On June 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders inside and outside of the brain, reported that the pricing of an underwritten public offering of 15 million shares of its common stock at a public offering price of $3.00 per share for total gross proceeds of approximately $45 million (the "Offering) before deducting underwriting discounts and commissions and offering expenses payable by Inhibikase(Press release, Inhibikase Therapeutics, JUN 16, 2021, View Source [SID1234584072]). In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to 2.25 million additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

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Inhibikase intends to use the net proceeds from the public offering, together with existing funds, to fund the costs of a Phase 1b extension study for IkT-148009 in Parkinson’s patients and to validate target engagement markers in the central and peripheral nervous system; to fund production of IkT-148009 for Phase 1b and Phase 2 clinical studies and to fund a Phase 2 efficacy trial of IkT-148009 in Parkinson’s patients. This funding will further support the clinical dose calibration study(ies) of IkT-001Pro in healthy subjects to support approval under the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act and to fund drug product production for IkT-001Pro. The balance will support general research and development activities, medicinal chemistry for additional molecules and IND-enabling studies, team building, and other general corporate activities

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering. JonesTrading Institutional Services LLC is acting as the co-manager for the offering.

The offering is being made pursuant to a registration statement on Form S-1 (File No. 333-257032) that was declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On June 16, 2021 Kytopen, a transformative biotechnology company offering non-viral delivery that links the discovery, development and manufacturing of engineered cell therapies, reported it was awarded a SBIR Fast Track grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH) (Press release, US NIH, JUN 16, 2021, View Source [SID1234584087]). Kytopen is eligible for up to $2M over the course of the 3-year award as project milestones are successfully completed within the Phase I and Phase II portions of the grant.
Natural killer (NK) cells represent a high impact population for cell therapy, but due to limitations in current methodologies for gene delivery, NK cells remain a largely untapped resource. This SBIR grant will be used to demonstrate that non-viral delivery via Kytopen’s Flowfect platform can alleviate this limitation on NK cell gene editing at both research and manufacturing scale, which is needed for pre-clinical and clinical studies. Due to the major potential impact NK cells represent in a clinical setting, non-viral Cas Ribonucleoprotein (RNP) gene knockout will allow for novel therapeutic applications in infectious disease, autoimmune disorders, and immuno-oncology.
Paulo Garcia, Kytopen’s CEO and Co-Founder will serve as the Principal Investigator (PI) on the grant. Dr. Garcia explains that "engineered NK cells have tremendous therapeutic promise including the potential to treat solid tumors in an allogeneic modality. The Flowfect platform will facilitate high-throughput target discovery while providing a clear path towards clinical manufacturing of next-generation cell products."
NK cells are a subset of innate immune cells that can respond to threat without antibody priming. This quick response to stimuli makes them an ideal immunotherapy candidate. Yet, genetic modification in NK cells has proven to be difficult using conventional viral and non-viral transfection methodologies. Alternative delivery methods are necessary in order to make genetic modifications at reproducible and efficient rates, while maintaining high cell viability and functionality.
The awarded study leverages continuous fluid flow coupled with low energy electric fields for transfection via a proprietary Flowfect platform (Figure 1). This platform represents a novel approach to non-viral delivery in historically "hard-to-transfect" human cells. The current research proposes to engineer non-activated NK cells with Cas RNPs for gene editing using the Flowfect platform. To achieve this goal, Kytopen has outlined a two-phase research strategy which focuses on stability and functionality of edited NK cells both in vitro and in vivo.
NIH sponsored grant programs are an integral source of capital for early-stage U.S. small businesses that are creating innovative technologies to improve human health. These programs help small businesses break into the federal research and development arena, create life-saving technologies, and stimulate economic growth. Kytopen is honored to be a recipient of this competitive award from the NIH/NIAID and looks forward to unlocking biological capabilities of engineered NK cells for improving patients’ lives during the performance of this project.

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About the Flowfect Technology
Kytopen’s proprietary Flowfect platform eliminates the complexity of gene editing and integrates discovery, development and manufacturing in one flexible and scalable non-viral delivery solution. The Flowfect technology utilizes electro-mechanical energy to disrupt the cell membrane and introduce genetic material (such as RNA, DNA, or CRISPR/Cas RNP) to a wide variety of hard-to-transfect primary cells. During the Flowfect process, a solution containing cells and genetic payload suspended in a proprietary buffer flows continuously through a channel while the solution is exposed to a low energy electric field. Due to the continuous flow and low electrical energy required, cells engineered using Flowfect exhibit high viability while also exhibiting high transfection efficiency post-processing. The Flowfect technology utilizes relatively high flow rates enabling cell engineering in minutes for discovery and optimization (e.g. 96 well plate in <10 minutes) and direct scale up to manufacturing volumes of >10mL, engineering over 2 billion cells per minute in a single channel.

On June 16, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported the acquisition of the remaining 22 percent of shares outstanding in its Founded Entity, Alivio Therapeutics ("Alivio") (Press release, PureTech Health, JUN 16, 2021, View Source [SID1234584766]). Alivio’s therapeutic candidates, in development for inflammatory disorders including inflammatory bowel disease (IBD), will be integrated into the Company’s Wholly Owned Pipeline.

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The acquisition aligns with PureTech’s strategy to advance a Wholly Owned Pipeline designed to harness key immunological, fibrotic and lymphatic system mechanisms to treat serious diseases with significant unmet needs. The programs and the underlying AlivioTM technology platform are expected to be funded by PureTech as well as through partnerships and grants. The integration of this program is in line with the budget for PureTech, which extends into the first quarter of 2025, as previously guided.

"PureTech founded Alivio alongside leading scientists Jeffrey Karp, Ph.D., Professor of Medicine at Brigham and Women’s Hospital and Robert Langer, Sc.D., David H. Koch Institute Professor at MIT to pioneer a novel strategy to more effectively treat inflammatory disorders through highly targeted immunomodulation at the site of disease. This promising approach fits well within our Wholly Owned Pipeline and we will be able to leverage our strength in immunology and related technologies as we progress therapeutic candidates to potentially treat inflammatory diseases," said Daphne Zohar, Founder and Chief Executive Officer of PureTech. "We’re pleased to add the Alivio programs to our pipeline and proud to advance a platform that we hope will bring new therapeutic options to millions of people with chronic and life-limiting autoimmune and inflammatory diseases."

The Wholly Owned Pipeline will include the addition of LYT-500, an orally-administered therapeutic candidate in development for the treatment of IBD. Utilizing the Alivio technology platform, LYT-500 consists of two active agents intended to selectively act at the inflamed tissues while reducing their impact on the normal tissue. LYT-500 contains a unique combination of IL-22 and an anti-inflammatory drug, which is designed to address the two key underlying causes of IBD pathogenesis and progression, namely mucosal barrier disruption and inflammation.

Existing biologic therapies indicated for IBD must be provided through multiple injections over time and are associated with several limitations including loss of efficacy over time and increased risk for opportunistic infections. Using the Alivio technology platform, a biologic agent and small molecule drug can be combined into a single oral dosage form that offers the potential for enhancing the treatment of inflamed tissues to maximize efficacy, while reducing systemic exposure to minimize toxicity. Unlike other therapies in development for IBD, LYT-500 has the potential to provide an oral drug therapy that targets multiple mechanisms of disease pathogenesis, while reducing the potential for systemic side effects.

The integration also includes the addition of therapeutic candidate, LYT-503/IMB-150, to the Company’s pipeline, which is being developed in collaboration with Imbrium Therapeutics as a potential non-opioid treatment for interstitial cystitis or bladder pain syndrome (IC/BPS). An IND filing for LYT-503/IMB-150 is expected in 2021. PureTech will also continue to evaluate existing and additional anti-inflammatory programs leveraging the Alivio platform technology.

PureTech’s Wholly Owned Pipeline also includes three clinical-stage programs: LYT-100, a selectively deuterated form of pirfenidone that has demonstrated anti‑inflammatory and anti-fibrotic activity and is being advanced for idiopathic pulmonary fibrosis and potentially other PF-ILDs, where registration-enabling studies are being planned and is currently being evaluated in a Phase 2 trial to treat respiratory complications and related sequelae of Long COVID as well as a Phase 2a proof-of-concept study in patients with breast cancer-related, upper limb secondary lymphedema; and LYT-200, a monoclonal antibody targeting immuno-suppressive galactin-9, which is in a Phase 1 trial for metastatic solid tumors. PureTech’s Wholly Owned Pipeline also includes LYT-300 an oral version of allopregnanolone (a natural neurosteroid), developed using PureTech’s proprietary Glyph platform, and several other discovery platforms leveraging the company’s expertise in lymphatic targeting.

The consideration for the acquisition of the minority interests in Alivio consist of a closing cash payment and potential future cash payments upon successful achievement of certain milestones. The transaction is a small transaction for the purposes of Annex 1 of Listing Rule 11 and smaller than a class 2 transaction for the purposes of Listing Rule 10.

On June 16, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate events(Press release, BeyondSpring Pharmaceuticals, JUN 16, 2021, View Source [SID1234584056]).

"This quarter was marked by meaningful progress on the road toward building our lead first-in-class asset, plinabulin, as a pipeline in a drug, from treating chemotherapy side effects to treating cancer directly," said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring. "We are grateful that our NDA for chemotherapy-induced neutropenia (CIN) prevention was filed by the U.S. FDA with priority review. Our plinabulin and G-CSF combination has the potential to elevate the standard of care in CIN for the first time in 30 years. In addition, in the coming months, we plan to announce topline anti-cancer overall survival data from the Phase 3 DUBLIN-3 trial in NSCLC. We are building clinical evidence to demonstrate that plinabulin is a potent antigen presenting cell (APC) inducer with potential to be a ‘game changer’ in cancer treatment for severely unmet medical needs."

Recent Corporate Highlights

Lead Asset Plinabulin, a "Pipeline in a Drug"

Clinical Update

June 2021: Announced Food and Drug Administration (FDA) filing of New Drug Application with Priority Review for plinabulin and G-CSF combination for the prevention of CIN. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021.

June 2021: Presented three poster presentations at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) highlighting the Company’s PROTECTIVE-2 Phase 3 data demonstrating combination plinabulin + pegfilgrastim offers superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone.

June 2021: Announced late-breaking poster presentation at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting highlighting data from Phase 3 PROTECTIVE-2 CIN Study showing plinabulin in combination with pegfilgrastim improves CIN prevention and reverses key aspects of the immune suppressive profile of monotherapy pegfilgrastim.

June 2021: Presented data at ASCO (Free ASCO Whitepaper) 2021 of plinabulin in combination with nivolumab and ipilimumab, showing a 46% objective response rate (ORR) in 13 evaluable patients with PD-1/PD-L1 naïve or resistant tumors in 2nd line and beyond in small cell lung cancer (SCLC). Additionally, data demonstrated the plinabulin combination was able to re-sensitize tumors to I/O therapy, that had progressed on prior PD-1/PD-L1 inhibitors, with a 43% ORR.

June 2021: Dosed first patient in a triple combination study with plinabulin, PD-1/PD-L1 inhibitor and radiotherapy at MD Anderson for the reversal of resistance to PD-1/PD-L1 inhibitors in patients with seven advanced solid tumors.

Upcoming Clinical Milestones

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Mid-2021 (DUBLIN-3): Topline overall survival (OS) data expected in pivotal Phase 3 non-small cell lung cancer (NSCLC) study.

2022: (Big Ten Cancer Research Consortium, Investigator Initiated study): Phase 2 Data expected in plinabulin + nivolumab + ipilimumab in checkpoint inhibitor-resistant SCLC.

2022: (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in PD-1/PD-L1-failed patients in seven cancers, including bladder cancer, melanoma, Merkel cell cancer, MSI-H Cancers (of any histology), NSCLC, renal cell cancer, and SCLC.

First Quarter 2021 Financial Results

Research and development ("R&D") expenses were $11.3 million for the quarter ended March 31, 2021, compared to $13.7 million for the quarter ended March 31, 2020. The decrease of $2.4 million was primarily due to a decrease in clinical trial expenses and non-cash stock-based compensation expense, partially offset by an increase in manufacturing costs and the cost of the plinabulin regulatory filings.

General and administrative ("G&A") expenses were $6.4 million for the quarter ended March 31, 2021, compared to $2.9 million for the quarter ended March 31, 2020. The $3.5 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, as well as costs associated with plinabulin pre-commercialization activities.

Net loss attributable to the Company was $17.0 million for the quarter ended March 31, 2021, compared to $16.1 million for the quarter ended March 31, 2020.

As of March 31, 2021, the Company had cash and cash equivalents of $90.6 million on hand. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to prepare for a potential launch of plinabulin in CIN in early 2022.

First Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, June 16, 2021, at 8:30 am ET. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or +1-631-891-4304 (International). The passcode for the conference call is 10014535 To access the live webcast or subsequent archived recording, click here or visit the "investors" section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the company’s website for 90 days.

On June 15, 2021 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that the expansion of its ongoing clinical collaboration with Merck to include multiple additional phase 2 cohorts(Press release, Linnaeus Therapeutics, JUN 16, 2021, View Source [SID1234584073]). Based on promising preliminary safety, pharmacodynamic and efficacy data, this expanded agreement will allow the companies to further evaluate the combination of LNS8801 and Merck’s anti-PD-1 therapy, KEYTRUDA(pembrolizumab) in patients with selected advanced solid tumors.

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LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers. Stimulating GPER rapidly and durably depletes the c-Myc oncoprotein, stops cancers from proliferating, and makes them more visible to the immune system.

Linnaeus and Merck are currently evaluating the combination of LNS8801 and KEYTRUDA in patients who had previously responded to PD-1/L1 therapy but have subsequently progressed on PD-1/L1 inhibitors. Additionally, Linnaeus is currently evaluating LNS8801 as a monotherapy in patients that cannot tolerate PD-1/L1 therapy due to serious immune-related adverse events.

Under the terms of the agreement, Linnaeus will conduct six additional Phase 2 cohorts evaluating the combination of LNS8801 and KEYTRUDA in several indications including NSCLC, head and neck cancer, cutaneous and uveal melanoma, among others.

"We are very pleased to expand our collaboration with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on the encouraging signals we have seen so far in the advanced cancer patients treated with the combination of LNS8801 and KEYTRUDA as well as LNS8801 as monotherapy, we are optimistic that the combination of LNS8801 and KEYTRUDA will provide meaningful benefit to this patient population."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801

LNS8801 is an orally bioavailable and highly specific, potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc oncoprotein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing phase human 1/2a study, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc oncoprotein depletion, and durable clinical benefit in patients with advanced cancer.