On October 3, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported completion of the dose-escalation portion and recommendation of the Phase 2 dose in transcendIT-101, a Phase 1/2 clinical trial to evaluate the safety and efficacy of TransCon TLR7/8 Agonist in locally advanced or metastatic solid tumors, alone or in combination with pembrolizumab (Press release, Ascendis Pharma, OCT 3, 2022, View Source [SID1234621613]). TransCon TLR7/8 Agonist is a novel investigational product candidate designed for sustained, localized release of resiquimod (a potent immune-response modifier with clinically demonstrated anti-tumor activity) with low systemic exposure. The abstract for the dose-escalation topline data was accepted for an oral presentation at SITC (Free SITC Whitepaper) 2022, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 8-12 in Boston.

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All patients in the dose escalation portion of the trial had advanced or metastatic solid-tumors and had progressed on prior treatments. In the next phase of the trial, the recommended Phase 2 dose of TransCon TLR7/8 Agonist will be evaluated in four cohorts focused on cancers where increased Toll-like receptor (TLR) activity has potential to improve adaptive immune activation and host defense against cancers. The cohorts include head and neck squamous-cell carcinoma (HNSCC); other HPV-associated cancers; melanoma; and cutaneous squamous cell carcinoma (cSCC). In this portion of the study, all participants will be treated every three weeks with intratumoral TransCon TLR7/8 Agonist in combination with intravenous pembrolizumab. Limits on prior lines of therapy vary by cohort.

"Our vision in oncology is to leverage TransCon technologies to turn the body’s immune system into a more potent anti-cancer therapeutic. In this first-in-human oncology trial, we are especially pleased to see TransCon hydrogel technology working as designed to achieve sustained intratumoral release of resiquimod over weeks while limiting systemic exposure," said Stina Singel, Senior Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. "With a favorable safety profile and early signs of clinical activity observed, we are especially excited to be presenting topline dose-escalation data, including pharmacokinetic and biomarker data from injected and non-injected tumors, at the upcoming SITC (Free SITC Whitepaper) meeting. We are thankful to have the continued trust and engagement of patients and physicians working to transform the future of cancer care."

Later this year, Ascendis will initiate a clinical investigation of TransCon TLR7/8 Agonist intratumoral treatment in combination with TransCon IL-2 β/γ, the company’s product candidate designed for systemic activation of tumor-antigen specific cytotoxic cells.

About TransCon TLR7/8 Agonist
Immunotherapies can stimulate, intensify, and sustain the immune system’s natural ability to recognize and eliminate cancer cells, yet many patients do not respond to immunotherapies currently on the market, most of which are designed for intravenous administration and many of which have unfavorable toxicity profiles at therapeutically effective doses. TransCon TLR7/8 Agonist is an investigational long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLRs) 7 and 8 designed to provide sustained activation of intratumoral antigen-presenting cells driving tumor antigen presentation and induction of immune-stimulatory cytokines for weeks with a single intratumoral injection. TransCon TLR7/8 Agonist leverages the unique ability of Ascendis Pharma’s TransCon hydrogel technology to achieve sustained, localized release of resiquimod (a potent immune-response modifier with clinically demonstrated anti-tumor activity) in the injected tumor over weeks, where it is designed to steadily activate and intensify the body’s innate and adaptive immune responses to eradicate cancer cells in both injected and distal tumors, while maintaining low systemic drug exposure.

On October 3, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported completion of the dose-escalation portion and recommendation of the Phase 2 dose in transcendIT-101, a Phase 1/2 clinical trial to evaluate the safety and efficacy of TransCon TLR7/8 Agonist in locally advanced or metastatic solid tumors, alone or in combination with pembrolizumab (Press release, Ascendis Pharma, OCT 3, 2022, View Source [SID1234621613]). TransCon TLR7/8 Agonist is a novel investigational product candidate designed for sustained, localized release of resiquimod (a potent immune-response modifier with clinically demonstrated anti-tumor activity) with low systemic exposure. The abstract for the dose-escalation topline data was accepted for an oral presentation at SITC (Free SITC Whitepaper) 2022, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 8-12 in Boston.

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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

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All patients in the dose escalation portion of the trial had advanced or metastatic solid-tumors and had progressed on prior treatments. In the next phase of the trial, the recommended Phase 2 dose of TransCon TLR7/8 Agonist will be evaluated in four cohorts focused on cancers where increased Toll-like receptor (TLR) activity has potential to improve adaptive immune activation and host defense against cancers. The cohorts include head and neck squamous-cell carcinoma (HNSCC); other HPV-associated cancers; melanoma; and cutaneous squamous cell carcinoma (cSCC). In this portion of the study, all participants will be treated every three weeks with intratumoral TransCon TLR7/8 Agonist in combination with intravenous pembrolizumab. Limits on prior lines of therapy vary by cohort.

"Our vision in oncology is to leverage TransCon technologies to turn the body’s immune system into a more potent anti-cancer therapeutic. In this first-in-human oncology trial, we are especially pleased to see TransCon hydrogel technology working as designed to achieve sustained intratumoral release of resiquimod over weeks while limiting systemic exposure," said Stina Singel, Senior Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. "With a favorable safety profile and early signs of clinical activity observed, we are especially excited to be presenting topline dose-escalation data, including pharmacokinetic and biomarker data from injected and non-injected tumors, at the upcoming SITC (Free SITC Whitepaper) meeting. We are thankful to have the continued trust and engagement of patients and physicians working to transform the future of cancer care."

Later this year, Ascendis will initiate a clinical investigation of TransCon TLR7/8 Agonist intratumoral treatment in combination with TransCon IL-2 β/γ, the company’s product candidate designed for systemic activation of tumor-antigen specific cytotoxic cells.

About TransCon TLR7/8 Agonist
Immunotherapies can stimulate, intensify, and sustain the immune system’s natural ability to recognize and eliminate cancer cells, yet many patients do not respond to immunotherapies currently on the market, most of which are designed for intravenous administration and many of which have unfavorable toxicity profiles at therapeutically effective doses. TransCon TLR7/8 Agonist is an investigational long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLRs) 7 and 8 designed to provide sustained activation of intratumoral antigen-presenting cells driving tumor antigen presentation and induction of immune-stimulatory cytokines for weeks with a single intratumoral injection. TransCon TLR7/8 Agonist leverages the unique ability of Ascendis Pharma’s TransCon hydrogel technology to achieve sustained, localized release of resiquimod (a potent immune-response modifier with clinically demonstrated anti-tumor activity) in the injected tumor over weeks, where it is designed to steadily activate and intensify the body’s innate and adaptive immune responses to eradicate cancer cells in both injected and distal tumors, while maintaining low systemic drug exposure.

On October 2, 2022 Myovant Sciences Ltd. (NYSE: MYOV) (the "Company") reported that it has received a preliminary, non-binding proposal (the "Proposal") from Sumitovant Biopharma Ltd. ("Sumitovant") and Sumitomo Pharma Co., Ltd. (collectively with Sumitovant, "Sumitomo") to acquire the remaining shares of the Company that Sumitovant does not currently hold, for a price of $22.75 per share in cash. Sumitovant currently holds approximately 52% of the outstanding shares of the Company (Press release, Myovant Sciences, OCT 2, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-special-committee-board-confirms-receipt [SID1234621597]).

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The Company’s board of directors has formed a special committee of independent directors comprised of the members of the Audit Committee of the Company (the "Special Committee") to evaluate and consider the Proposal and any alternatives thereto, with the assistance of its financial and legal advisors. The Special Committee, in consultation with its financial and legal advisors, has carefully reviewed the Proposal and determined that it significantly undervalues the Company and, therefore, is not in the best interests of the Company or its minority shareholders. The Special Committee remains open to considering any improved proposal that reflects the full and fair value of the Company and is otherwise in the best interests of the Company and its shareholders, and is prepared to engage further with Sumitomo regarding any such proposal.

There can be no assurance as to whether an agreement relating to any proposed transaction will be reached or as to the terms thereof if an agreement is reached. The Company does not intend to comment further or disclose any developments regarding the Special Committee’s consideration of the Proposal unless and until it deems further disclosure is appropriate or required. The Company’s shareholders do not need to take any action at this time.

The Special Committee has retained Goldman Sachs & Co. LLC as its financial advisor, and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor to assist with its review of the Proposal and any alternatives thereto.

On October 1, 2022 Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for solid cancers, reported that it has appointed Jason Sager, MD, as Chief Medical Officer (CMO) (Press release, Angiex, OCT 1, 2022, View Source [SID1234621831]).

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Following a 12-year career as a practicing pediatric oncologist, Dr. Sager gained extensive oncology drug development experience at Genentech, Novartis, Sanofi and Ikena Oncology where he led the early clinical development of many important therapeutics. His résumé includes 14 INDs. Over the past 18 months, he led the design of the clinical program for Angiex’s lead drug, AGX101.

Angiex CEO, Marty J. Duvall said, "The addition of Jason to our executive team is a critical step in the growth of our company. His extensive know-how and drug development network will help accelerate our company forward."

"I am highly motivated to join Angiex. The company has a deep scientific foundation in angiogenesis, vascular biology, and antibody-drug conjugate chemistry. I am driven to translate that into a meaningful benefit for cancer patients," said Dr. Sager.

Iain Dukes, executive chairman of Angiex and venture partner of Orbimed Advisors, said, "Adding Jason to the executive team marks another important milestone in the building of Angiex. Angiex’s ND-ADC technology holds great promise for the treatment of solid cancers and deserves a world-class team to drive it forward."