On October 5, 2021 Himalaya Therapeutics of Shanghai has submitted four INDs in China for two Conditionally Active Biologics, each one aimed at two solid tumor cancer indications(Press release, Himalaya Therapeutics, OCT 5, 2021, View Source [SID1234590817]). The company describes itself as a global clinical-stage biotech developing drugs that have more selective targeting for greater safety and efficacy. It also works to be more cost-efficient with highly predictable manufacturing compared to traditional antibodies. Himalaya, a majority owned subsidiary of San Diego’s BioAtla, develops BioAtla’s products in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On October 5, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Dr. Joseph Sarret, will present a company overview at the H.C. Wainwright 5th Annual NASH Investor Conference, being held virtually on October 12, 2021 (Press release, CohBar, OCT 5, 2021, View Source [SID1234590837]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

H.C. Wainwright 5th Annual NASH Investor Conference
Tuesday, October 12, 2021 at 12:00pm ET
Webcast: The presentation may be accessed via webcast at the scheduled time, or following the presentation, using the following link: View Source
A replay of the webcast will be available in the events section of the CohBar website for two weeks following the presentation.

On October 05, 2021 Lanier Biotherapeutics Inc., a developer of first-in-class antibodies targeting retina, dermatology, and Type 2 Inflammatory specialty diseases, reported that it has entered into a license agreement (the "Agreement") with Alloy Therapeutics ("Alloy"), a privately held drug discovery company (Press release, Abeome, OCT 5, 2021, View Source [SID1234592023]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Alloy will acquire the AbeoMouse and Direct Selection of Hybridomas (DiSH) antibody discovery technologies, which were originally developed by Abeome Corporation, Inc. ("Abeome"), one of Lanier’s two predecessor companies. Upon closing of the Agreement, Alloy will license to Lanier certain rights to AbeoMouse and Alloy’s ATX-Gx platform of proprietary transgenic mouse strains.

"We are pleased to enter into this mutually beneficial Agreement, which provides both companies with access to enabling antibody discovery technologies while augmenting our development pipeline and further strengthening our balance sheet," said Kirby Alton, Lanier’s Chairman.

Lanier was recently formed by combining the businesses of Abeome and Biophtha Inc., with bridge funding from investors, including founders Kirby Alton, PhD, former Senior Vice President of Development at Amgen; and Daniel White, MBA, former CEO of Clearside Biomedical. Messrs. Alton and White are joined by Lanier’s other two founders, Martin Simonetti, MS, MBA and Chris McLeod, MS, to form Lanier’s experienced leadership team:

President, CEO & Director, Daniel White, is an accomplished entrepreneur and visionary in the biotech and pharmaceutical space. As the founder and CEO of Clearside Biomedical, he led the company from early private financing through its initial public offering and brings a wealth of biomedical development and successful fundraising experience.
Chairman, Kirby Alton, reprises his role of Chairman of Abeome, and brings deep product development expertise gained as one of Amgen’s original scientists.
Director, Martin Simonetti, has significant Amgen and Genentech experience; an immense track record of leadership and growth across several biotechnology enterprises; and has led successful financings in both private and capital markets.
Director, Chris McLeod, is an experienced biotechnology executive with vast expertise in growth companies and strategic collaborations. He is a former Executive Vice President of CuraGen and President of 454 Life Sciences; and is the current managing partner of Elm Street Ventures.
Lanier is developing a portfolio of 11 first-in-class therapeutic antibodies for specialty disease across four major verticals: Multi-functional Retina, Type 2 Inflammation, Dermatology, and ImmunoOncology.

"With a robust portfolio of 11 first-in-class, proprietary therapeutic antibodies, we are eager to progress toward the clinic with our two lead candidates: one targeting retinal disease using our multifunction anti VEGF inhibitor and the second using the most advanced and proprietary anti IL25 to treat Type 2 Inflammatory diseases," said Daniel White, President and CEO of Lanier. "Lanier has initiated a fund raise to launch these two programs that hold promise for improving treatment to provide a better life for patients."

Multi-functional Retina

Lanier’s LNR 653.1 is a proprietary bifunctional antibody being developed for the treatment of retinal neovascularization diseases (wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. LNR 653.1 is designed to combine the anti-vascular endothelial growth factor (VEGF) effect of aflibercept (marketed as Eylea by Regeneron) with the anti-inflammatory and anti-apoptotic effects similar to that of secukinumab (marketed as Cosentyx by Novartis). Preclinical data suggest that LNR 653.1 is safe, with efficacy similar or superior to aflibercept. Lanier is currently conducting pre-formulation experiments and non-clinical functional testing, with plans to initiate investigational new drug ("IND")-enabling studies of LNR 653.1 in 2022.

Type 2 Inflammation

LNR 125.38 is a monoclonal antibody that inhibits the upstream cytokine IL-25. By reducing, or even eliminating the effects of downstream allergic and antiviral cytokines, LNR 125.38 targets Type 2 Inflammation, which is implicated in different atopic, allergic and inflammatory diseases. Lanier is prioritizing the development of LNR 125.38 across a broad range of potential treatments of moderate to severe asthma that is classified as either high or low eosinophil challenge by allergy or rhinovirus; chronic sinusitis with nasal polyps; and eosinophil esophagitis and gastritis. Preclinical data have demonstrated that LNR 125.38 significantly reduces Type 2 (downstream) cytokines and inflammatory cells in allergic mouse and rhinovirus-induced asthma exacerbations. Lanier is currently conducting pre-formulation experiments and non-clinical functional testing, with plans to initiate IND-enabling studies of LNR 125.38 in the second half of 2022.

Dermatology

Lanier is developing LNR 653.1 for the treatment of psoriasis, where functional testing has demonstrated potency and efficacy comparable to secukinumab and ixekizumab (marketed as Taltz by Eli Lilly). The Company is also developing LNR 125.38 for the treatment of chronic urticaria and atopic dermatitis.

ImmunoOncology

MT-6402 is an engineered toxin body manufactured by Molecular Templates, Inc., which contains a PDL-1 inhibitor previously licensed by it from Lanier’s extensive library of proprietary checkpoint inhibitors. In July, Molecular Templates dosed the first subject in a Phase 1 study evaluating MT-6402 in patients with PD-L1-positive solid tumors and expects to provide an update on the study by the end of this year.

On October 5, 2021 Coherus BioSciences, Inc. ("the Company"; Nasdaq: CHRS) reported positive results from a randomized, open-label, crossover study assessing the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed UDENYCA pre-filled syringe (PFS)(Press release, Coherus Biosciences, OCT 5, 2021, View Source [SID1234590818]). The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). No new safety signals were observed. The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of UDENYCA: OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Coherus plans a 2022 submission to the United States Food and Drug Administration (FDA) of a prior approval supplement to seek marketing authorization for the UDENYCA OBI and anticipates a standard 10-month review period. Coherus expects commercial launch of the UDENYCA OBI directly post approval.

"UDENYCA quickly became the top-selling pre-filled syringe pegfilgrastim in the U.S. within months of launch in 2019, establishing Coherus as a trusted partner to oncologists and demonstrating the power of biosimilar competition to expand patient access to an important cancer medicine," said Denny Lanfear, CEO of Coherus. "With our OBI program progress, we are excited by the potential to offer to providers and patients a new on-body injector presentation of UDENYCA, if approved, and to compete directly with Neulasta Onpro, which retains more than 50% share of the overall pegfilgrastim market."

An FDA-approved UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system and eliminate the need for patients to return to a hospital or other clinical setting the day after chemotherapy to receive UDENYCA.

About UDENYCA
UDENYCA is the #1 prescribed pegfilgrastim pre-filled syringe in the United States.
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.

Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

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.

On October 5, 2021 Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company’s CEO Dr. Pnina Fishman will present at the H.C. Wainwright 5th Annual NASH Investor Conference at 9:30 am ET on Tuesday, October 12, 2021 (Press release, Can-Fite BioPharma, OCT 5, 2021, View Source [SID1234590838]). The virtual conference will feature a panel discussion by several renowned key opinion leaders in NASH. Management will conduct virtual 1×1 meetings with institutional investors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Can-Fite’s drug candidate Namodenoson is expected to commence patient enrollment in a Phase IIb NASH trial in Q4 2021. In a prior Phase IIa NASH trial, Namodenoson achieved its study endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.

NASH is a clear and urgent unmet medical need, as there currently is no U.S. approved drug to treat the disease. As of 2016, NASH was the leading cause for liver transplants among women and second leading cause for liver transplants overall. NASH is expected to become the leading indication for liver transplants in males as well. The NIH estimates the incidence of NASH in the U.S. at 2-5% of the population. Incidence is increasing based on rising obesity rates. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.