On September 20, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported the pricing of its underwritten public offering of 13,606,000 shares of its common stock pursuant to its existing shelf registration statement (Press release, Alpine Immune Sciences, SEP 20, 2022, View Source [SID1234619701]). The shares of common stock are being offered at a public offering price of $7.35 per share. The gross proceeds to Alpine from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Alpine, are expected to be approximately $100.0 million. In addition, Alpine has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 2,040,900 shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares of common stock to be sold in the offering are being sold by Alpine. The offering is expected to close on or about September 23, 2022, subject to customary closing conditions.

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Morgan Stanley, SVB Securities and Cowen are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

A shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on May 14, 2021 and declared effective by the SEC on May 20, 2021. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone: 1-866-718-1649, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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 other jurisdiction.

On September 20, 2022 Exscientia (Nasdaq: EXAI), ETH Zurich, the Medical University of Vienna, and the Center for Molecular Medicine (CeMM) reported a new publication in Blood Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), titled "Deep Morphology Learning Enhances Precision Medicine by Image-Based Ex Vivo Drug Testing" from the laboratory of Prof. Berend Snijder (Press release, Exscientia, SEP 20, 2022, View Source [SID1234619700]). This post-hoc analysis builds on the transformative work of the EXALT-1 trial, published in Cancer Discovery, by using deep learning algorithms to classify complex cell morphologies in patient cancer tissue samples into disease "morphotypes."

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EXALT-1 was the first prospective trial to demonstrate significantly improved outcomes for late-stage haematological cancer patients using an AI-supported precision medicine platform to guide personalised treatment recommendations as compared to physician’s choice of treatment. In EXALT-1, 40% of patients experienced exceptional responses lasting at least three times longer than expected for their respective disease. The post-hoc analysis published today in Blood Cancer Discovery shows that combining the technology as used in EXALT-1 with new deep learning advancements that take advantage of cell-specific features in high-content images revealed a potential to further increase these patient outcomes.

"Following results of the EXALT-1 study, these findings continue to validate that our AI-guided precision medicine platform has the ability to identify highly actionable clinical treatment recommendations for blood cancers, deepening our insights and enhancing the clinical predictive power of the platform to help patients," said Gregory Vladimer, Ph.D., VP Translational Research at Exscientia and co-inventor of the platform technology. "Cell morphology, or assessing the characteristics of cells, is fundamental to the diagnosis of cancer. Within this research, we were able to utilise deep learning within the platform to improve our ability to identify personalised cancer treatments, leading to improved clinical outcomes for patients. At Exscientia, we are excited to expand the platform’s applications in order to bring personalised medicine to broader populations."

"We believe performing drug screens directly in tumour tissues of cancer patients is a great step forward in understanding tumour complexity compared to traditional cell model systems. The fact that we can now harness the power of deep learning to turn these terabytes of images into actionable insights is very exciting indeed," added Prof. Berend Snijder, Principal Investigator at the Institute of Molecular Systems Biology of the ETH Zurich in Switzerland.

The impact of deep learning on the clinical predictive power of ex vivo drug screening was assessed in a post-hoc analysis of 66 patients over a period of three years in a combined data set of 1.3 billion patient cells across 136 ex vivo tested drugs across haematological diagnoses including acute myeloid leukaemia, T-cell lymphomas, diffuse large B-cell lymphomas, chronic lymphocytic leukaemia and multiple myeloma. Patients receiving treatments that were recommended by the platform’s immunofluorescence analysis or deep learning on cell morphologies showed an increased rate of achievement of exceptional clinical response, defined as a progression free survival period that lasted three times longer than expected for each patient’s respective disease. Post-hoc analyses confirmed that the clinical predictions became more accurate when also considering the drug toxicity on the healthy cells within the tested patient sample.

Exscientia’s precision medicine platform uses custom deep learning and computer vision techniques to extract meaningful single-cell data from high content images of individual patient tissue samples. This analysis generates clinically-relevant insights into which treatments will deliver the most benefit to an individual patient. Further evaluation of individual patient results through Exscientia’s genomics and transcriptomics capabilities may help Exscientia further understand which other patients may benefit from similar treatments. The underlying technology was developed by Dr. Gregory Vladimer and Prof. Berend Snijder while working in the laboratory of Giulio Superti-Furga at the CeMM Research Center for Molecular Medicine in Austria.

On September 20, 2022 ImmunoScape, a pre-clinical biotechnology company focused on the discovery and development of next-generation TCR-T-cell therapeutics reported that it has raised $14M in new financing (Press release, immunoSCAPE, SEP 20, 2022, View Source [SID1234619699]). Existing investor Anzu Partners led the round with participation from new investor Amgen Ventures and Singapore-based global investor EDBI.

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ImmunoScape’s differentiated Deep Immunomics platform utilizes the company’s proprietary combinatorial barcoding technology to enable the discovery and in-depth characterization of rare cancer-specific T-cells at high resolution. ImmunoScape’s platform is able to simultaneously evaluate tens of millions of T-cells in blood samples from hundreds of cancer patients to identify rare clinically relevant T-cell clones. The corresponding TCRs are then evaluated and prioritized to build a diverse portfolio of TCR-T-cell therapies.

By leveraging computational biology and machine learning, together with high throughput screening and evaluation of T-cell clones, ImmunoScape is able to efficiently identify novel T-cell therapy targets and TCR candidates. ImmunoScape has extensively validated its computational platform using virus-specific T-cells and is applying the same methods to build an extensive portfolio of cancer-specific TCRs.

"We have made significant strides in our discovery program and have identified several compelling clinical TCR candidates using our Deep Immunomics platform," said Choon Peng Ng, CEO, ImmunoScape. "The new funding will allow us to expedite our development efforts and help us to advance our therapeutic candidates toward the clinic. We are especially delighted that Amgen Ventures has become an investor and we look forward to working with their team to address important unmet medical needs with ImmunoScape’s technology."

"Amgen invests in promising new solutions to address healthcare’s biggest challenges, especially those that offer unique, value-based approaches that align with our mission to serve patients fighting serious illness," said Philip Tagari, vice president of research (therapeutic discovery), Amgen. "ImmunoScape’s Deep Immunomics and machine learning platforms have the potential to help uncover new treatments as we continue to develop the next generation of innovative medicines. We are excited to work with their team to unlock the full power of this technology."

"With research laboratories in both San Diego and Singapore, ImmunoScape is one of the global pioneers of TCR discovery. Their unique high-throughput TCR discovery and evaluation platform has an unprecedented capacity to test millions of human T-cells against hundreds of cancer antigens," said David Michael, managing partner at Anzu Partners. "From their origins at Singapore’s Agency for Science, Technology, and Research (A*Star), the company’s global team of immunologists are pursuing major breakthroughs in TCR cell therapy. We are delighted to work more closely with Amgen on these important efforts."

On September 20, 2022 Invenra, a company developing next generation therapeutic antibodies, reported that Chief Scientific Officer Daniel Pereira, Ph.D., will present preclinical data supporting the ongoing development of INV322, an antibody-based cancer therapeutic (Press release, Invenra, SEP 20, 2022, View Source [SID1234619698]). The preclinical research findings will be presented at the 13th Annual World Bispecific Summit, Thursday, September 22nd, 2022 and at the Immuno-Oncology Summit, Wednesday, October 12th, 2022, both in Boston.

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The presentation will highlight preclinical data related to the lead candidate INV322, a SNIPER Bispecific Antibody co-targeting CTLA-4 and CD25. In vitro studies have characterized avidity-mediated binding of INV322 to these tumor Treg antigens as well as an antibody dependent cell cytotoxicity (ADCC) mediated mode of action. In vivo studies using a murine surrogate also show potent anti-tumor responses after a single dose and selective regulatory T cell (Treg) depletion in syngeneic mice. Moreover, synergistic anti-tumor activity was also observed in combinations with anti-PD-1 and anti-PD-L1 agents.

"We are very pleased with the strong preclinical data that our research team has generated with INV322 using our proprietary multispecific B-Body Platform. INV322 also appears well tolerated in ongoing toxicology studies and thus we are also encouraged by its therapeutic potential as we progress our IND-enabling activities," said Pereira. "These efforts are also providing validation for both the SNIPER Bispecific antibody therapeutics approach, and our robust multispecific B-Body Platform."

Jonathan Davis, Ph.D., Invenra VP of Innovation and Strategy, will also be presenting on the Invenra B-Body Platform at the 13th Annual World Bispecific Summit. "Our platform has binding, biophysical, and manufacturing properties equivalent to the best conventional monoclonal antibodies, and far superior to the typical bispecific antibody platform," said Davis. "We are very excited to see the B-Body Platform and SNIPER Bispecific antibodies advancing in multiple indications and believe this will be a pivotal platform for bispecific antibody therapeutics."

About INV322

INV322 is a next generation anti-CTLA-4 x CD25 bispecific mAb developed using Invenra’s high-developability B-Body Platform. Using the SNIPER Bispecific approach, the antibody was designed with optimized affinities for both antigens, permitting avid antibody binding specifically when both antigens are present. The antibody was also optimized for an ADCC-mediated MOA and has exhibited excellent developability properties at scale.

On September 20, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage, clinical biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, and Renovacor, Inc. (NYSE: RCOR), a biotechnology company focused on delivering innovative precision therapies to improve the lives of patients and families battling genetically-driven cardiovascular and mechanistically-related diseases, reported a definitive agreement under which Rocket will acquire Renovacor in an all-stock transaction for an implied value of approximately $2.60 per share, based on the volume weighted average trading price of Rocket shares of $15.51 for the 30 trading days through and including Monday, September 19, 2022 (Press release, Rocket Pharmaceuticals, SEP 20, 2022, View Source [SID1234619697]). The boards of directors of both companies have unanimously approved the transaction, which is currently expected to close by the first quarter of 2023.

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"The acquisition of Renovacor aligns with our strategy to expand our leadership position in AAV-based gene therapy for cardiac disease and gives us a perfect opportunity to continue on our mission to transform the lives of heart failure patients through the power of gene therapy," said Gaurav Shah, M.D., Chief Executive Officer of Rocket. "Building on our success in Danon Disease to date, I am particularly excited to expand our cardiology focus and capabilities and address a clear unmet medical need in BAG3-associated dilated cardiomyopathy. By combining Renovacor’s compelling preclinical work with our joint clinical, regulatory and CMC expertise, we believe we will be well-positioned to bring the highest impact gene therapy with the best chance for success to these patients in the most productive and efficient manner possible."

Dr. Shah continued, "Given the positive pediatric safety data previously announced from our Phase 1 RP-A501 Danon Disease program, and the upcoming pediatric efficacy data and longer-term adult cohort data we anticipate presenting at the Heart Failure Society of America (HFSA) Scientific Meeting at the end of this month, this strategic acquisition gives us what we believe is the broadest platform in the field to address these devastating rare cardiac diseases. Furthermore, the acquisition will bring to Rocket key personnel, namely a team of leading cardiology drug development experts, critical capabilities, and valuable IP to support continued development of the BAG3 as well as other potential cardiac programs, including a gene therapy research collaboration for arrhythmogenic cardiomyopathy."

Renovacor’s most advanced program, REN-001, is an AAV-based gene therapy targeting BAG3-associated dilated cardiomyopathy (DCM), a severe form of heart failure. BAG3-DCM represents a significant unmet medical need in a patient population with rapidly progressive cardiac dysfunction in whom no treatments targeting the underlying mechanism of disease exist. Renovacor has deep technical expertise in the development of precision therapies that address genetically driven cardiac diseases. Further, Renovacor is supported by world-class scientific collaborators, a robust intellectual property portfolio and personnel with expertise in BAG3-DCM. These assets and capabilities, all together, represent tremendous value and will enhance Rocket’s leading position in cardiac AAV-based gene therapy.

"Renovacor has made tremendous progress in advancing targeted gene therapies to address the high unmet medical needs of patients living with genetically driven forms of heart disease," said Magdalene Cook, MD, Chief Executive Officer of Renovacor. "Our experienced team is excited to join Rocket in a shared vision of broadening patient access to precision medicines for cardiovascular disease and addressing common barriers jointly. We look forward to combining the considerable resources and expertise of Renovacor and Rocket in creating a category leader in the precision cardiology field. As a result of this combination, we will be suspending current guidance regarding preclinical and clinical timelines for our programs as we evaluate these items with the Rocket team."

Transaction Details

Under the terms of the definitive agreement, Renovacor shareholders will receive approximately 0.1676 shares of Rocket in exchange for each of their shares in Renovacor (subject to adjustment as described below) and are expected to own approximately 4.6% percent of Rocket equity on a fully diluted basis immediately following the closing of the transaction. The exchange ratio implies an equity deal value of approximately $53 million based on fully diluted shares outstanding and the acceleration and vesting of all earnout shares, or $2.60 per share of Renovacor, based on the volume weighted average trading price of Rocket shares of $15.51 for the 30 trading days through and including Monday, September 19, 2022. The exchange ratio is subject to adjustment based on Renovacor net cash at closing.

It is currently anticipated that the transaction will close by the first quarter of 2023, subject to approval by Renovacor and Rocket shareholders, receipt of any required customary regulatory approvals and the satisfaction of other customary closing conditions. RTW Investments, LP, a significant shareholder of both Rocket and Renovacor, has entered into a voting agreement with Renovacor, pursuant to which they have agreed, among other things, and subject to the terms and conditions of the agreement, to vote in favor of the Renovacor acquisition as a Rocket stockholder.

SVB Securities is serving as exclusive financial advisor and Goodwin Procter LLP is serving as legal counsel to Rocket. Wells Fargo Securities is serving as exclusive financial advisor and Troutman Pepper Hamilton Sanders LLP is serving as legal counsel to Renovacor.

Investor Webcast Information

Rocket management will discuss the transaction via webcast today, Sept. 20, 2022, at 8:00 a.m. ET. To access the webcast, please register online at: View Source Participants are requested to register a minimum of 15 minutes before the start of the call. The webcast replay will be available on the Rocket website upon completion of the event.