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Positive Early Preclinical Ovarian Cancer Results

On February 23, 2021 Race Oncology Limited (ASX: RAC) reported to share further interim results of our continuing collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, FEB 23, 2021, View Source [SID1234576448]). Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute is leading the project .

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The aim of this recent preclinical research program is to explore Bisantrene efficacy in ovarian cancer. Bisantrene was the subject of two-Phase II clinical trials in the USA in advanced ovarian cancer patients in the 1980s. These trials showed that Bisantrene was able to induce a clinical response in heavily pre-treated ovarian cancer patients, including those resistant to doxorubicin and other standard of care drugs of the period.

Early results show Bisantrene to be an effective chemotherapeutic agent in patient- derived ovarian cancer cell lines. Bisantrene was able to kill these cancer cells that were resistant to the current standard of care ovarian drugs, cisplatin, 5-fluorouracil and chlorambucil.

Race’s CSO Dr Daniel Tillett commented "These initial results from Nikki’s team further highlight Bisantrene’s potential use in ovarian cancer patients as a safer alternative to the commonly used anthracyclines which can be very dangerous to the hearts of patients. It is highly encouraging that bisantrene is able to kill ovarian cancer cells resistant to currently used treatments and these findings support further exploration of the use of Bisantrene in ovarian cancer patients."

Race’s CEO Mr Phillip Lynch added, "We continue to generate results reconfirming the historical positives for Bisantrene, in this case in ovarian cancer, the 5th most common form of cancer in women. Race Oncology has a broad range of opportunities, ovarian cancer included. This program is further evidence of Race delivering against the Three Pillar strategy, taking counsel, and completing feasibility assessments with a view to mapping promising yet attainable clinical paths for Bisantrene."

Caribou and AbbVie Initiate Development Partnership for CAR T-Cell Products

On February 23, 2021 AbbVie and Caribou Biosciences, Inc reported that the companies have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR) T-cell therapeutics (Press release, Caribou Biosciences, FEB 23, 2021, View Source [SID1234575782]).

The terms of the multi-year agreement will allow AbbVie to utilize Caribou’s next-generation Cas12a clusters of regularly interspaced short palindromic repeats (CRISPR) hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to research and develop 2 new CAR T-cell therapies. AbbVie will be given exclusive rights to Cas12a for the targets of their choosing. Caribou will perform certain pre-clinical research, development, and manufacturing activities for the collaboration programs, while AbbVie will handle development, commercialization, and other manufacturing efforts.1,2

A $40 million upfront cash payment and equity investment will be directed to Caribou, as well as up to $300 million in future development, regulatory, and launch milestones. Additionally, there will be the potential for Caribou to receive additional payments for commercial milestones and global tiered royalties. AbbVie has the option to expand the collaboration to include an additional 2 CAR T -cell therapies for a fee.1

"Caribou’s next-generation CRISPR genome editing technologies hold broad promise for new therapy development," Rachel Haurwitz, PhD, president and CEO of Caribou said in an interview with OncLive. "A partnership with AbbVie allows Caribou to increase the number of targets and diseases addressable by these technologies. It’s an important opportunity to expand upon what we hope to do for patients. The collaboration is also an important validation of Caribou’s differentiated next-generation CRISPR genome editing technologies."

CRISPR gene editing technology utilizes modular, biological tools to induce DNA changes in living cells. The 2 basic components of CRISPR systems are the nuclease proteins and the RNA molecules. The nuclease proteins cut DNA while the RNA molecules guide the nuclease to generate a site-specific, double-stranded break, which result in editing at the targeted genomic site. CRISPR systems are differentiated by the presence of a class 1 multiprotein effector complex or a class 2 single effector protein.2,3

CRISPR systems have been shown to achieve several different types of genetic modifications in different types of cells. CRISPR techniques have achieved recombination, engineered immunity, mutagenesis, and donor-mediated gene disruption in bacteria, yeast, and filamentous fungi cells. The technique has also been used to achieve RNA-guided gene editing in multiple human cell lines with high specify and efficiencies of up to approximately 50%.3,4

CRISPR systems can sometimes unintentionally edit certain genomic sites, leading to harmful effects on cellular function. Caribou’s chRDNAs are highly specific RNA-DNA hybrid guides that are used in combination with CRISPR to direct more precise genome editing.2

"Caribou utilizes CRISPR hybrid RNA-DNA guides that contain both DNA and RNA nucleotides," Haurwitz explained. "These hybrid guides drive much more specific genome editing than all RNA guides. Caribou uses chRDNA guides in concert with a CRISPR enzyme to develop complex immune cell therapies."

By using CRISPR technology to engineer CAR T-cells to withstand host immune attack, Caribou hopes to develop "off-the-shelf" cellular therapies aimed at benefitting a broad patient population. The company is currently focusing on genome-edited off-the-shelf allogenic CAR T-cell and natural killer cell therapies for the treatment of patients with intractable malignancies.5

Current programs in the discovery phase include CB-011 and CB-012 which use T cells to target BCMA and CD371 for patients with hematologic malignancies, respectively. Another product, CB-020, focuses on using natural killer cells therapies for an undisclosed target for patients with solid tumors. The CB-010 program, currently in phase 1 exploration, uses T cells to target CD19 and for patients with relapsed/refractory B-cell non-Hodgkin lymphoma.5

"I am excited about the opportunity for our companies to collaboratively develop 2 additional CAR T- [cell products], expanding upon the total number of therapies Caribou’s technologies underpin," Haurwitz concluded.

XOMA to Present at Upcoming Investor Conferences

On February 23, 2021 XOMA Corporation (NASDAQ: XOMA) reported its Chief Executive Officer, Jim Neal, will present at the following upcoming investor conferences (Press release, Xoma, FEB 23, 2021, View Source [SID1234575745]):

The Cowen 41st Annual Virtual Health Care Conference. Mr. Neal will be featured in a panel session entitled, "Blazing New Paths in Clinical Development and Structure" on Tuesday, March 2, 2021 at 2:10 PM ET. The session will be available via live webcast to conference attendees.
H.C. Wainwright Global Life Science s Conference. The presentation will be available on demand beginning March 9, 2021 at 7:00 AM ET and can be accessed at http://bit.ly/3k8O9yj. The presentation can also be accessed by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

Biofrontera AG Announces Pricing of US$8.9 Million Firm Commitment Public Offering of American Depositary Shares

On February 23, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) ("Biofrontera" or the "Company"), an international biopharmaceutical company, reported the pricing of a U.S. underwritten public offering of 1,334,002 American Depositary Shares, or ADSs, at an offering price of $6.68 per ADS (Press release, Biofrontera, FEB 23, 2021, View Source [SID1234575548]). Each ADS represents two of Biofrontera’s ordinary shares, nominal value €1.00 per share.

The Company expects to receive aggregate gross proceeds of approximately $8.9 million from this offering, before deducting underwriting discounts, commissions and other related expenses. The offering is expected to close on or about February 26, 2021, subject to completion of the capital increase, which has to be recorded in the commercial register of the Company.

This offer is part of a concurrent preemptive rights offering by Biofrontera of its ordinary shares pursuant to German law to its existing holders of ordinary shares, under which Biofrontera offers a total of 8,969,870 ordinary shares at an offering price of €2.75 per share (or approximately $3.34 per share, representing the same per share price as the one used in the ADS offering).

Proceeds from these offerings will be used to conduct clinical studies aimed at improving the market positioning of Biofrontera’s lead product Ameluz, in particular to seek FDA or other applicable regulatory approval for the extension of the indications in the United States to basal cell carcinoma, acne and actinic keratoses on body areas other than the face and scalp, as well as to complete the development of a larger BF-RhodoLED lamp, invest in the procurement of the necessary materials for it and to seek any FDA or other regulatory approvals required to launch the new lamp, and for general corporate purposes.

The Benchmark Company, LLC is acting as the managing underwriter with Lake Street Capital Markets acting as co-manager and as the "qualified independent underwriter" in connection with this offering.

A registration statement on Form F-3 relating to this U.S. offering has been filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). The U.S. offering of these securities is being made only by means of a prospectus supplement, forming a part of the effective registration statement and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement relating to the U.S. offering, when available, may be obtained from Biofrontera, with an address of Hemmelrather Weg 201, D-51377, Leverkusen, Germany Telephone: +011 49 214 876 00, emailing: [email protected]. In addition, the registration statement, including the prospectus supplement, is available to the public at www.sec.gov or www.biofrontera.com. In addition, you may contact The Benchmark Company by calling 212-312-6700 or [email protected].

McGuireWoods LLP is acting as U.S. legal counsel to Biofrontera.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the securities described above, 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 their registration or qualification under the securities laws of any such state or jurisdiction.

Bio-Techne and Luminary Therapeutics sign license agreement for use of Bio-Techne’s TcBuster™ for the development of Luminary’s CAR-T cell therapies

On February 23, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported the signing of a license agreement with Luminary Therapeutics for the use of TcBuster for the manufacturing of gene-modified cell therapies (Press release, Bio-Techne, FEB 23, 2021, View Source [SID1234575503]). TcBuster is Bio-Techne’s proprietary non-viral transposon-based gene delivery system used to advance cell therapy manufacturing.

Under the terms of this agreement, Bio-Techne grants Luminary Therapeutics a non-exclusive license for TcBuster. Luminary Therapeutics will use TcBuster in their LMY-920 program, a BAFF-CAR-T product. Luminary Therapeutics plans to file an IND with the FDA later this calendar year.

"This agreement with Luminary Therapeutics brings Bio-Techne’s cutting-edge TcBuster system one step closer to delivering gene-modified cell therapies," said Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "With this license agreement, Bio-Techne will increase its presence as a key player in the cell and gene therapy market."

"The use of TcBuster during the manufacturing process provides significant benefits over the current viral approaches allowing for delivery of larger cargo with safe integration profiles," said John Hurley, Luminary Therapeutics’ COO. "We are excited to utilize GMP grade TcBuster reagents to provide our patients with a cutting-edge next generation CAR-T therapy."