On June 17, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that the publication of data from the IMbark Phase 2 clinical trial in the Journal of Clinical Oncology in a paper entitled, "Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis(Press release, Geron, JUN 17, 2021, View Source [SID1234584114])." The publication highlights the clinical benefits observed in the study, including symptom response and overall survival, as well as the evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the publication of our IMbark Phase 2 data in the high-impact Journal of Clinical Oncology. This highlights the importance of the study data in the advancement of treatment options for MF patients who no longer respond to currently approved JAKi therapies," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Imetelstat is a novel telomerase inhibition approach that may alter the course of the disease in patients with myelofibrosis. We look forward to confirming these results in our ongoing IMpactMF Phase 3 clinical trial in refractory MF."

The publication reports efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial and is available online. As stated in the paper, IMbark tested two imetelstat doses and the 9.4 mg/kg dose every three weeks demonstrated clinical benefits in symptom response rate, with an acceptable safety profile for this poor-risk JAKi relapsed/refractory MF patient population. Biomarker and bone marrow assessments suggested selective effects on the malignant clone.

"In these heavily pre-treated patients with high disease burden whose outcome is dismal, imetelstat treatment resulted in multiple clinical meaningful benefits, including symptom response and potential improvement in overall survival," said John Mascarenhas, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and lead author of the paper. "In addition, the reductions in key driver mutations of the disease that were also correlated to clinical benefits suggest disease-modifying activity of imetelstat by targeting the underlying MF malignant clones, which differentiates imetelstat from other therapeutic agents currently in development for MF."

Ongoing IMpactMF Phase 3 Clinical Trial

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is planned to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About Myelofibrosis (MF)

Myelofibrosis, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain.

Approximately 70% of MF patients are classified as having Intermediate-2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus. There are more than 35,000 patients worldwide and more than 13,000 patients in the U.S. living with Intermediate-2 or High-risk MF. The only drug therapies approved for treating these MF patients are JAK inhibitors (JAKi). Currently, MF patients who fail or no longer respond to JAKi treatment have no or limited options, resulting in shortened median overall survival.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase inhibitor (JAKi) treatment.

On June 17, 2021 Codex DNA, Inc. ("Codex DNA"), creators of the BioXp system, a fully automated benchtop instrument that enables numerous synthetic biology workflows, reported the pricing of its initial public offering of 6,666,665 shares of its common stock at a public offering price of $16.00 per share (Press release, Research Corporation Tech, JUN 17, 2021, View Source [SID1234584131]). All of the shares are being offered by Codex DNA. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Codex DNA, are expected to be $106.7 million. The shares are expected to begin trading on the Nasdaq Global Select Market on June 18, 2021, under the ticker symbol "DNAY." The offering is expected to close on June 22, 2021, subject to the satisfaction of customary closing conditions. In addition, Codex DNA has granted the underwriters a 30-day option to purchase up to an additional 999,999 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies LLC, Cowen and Company, LLC and KeyBanc Capital Markets Inc. are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities became effective on June 17, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by e-mail at [email protected]; or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, or by e-mail at [email protected]; or by telephone at (833) 297-2926; KeyBanc Capital Markets Inc., Attention: Equity Syndicate, 127 Public Square, 4th Floor, Cleveland, Ohio 44114, or by telephone at (800) 859-1783. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 June 17, 2021 Apollo Therapeutics, a portfolio-based biopharmaceutical company rapidly advancing potentially transformative treatments based on breakthrough discoveries, reported that it has completed a $145 million (over £100 million) financing (Press release, Apollo Therapeutics, JUN 17, 2021, View Source [SID1234584153]). The financing was led by Patient Square Capital, which will take a controlling position in the business, with participation from additional investors including Rock Springs Capital, Reimagined Ventures and UCL Technology Fund. Proceeds from the investment will support advancement of Apollo’s robust pipeline into development, expansion of the company’s operations including establishment of a presence in the Boston, MA area and pursuit of new collaborations globally.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Five years ago, Apollo’s innovative model was created by three world-leading universities Cambridge, Imperial College London and University College London forming a joint venture with global pharma partners AstraZeneca, GlaxoSmithKline and Johnson & Johnson Innovation to efficiently advance breakthrough discoveries that have the potential to be transformative treatments for patients," said Dr. Richard Mason, CEO of Apollo. "In that time, Apollo has exceeded traditional growth benchmarks – rapidly building a pipeline of over 15 promising programs. There is significant opportunity ahead of us to bring new treatments to market as our lead programs move into clinical development. We will look to build on our existing collaborations, foster new relationships with additional top academics around the world and in-license drug candidates from new partners."

Added Jim Momtazee, Managing Partner of Patient Square and member of Apollo’s Board of Directors, "For the past twenty years, I have pursued a thesis in therapeutics of backing outstanding teams and building multi-product portfolios in important areas of medicine. Patient Square continues to be very enthusiastic about that business model. We are extremely excited to partner with the team at Apollo, as we see tremendous potential in their product portfolio and their novel partnership approach with three of the world’s top academic institutions pursuing some of the most innovative science globally. We look forward to working closely with the Apollo team to broaden their reach globally and to bring a number of potentially life-changing medicines to patients."

Rooted in Collaboration

Apollo was originally established in late 2015 as a unique joint venture between the University of Cambridge, Imperial College London (then subsequently IP Group Plc), University College London, AstraZeneca, GlaxoSmithKline (GSK) and Johnson & Johnson Innovation. Apollo was set-up to bridge the gap from deep academic science to patient benefit in the most capital and time efficient way possible. By fostering relationships with top academic scientists and leveraging insights from strategic partners with late-stage development and commercial expertise, Apollo seeks to develop therapeutics that have transformative potential above the current standard of care. The company evaluates breakthrough scientific discoveries across multiple criteria, including having a compelling and testable biological hypothesis or having a differentiated mechanism or technology compared to other therapeutics in development or on the market. Each of the joint venture founders retains a minority stake in the company post financing.

Efficiency in Development

To advance programs efficiently, Apollo leverages a portfolio-based model with a centralized team of drug development ‘architects’ working alongside asset-level teams of subject matter experts. Together, these teams are able to rigorously evaluate therapeutic programs in an objective, data-driven manner – prioritizing critical experiments to de-risk programs early. The company is able to comprehensively evaluate programs, while committing minimal spend until demonstrating biological validation. This capital efficiency allows Apollo to focus on scaling a robust and potentially transformative pipeline, with over 15 therapeutic programs in development today across oncology, major inflammatory disorders and rare disease.

Building Upon Success

With proceeds from this financing, Apollo plans to advance its lead therapeutic programs into clinical development as well as identify new programs. In addition, the company plans to expand its UK operations in the Cambridge area, and in the United States with a new facility in Boston/Cambridge. Apollo’s growing team will also explore additional collaborative relationships with leading academic researchers around the world.

Established Leadership

Apollo is led by Dr. Richard Mason, who was recently appointed as chief executive officer. Dr. Mason has over 20 years’ experience in the biotech industry, including serving as the head of the Johnson & Johnson Innovation Center in London. Before this, he was CEO of novel anticoagulant antibody company XO1 until the sale of the company. Previously, Dr. Mason was the executive leadership team member responsible for strategy and business development at listed companies BTG and Cambridge Antibody Technology where he led numerous M&A and partnering transactions. He received degrees in medicine from St. Bartholomew’s Hospital Medical College and immunology from University College London and trained in internal medicine in London.

In conjunction with the financing, Jim Momtazee, Managing Partner of Patient Square Capital, will join Apollo’s Board of Directors. Prior to Patient Square, Mr. Momtazee spent over 21 years at KKR, where he helped establish the firm’s health care industry group in 2001 and subsequently was head of the Americas Health Care Investment Team for over 10 years. Mr. Momtazee has spent years on the board of directors of Jazz Pharmaceuticals, HCA, PRA Health Sciences and BridgeBio Pharma, among other companies. Jazz Pharmaceuticals and BridgeBio Pharma are both examples of the multi-product thesis pursued by the Patient Square team, and that accumulated experience will be particularly additive in supporting the growth and expansion of Apollo in the years to come.

Dr. Richard Butt who has been with Apollo since its inception, will serve as the company’s chief scientific officer. Jamie Heath will join the company as chief financial officer and Arjun Krishnan as chief business officer. Dr. Ian Tomlinson who previously chaired Apollo’s investment committee, will join the Board as a non-executive director.

About Patient Square Capital

Patient Square Capital is a dedicated health care investment firm that partners with best-in-class management teams whose products, services and technologies improve health. We utilize our deep industry expertise, our broad network of relationships and a true partnership approach to make investments in companies that will grow and thrive. We believe in the power these companies have to improve patient lives, strengthen communities and create a healthier world. Patient Square is purpose-built by a team of industry-leading executives, differentiated by the depth of our focus in health care, the breadth of our health care investing experience, and the network we can activate to drive differentiated outcomes. Most importantly, patients are squarely at the center of all that we do. For more information, visit www.patientsquarecapital.com.

On June 17, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Dean Li, executive vice president and president, Merck Research Laboratories, is scheduled to participate in a virtual fireside chat at the Guggenheim Biopharma Strategy Series with Senior Management to discuss Biopharma’s Next Decade: Views from the Top on Global Strategy and Innovation on June 22, 2021, at 9:00 a.m. EDT(Press release, Merck & Co, JUN 17, 2021, View Source [SID1234584095]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On June 14, 2021 Intellia Therapeutics, Inc. ("Intellia") entered into Amendment #3 (the "Amendment") to its License and Collaborative Research Agreement (the "Collaboration Agreement"), dated as of December 18, 2014, with Novartis Institutes for Biomedical Research, Inc. ("Novartis")(Press release, Intellia Therapeutics, JUN 17, 2021, View Source [SID1234584115]). The Amendment amends Novartis’ rights with respect to all the CAR-T Therapeutic Targets (as defined in the Collaboration Agreement) that Novartis selected under the Collaboration Agreement, including (a) making Novartis’ license non-exclusive for such CAR-T Therapeutic Targets, (b) removing Novartis’ diligence and related reporting obligations for such CAR-T Therapeutic Targets, and (c) refining the scope of Novartis’ sublicense rights for such CAR-T Therapeutic Targets. Intellia agreed to pay to Novartis a one-time payment of $10.0 million within 30 days after the effective date of the Amendment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The foregoing summary is qualified in its entirety by reference to the Amendment filed as an exhibit to this Form 8-K. The Company has sought confidential treatment for certain portions of the Amendment.