On January 26, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported the initiation of the company’s global Phase 2 clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, which is referred to as the ASPIRE trial (Press release, Panbela Therapeutics, JAN 26, 2022, View Source [SID1234607396]).

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Arvind Chaudhry MD, PhD, Principal Investigator at Summit Cancer Centers in Spokane, Washington was the first clinical site activated, with approximately 60 additional sites expected to be activated in 2022. Panbela has commenced screening for eligible patients, with enrollment expected to complete in approximately 12 months.

The ASPIRE trial is designed as a randomized double-blind placebo-controlled trial, with a primary endpoint of overall survival. The design includes a futility analysis after 104 progression-free survival events. Panbela is seeking to conduct the trial at leading cancer centers in the United States, Europe, and the Asia-Pacific region.

"Pancreatic cancer is one of the most common causes of cancer deaths in the United States and represents a significant unmet medical need, as is underscored by SBP-101’s Fast Track and Orphan Drug designations," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "We are enthusiastic about having initiated the ASPIRE global randomized Phase 2 trial. Given the rigor of the trial design, we expect the resulting data to support our registration effort."

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On January 26, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the pricing of an upsized underwritten public offering of 4,074,075 shares of its common stock and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock pursuant to its existing shelf registration statement (Press release, Sierra Oncology, JAN 26, 2022, View Source [SID1234607414]). The shares of common stock are being offered at a public offering price of $27.00 per share and the pre-funded warrants are being offered at a public offering price of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The expected gross proceeds to Sierra Oncology from the offering is approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Sierra Oncology has granted to the underwriters a 30-day option to purchase up to 750,000 of additional shares of its common stock at the public offering price less underwriting discounts and commissions. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. All of the securities are being offered by Sierra Oncology. The offering is expected to close on or about January 31, 2022, subject to customary closing conditions.

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Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the SEC on November 5, 2021 and declared effective by the SEC on November 12, 2021. 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. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, 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 January 26, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company reported that its Founded Entity, Akili Interactive ("Akili"), a leading digital medicine company developing cognitive treatments through game-changing technologies, has entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), a special purpose acquisition company (Press release, PureTech Health, JAN 26, 2022, View Source [SID1234607433]). The transaction is expected to close in mid-2022, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol "AKLI." As a public company with world-class backing and strong financial flexibility, Akili will be positioned to pioneer a new class of digital medicines for millions of people living with cognitive impairment.

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"Akili, as with all our Founded Entities, was co-invented and advanced through initial milestones by the PureTech team, and we are proud of Akili’s continued path of success, most notably with the FDA clearance of EndeavorRx and now with its potential listing on Nasdaq," said Bharatt Chowrira, Ph.D., J.D., President and Chief Business, Legal and Operating Officer of PureTech and Akili Board Member. "With Akili on its way to becoming yet another publicly-traded Founded Entity for PureTech, our unique model continues to demonstrate the multiple ways in which we are generating value at PureTech, including equity stakes in public and private Founded Entities, royalties and milestone payments due to us from certain invented products, pharma collaborations to advance non-core programs and – importantly – our rapidly progressing and advanced Wholly Owned Pipeline which we see as our major value driver going forward."

The full text of the announcement from Akili is as follows:

Akili Interactive, a Leader in Digital Medicine, to Become Publicly Traded Through Combination with Social Capital Suvretta Holdings Corp. I

●Akili’s leading digital therapeutic platform combines science and technology to address cognitive impairments in patients, reimagining how central nervous system medicines are designed, developed, and delivered

Transaction will support commercial launch of EndeavorRx, a first-of-its-kind, FDA-cleared and CE-marked prescription digital therapeutic for pediatric ADHD, as well as advance clinical development pipeline across multiple neuropsychiatric diseases, including expanded ADHD populations, multiple sclerosis, autism, and depression

●Transaction values the combined company at an equity value post-money of up to approximately $1 billion and is expected to provide up to $412 million in gross cash proceeds

●Fully committed PIPE of $162 million led by $100 million from Social Capital with remaining $62 million from new and existing investors including: Suvretta Capital Management’s Averill strategy, Apeiron Investment Group, Temasek, co-founder PureTech Health, Polaris Partners, Evidity Health Capital, JAZZ Venture Partners and Omidyar Technology Ventures

●Chamath Palihapitiya expected to become Chair of Akili’s Board of Directors upon transaction close

BOSTON, Mass. and PALO ALTO, Calif. – January 26, 2022 – Akili Interactive ("Akili" or the "Company"), a leading digital medicine company developing cognitive treatments through game-changing technologies, has entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), a special purpose acquisition company. The transaction is expected to close in mid-2022, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol "AKLI." As a public company with world-class backing and strong financial flexibility, Akili will be positioned to pioneer a new class of digital medicines for millions of people living with cognitive impairment.

New Digital Approach to Cognitive Medicine

The Akili software platform was built on the belief that directly engaging brain function is the next frontier of science and medicine. Cognitive impairments – including poor concentration, memory loss, difficulties learning new skills, and difficulties with decision making – are in aggregate among the largest unmet medical needs, and are increasingly recognized as contributing to or associated with dozens of chronic diseases and acute illnesses, including attention-deficit/hyperactivity disorder (ADHD), major depressive disorder (MDD), multiple sclerosis (MS), and autism spectrum disorder (ASD), as well as postoperative cognitive dysfunction and COVID-19 "brain fog."

Despite the rapidly growing prevalence of these conditions, the acute exacerbation of these issues by the pandemic’s impact, and the chronic, escalating cognitive overload from the proliferation of on-demand attention-capturing technology, there has been limited innovation of novel treatment options. Specifically, current treatment options are designed to focus on symptoms and coping strategies instead of directly targeting cognitive functioning. These therapeutic shortfalls are especially concerning for younger populations who are potentially facing a lifetime of managing these conditions.

Akili’s First-of-Its-Kind, Clinically Validated Therapeutic

By harnessing advances in cognitive neuroscience and consumer technology, Akili is changing the neuropsychiatric treatment paradigm. Akili’s patented and clinically validated technology platform represents a new category of software-based medicine: advanced and proprietary digital therapeutics that are designed to directly target neural physiology to better serve the needs of patients and their families.

Akili’s core therapeutic engine, the Selective Stimulus Management Engine (SSMETM), is specifically designed to target and activate neural systems involved in attentional control. This core platform has the potential to be applied across a diverse set of indications within psychiatry and neurology. Backed by robust clinical research, Akili’s treatments are delivered to patients through engaging interactive mobile games, personalized to each individual and built to feel like high-end entertainment products.

The SSMETM technology has already demonstrated proof-of-concept in controlled trials targeting attention and cognitive dysfunction in ADHD, ASD, MS, and MDD. Built on the SSMETM technology, Akili developed EndeavorRx, the first-ever FDA-cleared prescription video game and the first-ever FDA-cleared commercial product indicated to improve attention function in children between the ages of 8 to 12 years with primarily inattentive or combined-type ADHD (see full indication below).

Key Investment Highlights:

●Patented and clinically validated technology platform. Developed with the collaboration of cognitive neuroscientists and mobile game developers, Akili’s proprietary technology is designed to target key neural systems underlying specific cognitive functions through adaptable, personalized closed-loop algorithms. The technology is clinically validated, using recognized endpoints, and delivered through smartphones or other mobile devices.

● First-and-only FDA-cleared video game-based digital therapeutic. Anticipated to launch in the second half of 2022, EndeavorRx is the first and only prescription video game treatment with FDA clearance and a CE mark (designating it has met European health, safety, performance, and environmental requirements) in pediatric ADHD. EndeavorRx has been validated through multiple clinical trials, including large randomized, controlled trials demonstrating improved patient outcomes.

●Large and growing market opportunity. Tens of millions of people worldwide live with cognitive health issues, and many are actively searching for better solutions. With EndeavorRx, Akili is initially targeting the approximately $10 billion U.S. ADHD market. EndeavorRx will first launch for the FDA-cleared 8 to 12-year-old pediatric population. Akili is also seeking to expand into other U.S. ADHD populations, including younger children (3 to 7 years old), teens, and adults, while simultaneously working with a partner to gain approval as a treatment for pediatric ADHD in Japan.

● Strong clinical rigor. Akili has completed 20 clinical trials across 2,900 patients and nine disease populations. In addition, Akili’s clinical studies and data have been published in 16 leading peer-reviewed journals.

● Robust research and clinical pipeline. Akili has a strong development pipeline, initially focused on treatments for cognitive impairments across nine patient populations. In addition, Akili is progressing early discovery for two new platform technologies to address additional cognitive impairments and facilitate broader reach across disease spectrums. Akili is poised to begin pivotal studies in multiple indications where proof-of-concept has been achieved, including additional ADHD populations, ASD, MS, and MDD.

Management Comments

Eddie Martucci, Chief Executive Officer of Akili, said: "This transaction represents the next step in our journey to become the world’s leading digital medicine company directly targeting neurological function. Over the past 10 years, we have created a platform representing a new era of cognitive medicine, driven by our fundamental focus on patients, advanced science and proprietary technology, and the mission-driven hard work of our entire team. We believe medicine now can be both effective and engaging. Social Capital Suvretta shares our vision for the future, and we look forward to applying our combined experience as we drive the commercialization of our platform and advance our deep pipeline of prescription digital therapeutics to help people living with cognitive impairments across the globe."

Chamath Palihapitiya, Founder and CEO of Social Capital and Chairman and CEO of SCS, commented: "Akili is taking a new approach to cognitive science – using software to target our underlying cognitive function and creating an entirely new class of medicine as a byproduct. With its first-ever, clinically validated digital therapeutic (EndeavorRx), Akili has the unique opportunity to change how we treat pediatric ADHD. They have also laid the groundwork to treat a wide range of other cognitive issues affecting tens of millions of people around the world."

Kishen Mehta, Portfolio Manager of the Averill strategy at Suvretta Capital Management and President of SCS, said: "Akili has created a unique disease-agnostic technology platform with an advanced pipeline of product candidates across multiple indications where proof-of-concept has already been achieved. The Company is leading the advancement of digital cognitive therapies with an FDA-cleared product already on the market, and we believe Akili has only just scratched the surface of this new and exciting field of medicine. We look forward to working with Akili to accelerate the Company’s growth and allow it to continue developing treatment options for the hundreds of millions of people living with cognitive impairments."

Transaction Overview

The transaction implies a post-money equity value of the combined company of up to approximately $1 billion and is expected to deliver up to $412 million in gross cash proceeds to the Company, including the contribution of up to $250 million of cash held in SCS’s trust account and $162 million from PIPE investors at $10 per share. All references to available cash from the trust account and retained transaction proceeds are subject to any redemptions by the public shareholders of SCS and payment of transaction expenses. Akili plans to use the net proceeds to help fund the Company’s go-to-market strategy, to further advance its pipeline of prescription digital therapeutics targeting a range of chronic and acute cognitive disorders, and for other general corporate purposes.

Existing Akili shareholders will roll 100% of their equity into the combined company and will be eligible to receive additional SCS shares pursuant to an earnout based on the combined company’s future stock performance.

Chamath Palihapitiya is expected to join Akili’s board of directors as chair, upon the close of the transaction.

The proposed business combination, which has been unanimously approved by the boards of directors of both Akili and SCS, is expected to close in mid-2022, subject to approval by SCS’s and Akili’s shareholders, regulatory approvals, and other customary closing conditions.

Advisors

Morgan Stanley & Co. LLC ("Morgan Stanley") and Cowen and Company, LLC ("Cowen") are serving as financial advisors to Akili. Morgan Stanley, Credit Suisse, and Cowen are serving as co-placement agents to SCS with respect to the portion of the PIPE financing raised from non-insider qualified institutional buyers and institutional accredited investors. Morgan Stanley, Credit Suisse, and Cowen are not acting as agents or participating in any role with respect to, and will not earn any fees from, the portion of the PIPE financing raised from insiders and individual investors. Credit Suisse and Cowen are serving as capital markets advisors to Akili. BofA Securities, Inc. is acting as capital markets advisor to SCS.

Goodwin Procter LLP is serving as legal counsel to Akili. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to SCS. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to the PIPE placement agents.

Conference Call Information

A presentation made by the management teams each of Akili and SCS regarding the transaction will be available at View Source at 8:00 AM ET.

Additional information about the proposed transaction, including an investor presentation, will be provided in a Current Report on Form 8-K to be filed by SCS with the Securities and Exchange Commission and available at www.sec.gov.

On January 25, 2022 LUMICKS, a next generation life science tools company, reported that research findings from a consortium, led by researchers at Cancer Center Amsterdam, Amsterdam University Medical Centers, published in Science Translational Medicine, detailed a novel design strategy for preventing tumor escape through improved chimeric antigen receptor (CAR) T cell therapy for common blood cancers (Press release, LUMICKS, JAN 25, 2022, View Source;utm_medium=rss&utm_campaign=new-study-published-by-group-of-maria-themeli-cell-aviditys-power-as-a-functional-biomarker-for-improved-car-t-design-in-preventing-tumor-relapse [SID1234606761]).

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Using both cell avidity measurements, as provided by LUMICKS’ z-Movi Cell Avidity Analyzer, and traditional immuno-assays, the researchers successfully demonstrated that co-expression of costimulatory receptors (CCR) along with an FDA approved BCMA and CD19 CAR can improve both durability of potential treatments as well as sensitivity to recognize and lyse various variants of multiple myeloma and acute lymphoblastic leukemia with low antigen density. This innovative dual-targeting approach provides an exciting new avenue for next-generation therapies that may overcome many common problems of current approved therapies, including high rates of relapse. The study was published in the December 2021 issue of Science Translational Medicine.

In the study profiled, the researchers set out to characterize the dual targeting system through co-expression of high-affinity engagement of co-stimulatory molecules with a BCMA CAR. Using LUMICKS’ z-Movi Analyzer, the researchers were able to determine that dual targeting with CD38-binding CCR enhanced the cytotoxicity of BCMA-CAR-T cells by increasing their binding avidity. This increasing activity improved the overall sensitivity of these cells as compared to other approved therapies. The measurement of cell avidity’s power as a functional biomarker provided strong support for the mechanism of action underlying these results and a rational basis for ongoing efforts to improve next-generation CARs for enhanced therapeutic efficacy.

"The z-Movi platform’s distinct ability to measure and quantify avidity provides a powerful tool for immuno-oncologists," said Maria Themeli, M.D., Ph.D. Assistant Professor at Amsterdam UMC and corresponding author of the study. "The instrument provided an essential piece of evidence in our investigation, giving us critical insight into how these engineered cells work and what is ultimately responsible for their changes in behavior with this new dual-targeting strategy. Understanding mechanism of action is fundamentally important for any effective drug development study."

The LUMICKS z-Movi platform provides the unique ability to measure the avidity of hundreds of cells in parallel using an intuitive and convenient workflow based on the application of acoustic force. The strength of interaction between single targeting (first generation) and double-targeting T cells and MM1.S target cells was measured in the study. Statistically robust differences in avidity were measured between the two CAR designs, demonstrating the underlying cause of the enhanced cytotoxicity of the dual targeting system.

"This innovative new work, highlighting LUMICKS’ z-Movi as a critical tool to enable CAR-T developers to precisely understand fundamental principles of therapy design, is both exciting and important," said Andrea Candelli, Ph.D., Chief Scientific Officer and co-founder of LUMICKS. "This is the first step in our mission to demonstrate and validate the power of cell avidity as the biomarker for immuno-oncology research and development."

On January 25, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported clearance of its Clinical Trial Application (CTA) by the regulatory authorities of the Republic of Korea for ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations (Press release, ORIC Pharmaceuticals, JAN 25, 2022, View Source [SID1234606777]).

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"This marks our third IND/CTA regulatory clearance in the last eight months and further demonstrates the productivity and commitment of our team as we expand our clinical portfolio to advance our mission on behalf of patients," said Jacob M. Chacko, M.D., president and chief executive officer. "We are encouraged by the brain penetrant properties and selectivity that ORIC-114 has demonstrated in preclinical studies, and we look forward to advancing the program into a Phase 1 study in the coming months. As we enter 2022, we are well positioned with five expected clinical updates across four clinical programs through the first half of 2023, and with cash and investments to fund our operating plan into the first half of 2024."

About ORIC-114

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated systemic tumor regressions and strong intracranial antitumor activity in various EGFR exon 20 insertion NSCLC and HER2-positive breast cancer models. ORIC-114 also compares favorably in head to head in vivo studies versus multiple approved and clinical stage EGFR exon 20 and HER2 inhibitors. The company plans to initiate a Phase 1b single agent study in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial data from this trial in the first half of 2023.