On March 24, 2021 Step Pharma, a biotech company developing novel drugs for oncology and autoimmune diseases, reported the successful closing of a EUR35 million Series B financing (Press release, Step Pharma, MAR 24, 2021, View Source [SID1234577054]). New investors Hadean Ventures and Sunstone Life Science Ventures co-led the round, joining existing investors Kurma Partners, Pontifax and Bpifrance, which reinvested through its Innovative Biotherapies and Rare Diseases fund and InnoBio 2 fund. As part of the financing, Jacob L Moresco from Sunstone Life Science Ventures and Walter Stockinger from Hadean Ventures will join the Step Pharma Board of Directors.

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The proceeds will be used to advance Step Pharma’s lead proprietary CTPS1 inhibitor, STP938, into clinical development for the treatment of T-cell malignancies. In addition, Step Pharma will use the funding to advance development of CTPS1 inhibitors in other haematological malignancies and solid tumours. CTPS1 (cytidine triphosphate synthase 1) is an enzyme that plays a critical role in DNA synthesis, cell division and proliferation but whose function is highly selective to certain cell types, in particular proliferating T cells, making it an ideal target for drug development.

Roger Franklin, Partner at Hadean Ventures said: "CTPS1 is an elegant target for the development of drugs in the T-cell malignancy space in which there is significant unmet need. The strength of the underlying science, its support from human genetic work as well as the clear commercial opportunity were key factors in our decision to back Step and co-lead this significant financing. We very much look forward to working with the great team at Step Pharma as this exciting programme moves into the clinic."

"Step Pharma is a clear leader in CTPS1 research. They have made significant progress in advancing their first-in-class selective CTPS1 inhibitors toward clinical development and expanding the potential therapeutic applications," added Jacob L Moresco from Sunstone Life Science Ventures

"The closing of this Series B will enable Step Pharma to transform into a clinical-stage company and advance our lead compound into the clinic in Q1 2022," said Andrew Parker, CEO of Step Pharma. "We’d like to welcome our new investors and thank existing investors for their continued support of the company."

Targeting CTPS1
Cytidine nucleotide triphosphate (CTP) is a precursor required for DNA synthesis and cell division. Patients deficient in the enzyme CTPS1 have an altered immune cell proliferation response to immune challenge but no other deleterious effects. This same pathway supports the uncontrolled growth of cancerous T and B cells, thus inhibiting CTPS1 represents a novel precision oncology approach to specifically block proliferation and induce killing of cancerous cells in lymphoma and leukaemia.

On March 23, 2021 Bayer reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi, for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors (Press release, Bayer, MAR 23, 2021, View Source;ref=irrefndcd#:~:text=Berlin%2C%20March%2023%2C%202021%20%E2%80%93,advanced%20or%20recurrent%20solid%20tumors [SID1234613723]). Vitrakvi is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion. Vitrakvi has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion cancer. For those patients with primary central nervous system (CNS) tumors and with CNS metastases, responses and a high disease control rate have been observed. It is already approved in the U.S., countries of the European Union (EU), the UK and other markets around the world.

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"There remains a high unmet need for new and innovative cancer treatments in Japan. The approval of Vitrakvi marks an important step towards treating TRK fusion cancer based on the oncogenic driver rather than the site or origin in the body," said Makoto Tahara, MD., Ph.D. Chief, Department of Head and Neck Medical Oncology, National Cancer Center Hospital East. "Clinicians now have the option to replace less tailored treatment approaches with a precision oncology treatment specifically designed to treat patients with TRK fusion cancer."

The marketing authorization of Vitrakvi follows the approval of the expanded use of FoundationOneCDx, a comprehensive genomic profiling (CGP) test, in Japan for use as a companion diagnostic (CDx) to identify patients with TRK fusion cancer who are expected to benefit from treatment with Vitrakvi. The CDx approval is part of the global collaboration between Bayer and Foundation Medicine, Inc. (FMI), for which Chugai is the local development partner of FMI.

"Treatments that directly address the genomic abnormality driving tumor growth, such as Vitrakvi, can provide value to patients and physicians in Japan with the potential to significantly improve treatment outcomes regardless of tumor type or patient age," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. "This approval further underscores the importance of high quality and accessible genomic testing to allow more precise identification of patients who are most likely to benefit from a treatment specifically designed to treat tumors with an NTRK gene fusion. It supports clinicians to get the right treatment, that is efficacious and has a favorable safety profile, to the right patient at the right time."

The approval of Vitrakvi in Japan is based on data from 125 patients from the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. Results analyzed from the NAVIGATE trial population showed an overall response rate (ORR) of 65.2% with a complete response (CR) rate of 16.9% and in SCOUT an ORR of 88.9% with a CR rate of 22.2%. Larotrectinib showed a favorable safety profile based on the safety data from 116 patients in the NAVIGATE trial and 73 patients in the SCOUT trial.

TRK fusion cancer is rare overall, affecting both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body. Vitrakvi, an oral, highly selective TRK inhibitor, was investigated in clinical trials across multiple different histologies of solid tumors including lung and thyroid cancer, melanoma, gastrointestinal stromal tumors, colon and breast cancer, soft tissue sarcomas, salivary gland cancer and infantile fibrosarcoma. It has shown remarkable efficacy and tolerability across tumor types regardless of patient age in clinical trials with a follow-up time of more than three years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors.

About Vitrakvi (Larotrectinib)
Vitrakvi (larotrectinib), a highly selective TRK inhibitor, was exclusively designed to treat tumors that have a NTRK gene fusion. The compound has demonstrated high response rates and durable responses over three years in adults and children with TRK fusion cancer, including responses and a high disease control rate in central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The dataset of 159 patients was published in The Lancet Oncology and additional updates were presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020.

Vitrakvi is approved in more than 40 countries, including the U.S., countries of the European Union (EU), the UK and other markets around the world. Additional filings in other regions are underway or planned.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer now possesses the exclusive rights to develop and commercialize larotrectinib worldwide, and also has exclusive rights to the investigational TRK inhibitor selitrectinib (BAY 2731954) which is currently in clinical development.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. We have the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. Bayer focuses its research activities on first-in-class innovations across the following scientific platforms: Oncogenic Signaling, Targeted Alpha Therapies, and Immuno-Oncology. A key focus at Bayer is on innovative precision oncology treatments, with an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread, and another TRK inhibitor advancing through the pipeline. The company’s approach to research prioritizes targets and pathways with the potential to impact the way that cancer is treated.

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.