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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.

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"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.

Owkin enters collaboration agreement with MSD to develop AI-powered diagnostics for cancer

On December 19, 2023 Owkin, a French-American biotechnology company that applies artificial intelligence (AI) to drug discovery, development, and diagnostics, reported that it has entered into a collaboration agreement with MSD, the trade name of Merck & Co Inc., Rahway NJ USA to develop and commercialize AI-powered digital pathology diagnostics for the EU market (Press release, Owkin, DEC 19, 2023, View Source [SID1234638708]).

Clinical trials have shown that the MSI-H tumor phenotype has potential prognostic and therapeutic importance, especially with the increased application of immune checkpoint inhibitor (ICI) therapies.1,2,3,4 As such, MSI-H has become an important genomic biomarker with applications across several types of cancer. As a result, testing for MSI-H is now recommended by consensus guidelines internationally.5,6,7,8

Meriem Sefta, Chief Diagnostics Officer, said, "This strategic alliance with MSD is focused on improving the way patients are diagnosed and receive treatment, advancing our shared mission of supporting healthcare providers in their adoption of innovative digital diagnostics. It is clear that there is a need for AI diagnostics that can both ease bottlenecks and resource pressures while also ramping up biomarker testing to match patients with optimal treatments."

This collaboration seeks to develop a pre-screening procedure to improve testing rates for MSI-H in endometrial, gastric, small intestinal, and biliary cancers. In these cancer types, MSI-H prevalence is low and MSI-H screening is not routinely performed. The collaboration will initially be focused in the European Union.

"The application of AI technologies holds tremendous potential in the screening of patients and the diagnosis of disease," said Scott K. Pruitt, associate vice president and head, Translational Oncology, MSD Research Laboratories. "We look forward to working with the Owkin team toward harnessing this opportunity to identify more patients with MSI-H cancers who may benefit from ICI therapy."

Owkin, which currently has the only MSI digital pathology diagnostic CE-marked in colorectal cancer, will extend the development of its MSI-H AI diagnostics into four new cancer types, leveraging multimodal patient data from multiple academic centers and hospitals.

Innate Pharma Announces Licensing of a Fourth Natural Killer Cell Engager in Oncology to Sanofi

On December 19, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) and Sanofi (NASDAQ: SNY) reported that Sanofi has exercised its option to license a natural killer (NK) cell engager program in solid tumors from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform pursuant to the terms of the research collaboration and license agreement signed in December 2022 (Press release, Innate Pharma, DEC 19, 2023, View Source [SID1234638707]). Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization. Sanofi still retains the option to one additional ANKET target as per the license agreement.

Eric Vivier, Ph.D., DVM, PhD, Senior Vice President, Chief Scientific Officer of Innate Pharma, said: "We have been collaborating with Sanofi since 2016 and together we have made significant progress in advancing multi-specific NK Cell Engagers for the treatment of various cancers with two programs now in the clinic. Building on our partnership with Sanofi, the exercise of this option is another important milestone as we continue to grow our ANKET platform."

Under the terms of the December 2022 agreement, Innate will receive a €15m payment for the exercise of this option. Innate Pharma is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.

Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi, states: "Sanofi is pleased with our collaboration with Innate and continues to be excited at the potential of investigational NK Cell Engagers. The emerging results we have seen show promise at the possibility of offering options to patients who have limited treatments available to them."

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About the Innate-Sanofi research collaboration and license agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, IPH6101/SAR’579 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and IPH6401/SAR’514 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 (B7-H3) and one undisclosed ANKET programs and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.