On July 22, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported the first publication in the peer-reviewed journal, Cancer Cell, of preclinical data from its lead asset, RBN-2397, a small molecule inhibitor of PARP7 (Press release, Ribon Therapeutics, JUL 22, 2021, View Source [SID1234585077]). The published data demonstrate that inhibition of PARP7 can activate antitumor immune responses in cancer cells through restoration of Type I interferon (IFN) signaling and cause complete regressions in preclinical models. These preclinical findings support Ribon’s development program for RBN-2397 and validate targeting of PARP7, a key vulnerability in cancer stress support pathways, as a therapeutic strategy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung (SCCL), which represents approximately 30% of all non-small cell lung cancers. PARP7 is the first monoPARP to be targeted therapeutically and RBN-2397 is the first potent and selective PARP7 inhibitor to enter clinical development.

"This publication in Cancer Cell demonstrates RBN-2397’s mechanism of action of inhibiting a key stress response pathway in cancer cells, illustrating how inhibition of PARP7 can elicit complete tumor regression in preclinical models, as well as tumor-specific adaptive immune response, through restoration of Type I IFN signaling in tumor cells," said Heike Keilhack, Ph.D., Senior Vice President of Biological Sciences, Ribon Therapeutics. "We are pleased that these data provide further evidence of the critical role PARP7 plays in cancer and antitumor immunity, independent of other PARPs, as well as a strong rationale for clinical development of RBN-2397."

Key findings of the publication are summarized below:

PARP7 is a monoPARP that acts as a brake in cytosolic nucleic acid sensing in a TBK1-dependent manner blocking Type I IFN signaling and antitumor immunity
RBN-2397 is a potent and selective inhibitor of PARP7, and drug effects in tumor models are dependent on PARP7, but not PARP1
Inhibition of PARP7 by RBN-2397 induces complete tumor regression in a lung cancer xenograft and tumor-specific adaptive immune memory in an immunocompetent mouse cancer model by restoration of Type I IFN signaling
"These findings illustrate the foundational science behind RBN-2397 and our preclinical programs, which we have identified by combining our deep understanding of the critical roles of NAD+-utilizing enzymes in cancer and inflammatory diseases, with our team’s drug development expertise, to bring novel treatments to patients with limited options," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We look forward to providing updates on our clinical studies with RBN-2397 and the rest of our pipeline leveraging our BEACON+ platform."

Ribon recently completed the dose-escalation portion of its Phase 1 trial evaluating RBN-2397 as a monotherapy in patients with advanced solid tumors. In June 2021, data from this portion of the study, presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, showed RBN-2397 was well tolerated with evidence of PARP7 inhibition and preliminary signs of antitumor activity.

The expansion portion of the Phase 1 trial is currently enrolling patients in a number of defined cohorts, including SCCL. Ribon plans to initiate a Phase 1b/2 study with checkpoint inhibitors in SCCL in the second half of 2021.

A link to the publication can be found here: View Source

About RBN-2397

RBN-2397 is an orally available small molecule inhibitor of PARP7 that Ribon Therapeutics is developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors (NCT04053673). PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.

On July 22, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported plans to report second quarter financial results on Monday, August 9, 2021, before market open (Press release, Rubius Therapeutics, JUL 22, 2021, View Source [SID1234585093]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company will not be hosting a teleconference in conjunction with its financial results press release.

On July 22, 2021 Plexxikon, a member of the Daiichi Sankyo Group and a leader in structure-guided discovery and development of novel small molecule pharmaceuticals, reported that it has won its patent infringement lawsuit against Novartis (Press release, Plexxikon, JUL 22, 2021, View Source [SID1234585110]). In a jury trial at the U.S. District Court for the Northern District of California, Novartis conceded infringement and sought to invalidate Plexxikon’s patents covering Tafinlar on the grounds of anticipation, written description and enablement. The jury rejected Novartis’s arguments, upheld the validity of Plexxikon’s patents, and found Novartis’s infringement was willful. Plexxikon was awarded damages of $178 million for past infringement of its patents and will receive additional royalty payments for future sales of Tafinlar in the United States through the life of the patents.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted with the jury’s verdict which validates Plexxikon’s pioneering role in the field of BRAF inhibitors and enables proper credit for our proprietary discovery efforts," said Chao Zhang, PhD, chief executive officer. "Genus patents — like those in the lawsuit — are routinely used to prevent competitors from knocking off our scientific innovations with slight molecular changes. We are gratified that the jury upheld their validity, protecting our investment so that we can continue discovering and developing innovative new drugs for patients in need."

Tafinlar was developed by GSK and acquired by Novartis for $2.4B. Tafinlar is a BRAF inhibitor that is approved for the treatment of metastatic melanoma, adjuvant melanoma, non-small cell lung cancer and anaplastic thyroid cancer. Tafinlar also competes with Zelboraf, another BRAF inhibitor that was discovered by Plexxikon and licensed to Roche.

In the suit, Plexxikon alleged that Novartis owed the company substantial royalties on its drug Tafinlar, which infringes two Plexxikon patents (U.S. Patent Nos. 9,469,640; and 9,844,539).

On July 22, 2021 Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported the pricing of its upsized initial public offering of 19,000,000 shares of common stock at a public offering price of $16.00 per share (Press release, Caribou Biosciences, JUL 22, 2021, View Source [SID1234585132]). All of the shares of common stock are being offered by Caribou. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Caribou, are expected to be $304.0 million. In addition, Caribou has granted the underwriters a 30-day option to purchase up to an additional 2,850,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The shares are expected to begin trading on the Nasdaq Global Select Market on July 23, 2021, under the ticker symbol "CRBU." The offering is expected to close on or about July 27, 2021, subject to the satisfaction of customary closing conditions.

BofA Securities, Citigroup, and SVB Leerink are acting as joint book-running managers for this offering.

A registration statement relating to the offering has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on July 22, 2021. The 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: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. Copies of the final prospectus, when available, related to the offering will also be accessible through the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the 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 contains statements that constitute "forward-looking statements" and include, without limitation, statements regarding Caribou’s expectations with respect to the commencement of trading of its shares on the Nasdaq Global Select Market and the size, completion and timing of the closing of the initial public offering. No assurance can be given that the offering discussed above will be completed on the terms or timing described in this release, or at all. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and preliminary prospectus filed with the SEC. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

On July 22, 2021 ANOCCA AB reported that it WILL USE A just completed $47m Series B financing to advance its industrialised cellular biology platform and pipeline of TCR-T cellular therapies into Phase I/IIa oncology clinical trials, its CEO tells Scrip (Press release, Anocca, JUL 22, 2021, View Source [SID1234591029]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Developing next-generation T-cell immunotherapies using proprietary technology and in-house manufacturing is how privately owned Anocca AB will use a $47m Series B financing that brought the Swedish biotech’s cash mound to more than $100m, its CEO and co-founder Reagan Jarvis told Scrip.

Since its founding eight years ago, Anocca has generated a preclinical pipeline of engineered T-cell receptor therapies for use against multiple antigen classes, including targets that are shared amongst tumours, against specific genetic mutations that drive cancer, and against viruses that cause cancer.

Like CAR-T cell therapy, engineered T-cell receptor (TCR) therapy involves treating cancer with activated T lymphocytes from the body. Both strategies attach new receptors to the cells’ surfaces, enabling them to attack different forms of cancer.

"Our TCR assets pipelines address a range of HLA restrictions, expanding the reach of TCR-modified T-cell therapies to many more patients. Anocca is also deploying our technology to systematically isolate TCRs for neoantigens identified from tumours on an entirely individualised basis," Jarvis said in an interview.

The series B financing was completed 22 July and netted SEK400m. It will be used to advance the company’s industrialised cellular biology platform and progress its pipeline of TCR-T cellular therapies into Phase I/IIa oncology clinical trials by the end of 2022. Anocca is based in Södertälje, Sweden.

"These will be relatively modest sized trials, as they usually are for cell therapies. But we’ll be aiming to bring in multiple assets into that design. Whether that’s on a single protocol and multiple protocols, that doesn’t really matter as that’s just different paperwork. The point is that you can match patients to assets, based on target expressions," Jarvis said.

The biotech’s technology platform is composed of various proprietary cell biology and molecular genetics technologies that enables the scalable high-precision analysis needed to develop highly targeted therapeutics that leverage T-cell immunity. The platform is underpinned by proprietary, fully integrated, information management and bioinformatic software tools developed in-house.

"This series B takes us to well over $100m raised since our founding in 2014 and represents a further strong endorsement of our approach to industrialised high-precision analysis of T-cell biology, which can be applied to any therapy area and which can reach an unprecedented number of intracellular and extracellular druggable targets in liquid and solid tumours, as well as other therapeutic areas, such as infectious diseases and autoimmune disorders," Jarvis said.

The financing was led by advisor Danske Bank and included new investors such as Swedbank Robur Ny Teknik, Ramsbury Invest, as well as existing investors Mellby Gård, Nidoco and Anocca co-founder Mikael Blomqvist.