On March 1, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen. The product will be marketed under the proprietary name RELEUKOTM (Press release, Amneal Pharmaceuticals, MAR 1, 2022, View Source [SID1234609293]).

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RELEUKOTM was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Amneal expects to launch RELEUKOTM in the third quarter of 2022, along with a full patient support program.

The Company is planning for a pegfilgrastim biosimilar referencing Neulasta and a bevacizumab biosimilar referencing Avastin to launch in 2022. Both are being reviewed by the FDA.

"The U.S. approval of our first biosimilar is a very significant milestone for Amneal. Biosimilars represent the next wave of providing access to affordable medicines in the U.S. We are building a global biosimilars business by leveraging partner assets to start and then leveraging our own key capabilities over time. Our goal is to become a meaningful long-term player in biosimilars," said Chirag and Chintu Patel, Co-Chief Executive Officers.

"It is a proud moment for the Kashiv Biosciences team and our partners at Amneal to have our first biosimilar, RELEUKO, approved by the U.S. FDA. Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible," said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

According to IQVIA, U.S. annual sales for filgrastim for the 12 months ended December 2021 were $407 million, of which $275 million represents biosimilar sales.

RELEUKOTM in the U.S. is indicated:

To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
RELEUKOTM IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before you take RELEUKOTM, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

WARNINGS AND PRECAUTIONS

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKOTMin patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKOTM. Discontinue RELEUKOTMif sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKOTM in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKOTM. Consider dose-reduction or interruption of RELEUKOTMin patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKOTMin conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia

On March 1, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that Janux management will participate in three upcoming investor conferences (Press release, Janux Therapeutics, MAR 1, 2022, View Source [SID1234609292]):

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Cowen’s 42nd Annual Health Care Conference
Forum: Panel titled "Novel IO"
Location: Virtual
Date: Monday, March 7
Time: 10:30 a.m. – 11:30 a.m. ET

Barclays Global Healthcare Conference
Forum: Corporate Presentation
Location: Miami, Florida
Date: Wednesday, March 16
Time: 2:35 p.m. – 3:00 p.m. ET

Oppenheimer’s 32nd Annual Healthcare Conference
Forum: Corporate PresentationLocation: Virtual
Date: Thursday, March 17
Time: 8:40 a.m. – 9:10 a.m. ET

All presentations and subsequent archived replays may be accessed via the Investors & Media section of Janux’s website. An archived replay of the webcasts will be available on the website for approximately 90 days following the presentation.

On March 1, 2022 CatalYm reported treatment of the first patients in a series of phase 2a cohorts targeting solid tumors, initiating phase 2 development of CTL-002 (Press release, Catalym, MAR 1, 2022, View Source [SID1234609291]). The trial will evaluate the safety and efficacy of the company’s lead product candidate, the GDF-15 neutralizing antibody CTL-002 (visugromab), at the confirmed target dose in five cohorts in combination with nivolumab in patients that are relapsed/refractory to anti-PD1/-L1 treatment and in one cohort that is anti-PD-1/-L1 naïve. All six target tumor types were identified by translational research data to exhibit GDF-15-mediated tumoral immunosuppression.

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CTL-002, which the company will going forward refer to as visugromab, the recently approved International Nonproprietary Name (INN) by the World Health Organization, is a monoclonal antibody against the novel cancer target Growth and Differentiation Factor 15 (GDF-15). GDF-15 has been shown to play a central role in immune system evasion mechanisms in the tumor microenvironment and its overexpression correlates with reduced immune cell influx into the tumor, suppression of the adaptive immune response and poor outcome including anti-PD1/-L1 treatment resistance.

Visugromab has successfully completed phase 1 development demonstrating excellent tolerability as a monotherapy as well as in combination with a PD-1 checkpoint inhibitor. Initial results from the trial have been presented at the AACR (Free AACR Whitepaper)-EORTC-NCI meeting in October 2021 and at the SITC (Free SITC Whitepaper) Annual Meeting in Nov 2021. In this dose escalation trial named GDFATHER-1 (GDF-15 Antibody-mediaTed Human Effector cell Relocation phase 1, NCT04725474), several patients with solid tumor indications known to be difficult to treat with immune-oncology (I/O) therapy have shown deep and lasting responses post treatment with visugromab + nivolumab after prior failure of anti-PD1/-L1 therapy. Two of the three responders have already passed the six-month follow-up mark showing lasting and continued responses. The full results from the phase 1 part of the study including biomarker profile correlations are planned to be shared at an upcoming conference in the first half of 2022.

Prof. Ignacio Melero (Center for Advanced Medical Research, CIMA/Pamplona, Spain), Principal Investigator of the GDFATHER-1 trial, commented: "There is mounting evidence from several research groups demonstrating that GDF-15 plays an important role in tumor-mediated immunosuppression across various major solid tumor indications. Visugromab has the potential to neutralize GDF-15 in the tumor microenvironment and to reverse this immunosuppression. The initial signs of efficacy combined with a very safe combination treatment profile even in heavily pretreated patients are very encouraging to me and I look forward to seeing the impact visugromab will have on larger patient populations treated at earlier stages of the disease."

The initial phase 2a exploration, the GDFATHER-2 trial series, is planned to enroll up to 164 patients across six major solid tumor indications in trial sites in Spain, Germany and Switzerland in a Simon-2-stage design. The study will evaluate the efficacy of visugromab at target dose in combination with the PD-1 checkpoint inhibitor, nivolumab, in six solid tumor indications that were selected based on significant translational research data obtained by CatalYm and the phase 1 results. The first five cohorts will include patients with relapsed/refractory tumors that received PD-1 checkpoint inhibitor treatment prior to this study. The sixth cohort is recruiting PD-1 checkpoint naïve patients. The first results from the phase 2a study are expected in the second half of 2022.

Prof. Eugen Leo, Chief Medical Officer at CatalYm stated: "In 2021, we were able to demonstrate in the GDFATHER-1 trial that treatment with visugromab is not only safe and very well tolerated in a very advanced and heavily pretreated patient population, but we also saw encouraging signs of potent antitumoral activity in previously anti-PD1/-L1 relapsed/refractory patients. Now, in 2022, our goal is to maximize the clinical impact of our lead candidate in a variety of cancer indications both PD-1 refractory and naïve with the phase 2a GDFATHER-2 trial series. Advancing into phase 2a development marks an important scientific and clinical milestone for CatalYm and we are looking forward to sharing further data from our phase 1 trial and early phase 2 data with the scientific and medical community in the near future."

CatalYm’s CEO, Phil L’Huillier concluded: "Advancing this program into phase 2 at such a fast pace demonstrates the dedication and experience of our clinical operations and translational research team as well as our collaborators and I applaud them for their enormous contributions in making this possible. In light of the exciting emerging preclinical and clinical data for the program we will add further trial segments to our phase 2 program over the course of 2022 to further accelerate visugromab development towards a registration trial."

About the GDFATHER-2 Trials

The GDFATHER-2 trials (GDF-15 Antibody-mediaTed Human Effector cell Relocation phase 2) (NCT04725474) are ongoing first-in-human phase 2a cohorts investigating the effect of visugromab (CTL-002) as monotherapy and/ or in combination with a PD-1 checkpoint inhibitor in patients with advanced-stage, relapse/refractory solid tumors. The study consists of two segments with a total of six cohorts, enrolling up to 164 patients in Simon-2-stage designs to confirm a certain response rate within each tumor type. Five cohorts are within tumor types with anti-PD1/-L1 label, recruiting patients that either were refractory to or relapsed post prior anti-PD1/-L1 treatment. One cohort entails treatment of an anti-PD1/-L1 naïve tumor type in an indication without anti-PD1/-L1 approval.

About Visugromab (CTL-002)

Visugromab, formerly known as CTL-002, is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. Visugromab counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.

On March 1, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present at Cowen’s 42nd Annual Healthcare Conference being held virtually March 7-9, 2022 (Press release, Biodesix, MAR 1, 2022, View Source [SID1234609290]).

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Cowen’s 42nd Annual Healthcare Conference
Date: Tuesday, March 8, 2022
Time: 2:50 PM ET

The presentation will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On March 1, 2022 NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, reported its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors (Press release, NextRNA Therapeutics, MAR 1, 2022, View Source [SID1234609289]). Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs.

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The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called "non-coding RNAs," play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets.

"NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines," said Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA. "We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas."

NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. "By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines," said Dr. Novina, co-founder of NextRNA.

Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology.

"NextRNA is at the forefront of innovation in the field of non-coding RNAs," said Todd Kaloudis, Managing Director at Cobro Ventures. "There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients."