On April 10, 2025 Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), reported that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use (Press release, Biocon, APR 10, 2025, View Source [SID1234651875]). JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor.

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The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY.

The U.S. FDA has approved Jobevne (bevacizumab-nwgd) from Biocon Biologics to treat several different types of cancer.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: "The U.S. FDA approval of JOBEVNE (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients."

In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.**

Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many "firsts" in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.

About JOBEVNE:

The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin (bevacizumab).

The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

INDICATIONS AND USAGE:

JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment.*
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.*
Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
Recurrent glioblastoma in adults.
Metastatic renal cell carcinoma in combination with interferon alfa.
Persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
in combination with carboplatin and paclitaxel, followed by JOBEVNE as a single agent, for stage III or IV disease following initial surgical resection
in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens
in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by JOBEVNE as a single agent, for platinum-sensitive recurrent disease
* Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer.

WARNINGS AND PRECAUTIONS:

Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any organ
Surgery and Wound Healing Complications: In patients who experience wound healing complications during JOBEVNE treatment, withhold JOBEVNE until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer JOBEVNE for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis.
Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage.
Arterial Thromboembolic Events (ATE): Discontinue for severe ATE.
Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE.
Hypertension: Monitor blood pressure and treat hypertension. Withhold until medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy.
Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue.
Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.
Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy.
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception.
Ovarian Failure: Advise females of the potential risk.
Congestive Heart Failure (CHF): Discontinue JOBEVNE in patients who develop CHF.
Please refer to full Prescribing Information for Jobevne (bevacizumab-nwgd) for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company.
OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company.
BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited.
All other trademarks are the property of their respective owners.
**Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data.

On April 10, 2025 Omeros Corporation (Nasdaq: OMER) reported the establishment of the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia (AML) (Press release, Omeros, APR 10, 2025, View Source [SID1234651874]). AML is the most fatal form of leukemia and accounts for approximately 80 percent of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow, representing a high unmet need. Omeros’ OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.

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Members of the Omeros Oncology Clinical Steering Committee include:

Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center (Chair of the Omeros Oncology Clinical Steering Committee)
Aref Al-Kali, M.D., Chair of the Acute Myeloid Group and Research Chair of the Acute Leukemia and Myeloid Neoplasms Disease Group at Mayo Clinic
Jessica K. Altman, M.D., Professor of Medicine in the Division of Hematology and Oncology and Director of the Leukemia Program of Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Jayastu Senapati, M.B.B.S., M.D., D.M., Assistant Professor in the Department of Leukemia at MD Anderson Cancer Center
Mithun Shah, M.D., Ph.D., Assistant Professor of Medicine and Oncology, and Consultant in the Division of Hematology at Mayo Clinic
Anthony S. Stein, M.D., Co-director of the Gehr Family Center for Leukemia Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at City of Hope
Eytan M. Stein, M.D., Chief of the Leukemia Service and Director of the Program for Drug Development in Leukemia in the Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center
Roland B. Walter, M.D., Ph.D., M.S., Professor in the Translational Science and Therapeutics Division and José Carreras/E. Donnall Thomas Endowed Chair for Cancer Research at the Fred Hutchinson Cancer Center
The steering committee will, among other activities, assist Omeros with development of the OncotoX-AML program, clinical trial design and interactions with institutional review boards and will participate in OncotoX-AML clinical trials.

"AML is a devastating disease, and these patients have difficulty tolerating the side effects of chemotherapeutic agents and current antibody-drug conjugates, which generally have a narrow therapeutic index," stated Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center and Chair of the Omeros Oncology Clinical Steering Committee. "The OncotoX platform is designed to kill only dividing cancer cells while sparing normal cells. In animal models using cell lines derived from AML patients, the OncotoX-AML molecule has shown superior efficacy to current standard of care in AML treatment, and its potential utility extends broadly beyond AML to other types of leukemia. Together with my esteemed physician-scientist colleagues on the steering committee, I look forward to advancing the Omeros therapeutic for AML and bringing this novel treatment to patients as quickly as possible."

Across extensive in vivo and ex vivo studies, the OncotoX-AML therapeutic has shown to be highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy (venetoclax and azacytidine). These studies, conducted with human cell lines in well-established animal models and considered predictive of clinical response, have targeted AML tumors with mutational backgrounds commonly found in nearly 90 percent of AML patients (TP53, NPM1, KMT2a, and FLT3) indicating that the OncotoX-AML therapeutic could be "mutation-agnostic," a currently large unmet need for oncologists and their patients. In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells). OncotoX-AML also targets leukemia stem cells (LSC), which are often refractory to chemotherapy and represent another major challenge in the treatment of AML. The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse. Preliminary in vivo tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values.

Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic. Clinical efficacy in AML, considered one of the most aggressive leukemias, is thought to bode well for a therapeutic agent’s broad applicability across leukemias. In addition to OncotoX-AML, Omeros’ portfolio of oncology platforms include signaling and antigen-driven immunomodulators, immune memory-enhancing immunostimulators, and an adoptive T-cell technology that, unlike other cell therapy approaches, does not require cellular engineering.

"We are very pleased to be working with all the members of our oncology steering committee," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "Each is an internationally recognized leader in the fields of leukemia and AML and has been integrally involved in the development of new treatments for their patients. Their willingness to invest time and effort in our OncotoX-AML program is a strong endorsement of our molecule’s potential and, with their help, we look forward to assessing this next-generation therapeutic in AML patients."

In the U.S. alone, AML is diagnosed in over 20,000 patients annually and is responsible each year for more than 11,000 deaths. In 2030, the global AML therapeutic market size is projected to be over $6 billion with the leukemia therapeutic market forecast at $29 billion.

On April 10, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting taking place from April 26, 2025 to April 29, 2025 in Las Vegas (Press release, Protara Therapeutics, APR 10, 2025, View Source [SID1234651873]).

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A copy of the abstract for the ADVANCED-2 interim analysis is now available on the AUA website. Updated safety and efficacy data, including data from patients who have reached the 12-month evaluation timepoint, will be featured during an interactive poster session on Saturday, April 26, 2025.

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=30). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the U.S. Food and Drug Administration’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment, Draft Guidance for Industry.

Presentation Details:

Title: Preliminary Anti-Tumor Activity and Safety Results from ADVANCED-2: A Phase 2 Open-Label Study of Intravesical TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
Session: Bladder Cancer: Non-Invasive I
Presenter: Gautam Jayram, M.D., Director, Advanced Therapeutics Center, Urology Associates P.C., Nashville, TN
Session Date and Time: Saturday, April 26, 2025, 7:00 a.m. – 9:00 a.m. PT
Location: Marco Polo 701
Title: ADVANCED-2: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
Session: Clinical Trials in Progress: Bladder Cancer
Presenter: Brian Mazzarella, M.D., Vice President of Research at Urology America, Austin, TX
Session Date and Time: Monday, April 28, 2025, 9:16 a.m. – 9:24 a.m. PT
Location: Hall C, The Square, Learning Lab
AUA Learning Lab Featured Trials Panel Discussion Details:

Title: ADVANCED-2: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
Moderator: Jacqueline Zummo, Ph.D., Co-Founder, Senior Vice President, Chief Scientific Operations Officer, Protara Therapeutics
Speakers:
Timothy D. Lyon, M.D., Associate Professor of Urology and Urology Residency Program Director at Mayo Clinic, Jacksonville, FL
Brian Mazzarella, M.D., Vice President of Research at Urology America, Austin, TX
Alex Sankin, M.D., MS, Director of Clinical Trials Program, Associate Program Director of Urology Residency, Associate Professor and Attending Physician at Montefiore Medical Center, Bronx, NY
Date and Time: Monday, April 28, 2025, 11:00 a.m. – 11:30 a.m. PT
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On April 10, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification (Press release, Pasithea Therapeutics, APR 10, 2025, View Source [SID1234651872]). This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date during the DLT period in any of the first 19 patients in either capsule (15 patients) or tablet (four patients) formulation of PAS-004. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the discontinuation rate in real world practice.

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"We are seeing substantial enrollment demand and have already identified Cohort 6 patients. In addition, we continue to observe substantial exposure levels of PAS-004, and remain excited about the possibility of delivering relevant pERK inhibition below the no observed adverse effect levels (NOAEL) as we modeled and observed during our previously conducted nine-month chronic toxicity studies. The on label rash rate for both approved MEKi for NF1 exceeds 80% which leads to patients discontinuing who otherwise should remain on treatment for longer periods of time", stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We will provide additional safety, pharmacokinetic (PK) and pharmacodynamic (PD) data over the next several weeks."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

On April 10, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported it was discussed by field-leading key opinion leaders (KOLs) during a recent event hosted by H.C. Wainwright (Press release, Oncolytics Biotech, APR 10, 2025, View Source [SID1234651871]).

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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

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Martine Piccart, M.D., Ph.D., an Honorary Professor of Oncology at the Université Libre de Bruxelles (ULB) and Scientific Director of Oncology at the Institut Jules Bordet, in Brussels, Belgium, offered a detailed overview of the HR+/HER2- metastatic breast cancer landscape and emphasized the need for new treatment innovations, such as pelareorep, that work to activate the immune system to recognize and kill cancer.

Alexander Eggermont, M.D., Ph.D., Professor of Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany, provided insights on the current standards for treating pancreatic ductal adenocarcinoma (PDAC), a cancer type known for its resistance to treatment, and the potential impacts that an immunotherapy such as pelareorep might have on the field.