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SURGE Therapeutics Raises $32M Series B Financing to Advance Intraoperative Immunotherapy to Improve Cancer Patient Survival Outcomes Post-Surgery

On July 19, 2023 SURGE Therapeutics (SURGE), a biotech company pioneering the delivery of immunotherapy during cancer surgery, reported the completion of a $32 million Series B financing led by Bioluminescence Ventures, with participation from KdT Ventures, Piedmont Capital, and existing investors 8VC, Alumni Ventures, Camford Capital, Cancer Research Institute, Intuitive Ventures, Khosla Ventures, and Pitango HealthTech (Press release, SURGE Therapeutics, JUL 19, 2023, View Source [SID1234633324]).

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The funding will be used to further development of the SURGE intraoperative immunotherapy approach, expand the team, and advance multiple clinical trials for its injectable biodegradable hydrogel, which may be administered during any surgical oncology procedure. In connection with the financing, Kouki Harasaki, Ph.D., Managing Partner at Bioluminescence Ventures, will join SURGE’s Board of Directors.

The company recently dosed the first two patients in a Phase 1/2a trial for its lead intraoperative immunotherapy candidate, STM-416, in patients with recurrent bladder cancer – a major unmet medical need – to improve post-resection outcomes. SURGE’s intraoperative approach enables extended, localized release of immunotherapy at the site of surgical tumor resection. This intervention may prevent tumor relapse and induce systemic antitumor immunity, potentially eliminating existing micrometastases.

"The capital that we have raised to date will allow SURGE to generate proof-of-concept event-free survival data with our lead program and advance our second and third programs through Phase 1," said Michael Goldberg, Ph.D., CEO & Founder, SURGE Therapeutics. "Intraoperative immunotherapy is a platform approach that can potentially confer clinical benefit across multiple cancer types, using different molecules. Surgery is the standard of care for most patients with solid tumors, and it is common for a small number of cancer cells to remain behind. Our mission is to ensure that nobody grieves the loss of a loved one due to preventable post-surgical cancer recurrence."

"Currently, cancer surgery is a physical intervention only. Physicians typically do not administer any kind of immunotherapy during surgical tumor resection, which we believe is a missed opportunity, as post-surgical recurrence and metastasis account for 90 percent of cancer-related deaths," said Kouki Harasaki, Ph.D., Managing Partner, Bioluminescence Ventures. "SURGE has a unique first-mover advantage in the intraoperative immunotherapy space to potentially improve patient outcomes and become the standard of care as a seamless complement to surgery. We are very excited about working with the SURGE team towards realizing this objective."

Reprogramming the body’s response to surgery from immunosuppressive to immunostimulatory may trigger the patient’s immune system to destroy both local and distal residual cancer cells, reducing recurrence and improving survival. In multiple aggressive murine models of metastasizing cancer, intraoperative immunotherapy vastly improved survival benefit relative to traditional routes of administration, whether systemic or local. Confirmation in patients could represent a major advancement in cancer care.

Hoth Therapeutics Receives Protocol Approval for HT-001 Cancer Therapeutic

On July 19, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has received approval from the Food & Drug Administration ("FDA") for a protocol change in its Phase 2a clinical trial of HT-001 (Press release, Hoth Therapeutics, JUL 19, 2023, https://www.prnewswire.com/news-releases/hoth-therapeutics-receives-protocol-approval-for-ht-001-cancer-therapeutic-301880450.html [SID1234633323]). Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash and other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life.

The study will be completed in 2 parts: the first part is an open-label (unblinded) cohort and all patients will receive HT-001 topical gel with the active ingredient; the second part is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Hoth will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.

"With our recent change in protocol approved, we believe that HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors will be more widely available for patients suffering from chemo rash," stated Hoth Therapeutics Chief Executive Officer, Robb Knie.

More information on the trial can be found at clinicaltrials.gov.

BioCity announces the first patient dosed with its first-in-class CDH3-targeting ADC BC3195 in a Phase 1 Trial

On July 19, 2023 BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, reported the dosing of the first patient in a Phase 1a/1b clinical trial of its first-in-class CDH3 antibody drug conjugate (ADC), BC3195 in China (Press release, Biocity Biopharma, JUL 19, 2023, View Source [SID1234633322]). The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors.

BC3195 is a novel ADC targeting CDH3/P-cadherin, a calcium-dependent cell-cell adhesion glycoprotein highly expressed in a variety of malignancies, including lung, breast, gastric, ovarian, colorectal, and pancreatic cancers. CDH3 expression is low or undetectable in normal tissues, making it an ideal target for anticancer therapies, particularly ADCs.

Currently, BC3195 is the only ADC targeting CDH3 in clinical development globally. In preclinical studies, BC3195 binds to cell surface CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%.

In addition to clinical trials being conducted in China, BC3195 has an active US IND. BioCity Biopharma expects to obtain preliminary clinical data on BC3195 by the end of 2023 from clinical trials in China as well as in the US.

Biotheus Announces Strategic Research Collaboration and Worldwide License Agreement with BioNTech

On July 19, 2023 Biotheus Inc. ("Biotheus"), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, reported that it has entered into a strategic research collaboration, option and worldwide license agreement with BioNTech SE ("BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, Biotheus, JUL 19, 2023, View Source [SID1234633321]).

Under the terms of the agreement, Biotheus will grant BioNTech worldwide, exclusive options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer therapy. In addition, Biotheus will grant BioNTech exclusive licenses to existing panels of VHH binders against multiple targets along with options to request Biotheus to generate new panels of VHH binders against targets nominated by BioNTech. In exchange, BioNTech will provide Biotheus with an upfront payment and following option exercise on Biotheus’ preclinical-stage bispecific antibody, Biotheus will also be eligible for clinical, regulatory, and commercial milestone payments and tiered single digit royalties.

"Biotheus is deeply committed to leveraging advanced technologies to address unmet medical needs. Partnering with BioNTech, a pioneering leader in novel therapies, significantly furthers our mission. Through this collaboration, we can combine our expertise to discover innovative, potentially transformative therapies for patients worldwide," said Xiaolin Liu, Co-founder, Chairman, and Chief Executive Officer of Biotheus.

Tempest Announces Publication in Cancer Research Communications Highlighting the Significantly Increased Potency of TPST-1495 Against Prostaglandin-Driven Tumor Models by Blocking EP2 and EP4 Together

On July 19, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, reported that in vivo and in vitro data on the unique mechanism of TPST-1495, the company’s novel dual receptor inhibitor of prostaglandin E2 (PGE2) signaling, were published in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Tempest Therapeutics, JUL 19, 2023, View Source [SID1234633320]).

"While the biology of PGE2 in promoting tumor growth and immune suppression is well established, there are still no approved drugs for cancer that effectively block the prostaglandin pathway," said Tom Dubensky, Ph.D., president of Tempest. "Our innovation with TPST-1495 shows for the first time the effect of blocking PGE2 signaling through the EP2 and EP4 pro-tumor receptors while maintaining the important anti-tumor signaling of PGE2 through the EP1 and EP3 receptors, which could be an important advance to inhibiting PGE2. Additionally, these results further support what we believe is an innovative and robust pipeline at Tempest that includes TPST-1120, a novel PPAR⍺ antagonist, which has shown early positive data from an ongoing global randomized study in first-line HCC patients."

About TPST-1495

Described in the Cancer Research Communications publication, TPST-1495 is an orally-available and potent small molecule designed to block the receptors EP2 and EP4 in the prostaglandin pathway. PGE2 both promotes tumor cell growth and has strong immune-suppressive signaling through these receptors. Several malignancies are thought to be prostaglandin driven through expression of high levels of COX-2, the cellular enzyme that produces PGE2, including endometrial, bladder, breast, colorectal, and cervical cancers. Tempest has conducted multiple studies with peripheral blood mononuclear cells (PBMCs) from healthy adult donors and in several mouse tumor models that demonstrate a significant increase in immune activation and anti-tumor potency by inhibiting both EP2 and EP4, when compared to EP4-only targeted molecules and non-steroidal anti-inflammatory drugs (NSAIDS), such as celecoxib.