On June 2, 2021 Servier and LabCentral reported that the Servier Spark Award* 2021 goes to New Equilibrium Biosciences, a biotech that develops small molecules targeting intrinsically disordered proteins (Press release, Servier, JUN 2, 2021, View Source;utm_medium=rss&utm_campaign=servier-spark-award-goes-to-new-equilibrium-biosciences [SID1234583393]). This award will allow New Equilibrium Biosciences to continue developing its preclinical programs in Oncology and potentially in other therapeutic areas.

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New Equilibrium Biosciences develops small molecules from original structural studies of intrinsically disordered proteins, proteins involved in different pathologies, in Oncology or in Neurology. Due to the dynamism of their structures, these proteins are generally difficult to target and to inhibit. The original approach of New Equilibrium Biosciences could allow breakthroughs in the field. The first indications on which New Equilibium Biosciences are focusing are breast cancer or rare cancers.

New Equilibrium Biosciences’ line of research is aligned with Servier’s commitment to support innovation in Oncology and Neurology: "Intrinsically disordered proteins represent an attractive class of potential drug targets across a variety of disease indications and states. New Equilibrium Bio’s synergistic data- and wet-lab driven approach, backed by a strong team of scientific entrepreneurs, is well suited to tackle this challenge in two of Servier’s therapeutic areas of interest. We are proud to support their efforts at this early stage." said Christian Schubert, Global Head of External Innovation at Servier.

*The Spark Award (also known as Golden Ticket) is part of Servier’s sponsorship with LabCentral. This award allows the winning start-up to have access to LabCentral’s facilities, by covering the operating costs of a researcher for one year, thus giving the wining biotech the means to focus all its efforts on their scientific development. This prize is also intended to forge links between the winning biotech and Servier’s research teams, by opening a scientific dialogue.

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 Race Oncology Limited ("Race") reported it has appointed the Contract Research Organisation (CRO), Parexel International, to support an open label Phase 1/2 clinical trial in patients with relapsed or refractory (r/r) extramedullary Acute Myeloid Leukemia (AML) (Press release, Race Oncology, JUN 2, 2021, View Source [SID1234583390]).

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The trial will be led by Principal Investigator Associate Professor Anoop Enjeti, Director of Haematology at the Calvary Mater Newcastle and John Hunter Hospitals.

Dr Enjeti is a highly experienced clinical haematologist having designed and led more than 25 clinical trials. Dr Enjeti is the co-chair of the MDS/AML working party for the Australasian Lymphoma and Leukemia Group (ALLG) for Cooperative Clinical Trials.

Extramedullary AML
Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have the extramedullary form1. Extramedullary AML patients have no clinically approved treatments and limited experimental treatment options, with many clinical trials explicitly excluding this difficult to treat form of AML.

A recent Phase 2 clinical trial in r/r AML patients treated with Bisantrene by a team led by Prof Arnon Nagler of the Chiam Sheba Medical Center, Israel reported a 100% clinical response rate (4/4 patients) in those patients with the extramedullary form of this deadly cancer (ASX announcement: 16 June 2020).

Clinical Trial Design
This open label Phase 1/2 trial will recruit approximately 60 patients with 18F-FDG PET/CT imaging-identified extramedullary AML at 10 clinical sites across Australia using a two-stratum (arm) design. The first stratum will utilise Bisantrene as a high dose, single agent, treatment over 7 days in patients with extramedullary AML who are able to tolerate high intensity chemotherapy, followed by one or more cycles of consolidation treatment of Bisantrene in combination with azacitidine, a standard of care drug.

The second stratum will use Bisantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, Inqovi (decitabine and cedazuridine) for patients unable to tolerate high intensity chemotherapy. Published preclinical data from the City of Hope Hospital by Prof Chen’s team identified that Bisantrene is able to synergize with decitabine2. In mouse models of AML the combination provided improved therapeutic efficacy with, lower toxicity compared to when either drug was used alone3.

The primary endpoint for both strata will be complete response (CR) and complete response with incomplete haematological recovery (CRi) with an aim of bridging to an allogeneic hematopoietic stem cell transplant. Key secondary endpoints include safety and tolerability of Bisantrene, overall and event-free survival, and the level of FTO expression with response to treatment.

Indicative Costs and Timelines
The trial is expected to take 36 to 40 months to complete with full patient recruitment over approximately 18 months. Treatment of the first patient is targeted for Q4 CY 2021, subject to human ethics approval of the study and patient recruitment.

Race will pay Parexel an initial fee of $1.11 million under the Start Up Agreement (SUA). Additional payments will be made to Parexel under the Master Service Agreement (MSA) throughout the study upon reaching key milestones and will depend on the number of patients recruited and other operational variables.

Due to the adaptive nature of this study, the total study costs cannot be determined at this stage.

Race CSO Daniel Tillett said: "We are excited to begin this study with the twin aims of exploring the use of Bisantrene to treat FTO overexpressing cancers and bring it to market as a heart safer orphan drug treatment for AML. This trial will be transformational for Race and our shareholders."

Race CEO & MD Phillip Lynch said: "This study supports our Pillar 3 registration ambition to see Bisantrene’s historical safety and efficacy in AML demonstrated with superior drug combinations that may benefit patients who remain challenged by initial treatment failures."

Clinical Trial Summary
Study Title An open label Phase 1/2 study of high dose Bisantrene with cytarabine arabinoside (Ara-C) or low dose Bisantrene with oral decitabine for treatment of relapsed or refractory Acute Myeloid Leukemia (r/r AML) patients with extramedullary disease (BISECT)
Phase of Development Phase 1/2
Active Ingredient Bisantrene dihydrochloride
Study Description A two stratum trial of Bisantrene in patients with extramedullary AML diagnosed by 18F-FDG PET/CT imaging.
Principal Investigator A/Prof Anoop Enjeti
Sponsor Race Oncology
Indication/population Adult men and women ≥18 years of age with relapsed and/ or refractory Acute Myeloid Leukemia (R/R AML) presenting with non-CNS extramedullary disease.
Number of Subjects Stratum 1: up to 30 patients Stratum 2: 4 -10 patients (dose escalation); up to 30 patients in the expansion phase
Study Period 36 – 40 months
Study Design This is a two strata Phase 2, open-label study of high dose Bisantrene treatment given as a monotherapy induction and in combination with Ara-C as consolidation (Stratum 1) and lower dose Bisantrene in combination with decitabine (Inqovi) (Stratum 2) in patients with extramedullary r/r AML. As the patient population is considered relapsed and/or refractory to existing treatments, a comparator arm will not be used.
Statistical methods Bayesian Optimal Interval (BOIN) model-based design based on observed response rate of 30% for RR AML where the true response rate is expected to be <20% applying a 90% power.
End Points Primary: Achievement of a morphological overall response, i.e. complete response (CR) or complete response with incomplete count recovery (CRi), after commencing cycle 1 and before commencement of cycle 2. Key Secondary: Achievement of a PET/radiologic overall response, i.e. complete or partial metabolic response, after cycles 1, 2 and 4. Other Secondary: FTO status, event free survival, overall survival
Participating Centres 10 ALLG participating sites across Australia
Start Date First patient In: Q4 CY2021
End Date Last Patient In (anticipated): Q2 CY2023
End Date Last Patient In (anticipated): Q2 CY2023

On June 2, 2021 Portage Biotech Inc., (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies targeting cancer treatment resistance, reported that Intensity Therapeutics will present interim data from the Phase 2 portion of its IT-01 trial evaluating the safety and efficacy of INT230-6 (PORT-1) as both a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting, taking place virtually June 4-8 (Press release, Portage Biotech, JUN 2, 2021, View Source [SID1234583389]).

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PORT-1 is a novel intratumoral amphiphilic formulation developed by Intensity Therapeutics, a company affiliated with Portage. It delivers potent cancer-killing agents directly into the tumor to immediately reduce cancer burden, break down the cytokine wall, and recruit immune cells to attack residual disease.

Preliminary safety and survival data from the IT-01 trial demonstrate that both INT230-6 (PORT-1) monotherapy and combination therapy are well-tolerated with direct tumor-killing effects and generate abscopal responses likely from antigen presentation and immune activation. The data for PORT-1 as a monotherapy demonstrated an estimated 62% of patients alive at one year across all tumor types, with an estimated 78% survival at one year for patients who received ≥50% of the tumor dosed. Preliminary estimates for patients who received the pembrolizumab combination indicate approximately 88% alive at one year. The estimated median overall survival (mOS) was approximately 23.8 months in a heavily pre-treated mixed sarcoma population compared to 4-6 month expected mOS in a historical patient population with similar prognostic features.

"The toxicity of current standard of care treatments often creates systemic effects throughout the body which may impact the quality of life of cancer patients. With INT230-6 (PORT-1) and the amphiphilic intratumoral platform, we aim to limit these effects and increase the potency of this immunotherapy treatment through direct delivery of cancer-killing agents into targeted tumors to stimulate antigen presentation," said Dr. Ian Walters, chief executive officer of Portage Biotech. "We are encouraged by the promising safety and survival data of the IT-01 trial as it has now demonstrated proof of concept in humans. We look forward to further evaluation and additional clinical data reads from PORT-1 studies, conducted in collaboration with Bristol Myers Squibb and Merck, over the next 12-18 months."

The IT-01 trial is governed by joint development committees with Bristol Myers Squibb and Merck, in which Dr. Walters contributes as a representative of Intensity Therapeutics.

For more information on the data being presented, please see abstract numbers 11557 and 2592. To view the full announcement from Intensity Therapeutics, visit their website at www.intensitytherapeutics.com.

About PORT-1

INT230-6 (PORT-1) contains amphiphilic molecules combined with anti-cancer payloads, offering a next-generation formulation to safely deliver up to three times the systemic dose of cancer-killing agents directly into tumors. PORT-1 breaks down the cytokine wall and stimulates immune cells to process tumor antigens and attack residual disease. Used alone or in combination with checkpoint inhibitors, PORT-1 may lead to improved survival with dramatically fewer unwanted side effects. PORT-1 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for triple-negative breast cancer, demonstrating the importance of ongoing drug development and improved therapies for this aggressive type of cancer. Select members of the Portage management team contribute to the development efforts led by Intensity Therapeutics.

On June 2, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer, cannabinoids, and Covid-19 reported the closing of the second tranche of the non-brokered private placement announced on November 2, 2020, January 19, 2021 and January 22, 2021 (the "Private Placement") (Press release, Pascal Biosciences, JUN 2, 2021, View Source [SID1234583388]). Participants included long-term shareholders, new shareholders, and Company insiders. "This financing will greatly help Pascal move our programs forward. It’s encouraging to see the confidence of our long term shareholders and we welcome our new shareholders", stated CEO Patrick Gray. "Mark van der Horst, our vice president of Corporate Communications, has done a great job of presenting the Pascal story, and we will continue to actively deliver positive messaging to investors."

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The second tranche consists of 1,900,000 units (each a "Unit") for gross proceeds of $190,000. The first tranche closed on February 8, 2021 and the Company issued 5,600,000 Units for gross proceeds of $560,000. Each Unit consists of one common share in the capital of the Company (each a "Share") and one Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder to purchase one additional Share at a price of $0.15 per Share for a period of 24 months from the date of closing, subject to an exercise acceleration clause. Under the exercise acceleration clause, which the Company may exercise once the Units are free of resale restrictions and if the Company’s Shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days, the Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release.

The Company paid $1,365 in finder’s fees related to the second tranche of the Private Placement.

Certain directors and officers of the Company acquired 1,255,000 Units under the Private Placement. Any such participation is considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business.

The securities issued under the Private Placement are subject to a four-month and one day hold period. The private placement is subject to final acceptance by the TSX Venture Exchange upon filing of final documents.