On March 3, 2023 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported the completion of an end of Phase 1 (EOP1) meeting with the US Food and Drug Administration ("US FDA") (Press release, Aptorum, MAR 3, 2023, View Source [SID1234628132]). SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and has also received orphan drug designation previously from the US FDA.

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!

The EOP1 meeting was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma in pediatric patients aged 2-18. The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and our proposed clinical development plan for Phase 1/2 trials.

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: "We are pleased to announce the completion of End of Phase 1 Meeting with US FDA and this represents another key milestone for the company and one of the targeted strategic goals for the year of 2023. With additional supportive information from US FDA on the clinical development of SACT-1, this supports the continued focus of Aptorum Group to embark on the exciting Phase 1/2 clinical trials for SACT-1, subject to further FDA’s clearance of the final clinical protocol."

About SACT-1

SACT-1 is an oral suspension based repurposed small molecule drug formulated in oral suspension to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy. SACT-1 has been observed to be potentially applicable to neuroblastoma and other cancers in the preclinical studies.

On March 3, 2023 CEL-SCI Corporation (NYSE American: CVM) reported it will present new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), on March 8, 2023 at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal (Press release, Cel-Sci, MAR 3, 2023, View Source [SID1234628131]). CEL-SCI will publish a summary of the findings shortly after the presentation.

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 March 3, 2023 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, announced today its plans to present on the company’s myeloid biology research and clinical stage programs at three upcoming scientific and investor conferences in March. The presentations will highlight the potential of Immune-Onc’s pipeline of first-in-class myeloid checkpoint inhibitors to transform current treatment approaches for blood cancers and solid tumors.

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!

Keystone Symposia: Cancer Immunotherapy: Mechanisms of Response Versus Resistance
Date: Sunday, March 5 – Thursday, March 9
Location: Alberta, Canada

At the prestigious Keystone Symposia on Cancer Immunotherapy, Immune-Onc’s Scientific Founder Dr. Chengcheng Alec Zhang will join the company’s Chair of the Scientific Advisory Board (SAB), Dr. Michael Karin and Senior Director of Translational Research, Dr. Xiao Min Schebye for a series of pivotal presentations highlighting foundational research and insights driving our evolving understanding of mechanisms of response and resistance to cancer immunotherapy, and in particular, the LILRB family of immune inhibitory receptors as a promising class of therapeutic targets.

Oral Presentation Details:

Date: Monday, March 6
Presenter: Dr. Michael Karin, Immune-Onc SAB chair and professor of pharmacology at University of California, San Diego
Title: Inflammation and Cancer: A Double-Edged Sword
Oral Session: Dysfunctional Immune Cells in the TME
Date: Wednesday, March 8
Presenter: Dr. Xiao Min Schebye, senior director of translational research at Immune-Onc
Title: Anti-LAIR1 Antagonistic Antibodies Block Collagen-mediated Suppression of T Cell Activation
Oral Session: Workshop 2
Date: Wednesday, March 8
Presenter: Dr. Chengcheng Alec Zhang, scientific founder of Immune-Onc and the Morton H. Sanger Professorship in Oncology and Michael L. Rosenberg Scholar for Biomedical Research at University of Texas Southwestern Medical Center
Title: LILRBs – Myeloid Checkpoint Targets for Cancer Treatment
Oral Session: Innate Immune Pathways and the Anti-Tumor Response
2nd Year Anniversary Symposium of the Myeloid Network
Date: Thursday, March 9 from 11:00 a.m. – 2:30 p.m. ET
Title: Novel Myeloid Checkpoint Inhibitors as Next Generation Cancer Immunotherapy
Location: Virtual

Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc will present an overview of the company’s work advancing the field of myeloid checkpoint inhibitors at the 2nd Year Anniversary Symposium of the Myeloid Network. The Myeloid Network seeks to connect researchers worldwide to promote communication and advancement of research and medicine in the field of myeloid cell biology. "I think your work represents the biotechnology industry outstandingly and I would love to feature your work as the final talk of our annual symposium," said Judith Varner, Ph.D., co-founder of the Myeloid Network, professor of pathology and medicine and co-leader in solid tumor therapeutics at UC San Diego’s Moores Cancer Center in the invitation extended to Dr. Liao.

Oppenheimer 33rd Annual Healthcare Conference
Date: Monday, March 13 – Wednesday, March 15
Presentation: Tuesday, March 14 (4:00-4:30 p.m. ET)

Dr. Liao will present a corporate overview on Tuesday, March 14 at 4:00 – 4:30 p.m. ET (Track 2) and will participate in virtual one-on-one meetings.

On March 3, 2023 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that data for its lead oncogenic driver candidate targeting KRAS G12V, AFNT-111, will be presented at the AACR (Free AACR Whitepaper) Special Conference: Targeting Ras (Press release, Affini-T Therapeutics, MAR 3, 2023, View Source [SID1234628127]).

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 continue to see encouraging data from preclinical studies of AFNT-111 as we progress toward clinical investigation," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We have observed high potency and specificity as well as a favorable tolerability profile, which provides encouraging support for our oncogenic driver programs. We look forward to presenting these data at the AACR (Free AACR Whitepaper) Special Conference: Targeting Ras in Philadelphia."

Presentation details are as follows:

Abstract #A009, Poster Session A: March 6th 4:45-7:00 pm ET: AFNT-111: a novel TCR-engineered T cell therapy targeting the oncogenic driver KRAS G12V – Presenting Authors: Gary Shapiro, Ph.D. and Michele Hoffmann, Ph.D., Affini-T Therapeutics

On March 3, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that on March 1, 2023, the Compensation Committee of Puma’s Board of Directors approved the grant of an inducement restricted stock unit award covering 9,375 shares of Puma common stock to one new non-executive employee (Press release, Puma Biotechnology, MAR 3, 2023, View Source [SID1234628126]).

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!

The award was granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit award vests over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, March 1, 2023, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The award was granted as an inducement material to the new employee entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4).