On March 23, 2021 Instil Bio, Inc. ("Instil"), a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, reported the closing of its previously announced initial public offering of 18,400,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,400,000 shares of common stock at the public offering price of $20.00 per share (Press release, Instil Bio, MAR 23, 2021, View Source [SID1234583989]). The gross proceeds of the offering, before underwriting discounts and commissions and other offering expenses payable by Instil, are approximately $368.0 million. Instil’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "TIL."

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Morgan Stanley, Jefferies and Cowen acted as joint book-running managers for the offering. Truist Securities acted as lead manager for the offering.

The offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. 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 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 March 23, 2021 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the appointment of Christopher Turner, M.D., as Chief Medical Officer (Press release, Nuvalent, MAR 23, 2021, https://www.nuvalent.com/nuvalent-appoints-christopher-turner-m-d-as-chief-medical-officer/ [SID1234580618]). Dr. Turner brings more than 20 years of clinical experience in both early- and late-stage oncology drug development, having served in physician-scientist roles in both academia and the biotechnology industry. Dr. Turner will oversee the clinical development of Nuvalent’s portfolio of innovative small molecule kinase inhibitors, including parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), which are designed to overcome the limitations of existing therapies for these clinically proven targets.

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"Chris is a dedicated physician and drug developer who has guided the early development, global registration studies, and marketing approval of multiple kinase inhibitor therapies for patients with cancer," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "I am delighted to welcome him to the Nuvalent team, where his clinical vision and proven leadership will help drive the progression of our robust pipeline through multiple near-term clinical milestones."

Dr. Turner’s career reflects an established record of leadership across a broad range of precision oncology targets and therapeutic approaches, with a focus on highly selective kinase inhibitors.

Most recently, Dr. Turner was Vice President of Clinical Development at Blueprint Medicines, where he oversaw the development and approval of kinase inhibitor GAVRETO (pralsetinib) in RET fusion positive NSCLC and RET altered thyroid cancer. Additionally, Dr. Turner oversaw development programs for kinase inhibitors targeting FGFR4 and EGFR with emergent resistance mutations.

Dr. Turner previously led the development of novel antibody-drug conjugate (ADC) and immune-oncology pipeline compounds at Celldex Therapeutics, and prior to that, the clinical development at Ariad Pharmaceuticals of two kinase inhibitors that have since been approved, ICLUSIG (ponatinib) for patients with chronic myeloid leukemia, and ALUNBRIG (brigatinib) for patients with ALK-positive NSCLC.

"Smart target selection and selective inhibitor design are critical cornerstones of successful drug development, and the clear foundation for Nuvalent’s focused discovery efforts," said Dr. Turner. "I look forward to working together with this highly dedicated team to deliver tangible benefits to patients with cancer through innovative new kinase inhibitors that address treatment resistance, minimize adverse events, and drive more durable responses."

Dr. Turner is board certified in both Pediatrics and Pediatric Hematology and Oncology. He received his M.D. from the University of Rochester School of Medicine and Dentistry and completed a residency in General Pediatrics at the Children’s National Medical Center in Washington, D.C, as well as fellowships in both Pediatric Hematology/Oncology and Pediatric Neuro-Oncology at Duke University Medical Center. Dr. Turner has held positions as Director of the Pediatric Neuro-Oncology Outcomes Clinic at the Dana-Farber Cancer Institute/Children’s Hospital Boston and as an Instructor of Pediatrics at Harvard Medical School, where he treated children and young adults with brain tumors.

Nuvalent launched in January 2021 with a $50M Series A financing from Deerfield Management. The company’s novel molecules have been designed through Nuvalent’s proprietary discovery efforts to specifically solve for the dual challenges of kinase resistance and selectivity.

On March 23, 2021, Surface Oncology, Inc. (the "Company") reported that it entered into an Exclusive Product License Agreement (the "License Agreement") with Vaccinex, Inc. ("Vaccinex") (Filing, 8-K, Surface Oncology, MAR 23, 2021, View Source [SID1234578978]). Pursuant to the License Agreement, Vaccinex granted the Company a worldwide, exclusive, sublicensable license to make, have made, use, sell, offer to sell, have sold, import, and otherwise exploit licensed products that incorporate certain Vaccinex intellectual property which covers certain antibodies, including the antibody SRF114 targeting CCR8 (the "Licensed Products"). Under the License Agreement, the Company is obligated to use commercially reasonable efforts to develop, clinically test, achieve regulatory approval, manufacture, market and commercialize at least one Licensed Product and the Company has the sole right to develop, manufacture and commercialize the Licensed Products worldwide. The Company is responsible for all costs and expenses of such development, manufacturing and commercialization.

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Pursuant to the License Agreement, the Company paid Vaccinex a one-time fee of $850,000. Vaccinex is eligible to receive up to an aggregate of $3,500,000 based on achievement of certain clinical milestones and up to an aggregate of $11,500,000 based on achievement of certain regulatory milestones per Licensed Product. The Company also owes low single digit royalties on global net sales of any approved Licensed Products. Commencing on the third anniversary of the date of the License Agreement and continuing until the first dosing of a Licensed Product in a clinical trial, the Company will be required to pay Vaccinex a nominal yearly maintenance fee.

The License Agreement contains certain customary representations and warranties and indemnification obligations of each of the Company and Vaccinex.

The Company may terminate the License Agreement for convenience upon the notice period specified in the License Agreement. Either party may terminate the License Agreement for an uncured material breach by the other party. Vaccinex may terminate the License Agreement if the Company defaults on any payments owed to Vaccinex under the License Agreement, if the Company is in material breach of, and fails to cure, its development obligations, or institutes certain actions related to the licensed patents. In the event of termination, all rights in the licensed intellectual property would revert to Vaccinex.

The above description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, with confidential portions redacted, and will be incorporated by reference herein.

On March 23, 2021 CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, reported the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing (Press release, CellMax Life, MAR 23, 2021, View Source [SID1234577108]). Participation in the financing also includes a strategic investment from new investor, Aflac Ventures, the corporate venture arm of Aflac Incorporated (NYSE: AFL), and existing investor, ArtimanVentures.

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"Strategic financing from market leaders, Sebela and Aflac Ventures, is a testament to CellMax’s technology and vision," said Atul Sharan, chief executive officer, CellMax Life. "Sebela has a leading market position in the gastroenterology field in the United States. The financing will bring to life our vision of detecting colon cancer before it occurs through a globally marketed blood test that can detect pre-cancerous polyps."

The Series C financing will be used to accelerate the clinical development of CellMax’s multimodal liquid biopsy test, FirstSight, for the detection of colorectal cancer and pre-cancerous polyps, also known as advanced adenomas. CellMax recently initiated a multicenter U.S. study to further optimize its proprietary algorithm and cell capture techniques. CellMax and Sebela will collaborate on completing the development of FirstSight and, following approval from the U.S. Food and Drug Administration, Sebela will commercialize the test in the United States.

"For the last several years, we have closely followed the industry’s development of colorectal cancer liquid biopsies," said Alan Cooke, chief executive officer, Sebela Pharmaceuticals. "Sebela and our subsidiary, Braintree, have worked with gastroenterologists for over 35 years, and we expect FirstSight to play a central role in the future of colorectal cancer screening. FirstSight may not only enable the U.S. to exceed its 80% screening rate target, as set by the National Colorectal Cancer Roundtable, but can also help detect pre-cancerous adenomas early, referring patients to colonoscopy for preemptive removal."

This partnership complements Sebela’s portfolio of market-leading gastroenterology and colonoscopy preparation products, which are utilized to facilitate colonoscopies, the "gold standard" for the prevention and detection of colorectal cancer. Colonoscopies remain the only means of removing detected pre-cancerous lesions to prevent colorectal cancer.

At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium, Dr. Shai Friedland, professor of medicine at Stanford University Medical Center and chief of gastroenterology at the VA Palo Alto Health Care System, presented results from a prospective study performed on 458 subjects utilizing FirstSight, a multimodal assay comprised of circulating dysplastic epithelial cells and circulating tumor DNA mutation markers, in combination with a proprietary algorithm.

"A test that detects only colorectal cancer, and not adenomas, will result in missed opportunities to prevent cancer and subject patients to invasive cancer treatments," said Dr. Friedland. "Today, there is not a single non-invasive screening test that can accurately detect pre-cancerous polyps even nearly as effective as a colonoscopy. Our study data with the FirstSight blood test continues to show consistent ability to detect advanced adenomas with high sensitivity, enabling removal before they progress to carcinomas."

In clinical studies performed in the U.S. and Taiwan, FirstSight has demonstrated strong performance in detecting both advanced adenomas and colorectal cancer. FirstSight has also shown the ability to detect recurrent neoplasia following polypectomy. i-v

Colorectal cancer represents the second deadliest cancer in the U.S., despite being one of the most preventable.vi Additionally, screening adherence rates have fallen short of the 80% target, as only 68.8% of adults aged 50 to 75 years, and only 63.3% of adults aged 50 to 64 years, were up to date with colorectal cancer screening as of 2018.vii

On March 23, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported fourth quarter and full year 2020 results and provided a corporate update (Press release, aTyr Pharma, MAR 23, 2021, View Source [SID1234577091]).

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"Amidst the backdrop of the COVID-19 pandemic, 2020 was a highly productive year for aTyr that included significant clinical, research and discovery advancements that we expect to yield value for the company throughout 2021," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We are highly encouraged by our progress and look forward to building upon our programs and novel tRNA synthetase biology platform as we move forward this year."

"Most notably, we have advanced and expanded our clinical program for ATYR1923. We completed enrollment in our Phase 1b/2a trial for our lead interstitial lung disease (ILD) indication, pulmonary sarcoidosis, and data from this proof-of-concept study is expected in the third quarter of this year. We also reported positive results from a Phase 2 trial in patients with COVID-19, which demonstrated ATYR1923’s favorable safety profile and a signal of clinical activity. Furthermore, we gained key mechanistic insights from the study’s biomarker data, which showed that ATYR1923 is impacting inflammation in patients consistent with what we have seen preclinically, including inflammatory cytokines that are implicated in sarcoidosis and other forms of ILD."

"In order to accomplish such progress, we have remained steadfast with the efficient and judicious use of our capital. The capital we generated in 2020, including the upfront payment received under the Kyorin Agreement, and elimination of debt allowed us to end 2020 with approximately $31.7 million in cash. The year-end cash number, along with the more than $25.0 million we’ve received since year end from the receipt of a milestone payment and use of our equity vehicles, position us well to carry out our catalysts for the year ahead."

Fourth Quarter 2020 and Subsequent Period Highlights

Completed enrollment in its Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data is expected in the third quarter of this year.
Reported positive results from its Phase 2 randomized, double blind, placebo-controlled study of ATYR1923 in 32 COVID-19 patients with severe respiratory complications. The study met its primary safety endpoint and demonstrated a signal of activity through clinical improvement in the 3.0 mg/kg cohort compared to placebo. Biomarker data from the study showed that patients treated with ATYR1923 demonstrated a trend of overall improvement in 82% (14 of 17) of biomarkers analyzed compared to placebo. ATYR1923 reduced several inflammatory cytokines and chemokines, including those that are implicated in sarcoidosis and other ILD, which is consistent with findings from animal models. The data provides the first-in-patient mechanistic proof-of-concept for ATYR1923.
Under the collaboration and licensing agreement with Kyorin Pharmaceutical, Co., Ltd. (Kyorin) (the Kyorin Agreement) entered in early 2020 for the development and commercialization of ATYR1923 for ILD in Japan, aTyr has received $10.0 million in upfront and milestone payments.
Presented preclinical findings in a poster at the Keystone Symposia: Tumor Metabolism and the Microenvironment demonstrating that NRP2 is expressed on key immune suppressive cells, further validating NRP2 as a potential regulator of solid tumor progression.
Appointed leading cancer researcher Judith Varner, PhD, as a scientific advisor to the company to support the development of its NRP2 antibody programs. Dr. Varner, whose expertise includes myeloid cell biology and tumor macrophage signal transduction, currently serves as Professor in the Departments of Pathology and Medicine at the Moores Center at the University of California, San Diego.
Had two posters accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The posters, titled "The Neuropilin-2 targeting antibody ATYR2810 inhibits non-small cell lung cancer tumor growth in monotherapy and combination therapy" and "A domain-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast cancer," were completed in conjunction with the company’s scientific advisor Dr. Arthur Mercurio and his lab at the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School.
Presented a poster at the Society for Laboratory Automation and Screening International Conference and Exhibition describing the company’s novel approach to identify receptor targets for two extracellular tRNA synthetase fragments Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS), further validating the company’s biology platform.
Announced two tRNA synthetase discovery programs from its pipeline to investigate the functionality of selected fragments of AARS and DARS in cancer, fibrosis and inflammation. The programs will initially focus on natural killer cell biology.
Fourth Quarter 2020 Financial Results

Total revenues were $2.1 million and $0.1 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to $2.0 million from license and collaboration agreement revenue under the Kyorin Agreement. Research and development expenses were $4.7 million and $3.6 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between periods at $2.3 million and $2.5 million for the three months ended December 31, 2020 and 2019, respectively.

Year Ended 2020 Financial Results and Cash Position

Total revenues were $10.5 million and $0.4 million for the years ended December 31, 2020 and 2019, respectively. The increase was due primarily to $10.0 million from license and collaboration agreement revenue under the Kyorin Agreement. Research and development expenses were $17.3 million and $14.0 million for the years ended December 31, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between periods at $9.1 million and $9.4 million for the years ended December 31, 2020 and 2019, respectively.

As of December 31, 2020, aTyr had $31.7 million in cash, cash equivalents and investments. In November 2020, the company repaid all long-term loans. Since December 31, 2020, the company received $2.0 million related to the Kyorin Agreement, raised approximately $9.9 million in gross proceeds from its at the market offering program, before deducting commissions and offering expenses payable by aTyr and raised approximately $15.3 million in gross proceeds from its purchase agreement with Aspire Capital Fund, LLC.

The company expects its research and development expenses to increase in 2021 as it continues to develop ATYR1923 and ATYR2810 as well as its discovery programs.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 3291668. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.