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Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories

On December 20, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel or EBVALLOTM) (Press release, Atara Biotherapeutics, DEC 20, 2023, View Source [SID1234638716]). Building on the earlier partnership announced in October 2021 to commercialize tab-cel in Europe, this transaction provides Pierre Fabre Laboratories with the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets.

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"We are pleased to announce the closing of the transaction with Pierre Fabre Laboratories who are committed to expanding the reach of tab-cel to patients in the U.S. and across the globe," said Pascal Touchon, President and Chief Executive Officer of Atara. "Atara’s priority is to now submit the tab-cel BLA filing package, while initiating our first clinical study with ATA3219, a potential best-in-class allogeneic off-the-shelf CD19 CAR T with unique features."

With the closing of the transaction, Atara will receive approximately USD 27 million in cash upfront and initial inventory purchase. Under the agreement, Atara has the potential to receive up to a total of USD 640 million and significant double-digit tiered royalties on net sales, including up to USD 100 million in potential regulatory milestones through BLA approval. In addition, Pierre Fabre Laboratories will reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer, and purchase future tab-cel inventory through the manufacturing transfer date.

Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.

Atara plans to submit the BLA to the U.S. Food and Drug Administration (FDA) for tab-cel for the treatment of post-transplant lymphoproliferative disease (PTLD) in the second quarter of 2024.

Alpha Tau to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On December 20, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that Chairman and CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024, at 10:30 am PT / 1:30 pm ET, in San Francisco, CA, and will host institutional investor meetings at the event (Press release, Alpha Tau Medical, DEC 20, 2023, View Source [SID1234638715]).

A live webcast of the presentation will be available via a link located on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source The replay of the webcast will be archived on the Company’s website for 30 days following the conference.

In addition, the Company also announced plans to present on Monday, January 8, 2024 at 11:30am PT at the Biotech Showcase occurring in parallel with the Healthcare Conference in San Francisco, and will host institutional investor meetings at the event.

42nd Annual J.P. Morgan Healthcare Conference:

Presentation Date/Time: Thursday, January 11, 2024, at 10:30 am PT / 1:30 pm ET
Location: Westin St. Francis San Francisco; California East room
Webcast: Link located on the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source

Biotech Showcase:

Presentation Date/Time: Monday, January 8, 2024 at 11:30am PT
Location: Hilton San Francisco Union Square in San Francisco; Yosemite A (Ballroom Level)
To schedule a meeting, investors can register on the Biotech Showcase: https://informaconnect.com/biotech-showcase/registration-options/.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Atavistik Bio Raises Additional $40 Million to Advance Precision Allosteric Small Molecule Therapeutics

On December 19, 2023 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, reported that it has raised an additional $40 million to advance its lead precision allosteric small molecule therapeutic in oncology into the clinic and to advance its earlier stage pipeline (Press release, Atavistik Bio, DEC 19, 2023, View Source [SID1234647393]). The financing included existing investors, including The Column Group, Lux Capital, and Nextech Invest, Ltd. Atavistik Bio has raised $100 million in aggregate since its launch in August 2021.

"We’ve made tremendous progress identifying functional pockets of validated targets and have accelerated the development of precision allosteric therapeutics. Key to our success has been our outstanding team with the know-how and proven track record of discovering and developing transformative medicines," said Bryan Stuart, Chief Executive Officer at Atavistik Bio. "We’re grateful to our investors for their continued support of our mission. We look forward to using the proceeds from this raise to advance our lead program into the clinic and progress our additional programs and platform."

"Allostery continues to gain traction given its potential to modulate intractable targets and to offer better tolerated, more effective therapies for current sub-optimally treated diseases," said John Josey, Ph.D., Venture Partner at The Column Group and Atavistik Bio’s Board Chair. "In a short period of time, Atavistik Bio has quickly identified novel allosteric binding pockets in a broad range of targets and built a deep discovery pipeline. We believe that Atavistik Bio’s differentiated approach to identify chemical matter against challenging and valuable targets presents a compelling opportunity to bring important new, allosteric medicines to patients across a broad spectrum of disease areas."

Atavistik Bio seamlessly integrates its proprietary Atavistik Metabolite-Protein Screening (AMPS) technology with its AI-enabled discovery engine to rapidly advance programs from discovery into development. AMPS efficiently uncovers cryptic functional pockets not detectable with other techniques. It accomplishes this by leveraging metabolites, which are natural regulators of protein and RNA function in the body, as ‘bait’ to reveal otherwise hidden allosteric binding pockets on target proteins and functional sites on RNA. Atavistik Bio then applies its state-of-the-art, proprietary AI-enabled drug discovery engine to discover and design small molecules, enabling the rapid advancement of allosteric precision therapeutics.

Employing this integrated approach, Atavistik Bio has successfully and rapidly identified functional binding pockets for the development of small molecule therapeutics across a broad range of target classes, including kinases, enzymes, receptors, transcription factors, as well as protein complexes and RNA, and translated these insights into a robust discovery pipeline. The company’s internal efforts are focused on oncology and rare diseases. It intends to leverage partnerships to extend the reach of its platform to other therapeutic areas, including metabolic and cardiovascular disease, inflammation and immunology disorders, and neurodegenerative diseases.

Cellectar Biosciences Expands Iopofosine I 131 Collaboration with Wisconsin Alumni Research Foundation

On December 19, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported a new licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison (UW) with iopofosine I 131 in pediatric cancers (Press release, Cellectar Biosciences, DEC 19, 2023, View Source [SID1234638719]).

Under the terms of the agreement, Cellectar has an exclusive license to develop and commercialize iopofosine in various pediatric solid cancers, such as high-grade glioma, neuroblastoma and sarcoma.

"This licensing agreement further strengthens our iopofosine I 131 patent portfolio and our industry-leading position in radiopharmaceutical patent grants and applications. It also expands our long-standing relationship with the University of Wisconsin. WARF, the intellectual property management arm of the UW, is highly respected for its history of successfully protecting intellectual property associated with its license agreements." said James Caruso, president and CEO of Cellectar. "Based on the encouraging performance of iopofosine in our pediatric Phase 1a study, we were awarded a $2 million NCI grant to further evaluate the activity of iopofosine in pediatric high-grade gliomas with anticipation of first patient enrollment in the near term."

bluebird bio, Inc. Announces Pricing of $125 Million Public Offering of Common Stock

On December 19, 2023 bluebird bio, Inc. (Nasdaq: BLUE) ("bluebird") reported the pricing of its underwritten public offering of 83,333,333 shares of its common stock at a public offering price of $1.50 per share, before deducting underwriting discounts and commissions (Press release, bluebird bio, DEC 19, 2023, View Source [SID1234638717]). bluebird also granted the underwriters a 30-day option to purchase up to an additional 12,499,999 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds from the public offering are expected be $125 million, before deducting underwriting discounts and commissions and offering expenses payable by bluebird and assuming no exercise of the underwriters’ option to purchase additional shares of common stock. All shares in the offering are to be sold by bluebird.

Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC are acting as joint book running managers for the offering. Raymond James & Associates, Inc. is acting as co-manager for the offering.

bluebird intends to use the net proceeds of the offering (i) to support commercialization and manufacturing for its three approved gene therapies, ZYNTEGLO, SKYSONA and LYFGENIA; and (ii) to fund working capital and other general corporate purposes.

The offering is expected to close on or about December 22, 2023, subject to customary closing conditions.

The offering is being made pursuant to an effective shelf registration statement on Form S-3, including a prospectus, that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 9, 2023 and was declared effective by the SEC on May 19, 2023. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC. A final prospectus supplement will be filed with the SEC and will form a part of the effective registration statement. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected].

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 sale of these securities in any state or other 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.