On March 6, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that the U.S. Food and Drug Administration ("FDA") approved a single-dose, prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia (Press release, Coherus Biosciences, MAR 6, 2023, View Source [SID1234628183]). The UDENYCA autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.

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"The introduction of the autoinjector option for UDENYCA, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients," said Dr. Lee Schwartzberg, Chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and Professor of Clinical Medicine, University of Nevada. "There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device."

"The UDENYCA autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment," said Denny Lanfear, CEO of Coherus.

The UDENYCA autoinjector (AI) is an intuitive design with administration triggered by push-on-skin activation, immediately and reliably delivering a complete pegfilgrastim dose. The approval of UDENYCA AI was supported by a comprehensive analytical data package, as well as a pharmacokinetic, pharmacodynamic and immunogenicity study.1

Commercial availability of UDENYCA AI is planned for the second quarter of 2023.

About UDENYCA

UDENYCA is the only pegfilgrastim brand offering two on-demand options—prefilled syringe (PFS) and AI providing more choice and flexibility customized to meet the needs of patients and practices. UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device is under review by the FDA. If approved, UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system. Since its launch in 2019, over 263,000 patients have been treated with UDENYCA.

INDICATION
UDENYCA is a leukocyte growth factor indicated to

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS):
Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Prescribing Information available at www.UDENYCA.com

On March 6, 2023 Cellectis S.A. (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that Calyxt, Inc. (Nasdaq: CLXT), a plant-based synthetic biology company for which Cellectis owns 49.1% (as of December 31, 2022) of its issued and outstanding common stock, reported operating and financial results for its fourth quarter ended December 31, 2022 (Press release, Cellectis, MAR 6, 2023, View Source [SID1234628182]). The contents of Calyxt’s announcement are included below:

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—Announced proposed merger with Cibus Global and filed initial registration statement on Form S-4—

—Current customer projects under development are on track—

—Signed agreement with Evologic Technologies to further develop and scale production of its Plant Cell Matrix and BioFactoryTM technologies—

Merger Agreement with Cibus

On January 17, 2023, Calyxt announced it had entered into a definitive merger agreement with Cibus Global, LLC (Cibus), a leader in precision gene editing in agriculture, under which Calyxt and Cibus will merge in an all-stock transaction. The merger will create a new industry-leading company that combines the two pioneers in agriculture-based gene editing and establishes one of the world’s most sophisticated facilities for trait development and next-generation plant breeding.

Under the terms of the merger agreement, Calyxt will issue shares of its common stock to Cibus shareholders in an exchange ratio such that upon completion of the merger, Calyxt shareholders will own approximately 5% of the combined company, subject to adjustments permitted by the merger agreement. The Boards of Directors of both companies have unanimously approved the transaction. Concurrent with the execution of the merger agreement, certain officers of Calyxt, all of Calyxt’s directors, and Cellectis S.A., Calyxt’s largest shareholder, executed support agreements in favor of the merger. These support agreements provide 49.8% approval from Calyxt shareholders. A majority of Cibus’ shareholders have also provided support agreements in favor of the transaction. The merger is expected to close in the second quarter of 2023, subject to customary closing conditions, including approval of the merger by the shareholders of Calyxt.

"Cibus is an excellent strategic fit for Calyxt given our complementary technology platforms, and the merger provides a great opportunity to leverage multiple synergies to drive innovation and shareholder value," said Michael A. Carr, President and Chief Executive Officer of Calyxt. "I am deeply proud of the significant accomplishments made by our team and their commitment to further the science of biotechnology and synthetic biology in significant ways."

Upon closing of the transaction, the combined company, renamed Cibus Inc., is expected to trade on the Nasdaq Capital Market under the proposed ticker symbol CBUS. The current Cibus management team will lead the new combined organization with Rory Riggs assuming the roles of Chair of the Board of Directors and Chief Executive Officer. Corporate headquarters for the combined company will be located in San Diego, California and Calyxt’s offices, laboratory, and breeding facilities in Roseville, Minnesota will remain operational as a key site for the combined company.

On February 14, 2023, Calyxt filed a registration statement on Form S-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission. The Registration Statement contains a preliminary proxy statement / prospectus in connection with the transaction. Although the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Calyxt and the proposed transactions.

Other key accomplishments in the fourth quarter of 2022, and through the date of this press release, include the following:

Current Customer Projects Under Development are on Track

Calyxt continued to progress the pilot project for a major consumer packaged goods company with delivery of initial quantities of a plant-based chemistry for customer evaluation expected in the second quarter of 2023.
Calyxt continued to progress the development of its soybean-based palm oil alternative plant trait and it achieved the first milestone payment in the fourth quarter of 2022, with the overall project scheduled for completion in the first quarter of 2024, at which time the second milestone payment would be due.
Signed Agreement with Global Infrastructure Partner to Enable Growth and Scale of Calyxt’s Proprietary Plant Cell Matrix and BioFactory Technologies

On October 6, 2022, Calyxt announced that it signed an agreement with a manufacturing partner, Evologic Technologies GmbH (Evologic), to further develop and scale Calyxt’s proprietary Plant Cell Matrix (PCMTM) and BioFactory technologies. Evologic’s contract development and manufacturing services, based on its proprietary bioprocessing platform and technology, supports companies delivering unique and sustainable bioproducts. Under the terms of the agreement, Evologic will work alongside Calyxt to grow and scale Calyxt’s proprietary PCM structures and is currently scaling one PCM for Calyxt.
Additional Updates

In early November 2022, Calyxt reached a settlement with one of its technology vendors regarding alleged intellectual property infringement. As a result of the settlement, Calyxt received $750 thousand in the fourth quarter of 2022 and received another $750 thousand earlier in the first quarter of 2023.
Financial Results for the Three Months Ended December 31, 2022

Cash, cash equivalents, and restricted cash totaled $3.5 million as of December 31, 2022.
Revenue was nominal in the fourth quarter of 2022 compared to $1.9 million in the fourth quarter of 2021. The decrease in revenue was driven by the late 2021 completion of the wind-down of the Company’s soybean product line. Revenue in the fourth quarter of 2022 was primarily associated with the Company’s agreement with a food ingredient manufacturer to develop a palm oil alternative.
Total operating expenses were $3.4 million in the fourth quarter of 2022 compared to $6.6 million in the fourth quarter of 2021. The decrease was driven by actions taken by management to lower Calyxt’s operating expenses.
Cash runway, considering interim funding to be provided by Cibus as described in the Merger Agreement, is sufficient to fund operations through the second quarter of 2023.

On March 6, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has commenced an underwritten public offering of $150 million of shares of its common stock (Press release, BridgeBio, MAR 6, 2023, View Source [SID1234628181]). BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

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Goldman Sachs & Co. LLC, Evercore, and Morgan Stanley are acting as book-running managers for the proposed offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR that was previously filed with the U.S. Securities and Exchange Commission (SEC) on July 7, 2020 and automatically became effective upon filing. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, New York 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; Morgan Stanley & Co. LLC, by mail at 1585 Broadway, New York, New York 10036, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 6, 2023 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported a collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial that will evaluate the safety and feasibility of the Company’s lead clinical candidate motixafortide to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease (SCD), one of the most common genetic diseases globally (Press release, BioLineRx, MAR 6, 2023, View Source [SID1234628180]). Currently available mobilization regimens can carry serious risks and side effects for patients with SCD or may not reliably yield optimal numbers of HSCs for gene therapy.

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The clinical trial is part of the Company’s long-term growth strategy for motixafortide across multiple therapeutic areas, including a potential future indication as a stem cell mobilization agent to support gene therapy development.

"Autologous hematopoietic stem cell-based gene therapies now offer curative potential for patients with SCD, but they are dependent upon the collection of significant quantities of stem cells, including early progenitor stem cells," said John DiPersio, MD, PhD, Professor of Medicine and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine, and principal investigator of the trial. "The common mobilization agent G-CSF is contraindicated in patients with sickle cell disease, significantly limiting their stem cell mobilization options. The development of novel mobilization regimens has the potential to overcome this unmet need for patients."

"We are excited to be advancing this important collaboration, which has the potential to ultimately support sickle cell disease gene therapy for patients," said Tami Rachmilewitz, MD, Chief Medical Officer at BioLineRx. "Motixafortide is being developed across multiple therapeutic areas, including stem cell mobilization for multiple myeloma, treatment of pancreatic cancer, and now in support of stem cell mobilization for gene therapy development for genetic disorders, which, we believe, demonstrates its broad potential."

The proof-of-concept trial, which will study motixafortide as a single agent and in combination with natalizumab, will assess the safety and tolerability of the two regimens as mobilization agents of CD34+ hematopoietic stem cells in patients with SCD. The study is anticipated to begin enrollment in the second half of 2023.

About the Clinical Trial of Motixafortide in Sickle Cell Disease (SCD)
The trial is a safety and feasibility study to evaluate motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. The study will enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial’s primary objective is to assess the safety and tolerability of motixafortide alone and the combination of motixafortide + natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the kinetics of CD34+ HSPCs mobilization to peripheral blood in response to motixafortide alone and motixafortide + natalizumab in SCD patients.

About Sickle Cell Disease
Sickle cell disease (SCD) is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. Sickle cell disease arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells that tend to stick to blood vessels causing their occlusion. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.

On March 6, 2023 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the third quarter of fiscal year 2023 on March 13, 2023, after market close and will host a webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, MAR 6, 2023, View Source [SID1234628179]). Members of Avid’s senior management will discuss financial results for the third quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source