On August 16, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the company has been selected as a constituent stock of the Hang Seng Composite Index (HSCI), the Hang Seng Hong Kong-Listed Biotech Index (HSHKBIO) and the Hang Seng Healthcare Index (HSHCI) in accordance with the quarterly adjustment results of the latest index series released by Hang Seng Indexes Company Limited, with effect from September 7th , 2020 (Press release, Ascentage Pharma, AUG 16, 2020, View Source [SID1234563690]).

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HSCI is one of the important indexes in the Hong Kong equity market. Adopting the free-float-adjusted market capitalization methodology, the HSCI can be used as a basis for index funds, mutual funds as well as performance benchmarks. It now has 485 component stocks. This index offers a comprehensive Hong Kong market benchmark that covers the top 95th percentile of the total market capitalization of companies listed on the Main Board of the Stock Exchange of Hong Kong. The HSHCI aims to reflect the overall performance of stocks listed in Hong Kong that are related to healthcare businesses. This adjustment adds 12 new constituent stocks. It now has 47 component stocks. The HSHKBIO reflects the overall performance of the biotech companies that are listed in Hong Kong. Six new constituent stocks are selected this time and total 43 high-quality biotech stocks including Ascentage Pharma are included. The aforesaid three indexes provide important references for the Hong Kong equity market. It is particularly noteworthy that five biotechnology companies including Ascentage Pharma listed under Chapter 18A of the Listing Rules are included in HSCI, reflecting that the capital market has paid attention to and recognized this sector. Ascentage Pharma is one of the two biotechnology companies selected as components of the aforesaid three indexes.

Ascentage Pharma was successfully listed in Hong Kong in October 2019 and became the first stock related to small molecule innovative drugs. The company has further advanced global clinical development after listing and made a number of R&D progresses. It submitted the first New Drug Application (NDA) in June this year, making another milestone and taking an important step from a R&D company to a listed company with products.

"The selection of Ascentage Pharma as a constituent stock of the abovementioned index series of Hang Seng Indexes Company Limited represents the capital market’s recognition of and confidence in the company’s business, stock liquidity and development prospects. Additionally, it is expected to be conducive in introducing more diversified investors for the company and to promote the company’s reputation in the capital market," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Leveraging our core competency in research and development as well as operation, we will continue to seize the major opportunities in the development of the biopharmaceutical industry. Furthermore, we are committed to providing safe and effective treatment options for global patients and endeavor to create value for shareholders."

On August 14, 2020 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in Huntington’s disease and cancer, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Vaccinex, AUG 14, 2020, View Source [SID1234569919]).

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Pepinemab Clinical Updates:

Huntington’s Disease. The company’s ongoing SIGNAL clinical trial is evaluating its lead drug candidate, pepinemab, for the treatment of Huntington’s disease (HD). The company remains on track to complete the trial within the previously announced time frame. Subsequent to June 30, 2020, the last two patient treatment visits have been completed, and primary efficacy data has been collected from all subjects enrolled. The company continues to anticipate that topline data will be released by early October 2020.
Non-Small Cell Lung Cancer (NSCLC). CLASSICAL-Lung clinical trial. The CLASSICAL-Lung study is evaluating pepinemab in combination with the anti-PD-L1 checkpoint inhibitor BAVENCIO (avelumab) for the treatment of advanced (stage IIIB/IV) NSCLC. Near topline data for this trial presented at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in late May 2020 suggested that immunotherapy naive and PD-L1 negative or low patients achieved higher response rates with the combination than with avelumab alone.
Head and Neck Cancer. The company is preparing to initiate a new study of pepinemab in combination with an anti-PD-1 checkpoint inhibitor to treat front line head and neck cancer. The Company expects to provide further details on this study in the third quarter of 2020.
Alzheimer’s Disease. After a delay caused by the COVID-19 pandemic, the company expects to initiate enrollment in a clinical trial of pepinemab in Alzheimer’s disease in September 2020.
Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications including "window of opportunity" studies being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.
Other Second Quarter and Recent Accomplishments:

Presented updated interim results from CLASSICAL-Lung), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting.
Delivered a virtual presentation at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD Focus Meeting 2020 highlighting the potential of pepinemab to regulate glial cell activation and neurodegeneration in Alzheimer’s and Huntington’s disease.
"We are rapidly approaching a significant milestone for our company with top-line data from our potentially pivotal SIGNAL trial in Huntington’s disease expected by early October," stated Maurice Zauderer, Ph.D., president and chief executive officer of Vaccinex. "In parallel, we are exploring pepinemab’s potential utility in other slowly progressive neuroinflammatory and neurodegenerative diseases and anticipate commencing enrollment in a Phase 1/2 Alzheimer’s disease trial in September. We are very appreciative of financial support from both the Alzheimer’s Association and from the Alzheimer’s Drug Discovery Foundation to advance this important trial," Dr. Zauderer concluded.

Upcoming Expected Milestones:

Late September/Early October 2020 – Topline data expected from potentially pivotal SIGNAL Huntington’s disease study.
September 2020 – Anticipated enrollment of first patient in Alzheimer’s disease Phase 1/2 study.
Second half 2020 – Preparation expected to commence for Phase 2 study of pepinemab in combination with anti-PD-1 in head and neck cancer.
Financial Results for the Three Months Ended June 30, 2020:

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2020 were $4.6 million, as compared to $7.3 million for the comparable period in 2019. This decrease was primarily attributable to decreases in expenses in the CLASSICAL-Lung and SIGNAL studies as patients have come off study.

General and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2020 were $1.9 million, as compared to $1.5 million for the comparable period in 2019. The increase was due to increased stock-based compensation as a result of new option awards to employees and board members, as well as increased directors and officers insurance premiums.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2020 were $0.5 million, as compared to $2.8 million on December 31, 2019. Subsequent to the end of the second quarter, the company raised total proceeds, net of discounts and commissions and before expenses, of approximately $19.8 million through four financing transactions: $6.9 million through its existing at-the-market (ATM) equity facility, $8.0 million through the sale of a senior secured convertible debenture, $4.0 million through a private placement transaction, and $300,000 through the company’s existing equity line of credit facility. The company also received $575,000 of the previously announced $750,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud Program.

On August 14, 2020 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported the successful completion of the placing announced yesterday (the "Placing") (Press release, Acacia Pharma, AUG 14, 2020, View Source [SID1234568515]).

Capitalised terms not otherwise defined in this announcement have the meanings given to them in the announcement made by the Company at 3 p.m. CEST yesterday afternoon.

Pursuant to the Placing, Placees have agreed to subscribe for 12,500,000 New Ordinary Shares at a price of EUR 2.00 per share (the "Placing Price"), which represents a 24.8% discount to the closing share price on 13 August 2020. The Placing will raise gross proceeds of approximately EUR 25,000,000. The New Ordinary Shares issued pursuant to the Placing represent 17.2% of the Company’s issued share capital prior to the Placing.

Jefferies International Limited ("Jefferies") and Guggenheim Securities, LLC ("Guggenheim Securities") are acting as Joint Global Coordinators and Joint Bookrunners and Bank Degroof Petercam SA/NV is acting as Joint Bookrunner and Listing Agent (Jefferies, Guggenheim Securities and Degroof Petercam, together the "Joint Bookrunners" or the "Banks") in connection with the Placing.

An application has been made to Euronext Brussels for admission of the New Ordinary Shares to trading on the regulated market of Euronext Brussels ("Admission"). It is expected that Admission will take place on or around 08.00 CEST on 18 August 2020 (or such later time or date as the Banks may agree with the Company) and that unconditional dealings in the New Ordinary shares issued pursuant to the Placing will commence at the same time. The Placing is conditional upon, inter alia, Admission becoming effective and the placing agreement between the Company and the Banks not being terminated in accordance with its terms.

Following Admission, the total number of ordinary shares in issue in the Company will be 85,279,729.

Mike Bolinder, CEO of Acacia Pharma, commented: "The Company has made exciting progress during 2020, with the approval of two products that we are preparing to commercialize in the US. BARHEMSYS and BYFAVO are both targeted at anesthesiologists and are designed to improve the rate at which patients recover from surgery or invasive procedures, reduce the incidence of secondary complications and hospital readmittances and improve healthcare economics through better patient throughput. These are important objectives given the many millions of patients that undergo such procedures in the US and the backlog in hospitals that has resulted from the coronavirus pandemic. This situation, which is compounded by a national shortage of existing drugs for postoperative nausea and vomiting and procedural sedation, presents a significant market opportunity for Acacia Pharma’s products.

We are delighted with the outcome of this successful fundraising, which has provided the funds to build and strengthen our US commercial team and execute the next steps of our commercialization strategy as we target the launches of both BARHEMSYS and BYFAVO later in 2020. We thank our current and new investors for their support and look forward to providing further updates over the coming months."

Acacia Pharma intends to use the net proceeds of the Placing to:

recruit an initial sales force of approximately 30, with an additional ten support staff;
pay marketing costs relating to BARHEMSYS and BYFAVO including brand development and engagement (both virtually and, where possible, in person) with key opinion leaders, healthcare professionals, and medical conference and speaker programmes;
implement post-approval research and development commitments including paediatric studies for BARHEMSYS and BYFAVO and a renal study for BARHEMSYS;
satisfy interest and capital payments under existing loan agreements; and
general corporate purposes relating to ongoing commercial activities as well as supplementing existing stock of both BARHEMSYS and BYFAVO.

In connection with the Placing, the Company has agreed, pursuant to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, directors and senior managers of the Company and Cosmo Technologies Limited have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions.

The payment and delivery of the New Ordinary Shares is expected to take place on 18 August 2020 and is conditional on the UK Financial Conduct Authority approving a prospectus in accordance with Prospectus Regulation (EU) 2017/1129 (the "Prospectus Regulation") in relation to the application for Admission. The New Ordinary Shares to be issued pursuant to the Placing will have the same rights and benefits as, and rank pari passu in all respects with, the Existing Ordinary Shares.

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On 14 August 2020, Prescient stock zoomed up by 6.667% to A$0.064 at AEST 2:12 PM after the Company reported a research collaboration with the world-class cell therapy institute Peter MacCallum Cancer Centre (Peter Mac) for developing innovative cell therapy technologies, including CAR-T technologies (Press release, Prescient Therapeutics, AUG 14, 2020, View Source;utm_medium=rss&utm_campaign=only-asx-listed-healthcare-company-developing-car-t-programs-ptx-collaborates-with-peter-maccallum-cancer-centre [SID1234565506]).

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Under the terms of this research agreement, Prescient will own the IP (intellectual property) generated from the research program being led by Professor Phil Darcy of Peter Mac.

Melbourne-based Peter MacCallum Cancer Centre is an internationally recognised research and clinical leader in developing new therapies for cancer.

This is the second addition to the Cell Therapy Enhancement (CTE) Programs of Prescient Therapeutics. Prescient is already working with Carina Biotech and University of Adelaide on other CTE approaches.

Complementing the CTE programs, Prescient is also developing next-generation CAR-T therapies with its OmniCAR platform, following it announcement in late May 2020 that Prescient obtained key licenses from the University of Pennsylvania and Oxford University.

To Know More, Do Read: Impressive! Prescient Obtains Key Licenses for Next-Generation Immunotherapy Platform

Currently, Prescient Therapeutics is conducting a Share Purchase Plan (SPP) at 5.5c which closes on 20 August 2020 at AEST 5:00 PM. Click here to request personalised SPP forms.

Cell Therapy Enhancements Programs of Prescient

CAR-T is a cellular therapy that reprograms the immune cells of a cancer patient to identify and destroy cancer.

The research program, being undertaken in Professor Darcy’s laboratory at Melbourne-based Peter Mac, is an important addition to the Cell Therapy Enhancements (CTE) programs in the pipeline of Prescient.

On the same lines as the Cell Therapy Enhancements program that is underway with Carina Biotech, this research program aims to produce technologies complementing current CAR-T approaches.

The objective of Prescient’s CTE program is to develop efficacy as well as efficiency improvements that are relevant to 3rd parties in the cell therapy field (called CAR-T), which may incorporate these into their own programs under license.

Also Read: Get Acquainted with Prescient Therapeutics’ Next Generation Immunotherapy Platform

It is noteworthy to mention that Prescient will retain its previously built intellectual property and look to extend this portfolio by collaborating with world-renowned cancer centre Peter Mac.

Prescient Therapeutics CEO Steven Yatomi-Clarke stated that PTX is the only ASX-listed healthcare company developing CAR-T programs, and this is an important strategic initiative to complement programs of the Company in Cell Therapy Enhancements.

He also added-

Bottomline

Prescient has been progressing well in its cell therapy platform by obtaining two major licenses for developing innovative universal CAR Platform and now by collaborating with world-renowned Institute ‘Peter MacCallum Cancer Centre’. These developments drive Prescient to create innovative cell therapies for treating challenging cancers having unmet medical need.

These events demonstrate that Prescient Therapeutics is on a growth track backed by strong management in the most modern arena of cancer therapy.

On August 14, 2020 Prescient Therapeutics (ASX:PTX) reported that it has formed a cancer research partnership with the world-renowned Peter MacCallum Cancer Centre, ‘Peter Mac’, a leader in new clinical treatments for cancer to develop CAR-T cell therapy technologies (Press release, Prescient Therapeutics, AUG 14, 2020, View Source;utm_medium=rss&utm_campaign=prescient-partners-with-global-cancer-heavyweight-to-develop-new-treatments [SID1234565488]).

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The research program is being led by Professor Phil Darcy, head of cancer immunotherapy at Peter Mac’s Melbourne laboratory and will seek to produce technologies that can complement existing CAR-T cancer treatment approaches.

Prescient is the only ASX company that is developing CAR-T programs and it will own the intellectual property rights stemming from the research program.

The company’s CAR-T cancer treatment reprograms the Chimeric Antigen Receptors (CAR) on the outside of T-Cells to enable them to better target and eradicate cancer cells within patients.

Prescient Therapeutics chief executive Steven Yatomi-Clarke said the company’s research partnership with Peter Mac would greatly enhance efforts to advance new cancer treatments that would benefit patients.

"We look forward to working closely with Peter Mac as we employ our knowledge of targeted therapies and growing standing in cellular therapies to generate technologies that will be relevant for the CAR-T field," Yatomi-Clarke said.

Peter Mac research will advance PTX’s treatments
The research program at Peter Mac is an important addition to the Cell Therapy Enhancements (CTE) programs in Prescient’s treatments pipeline.

Prescient develops personalised medical approaches to cancer including targeted and cellular therapies such as its OmniCar immune receptor platform, an advanced version of CAR-T cancer treatment.

The company’s CTE programs aim to create efficacy and efficiency enhancements that are relevant to third parties in the cell therapy field, namely CAR-T, which may incorporate these into their own programs under licence.

Professor Darcy said the research with Prescient aimed to reprogram the microenvironment of cancer tumours to achieve better results with the CAR-T therapy.

"CAR-T therapy has shown strong therapeutic activity in certain haematological malignancies, however, the effects in solid cancers have been poor to date," he said.

"The approach we are exploring with Prescient may reprogram the tumour microenvironment that results in significantly enhancing CAR-T cell anti-tumour activity."

Boosting the coffers by $6.5m
Prescient has launched a capital raising for $6.5m via a share purchase plan to fund the expansion of its line of cancer treatments, including clinical trials of its PTX 100 and 200 products, and OmniCAR platform.

The SPP share issue is priced at 5.5c, a 15 per cent discount to its volume-weighted average share price prior to the SPP announcement, and it closes August 17.