On November 30, 2021 MANA Therapeutics, a clinical-stage company creating nonengineered, off-the-shelf allogeneic cell therapies that target multiple cancer antigens, reported the final closing of its Series A financing, bringing the total raised to $42 million (Press release, MANA Therapeutics, NOV 30, 2021, View Source [SID1234596284]). In addition, MANA closed a $7.5 million venture debt facility with Silicon Valley Bank with an initial tranche of $5 million available immediately.

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"This additional funding will enable us to accelerate the start of our clinical studies for our novel approach to off-the-shelf allogeneic cell therapy for patients with transplant-ineligible AML and select solid tumors," said Martin Silverstein, M.D., President and CEO of MANA Therapeutics. "It will also permit building out our pipeline of MANA-512 candidates, which will apply new sets of antigens to the EDIFY platform.

"In the meantime, MANA-312, an allogeneic donor-derived cell therapy candidate, has progressed steadily through the Phase 1 clinical trial that we initiated earlier this year. This is encouraging progress and the data we are collecting will inform the development of our off-the-shelf programs, including MANA-412, which is expected to advance into clinical trials in 2022," continued Dr. Silverstein.

"Next-generation cell therapies continue to be one of the most promising approaches in immuno-oncology, but face meaningful obstacles to be safely and economically available in an allogeneic format. MANA is utilizing its proprietary ManaMatch HLA matching protocol to build a bank of readily accessible nonengineered off-the-shelf therapies that could treat the majority of patients in targeted cancer indications and allow for repeat dosing," said Marc Cohen, Co-founder of Cobro Ventures and Co-founder and Executive Chairman of MANA Therapeutics.

The additional Series A funding comes from new investors J&W Partners, a South Korean private equity firm, and SK Securities, a leading securities firm in South Korea. As part of the agreement, J&W Partners will gain a seat on MANA’s Board of Directors.

About EDIFY

MANA Therapeutics’ EDIFY platform constitutes the next-generation cell therapy approach by leveraging natural immune system pathways to educate T-cells to target unique sets of antigens expressed by tumors, without the need for genetic modification. The EDIFY platform uses dendritic cells as antigen presenting cells. The dendritic cells are loaded with ManaMix antigens and stimulate and expand T-cells to generate product candidates. Product candidates developed from the EDIFY platform are designed to increase efficacy through multiple antigen targeting and to support a strong safety profile by utilizing a nonengineered approach that could permit for repeat dosing of patients. The EDIFY platform uses a simplified, high-yield manufacturing process.

On November 30, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported the pricing of its previously announced initial public offering (STAR Offering) on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE) (Press release, BeiGene, NOV 30, 2021, View Source [SID1234596282]). The total number of shares being offered in the STAR Offering is 115,055,260 ordinary shares, par value $0.0001 per share, which represents 8.62% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered. The shares offered in the STAR Offering will be issued to and subscribed for by permitted investors in the People’s Republic of China (PRC) and listed and traded on the STAR Market in Renminbi (RMB Shares).

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The public offering price of the RMB Shares is RMB192.60 per ordinary share, which equates to HK$234.89 per ordinary share and US$391.68 per American Depositary Share (ADS), based on an assumed exchange rate of RMB0.81996 to HK$1.00 and RMB6.3924 to US$1.00. Each ADS represents 13 ordinary shares.

The gross proceeds to BeiGene from the STAR Offering, before deducting underwriting commissions and other estimated offering expenses, are expected to be approximately RMB22.2 billion, or approximately US$3.5 billion, based on an assumed exchange rate of RMB6.3924 to US$1.00.

Subject to customary closing conditions, BeiGene expects to deliver the RMB Shares against payment on or about December 9, 2021 and the RMB Shares are expected to begin trading on the STAR Market on or about December 15, 2021 under the stock code "688235."

China International Capital Corporation Limited and Goldman Sachs Gao Hua Securities Co. Ltd. are acting as joint sponsors and joint bookrunners for the STAR Offering. J.P. Morgan Securities (China) Company Limited, CITIC Securities Co., Ltd. and Guotai Junan Securities Co., Ltd. are acting as joint bookrunners for the STAR Offering.

BeiGene has granted China International Capital Corporation Limited a 30-day overallotment option for up to 17,258,000 additional RMB Shares. If the over-allotment option is fully exercised, the total number of shares being offered in the STAR Offering will be 132,313,260 Shares, which represents 9.79% of BeiGene’s total outstanding ordinary shares as of October 31, 2021, after giving effect to the shares being offered.

BeiGene expects to use the net proceeds from the STAR Offering to fund its research and clinical development, construction of its research and development centers and a manufacturing plant in China, sales and marketing force expansion in China, and for working capital and general corporate purposes.

In accordance with applicable PRC laws and regulations, the STAR Offering is being conducted solely within the PRC and only to permitted investors who are eligible to participate in the STAR Offering in accordance with applicable PRC securities laws and regulations, and rules promulgated by the SSE and the China Securities Regulatory Commission (CSRC). The STAR Offering is being conducted pursuant to a prospectus and other offering materials prepared by BeiGene in Chinese language and as approved by and registered with the SSE and the CSRC, which are only permitted to be used within the PRC. No part of the STAR Offering is intended to involve a public offering or sale of the RMB Shares into or in the United States or any other jurisdiction outside of the PRC. In addition, although the RMB Shares are of the same class and have the same rights as the Company’s existing ordinary shares listed on the Hong Kong Stock Exchange (HKEx), the RMB Shares will not be fungible with the ordinary shares listed on the HKEx or the Company’s ADSs representing its ordinary shares listed on the NASDAQ Global Select Market (NASDAQ), and in no event will any RMB Shares be able to be converted into ordinary shares listed on the HKEx or ADSs listed on NASDAQ, or vice versa.

An automatically effective shelf registration statement on Form S-3 was filed with the Securities and Exchange Commission (SEC) on May 11, 2020. A preliminary prospectus supplement relating to and describing the key terms of the STAR Offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. The final terms of the STAR Offering will be disclosed in a final prospectus supplement to be filed with the SEC. The purpose of the prospectus supplement is to register all RMB Shares offered in the STAR Offering under the Securities Act of 1933, as amended (Securities Act) to ensure that the offer and sale of the RMB Shares, if any, to permitted investors who are U.S. persons (as defined in Regulation S under the Securities Act) in transactions outside the United States will not violate the registration requirements under Section 5 of the Securities Act.

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 offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. This press release is being issued pursuant to, and in accordance with, Rule 134 under the Securities Act.

On November 30, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated at its first Canadian site, Sunnybrook Health Sciences Centre in Toronto (Press release, Kintara Therapeutics, NOV 30, 2021, View Source [SID1234596281]).

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The Kintara treatment arm is also currently actively recruiting at 30 U.S. sites as of November 24, 2021.

The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara’s arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

"The Kintara treatment arm joined the GBM AGILE study in January of this year, and is already active at 31 sites in the US and Canada," stated Timothy Cloughesy, M.D., Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles and Principal Investigator for the GBM AGILE study. "This international clinical site, which we expect to be the first of many international sites, demonstrates the ability of GCAR’s GBM AGILE platform trial to materially accelerate the clinical development timelines for the company."

"The entire Kintara team remains excited by the pace at which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara’s Chief Executive Officer. "With 31 sites already active, including our first international site, we are delighted to witness GCAR’s exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

On November 30, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the commencement of a pivotal study to determine if the treatment PharmaCyte uses for locally advanced, inoperable pancreatic cancer—Cell-in-a-Box (CypCaps) combined with the cancer killing prodrug ifosfamide—can also delay the rate of production and accumulation of malignant ascites (Press release, PharmaCyte Biotech, NOV 30, 2021, View Source [SID1234596280]). This is fluid that accumulates in the abdominal cavity from various cancers.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are enthusiastic to relaunch our malignant ascites program and resume our work on developing a treatment for malignant ascites. We plan to conduct another preclinical study in Germany with Heidelberg Pharma that mimics an earlier study which showed the production of malignant ascites can be delayed by our cancer treatment. The cancer cells we will be using in the study have been ordered, and the design of the protocol is underway.

"The Chairman of our Medical and Scientific Advisory Board, Dr. Matthias Löhr, is overseeing the study. We will be using the same animal study model that Dr. Löhr used in the earlier study that showed promise."

Malignant ascites is fluid secreted by abdominal tumors which includes liver, breast, colon, stomach, intestine, ovarian and uterine cancers. This fluid contains cancer cells that can seed and form new tumors throughout the abdomen. Malignant ascites accumulates in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain. It must be removed on a periodic basis, which is painful and costly.

Currently, there is no available therapy that prevents or delays the production and accumulation of malignant ascites. PharmaCyte plans to change the treatment landscape for malignant ascites fluid using its treatment.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On November 30, 2021 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported promising interim efficacy, safety, and biomarker data on patients from ACTIVATE, a Phase 1b/2 study of its anti-TIGIT antibody, etigilimab, in combination with nivolumab in select recurrent advanced / metastatic solid tumors (Press release, Mereo BioPharma, NOV 30, 2021, View Source [SID1234596277]).

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"These early results from the ACTIVATE study are highly encouraging and support the further study of etigilimab in combination with an anti-PD-1 antibody in solid tumor types, especially in gynecologic malignancies," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "We are particularly excited by the complete response in the cervical cancer cohort and the partial response in one of the ovarian cancer patients treated to-date. In the efficacy analysis set, biomarker analysis showed a positive trend between baseline PVR expression and clinical benefit including in the absence of PD-L1 expression in the efficacy analysis population. Clinical benefit also occurred in tumor types with historically low response rates to anti-PD-1/PDL-1 antibodies. We look forward to providing additional updates on the study in 2022."

The ACTIVATE study aims to enroll approximately 125 patients across seven parallel cohorts. At the time of the data cut-off, 22 patients were included in the safety analysis set, 20 patients were evaluable with a minimum of at least one scan (as of November 8, 2021) and 15 patients were included in the efficacy analysis population.

As of the cut-off date, there are one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical cancer, and uveal melanoma. The ovarian cohort in ACTIVATE has now crossed futility for expansion into the second stage of the study (IDMC review pending). These results add to the earlier Phase 1b data of etigilimab in combination with nivolumab, with a partial response in the single ovarian cancer patient of the 8 patients evaluable and support the continued development of this dual checkpoint combination regimen.

The combination of etigilimab and nivolumab has been safe and well tolerated, with no new safety signals. The most common treatment-related adverse events were skin reactions, observed in seven patients. None of these reactions required treatment with systemic steroids. There was one case of immune diabetes mellitus.

Conference Call and Webcast

Mereo BioPharma will hold a conference call today, November 30, 2021, at 8:30am ET. To participate by telephone, please dial (866) 688-2942 (Domestic) or (561) 569-9224 (International). The conference ID number is 6585106. To view the slideshow please use the live webcast which can be accessed through the Investors section of the Company’s website at www.Mereobiopharma.com/investors. An archived replay of the webcast will be available on the Company’s website for two weeks following the live presentation.