their potential benefit for patients. At Kite, we are committed to developing next generation CAR T-cell therapies with the goal of reaching more patients with cancer who could benefit," said David Barrett, Vice President of Cell Biology and Translational Medicine at Kite. "We look forward to collaborating with Epic Bio with the goal of further advancing today’s cell therapies and potentially expanding their reach and impact on patients."

"We are proud to partner with Kite to extend the potential application of Epic Bio’s platform for cancer treatment. Epic Bio’s approach is not only promising for in vivo medicines, but may also enable next-generation cell therapies to reach a wide range of patient populations," said Amber Salzman, Ph.D., Chief Executive Officer of Epic Bio. "We look forward to applying our expertise in gene modulation to help advance CAR T-cell therapies."

Under the terms of the agreement, Epic Bio will develop constructs for Kite-selected targets for use in CAR T-cell therapies directed to blood cancers. Kite will make an upfront payment to Epic Bio and Epic Bio will be eligible to receive performance-based development, regulatory and sales milestone payments. Epic Bio is also eligible to receive tiered royalties on any approved products that result from the collaboration.

The transaction with Epic Bio is expected to have a de minimis financial impact on Gilead’s 2023 GAAP and non-GAAP EPS.

On October 31, 2023 XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported that it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG) (Press release, Xoma, OCT 31, 2023, View Source [SID1234636570]). The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act (PDUFA) date of April 30, 2024.

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"Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed," stated Owen Hughes, Executive Chairman of XOMA. "A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population."

In March 2021, XOMA paid $13.5 million upfront plus a share of a future event-based milestone, to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

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).

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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]).

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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.

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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.