On June 2, 2021 Global pharma major, Lupin Limited (Lupin) reported that the U.S. FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway(Press release, Lupin, JUN 2, 2021, View Source [SID1234584117]).

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Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).

Commenting on the development, Vinita Gupta, CEO, Lupin said, "FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need. This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment."

Nilesh Gupta, MD, Lupin said, "The pegfilgrastim filing is our first biosimilar filing in the U.S. and is a milestone in our research and innovation journey as we continue to focus on delivering unique and affordable solutions to alleviate disease burden. Biosimilars is a key part of our growth strategy and we are proud of the world-class achievements of our group.’’

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.

Dr. Cyrus Karkaria, President, Lupin Biotech said "With significant investment in our biotechnology division over the years, we remain committed to bringing much-needed innovative products to market. This milestone further encourages us to continue advancing our robust Biosimilars pipeline across the globe to provide effective, affordable alternative for consumers."

On June 2, 2021 Aptamer Science reported the company signed a joint research agreement with bio venture company PINOTBIO to develop anticancer drugs based on Aptamer Drug Conjugate (ApDC) (Press release, Aptamer Sciences, JUN 2, 2021, View Source;idx=127 [SID1234644070]).

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Both companies plan to accelerate the development of innovative targeted anti-cancer drugs that go beyond the limitations of existing ‘antibody-drug conjugate (ADC)’ technology by linking their respective core technologies, aptamer discovery technology and linker-drug conjugation technology. am.

The ‘Antibody-Drug Conjugate (ADC)’ technology, which has recently been in the spotlight, has difficulty controlling the conjugation of antibodies and drugs, and has limitations in penetrating cancer tissue due to its molecular size, so there is a steady demand for the development of technology to complement this. The situation continues.

Aptamers, a nucleic acid-based material that is attracting attention as a next-generation drug material, show high selectivity and binding ability to targets and have a molecular size that facilitates tissue penetration. In addition, the ability to design chemical reactions that can control the number and location of drug conjugates is considered an advantage of ApDC technology.

Under this agreement, the two companies plan to conduct joint research aimed at developing targeted anticancer drugs for glioblastoma and pancreatic cancer, which have high unmet medical needs. To this end, Aptamer Science will provide optimized cancer cell-targeting aptamers, and Pinobio will provide He will be responsible for conjugation and efficacy evaluation of tamers and drugs.

Dong-il Han, CEO of Aptamer Science, said, "Through joint research with Pinobio, which has its own linker-drug technology, we want to develop a new type of targeted anti-cancer drug that overcomes the limitations of existing ADC technology." He added, "The collaboration between the two companies is a meaningful clinical trial." "We will do our best to ensure that the outcome is favorable," he said.

Doo-young Jeong, CEO of Pinobio, said, "Through joint research with Aptamer Science, we are able to develop ApDC technology using aptamers, which have characteristics differentiated from antibodies, which are existing drug carriers, so we expect to quickly derive innovative candidates and ADC drug technology. "We expect to be able to present a new paradigm," he said.

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.