On March 9, 2022 Prelude Therapeutics Incorporated (Nasdaq: PRLD) a clinical-stage precision oncology company, reported that Jane Huang, M.D., has been appointed to the newly created position of President and Chief Medical Officer, effective on April 4, 2022 (Press release, Prelude Therapeutics, MAR 9, 2022, View Source [SID1234609759]). Dr. Huang is currently Chief Medical Officer, Hematology, at BeiGene, Ltd., a global, science-driven biotechnology company developing oral small molecules and monoclonal antibodies for cancer.

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!

"We are pleased to announce that Dr. Huang will be joining Prelude. Jane’s deep experience in oncology drug development and her strategic leadership throughout the lifecycle of multiple products resulting in successful global regulatory approvals will be of great value to Prelude," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.

Dr. Vaddi added, "With multiple distinct precision oncology programs underway, our growing pipeline offers tremendous promise. I am confident in Jane’s ability to build and lead high-performing cross-functional clinical development teams, and her strong relationships and recognized leadership within the cancer research community will be instrumental in achieving our goals to rapidly advance compounds through proof-of-concept and into potential registration trials."

"I am impressed by the strong execution of the Prelude R&D team and its ability to bring multiple proprietary and potentially best-in-class small molecule compounds forward. Their strategic selection of clinically relevant targets involved in many underserved cancers is equally impressive. This level of performance gives me confidence that Prelude is uniquely resourced to make a meaningful difference in the lives of cancer patients," stated Dr. Huang.

Most recently, Dr. Huang served as Chief Medical Officer of Hematology at BeiGene, Ltd. where she created a global development organization encompassing clinical pharmacology to global product safety and had strategic oversight of the development of five hematology medicines. During her tenure with BeiGene, she oversaw the approval of zanubrutinib in three diseases spanning more than 45 countries and was responsible for the first approval of tislelizumab in Hodgkin’s lymphoma. Prior to joining BeiGene in 2016, Dr. Huang served as Vice President, Clinical Development at Acerta Pharma, where she oversaw global clinical development of the BTK inhibitor, acalabrutinib. Prior to this, she worked at Genentech, where she played a leading role in drug development programs for multiple therapies throughout all stages of development, including, Rituxan, Avastin, Kadcyla, Venclexta and Gazyva. She is board certified in hematology, oncology, and internal medicine and is Adjunct Clinical Assistant Professor at Stanford University. Dr. Huang was recently named one of the 20 most influential women in biopharma R&D by Endpoints News.

On March 9, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported that two posters have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held April 8-13, 2022 at the Ernest N. Morial Convention Center in New Orleans, Louisiana (Press release, Shattuck Labs, MAR 9, 2022, View Source [SID1234609758]). The first poster will highlight preclinical data from the company’s GADLEN platform, while the second will highlight preclinical data from SL-9258 (TIGIT-Fc-LIGHT), derived from the company’s ARC platform, demonstrating its ability to broaden the activity of checkpoint inhibitors through targeted myeloid cell and effector lymphocyte activation.

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!

Presentation Details

Title: Bispecific gamma delta T cell engagers containing butyrophilin 2A1/3A1 heterodimeric fusion protein efficiently activate Vg9Vd2 T cells and promote tumor cell killing
Presenter: Dr. Anne Lai, Ph.D., Principal Scientist, Shattuck
Session: Immunology – Immunomodulatory Agents and Interventions 2
Date/Time: Tuesday, April 12, 2022, 1:30 p.m. to 5:00 p.m. ET
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 3514

Title: LIGHT (TNFSF14) costimulation with TIGIT blockade broadens the activity of checkpoint inhibitors (CPIs) into CPI refractory and resistant tumors through targeted myeloid cell and effector lymphocyte activation
Presenters: Dr. George Fromm, Ph.D., Vice President of Research and Development, Shattuck, and Kyung Jin Yoo, Research Associate, Shattuck
Session: Immunology – Combination Immunotherapies 2
Date/Time: Wednesday, April 13, 2022, 9:00 a.m. to 12:30 p.m. ET
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 4214

Additional meeting information can be found on the AACR (Free AACR Whitepaper) website, View Source The posters will be available under the Events & Presentations section of the Company’s website shortly after the event.

On March 9, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported an antibody discovery agreement for antibodies delivered using adeno-associated viral (AAV) gene therapy in therapeutic oncology applications (Press release, Kriya Therapeutics, MAR 9, 2022, View Source [SID1234609757]).

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!

"We believe that vectorized antibodies have the potential to transform the treatment of a range of serious diseases, particularly within the field of oncology," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "By combining Twist’s best-in-class antibody libraries and discovery expertise with Kriya’s proprietary, computationally-enabled vector engineering platform, we can accelerate the advancement of novel gene therapies that can be combined with other modalities in oncology, including current standards-of-care."

Twist Biopharma, a division of Twist Bioscience, expects to leverage its antibody discovery and optimization platform to discover novel antibodies against specific targets of interest that will be engineered into Kriya’s proprietary gene therapy technology platform for durable and targeted delivery.

"Targeted delivery of antibodies using gene therapy could open a new therapeutic channel that enables precise treatment where needed locally," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Viral vectors provide an expedited route to deliver much needed proteins to patients over traditional biologics development. Kriya’s AAV technology is world-leading so we are very pleased to partner with them in this field."

On March 9, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will present at the 32nd Annual Oppenheimer Healthcare Conference, taking place on March 15-17, 2022 (Press release, Ayala Pharmaceuticals, MAR 9, 2022, View Source [SID1234609756]). The company will also participate in one-on-one investor meetings at the conference.

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!

Details on the presentation can be found below.

32nd Annual Oppenheimer Healthcare Conference

Format: Virtual Presentation

Date: Tuesday, March 15, 2022

Time: 10:40 AM – 11:10 AM EDT
A webcast of the presentation will be available on the "Events and Presentations" section of the Ayala Pharmaceuticals website.

On March 9, 2022 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Lipocine, MAR 9, 2022, View Source [SID1234609755]).

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!

Clinical Program Highlights
LPCN 1148

Initiated a Phase 2 proof-of-concept clinical study evaluating LCPN 1148 for the management of decompensated liver cirrhosis in patients on the transplant waitlist
We currently expect enrollment in the Phase 2 study to be complete by the end of the second or third quarter of 2022 and top-line 24-week results by the end of 2022 or during the first quarter of 2023.
LPCN 1144

In August 2021, Lipocine announced positive topline 36-week results from its Phase 2 proof of concept LiFT ("Liver Fat intervention with oral Testosterone") clinical study investigating LPCN 1144 in men with biopsy-confirmed NASH. Key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and/or fibrosis improvement.
Lipocine held a Type C meeting with the U.S. Food and Drug Administration ("FDA") to discuss the clinical development path for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH"). The FDA suggested a Phase 3 trial with a primary multicomponent surrogate endpoint and indicated a study duration of 72 weeks would be adequate for seeking approval under an accelerated pathway, if successful.
TLANDO

Lipocine entered into a license agreement with Antares Pharma in 2021 to commercialize TLANDO in the U.S.
The FDA accepted a New Drug Application ("NDA") resubmission for TLANDO (testosterone undecanoate) and designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act ("PDUFA").
Neuroactive Steroids

The FDA has cleared an investigational new drug ("IND") application to conduct a Phase 2 proof of concept study of LPCN 1154, an oral endogenous neuroactive steroid ("NAS") product candidate, in postpartum depression.
An IND application is planned to be filed with the FDA in the second quarter of 2022 for LPCN 2101 to conduct and IND opening proof-of-concept study in women with epilepsy of childbearing age.
Year Ended December 31, 2021 Financial Results
Lipocine reported a net loss of $634,399, or ($0.01) per diluted share, for the year ended December 31, 2021, compared with a net loss of $21 million, or ($0.38) per diluted share, in the year ended December 31, 2020.

Lipocine recognized revenue of $16.1 million during the year ended December 31, 2021, compared to no revenue during the year ended December 31, 2020. Revenue in 2021 primarily related to licensing fees, minimum royalties and the sale of finished goods materials we received in accordance with the Antares Licensing Agreement for TLANDO which was signed on October 14, 2021.

Research and development expenses were $7.7 million for the year ended December 31, 2021, compared with $9.7 million for the year ended December 31, 2020. The decrease in research and development expenses during the year ended December 31, 2021 was primarily due a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, as well as decreases in other R&D expenses. These decreases were offset by increases in costs related to LPCN 1154, LPCN 1148 and LPCN 1107.

General and administrative expenses were $5.3 million for the year ended December 31, 2021, compared with $8.2 million for the year ended December 31, 2020. The decrease in general and administrative expenses during the year ended December 31, 2021 was primarily due to decreases in legal costs and personnel costs, offset by an increase in corporate insurance expenses and in other general and administrative expenses.

Lipocine recorded an expense of $4.0 million on litigation settlement during 2021 related to the Global Agreement with Clarus to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies. There was no comparable litigation settlement expense in 2020.

As of December 31, 2021, Lipocine had $44.6 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.