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]).

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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."

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.

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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.

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]).

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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.

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.

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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.

On December 19, 2023 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, reported dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, DEC 19, 2023, View Source [SID1234638706]).

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During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials. Subsequently, all future trial participants will be treated with THIO 180mg/cycle.

"All THIO dose levels tested exceeded the disease control rate (DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, beating our goal of disease control in 8 out of 19 patients per arm. Among the three studied doses, the 180mg dose showed stronger DCR and preliminary response rates compared to other doses," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

"These results are particularly impressive in this pool of patients who were heavily pre-treated and resistant to prior treatments with immune checkpoint inhibitors, a group that does not yet have standard of care treatment. We are highly encouraged by the unprecedented clinical data generated thus far in our Phase 2 trial, and as we move forward, we plan to pursue accelerated approval for THIO in the U.S. for the treatment of patients with advanced NSCLC. We believe THIO’s DCRs and ORRs in second line treatment suggest the drug’s potential to define the standard of care for this NSCLC patient population."

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.