On November 10, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming virtual investor conferences (Press release, G1 Therapeutics, NOV 10, 2021, View Source [SID1234595184]).

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On November 17, 2021 at 8:00 AM EST, G1’s Chief Executive Officer Jack Bailey will present at the Stifel 2021 Virtual Healthcare Conference.

On December 1, 2021 at 12:35 PM EST, Mr. Bailey will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference.
The webcast of both events will be accessible on the Events & Presentations page of View Source

On November 10, 2021 Taiga Biotechnologies, a cell-based immunotherapy company, reported that the Company has completed the site initiation session for the first site to participate in the TBX-2400-01 clinical trial, a Phase 1/2 study to evaluate the safety and early efficacy of TBX-2400 in acute myeloid leukemia (AML) and myelofibrosis patients undergoing hematopoietic stem cell transplant (HSCT), in Croatia (Press release, Taiga Biotechnologies, NOV 10, 2021, View Source [SID1234595157]).

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Taiga’s platform technology, TBX-4000 uses the MYC protein to regulate cellular function. When exposed to immune cells, TBX-4000 delivers MYC across the cell membrane directly to the nucleus where MYC drives the activation and proliferation of the cell. Hematopoietic stem cells (HSCs) derived from either bone marrow or GCSF-mobilized apheresis material treated with TBX-4000 form a new product designated as TBX-2400. TBX-2400 is an allogeneic stem cell therapy that improves the rate of engraftment and reconstitution of the immune system for patients receiving a bone marrow transplant.

Taiga has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Rare Pediatric Disease Designation from the FDA and Advanced Therapy Medicinal Product Designation from the EMA.

"The initiation of this study, under the aegis of the Croatian Ministry of Health and the EMA, represents a significant milestone for our TBX-2400 clinical development program," said Dr. Yosef Refaeli, Chief Executive Officer of Taiga Biotechnologies. "We believe TBX-2400 has the potential to dramatically change the HSCT market by reducing the risk and increasing the success rate of HSCT, reducing time and cost by as much as 50%, thereby, turning it into a commonplace procedure. In addition, TBX-2400 requires 1000x fewer cells than current procedures, which is expected to eliminate the supply-demand issues that currently limit the number of procedures performed and should increase the number of eligible procedures for acute cases, such as leukemia and lymphoma. Importantly, it has the potential to treat other immune-based diseases, such as diabetes and multiple sclerosis." This clinical study will be managed by Optimapharm, a full service European CRO headquartered in Zagreb, Croatia.

"We hope to positively impact difficult to perform HSCT transplants with the TBX-2400 program. We are encouraged by earlier pre-clinical data that support TBX-2400’s ability to enhance homing to the specialized HSC niches in the bone marrow as well as to improve engraftment," said Brian C. Turner, P.D., Co-founder, President and Chief Scientific Officer of Taiga Biotechnologies.

"We are keen to test the ability of HSCTs treated with TBX-2400 in the context of adult bone marrow failure syndrome as well as in hematologic oncology indications in this study as it holds the promise to significantly enhance and improve outcomes for these very sick patients who are faced with limited treatment options," said Nadira Durakovic, M.D., Associate Professor at the University of Zagreb School of Medicine and University Hospital in Croatia and a principal investigator of the study.

About TBX-2400-01
TBX-2400-01 is a Phase I study to assess the safety and early efficacy of TBX-2400 in enhancing engraftment in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) for the treatment of acute myelogenous leukemia or myelofibrosis. This is an interventional clinical trial that seeks to recruit 10-20 patients in 3 clinical sites (The University Hospital in Zagreb, The Hadassah Medical Center in Jerusalem, Israel, and the Rambam Medical Center in Haifa, Israel). The primary endpoint relates to the incidence of HSCT related severe adverse events as well as the frequency of successful transplant engraftment. In addition, the secondary endpoints include specific assessments of immune cell function following transplantation and engraftment.

More information on this clinical trial can be found at View Source;draw=2&rank=1.

About TBX-2400
Taiga has developed a proprietary recombinant protein that can passively enter cells without the need for binding and uptake by a cell surface receptor, which can transiently alter intracellular levels of a critical protein involved in survival and proliferation called "MYC." Hematopoietic stem cells (HSCs) derived from either bone marrow or GCSF-mobilized apheresis material treated with TBX-4000 form a new product designated as TBX-2400. The treatment of HSCs with TBX-4000 leads to improved homing to the specialized HSC stem cell niches in the bone marrow as well as improved engraftment. The TBX-2400-01 clinical trial aims to test the safety and early efficacy of TBX-2400 cells in adults who suffer from myelofibrosis or relapsed/refractory acute myeloid leukemia. TBX-2400 has been awarded Orphan Disease Designation by the U.S. FDA and EMA. In addition, this program has also been awarded Rare Pediatric Disease designation by the U.S. FDA.

On November 10, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update (Press release, Lipocine, NOV 10, 2021, View Source [SID1234595156]).

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Third Quarter and Recent Corporate Highlights

Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US
Lipocine to receive up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions
Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and tiered royalties on net sales of TLANDO from mid-teens up to 20%
Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S.
Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%)
The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH")
The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period
The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA’s Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022
Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH
Study met its primary endpoint. At 12 weeks, treatment with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF
Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis
Efficacy and safety results from the LiFT study have been accepted for late-breaking presentations at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting on November 12-15, 2021
Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements
Third Quarter Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.03) per diluted share, for the third quarter ended September 30, 2021, compared with a net loss of $4.3 million, or ($0.07) per diluted share, for the third quarter ended September 30, 2020.

Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense.

As of September 30, 2021, the Company had $38.7 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Subsequent to the end of the third quarter, the Company received an $11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO.

Nine Months Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $13.3 million, or ($0.15) per diluted share, for the nine months ended September 30, 2021, compared with a net loss of $16.5 million, or ($0.32) per diluted share, for the nine months ended September 30, 2020.

Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study, a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $4.3 million for the nine months ended September 30, 2021, compared with $5.9 million for the nine months ended September 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense. These decreases were offset by an increase in corporate insurance expense.

On November 10, 2021 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported third quarter 2021 financial results and a corporate update (Press release, Ryvu Therapeutics, NOV 10, 2021, View Source [SID1234595155]).

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"In the third quarter Ryvu has achieved several important milestones for its proprietary pipeline programs", said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We are excited to announce the latest clinical and translational data for our most advanced project RVU120 at the upcoming ASH (Free ASH Whitepaper) and SABCS conferences, and our preclinical data on HPK1 and STING compounds at the SITC (Free SITC Whitepaper) conference in November. These encouraging data further reinforce the therapeutic potential of our programs, and we look forward to seeing how our discovery and research are translating into a tangible promise for cancer patients."

Recent Highlights

Two Poster Presentations of HPK1 and STING programs at SITC (Free SITC Whitepaper)’s 36th Annual Meeting
Ryvu will present a poster on novel, orally administered HPK1 inhibitors which exhibit nanomolar activity in an immunosuppressive environment. These small molecules have shown favorable PK profiles allowing for in vivo target engagement after oral administration, and hold promising potential as a treatment in a variety of solid tumor indications.

The second poster will highlight a novel small-molecule STING agonist, RVU-27065. Selective STING pathway activation with RVU-27065 allows for repolarization of immunosuppressive tumor-associated macrophages into a pro-inflammatory phenotype without a negative impact on T-cell functioning. With favorable drug-like properties and good safety profile, RVU-27065 is a promising candidate for standalone treatment as well as targeted delivery as a payload for antibodies.

Presentation of clinical and translational data from RVU120 and SEL24/MEN1703 at the 63rd "ASH" Annual Meeting & Exposition and the 44th Annual SABCS
On November 4, Ryvu announced that, together with its collaborators from MD Anderson Cancer Center and the Menarini Group, it will present six posters showing new data demonstrating clinical and preclinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and selective PIM/FLT3 inhibitor SEL24 (MEN1703) during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and at the 44th Annual San Antonio Breast Cancer Symposium (SABCS).

The posters to be presented include: initial data from ongoing Phase Ib of RVU120 which demonstrates an acceptable safety profile and early signs of efficacy, including a Complete Remission (CR) within the first five dose cohorts; an ongoing dose escalation in AML and HR-MDS; translational research for RVU120 demonstrated a strong trend of efficacy in DNMT3A-mutated AML patient-derived cells; preclinical models showing potential for clinical efficacy of RVU120 in breast cancer. Ryvu licensee, Menarini Group will be presenting SEL24/MEN1703 data from the first-in-human, dose-escalation and cohort expansion CLI24-001 trial.

Ryvu’s partner Menarini Group receives FDA Orphan Drug Designation for SEL24 (MEN1703) for the Treatment of Acute Myeloid Leukemia
On November 4, Menarini Group announced that the FDA has granted an ODD to SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini Group from Ryvu. Currently SEL24/MEN1703 is being examined as part of the DIAMOND-01 trial as a single agent for the treatment of patients with AML. DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, investigated as a single agent for the treatment of patients with AML.

First patient dosed in Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory (R/R) metastatic or advanced solid tumors
On August 25, Ryvu announced that the first patient was dosed in the Phase I/II clinical trial investigating RVU120 in relapsed/refractory metastatic or advanced solid tumors. The single-agent, open-label Phase I/II trial is currently enrolling patients in Poland, and site expansion to Spain is in progress.

Publication of research on MCT4 inhibitors in the Journal of Medicinal Chemistry
On August 8, a joint publication of researchers from Ryvu Therapeutics and Merck KGaA on the discovery, development, and optimization of selective MCT4 inhibitors was published in the Journal of Medicinal Chemistry: "Discovery of 5-{2-[5-Chloro-2-(5-ethoxyquinoline-8-sulfonamido)phenyl]ethynyl}-4-methoxypyridine-2-carboxylic Acid, a Highly Selective in Vivo Useable Chemical Probe to Dissect MCT4 Biology."

In Q3 2021, Ryvu participated in the following investor conferences:

Morgan Stanley 19th Annual Global Healthcare Conference (September 9 – 15), where Ryvu’s Chief Business Officer, Vatnak Vat-Ho participated in a fireside chat as well as hosted investor meetings during the conference. 
H.C. Wainwright 23rd Annual Global Investment Conference (September 13 -15), where Ryvu presented during the event as well as hosted investor meetings.
Ryvu 2021 Third Quarter, Financial Results

In the nine months of 2021, the Company reported PLN 19.6 million (USD 5.1 million) of revenues. Over 90% of this number were grants (PLN 18.2 million or USD 4.8 million) and the remainder consisted of income from partnering (PLN 0.5 million or USD 0.1 million), other revenues (PLN 0.5 million or USD 0.1 million) and other operating revenues in total PLN 0.4 million (USD 0.1 million).

Operating costs, excluding the non-cash expense of the Incentive Program (PLN 15.0 million or USD 3.9 million), in the audited period amounted to PLN 66.2 million (USD 17.4 million), and related primarily to research and development expenditures, while the operational loss without the Incentive Program was PLN 46.6 million (USD 12.2 million) compared to PLN 24.2 million (USD 6.1 million) reported in the corresponding period in 2020. Net loss without the Incentive Program for the nine months of 2021 amounted to PLN 45.6 million (USD 12.0 million) and the reported loss for the corresponding period of 2020 amounted to PLN 20.7 million (USD 5.3 million).

On October 31, 2021, Ryvu Therapeutics held PLN 84.9 million (USD 21.3 million) in cash, cash equivalents, and short-term investments.

On November 10, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the 2021 annual Cowen IO Summit at 2:15 p.m. ET on Monday, Nov. 15, 2021 (Press release, Amgen, NOV 10, 2021, View Source [SID1234595154]). David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.