On June 2, 2021 QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, reported that it has dosed the first patient in the Phase Ib/IIa clinical trial of the company’s lead oncology molecule, tigilanol tiglate in combination with MSD’s immune checkpoint inhibitor KEYTRUDA (pembrolizumab) for patients with unresectable melanoma, the deadliest form of skin cancer (Press release, QBiotics, JUN 2, 2021, View Source;msd-clinical-trial-collaboration-for-unresectable-melanoma-301304596.html [SID1234583423]).

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The QB46C-H06 multi-centre, open label study will enrol approximately 22 patients with Stage IIIB to IV M1c-melanoma across a number of Australian sites over 24 months. The study will test up to three intratumoural doses of tigilanol tiglate at three escalating dose levels, administered 3 weeks apart in combination with intravenous pembrolizumab administered every 3 weeks for up to 24 months. The study will evaluate the safety, optimal dose and tumour response of the tigilanol tiglate and pembrolizumab combination in patients with late-stage unresectable melanoma, who have been previously exposed to immune checkpoint inhibitors.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said "We are very pleased to be collaborating with MSD in the fight against melanoma, a deadly form of skin cancer prevalent worldwide, but especially so here in Australia.

Dr Gordon continued "Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. We hope to see that when combined, tigilanol tiglate and KEYTRUDA may produce additive anti-tumour immune responses, improving outcomes for patients."

Over the last decade, the global cases of melanoma have increased by nearly 50 percent, with more than 320,000 people diagnosed annually. This translates to approximately 60,000 melanoma-related deaths per year[1]. Australia has the highest melanoma rates in the world, with one person diagnosed every 30 minutes, and an estimated 1,300 deaths each year.[2]

Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, vascular disruption, and immune-mediated mechanisms.[3] Pembrolizumab is a systemic immune checkpoint inhibitor, which reactivates the immune system by blocking the activity of PD-1, an immune checkpoint protein that prevents T cells from recognising and killing cancer cells.[4]

"The commencement of this trial with our first patient dosed is a significant milestone for QBiotics and is underpinned by positive outcomes from our Phase I QBC46-H01 Phase I study using tigilanol tiglate as a monotherapy in 22 patients with a broad range of refractory solid tumours. In this Phase I study a single injection of tigilanol tiglate showed an injected tumour response rate of 60% (CR of 20%, PR of 28%, SD of 12%).[5] Non-injected (abscopal) responses in distal tumours were observed in two patients with melanoma[6]," said Dr Gordon.

ABOUT TRIAL NCT04834973

A Phase Ib/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable, Stage IIIB to IV M1c melanoma.

The primary objectives are 1. To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) level of a single intratumoural injection of tigilanol tiglate administered in combination with intravenous pembrolizumab (200 mg), and 2. To assess the safety and tolerability of i) A single injection of tigilanol tiglate at escalating dose levels (dose-escalation) administered in combination with pembrolizumab; and ii) Repeat injections of tigilanol tiglate (maximum of 3) administered in combination with pembrolizumab. Secondary objectives include tumour responses according to RECIST 1.1 criteria, including loco-regional control of injected tumour(s) and non-injected tumour(s), and survival in patients. For more information, visit View Source

On June 2, 2021 Genmab A/S (Nasdaq: GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) reported that the companies have entered into an oncology research and development collaboration (Press release, Bolt Biotherapeutics, JUN 2, 2021, View Source [SID1234583375]). Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt’s proprietary Boltbody immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. This research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept.

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"This exciting collaboration will provide a unique opportunity to combine Genmab’s innovative bispecific antibody technologies with Bolt’s powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab’s partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options."

Randall Schatzman, Ph.D., Chief Executive Officer of Bolt, explained, "Our joint vision is to leverage Genmab’s and Bolt’s innovative technologies to develop a completely new type of ISAC with the aim to transform the way cancer is treated. Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients. We are delighted to be collaborating with the Genmab team and to have their deep expertise in discovering and developing bispecific antibodies brought to bear on this approach as we continue our mission to develop treatments that address key unmet needs for patients with cancer."

Financial Terms
Under the terms of the agreement, Genmab will pay Bolt an upfront payment of USD 10 million. Genmab will also make a USD 15 million equity investment in Bolt. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund pre-clinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.

On June 2, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported that the company will participate in the upcoming Goldman Sachs 42nd Annual Global Healthcare Conference (Press release, Revolution Medicines, JUN 2, 2021, View Source [SID1234583391]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a fireside chat at the event.

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Details of these company’s participation are as follows:

Goldman Sachs 42nd Annual Global Healthcare Conference
Conference Date: June 8-11, 2021
Fireside Chat Time/Date: 3:00 p.m. Eastern on Wednesday, June 9, 2021
Format: Virtual conference; webcast available
To access the live webcast of the fireside chat, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source A replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines’ website for at least 14 days following the conference.

On June 2, 2021 Proteros biostructures GmbH ("Proteros") reported that it has signed an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to jointly discover and develop novel small molecules for the potential treatment of various types of cancer (Press release, AstraZeneca, JUN 2, 2021, View Source [SID1234583407]).

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The collaboration brings together Proteros’ discovery capabilities which are tailored to unlock even the most technically challenging drug targets with AstraZeneca’s expertise in target biology and medicinal chemistry to jointly discover novel lead compounds which will be further developed, manufactured, and commercialized by AstraZeneca.

Under the agreement, AstraZeneca will provide research funding and Proteros will be eligible for success-based research, development, and commercial milestone payments up to 62 million EUR plus tiered royalties on annual net sales.

"We believe that advances in epigenomic capabilities will bring forward the next wave of innovation in cancer development through the discovery and development of novel small molecules," said Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca. "Proteros’ proprietary discovery platform enables us to screen epigenetic targets in a physiologically relevant setting, supporting accelerated discovery and development of the next wave of anti-cancer medicines."

"We are delighted AstraZeneca has selected Proteros to act as their discovery engine for a number of novel and very relevant oncology targets," said Dr Torsten Neuefeind, Proteros’ CEO. "These types of targets pose a number of challenges that Proteros’ discovery platform is uniquely positioned to overcome."

On June 2, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it will take part in a fireside chat at the 42nd Annual Goldman Sachs Global Healthcare Conference, which will be webcast on June 9 (Press release, Mirati, JUN 2, 2021, View Source [SID1234583424]). Charles M. Baum, M.D., Ph.D., president and chief executive officer, will answer questions about the company at 3:50 p.m. E.T./12:50 p.m. P.T.

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The webcast will be available through the "Investors" section of the Mirati website, Mirati Investor Events and Presentations, and a replay of the webcast will be made available for 90 days following the event.