On June 2, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the appointment of industry veteran Zelanna Goldberg, M.D., M.A.S. as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 2, 2021, View Source [SID1234583373]). Dr. Goldberg joins Alpine from Iovance Biotherapeutics, where she was Senior Vice President, Clinical Science.

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"We are very enthusiastic about the addition of Zelanna to the Alpine team, particularly as we pursue an expanding scope of clinical development activities across oncology and inflammatory disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Zelanna is an experienced clinical development executive with a commitment to helping patients with life-threatening and debilitating diseases."

"I am thrilled to join Alpine and lead the clinical strategy and development of the company’s extremely promising pipeline, including ALPN-101, ALPN-202, and ALPN-303," said Dr. Goldberg. "I look forward to integrating within the research and development team to continue to advance these unique therapies and those that are coming next from Alpine’s directed evolution platform to meaningfully improve the lives of patients with cancer and life-threatening auto-immune diseases."

Dr. Goldberg brings over 20 years of industry and clinical practice experience, including strategic and/or operational responsibility for multiple therapeutic products such as dacomitinib (Vizimpro), palbociclib (Ibrance), and avelumab (Bavencio). Most recently, Dr. Goldberg was Senior Vice President, Clinical Sciences at Iovance Biotherapeutics, where she oversaw multiple aspects of the clinical development program of lifileucel (LN-145). Prior to Iovance, Dr. Goldberg held roles of increasing responsibility at Sunesis, Oxigene and Pfizer, where she was the global clinical lead for multiple assets. Prior to entering industry, Dr. Goldberg was an Associate Professor in the Department of Radiation Oncology at the University of California, Davis Medical Center.

Dr. Goldberg received her M.D. degree from University of Toronto Faculty of Medicine. Dr. Goldberg completed her residency in Radiation Oncology at Ontario Cancer Institute/Princess Margaret Hospital-University of Toronto, and her post-doctoral training in radiosensitizing drugs at Stanford University.

Disclosure of Inducement Grant under Nasdaq Listing Rules

The compensation committee of Alpine’s board of directors granted Dr. Goldberg an option to purchase 160,000 shares of common stock. The option will vest with respect to 25% of the shares underlying the option on the one-year anniversary of Dr. Goldberg’s employment start date of June 1, 2021, and the remaining 75% of the shares underlying the option will vest in equal monthly installments over the 36-month period following the one-year anniversary of Dr. Goldberg’s employment start date, subject to her continued service to Alpine through each relevant vesting date. In addition, pursuant to the terms of Alpine’s change of control and severance policy, if there is a change of control and, upon or during the 12 months after the change of control, Dr. Goldberg’s employment is terminated either (i) by Alpine without cause or (ii) by Dr. Goldberg for good reason, the option will become fully vested and exercisable. The option has a ten-year term and an exercise price of $10.29, equal to the per share closing price of Alpine’s common stock as reported by Nasdaq on June 1, 2021.

The stock options were granted outside Alpine’s 2018 Equity Incentive Plan as an inducement material to Dr. Goldberg entering into employment with Alpine in accordance with Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the option are generally consistent with those in Alpine’s 2018 Equity Incentive Plan.

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 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, JUN 2, 2021, View Source [SID1234583405]):

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Jefferies Virtual Healthcare Conference – June 1-4, 2021

June 3, 2021, 2:30 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Goldman Sachs 42nd Annual Global Healthcare Conference – June 8-11, 2021

June 10, 2021, 2:10 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

2021 Virtual Alpha-1 National Conference – June 10-12, 2021

June 12, 2021 – Javier San Martin, M.D., Arrowhead’s chief medical officer, will deliver an oral presentation

Virtual Dana-Farber Harvard Cancer Center Symposium on HIF, VHL, and Kidney Cancer – June 17, 2021

June 17, 2021 – So Wong, Ph.D., Arrowhead’s senior director of biology, will deliver an oral presentation on the preclinical development of ARO-HIF2

LifeSci Partners Genetic Medicines Summit 2021 – June 22, 2021

June 22, 2021 – Members of Arrowhead management will participate in a fireside chat presentation

The International Liver Congress 2021 – The Annual Meeting of the European Association for the Study of the Liver (EASL) – June 23-26, 2021

Title: ARO-HSD reduces hepatic HSD17B13 mRNA expression and protein levels in patients with suspected NASH
Authors: Edward Gane, et al.
Type: Late-Breaking Poster
Date and Time: June 23, 2021 at 8:00 CEST

Title: Short interfering RNA JNJ-3989 combination therapy in chronic hepatitis B shows potent reduction of all viral markers but no correlate was identified for HBsAg reduction and baseline factors
Authors: Edward Gane, et al.
Type: Oral Presentation
Date and Time: June 25, 2021 at 15:15 CEST

Title: ARO-AAT an investigational RNAi therapeutic demonstrates improvement in liver fibrosis with reduction in intra-hepatic Z-AAT burden
Authors: Pavel Strnad, et al.
Type: Late-Breaking Oral Presentation
Date and Time: June 26, 2021 at 12:15 CEST

28th Annual FSHD Society International Research Congress – June 24-25, 2021

June 25, 2021 – Jonathan Van Dyke, Ph.D., Arrowhead’s senior scientist II of biology, will deliver an oral presentation on the preclinical development of ARO-DUX4

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

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 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in a virtual format from June 4 to 8, 2021 (Press release, Blue Earth Diagnostics, JUN 2, 2021, View Source [SID1234583374]). The two abstracts outlined the launch of studies investigating the use of Axumin (fluciclovine F 18, also known as FACBC) PET in the management of oligometastatic, recurrent prostate cancer, and its role, as assessed by the impact on radiographic progression-free survival, in guiding radiotherapy planning for patients with recurrent disease. Details of the presentations to be given by Blue Earth Diagnostics’ collaborators are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All ASCO (Free ASCO Whitepaper) presentations are available beginning Friday, June 4, 2021, at 9:00 a.m. ET.

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial

Author(s): Risa Liang Wong, Sarah K Holt, Jing Zeng, Laura Graham, Rachel Kang, Nathan Conrad, Andrea Toulouse, Zoya Bauer, Michael Lai, Todd Yezefski, Jonathan L. Wright, Emily Steinberger Weg, Andrew Caleb Hsieh, Heather H. Cheng, Jean H Lee, Delphine L. Chen, Daniel W. Lin, Evan Y. Yu

Session: Poster session

Abstract: TPS5099

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: Phase III study of local or systemic therapy INtensification DIrected by PET in prostate

CAncer patients with post-prostaTEctomy biochemical recurrence (INDICATE): ECOGACRIN EA8191

Author(s): Neha Vapiwala, Yu-Hui Chen, Steve Y. Cho, Fenghai Duan, Christos Kyriakopoulos, Daniel H. Shevrin, Rana R. McKay, Bridget F. Koontz, Evan Y. Yu, Volkan Beylergil, David A. Mankoff, Jonathan McConathy, Glenn Liu, Terence Z. Wong, Michael Anthony Carducci

Session: Poster session

Abstract: TPS5098

Blue Earth Diagnostics invites participants at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting to attend the above presentations and to learn more about the Company at www.blueearthdiagnostics.com. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) online program here.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at:

View Source
About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.