On May 16, 2022 Flamingo Therapeutics, a biotechnology company pioneering RNA-targeting therapies in oncology, reported that Mike Garrett, Chief Executive Officer, will present a company overview at the BioEquity Europe and Knowledge for Growth meetings, taking place May 16-18 in Milan, Italy and May 18-19 in Ghent, Belgium (Press release, Flamingo Therapeutics, MAY 16, 2022, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-to-present-at-the-bioequity-europe-and-knowledge-for-growth-conferences-in-may-2022 [SID1234614588]). The Flamingo management team will also participate in one-on-one meetings with investors during both conferences.

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The presentations for both conferences will be available on-demand for registered attendees.

On May 16, 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 first-quarter 2022 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAY 16, 2022, View Source [SID1234614637]).

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"We continued to execute on advancing our clinical programs during the first quarter of 2022," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Our highest immediate priority is completing Part A of the RINGSIDE study evaluating AL102 in desmoid tumors and we are on target to announce initial interim data around mid-year. This will be followed by initiation of Part B, the randomized portion of the study, immediately thereafter. We are very encouraged by the positive feedback received from investigators in the study and by early signs of anti-tumor activity. Other important milestones expected this year include clinical updates from the ongoing ACCURACY trial of AL101 in adenoid cystic carcinoma and the planned initiation of a Phase 2 trial of AL102 in T-ALL."

First-quarter 2022 and Recent Business Highlights

Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 42 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.

Initiated "Window of Opportunity" study of AL101 in adenoid cystic carcinoma (ACC): The study, which is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma (ACC) Research Foundation, is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regimen and generate data for the future development strategy.
Upcoming Milestones

Initial interim data from pivotal Phase 2/3 RINGSIDE trial in desmoid tumors: Ayala expects to report an initial interim data read-out from Part A of Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression free survival with secondary endpoints including objective response rates, duration of response and patient reported quality of life measures.
Clinical data from Phase 2 ACCURACY trial of AL101 in ACC: The Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. A poster at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting is expected to feature safety, efficacy, pharmacokinetics, and pharmacodynamics data from the 6mg AL101 cohort in the trial.
Initiate Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.
First-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $27.4 million as of March 31, 2021, as compared to $37.3 million at December 31, 2021.

Collaboration Revenue: Collaboration revenue was $0.4 million for the first quarter of 2022, as compared to $1.0 million for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.9 million for the corresponding quarter in 2021.

G&A Expenses: General and administrative expenses were $2.4 million for the first quarter of 2022, compared to $2.3 million for the first quarter of 2021.

Net Loss: Net loss was $10.0 million for the first quarter ended March 31, 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.6 million for the first quarter ended March 31, 2021, or basic and diluted net loss per share of $0.74.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 16, 2022.

On May 16, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported first quarter 2022 financial results and business highlights (Press release, Biomea Fusion, MAY 16, 2022, View Source [SID1234614653]).

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"We had a very exciting start to the year as we initiated our first Phase I study of BMF-219, COVALENT-101, in AML and ALL patients. We have now expanded enrollment to include also DLBCL and MM patients. Targeting menin with our covalent inhibitor is an innovative approach with potential safety, tolerability, efficacy, and durability advantages. Our COVALENT-101 investigators are enthusiastic to use BMF-219 for many of their patients who currently have relapsed from or not responded to traditional approaches," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board.

Mr. Butler continued, "We believe covalent inhibitors afford the optimal profile for a therapeutic. The aim is to maximize depth and durability of response, to support improved survival, while minimizing exposure, which is the source for unwanted toxicity. We have now provided preclinical evidence highlighting BMF-219’s profound anti-tumor effects in MYC-driven cancers and pan-KRAS mutant solid tumors. By indirectly targeting MYC and KRAS via the scaffold protein menin, our preclinical data demonstrates that BMF-219 can affect these oncoproteins in a very meaningful way. We are managing our expenses and will continue to execute on the clinical development of this first-in-human and first-in-class covalent menin inhibitor not only in the various tumor types, but also in type 2 diabetic patients."

Clinical and Regulatory Highlights

Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219 in patients with relapsed or refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
Presented preclinical data at AACR (Free AACR Whitepaper) 2022 highlighting impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines.
Announced upcoming presentation of preclinical BMF-219 data from multiple in vivo models of diabetes at ADA Scientific Sessions 2022.
Announced upcoming presentation of preclinical BMF-219 data from multiple ex vivo models of CLL at ASCO (Free ASCO Whitepaper) 2022.
Corporate Highlights

Appointed Steve Morris, M.D. as Chief Medical Officer. Dr. Morris led a basic and translational research laboratory at St. Jude Children’s Research Hospital, where he served for 25 years. Among his lab’s pioneering work at St. Jude was the discovery and characterization of anaplastic lymphoma kinase, or ALK.
First Quarter 2022 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $16.4 million for quarter ended March 31, 2022, compared to a net loss of $5.9 million for the same period in 2021.
R&D Expenses: Research and development expenses were $11.4 million for the quarter ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase of $7.6 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s lead product candidate, BMF-219.
G&A Expenses: General and administrative expenses were $5.1 million for the quarter ended March 31, 2022, compared to $2.1 million for the same period in 2021. The increase of $3.0 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of March 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $165.6 million, compared to $175.7 million as of December 31, 2021.

On May 16, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with life science companies through a profit-share, revenue share, or franchise model, reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Global Investment Conference, being held May 23-26, 2022 (Press release, Tracon Pharmaceuticals, MAY 16, 2022, View Source [SID1234614669]).

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The presentation will be available on-demand beginning at 7:00 AM Eastern Time on Tuesday, May 23, 2022, in the Investors section on the Company’s website at www.traconpharma.com.

On May 16, 2022 PACT Pharma, Inc., a clinical-stage company developing transformational personalized neoantigen-specific T cell receptor (neoTCR) T cell therapies for the eradication of solid tumors, reported that new data on PACT^NV, the company’s non-viral precision gene editing technology, were highlighted in a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting (Press release, PACT Pharma, MAY 16, 2022, View Source;cell-therapy-asgct-25th-annual-meeting-301547277.html [SID1234614685]). Presented findings demonstrated the potential of the PACT^NV technology to enhance the functionality and applicability of T cell-based therapeutics, as well as other cellular therapies, through targeted gene editing. Specifically, researchers showed the ability of the versatile platform to knock-out, knock-down, knock-in and precisely regulate target genes in a single step to achieve desired activity for its neoTCR T cells. The ASGCT (Free ASGCT Whitepaper) conference is being held May 16-19, 2022, in Washington, D.C.

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The poster presentation reported research findings by PACT scientists demonstrating the ability to utilize the company’s PACT^NV technology to generate TCR T cells in a single step. In creating these novel patient-specific neoTCR T cells, PACT highlighted the following capabilities of its gene editing platform:

Insertion and expression of neoTCRs within T cells.
Simultaneous elimination of the expression of the endogenous TCRs within same T cells.
Knock-out of the transforming growth factor beta (TGF-β) receptor type 2 (TGFBR2) gene, generating a T cell that can both recognize a patient-specific tumor and is resistant to the immunosuppressive signaling by TGF-β.
shRNA driven knock-down of multiple additional genes without any associated double-stranded break, generating enhanced T cells that can both recognize a patient-specific tumor and, depending on the targeted transcript, possess resistance to immunosuppression, increased persistence, and/or improved functional avidity.
Development of T cell activation-induced promoters for conditional expression of payloads.
"Taken together, the powerful gene editing capabilities possessed by our PACT^NV platform offer the potential to expand the applicability of T cell therapeutics, while extending the potential use of the technology to other cellular therapies," said Stefanie Mandl, Ph.D., senior vice president, head of research at PACT Pharma. "We are particularly excited about the versatility to add, eliminate and/or precisely modulate multiple genes within our neoTCR T cells to create novel, personalized therapeutic candidates with the potential to address a range of solid tumors. We look forward to continuing our research and development efforts in support of our PACT^NV technology, while continuing our ongoing Phase 1 clinical trial of non-viral PACT^NV gene-edited autologous neoTCR T cells in advanced and metastatic solid tumors."

PACT is currently conducting a Phase 1 clinical trial evaluating the safety, tolerability and feasibility of adoptive cell therapy with its non-viral PACT^NV gene-edited autologous neoTCR T cells in advanced and metastatic solid tumors. This trial, in combination with extensive preclinical studies, has provided the company with unique data sets and insights derived from the core technologies that comprise its personalized adoptive T cell therapy platform for the treatment of solid tumors.

A copy of the poster presented at the ASGCT (Free ASGCT Whitepaper) conference is available on the "Events" page of the PACT Pharma website at: View Source