On September 28, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the closing of its previously announced underwritten public offering (Press release, Onconova, SEP 28, 2021, View Source [SID1234590469]). A total of 5,000,000 shares of its common stock were sold at a public offering price of $4.20 per share. The gross proceeds of the offering to the Company are $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is also available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

On September 28, 2021 XtalPi, a leading AI drug discovery company, reported a research collaboration with Acerand Therapeutics, a biotechnology company specialized in developing best-in-class and or first-in-class drugs (Press release, Acerand Therapeutics, SEP 28, 2021, View Source [SID1234641762]). The partnership will leverage XtalPi’s highly accurate physics-based models and machine learning models to develop potential novel chemical entities for a cancer target.

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The collaboration focuses on facilitating new scaffold identification and lead optimization for a promising oncology target using highly accurate physics-based methods and machine learning models. XtalPi will provide machine learning-based high throughput screening for identification of novel scaffold and new chemical entities on a large-scale cloud computing platform. The proprietary free energy perturbation method in combination with a highly automated design-calculation workflow will be used to predict and analyze the binding affinities and inhibition mechanism during lead optimization. Acerand Therapeutics will provide highly valuable medicinal chemistry expertise and key experimental data to further refine the computational models and improve estimation accuracy.

XtalPi’s automated calculation platform built with high accuracy free energy calculations can precisely depict the interaction between ligands and their targets. The utilization of this technology increases the success rate of lead optimization and novel scaffold identification, and reduces the time required for lead optimization.

XtalPi CEO Dr. Ma Jian’s remark:

The nature of lead optimization is a long and highly complex process involving optimizing molecule physical chemical, ADME, and PK properties. High speed and accurate prediction of ligand affinity and ADMET can significantly reduce the time and cost associated with the development of drugs, especially, the first-in-class drugs. XtalPi can simultaneously evaluate many molecules and speed up the design cycle using the in-house high precision computational chemistry and machine learning technologies combined with our high-capacity cloud computing platform. It is our pleasure to work with Acerand Therapeutics. By collaborating with Acerand Therapeutics, we take advantages of their medicinal chemistry and biology expertise in drug discovery combined with our stength in AI and computational chemistry to more effectively develop potential novel anti-cancer drugs to the patients across the globe.

Acerand Co-Founder and SVP Dr. Genshi Zhao’s remark:

We are thrilled to join forces with XtalPi to develop potential novel anti-cancer therapies for the patients. As we all know, the drug discovery and development is a long and expensive process and there is an urgent need for the efficiency in the development of novel therapies. By leveraging XtalPi’s leading physics-based models and machine learning capabilities, we can rapidly evaluate many molecules with high precision regarding their binding affinities and ADMET properties, which will significantly shorten the lead optimization process, thereby accelerating our drug discovery & development. Learnings from this target should apply to other targets. We believe this is a beginning of a long term and productive collaboration between Acerand Therapeutics and XtalPi.

On September 28, 2021 Novartis reported that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting (Press release, Novartis, SEP 28, 2021, View Source [SID1234590375]). With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1.

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Priority Review is based on positive data from the pivotal, Phase III VISION study showing 177Lu-PSMA-617 plus standard of care (SOC), significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC compared to SOC alone2
Two additional studies with 177Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating clinical utility in the pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition)3,4
The FDA previously granted Breakthrough Therapy designation for 177Lu-PSMA-617 for the treatment of mCRPC. Data from the VISION study were published in The New England Journal of Medicine (NEJM)2. Novartis is also evaluating additional opportunities to investigate 177Lu-PSMA-617 in earlier stages of prostate cancer.

On September 28, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the Chardan’s 5th Annual Genetic Medicines Conference on Monday, October 4, 2021 at 2:00 p.m. ET (Press release, CRISPR Therapeutics, SEP 28, 2021, View Source [SID1234590399]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following each presentation.

On September 28, 2021 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Cherokee Nation to pay approximately $75 million over 6.5 years to resolve opioid-related claims (Press release, Cardinal Health, SEP 28, 2021, View Source [SID1234590418]). This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities. The companies view today’s settlement as an important step toward reaching a broader settlement with all federally recognized Native American tribes across the country.

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This settlement reflects an agreement of the Cherokee Nation to dismiss its ongoing lawsuit in exchange for the companies’ agreement that the Cherokee Nation will receive a settlement amount consistent with its anticipated allocation under a broader agreement with Native American tribes.

While the companies strongly dispute the allegations against them, they believe this resolution will allow the companies to focus their attention and resources on the safe and secure delivery of medications and therapies while delivering meaningful relief to affected communities, and will also support efforts to achieve a broad resolution with the remaining Native American tribes.

The companies remain deeply concerned about the impact the opioid epidemic is having on communities across the nation and remain committed to being part of the solution.