On November 6, 2024 Affini-T Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of precision immunotherapies for treatment of patients with solid tumors, reported that a Trial-In-Progress poster for the Company’s Phase 1 clinical trial evaluating AFNT-211 targeting KRAS G12V will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting held in Houston, TX, November 6-10 (Press release, Affini-T Therapeutics, NOV 6, 2024, View Source [SID1234647870]). The team will present three additional posters with preclinical data from its non-viral TRAC-knocked-in T cell therapy targeting TP53-R175H and bi-specific T cell engager programs targeting TP53-R175H, KRAS G12D and KRAS G12V.

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"We are going after cancers with tumor driver mutations like KRAS," said Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics. "Our two clinical stage programs, AFNT-111 and AFNT-211, are specifically designed to leverage precision immunotherapy and synthetic biology approaches to target oncogenic driver mutation KRAS G12V in HLA-A*11:01-positive patients. We started treating patients across these trials earlier this year and we continue to advance these programs through Phase 1."

"Our mission is to address the significant unmet needs of patients with hard-to-treat solid tumors by advancing precision engineered T cell and bispecific T cell engager immunotherapies that target oncogenic driver mutations," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We believe that our non-viral multi-kilobase size gene targeted knock-in platform, THRIVETM, will enable us to cost-effectively engineer safe and effective T cell therapy products. We look forward to presenting new preclinical data for THRIVETM-engineered TP53 R175H-targeting TCR T cells (AFNT-313). We will also be disclosing, for the first time, preclinical data for T cell engagers targeting TP53 R175H and KRAS G12V/D mutations from Affini-T’s TETHERTM bispecific platform."

Poster presentation details are as follows:

Title: A Phase 1 Study of Autologous CD4+ and CD8+ T Cells, HLA-A*11:01-restricted, KRAS G12V-specific, Transgenic TCR; CD8α/β Coreceptor and a FAS41BB Switch Receptor in Patients with Solid Tumors
Abstract #662, Primary Category: Clinical Trials in Progress
Presenting Author: Soumit Basu, M.D., Senior Medical Director, Clinical Development, Affini-T Therapeutics
Session Date/Time: Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Non-Virally Engineered T Cell Therapy Targeting the Hotspot Mutation R175H in TP53 with Signals 1, 2, and 3 (TCR, Co-stimulation, and Cytokine) Drives a Coordinated Antitumor CD4/8 T Cell Response
Abstract #393, Primary Category: Cellular Therapies
Presenting Author: Santosh Narayan, Ph.D., Senior Scientist, Immunology & Gene Editing, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

Title: T Cell Engagers Targeting HLA-A*11:01 KRAS-G12D and KRAS-G12V Mutations for Cancer Immunotherapy
Abstract #1066, Primary Category: Immuno-Conjugates and Chimeric Molecules
Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Novel T Cell Engager Targeting HLA-A*02:01 TP53-R175H for Cancer Immunotherapy
Abstract #1315, Primary Category: Novel Single-Agent Immunotherapies
Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

About AFNT-211

AFNT-211 is an investigational autologous T cell therapy that is being administered to patients for the first time. AFNT-211 is currently being evaluated in a Phase 1 clinical trial open to adult patients with solid tumors who have a KRAS G12V mutation. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov, NCT06105021.

On November 5, 2024 Avid Bioservices, Inc. (NASDAQ: CDMO) ("Avid" or the "Company"), a dedicated biologics contract development and manufacturing organization ("CDMO") working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, GHO Capital Partners LLP ("GHO") and Ampersand Capital Partners ("Ampersand") reported they have entered into a definitive merger agreement for Avid to be acquired by funds managed by GHO and Ampersand in an all-cash transaction valued at approximately $1.1 billion (Press release, Avid Bioservices, NOV 6, 2024, View Source [SID1234647786]).

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Under the terms of the merger agreement, GHO and Ampersand would acquire all the outstanding shares held by Avid’s stockholders for $12.50 per share in cash. The per share purchase price represents a 13.8% premium to Avid’s closing share price of $10.98 on November 6, 2024, the last full trading day prior to the transaction announcement, and a 21.9% premium to the Company’s 20-day volume-weighted average share price for the period ended November 6, 2024. This transaction equates to an enterprise value of approximately $1.1 billion, a 6.3x multiple to consensus FY2025E revenue.

"Since our founding, Avid Bioservices’ business has grown by evolving to meet our customers’ broad range of development and manufacturing needs. After years of investment and expansion, now is the right time to move forward as a private company with new owners that will support our next phase," stated Nick Green, president and CEO of Avid Bioservices. "In evaluating this transaction, our Board considered a range of alternatives and determined that it provides our stockholders significant, immediate and certain cash value for their shares. Partnering with GHO Capital and Ampersand Capital Partners allows us to build on our strong foundation by accessing their significant knowledge base, network and capital to position the business for the future with our customers."

"We are excited to announce this recommended cash acquisition of Avid," said Alan MacKay and Mike Mortimer, Managing Partners of GHO. "As experienced CDMO industry investors, GHO brings deep expertise and experience to support Avid’s management team going forward. Our mission at GHO is to make healthcare better, faster, and more accessible and at the heart of this is enabling efficient, high-quality manufacturing of innovative treatments. Avid exemplifies this perfectly – the Company operates in high-growth markets, producing complex biologics for leading pharmaceutical and biotech innovators at both the clinical and commercial stages. Avid’s recent investments, both in capacity and its exemplary team, position it strongly for future growth. We look forward to working with the Avid team to unlock the Company’s full potential through our established playbook of expanded offerings, talent investment and greater geographic reach."

"Avid has long been a trusted provider of biopharmaceutical development and manufacturing services, and we have tremendous respect for its team’s expertise, its broad spectrum of customized services and its strong regulatory track record. We look forward to leveraging our deep industry experience, focused strategy, and collaborative approach to drive growth," said, David Anderson, General Partner of Ampersand.

Transaction Details

The transaction, which was unanimously approved by the Avid Board of Directors, is currently expected to close in the first quarter of 2025, subject to customary closing conditions, including approval by Avid’s stockholders and receipt of required regulatory approvals. The transaction is not subject to a financing condition. The companies will continue to operate independently until the proposed transaction is finalized.

Upon completion of the transaction, Avid common stock will no longer be listed on any public stock exchange. The Company will continue to operate under the Avid name and brand.

Advisors

Moelis & Company LLC is serving as exclusive financial advisor to Avid, and Cooley LLP is serving as legal counsel to Avid. William Blair & Company, LLC is serving as exclusive financial advisor and Ropes & Gray LLP is serving as legal counsel to GHO and Ampersand.

On November 6, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, reported that clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, an experimental treatment for indolent non-Hodgkin B-cell lymphoma (iNHL), will be presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Conference, to take place December 7-10, 2024, in San Diego, California, and online (Press release, Enterome, NOV 6, 2024, View Source [SID1234647810]).

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These presentations will disclose the first data from Phase 2 Cohort 2, evaluating EO2463 as monotherapy for newly diagnosed patients with asymptomatic follicular lymphoma, where EO2463 may offer a safe, proactive immune therapy alternative to the usual "watch-and-wait" observation strategy. The data also report initial findings on a biomarker with potential to predict long-term response to EO2463, both as monotherapy, and in combination with standard treatments, in relapsed/refractory iNHL.

Details of the poster presentations:

Abstract #1616

Title: EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab
Presenting Author: J.C. C. Villasboas Bisneto, M.D., Mayo Clinic
Session: 622. Lymphomas: Translational – Non-Genetic: Poster I
Session Date: Saturday, December 7, 2024
Presentation Time: 5:30 PM – 7:30 PM
Abstract #4395

Title: EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
Presenting Author: Stephen Smith, M.D., Associate Professor, UW Medicine & Fred Hutchinson Cancer Center
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 PM – 8:00 PM
SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

For more information on the study, visit www.Clinicaltrials.gov, reference: NCT04669171.

About EO2463:

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms.

On November 6, 2024 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a fireside chat at the Guggenheim Inaugural Healthcare Innovation Conference on Wednesday, November 13, 2024, at 2:00 pm ET in Boston (Press release, Protara Therapeutics, NOV 6, 2024, View Source [SID1234647826]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

On November 6, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that the enrollment of the first patient at Penn State Health Children’s Hospital in its Phase I/II clinical study evaluating the efficacy of Silmitasertib (CX-4945) in combination with chemotherapy for children and young adults with relapsed or refractory solid tumors (Press release, Senhwa Biosciences, NOV 6, 2024, View Source [SID1234647855]). This innovative trial seeks to establish a recommended dose of Silmitasertib in combination with chemotherapy and assess the safety, tolerability and efficacy in patients with cancer, with a focus on neuroblastoma, Ewing’s sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.

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"This clinical trial is a critical piece in understanding the mechanism of how the medicine works and develop more precise treatments for our patients," said Dr. Chandrika Behura, study chair and principal investigator, Four Diamonds researcher and associate professor of pediatrics at the College of Medicine. "It’s very important to develop the right combination that can be the most toxic to cancer cells, but the least harmful to the normal cells around them."

The study is projected to enroll up to 114 participants nationwide through the Beat Childhood Cancer Research Consortium member hospitals. By evaluating the activity of the study treatments based on individual responses and duration of disease control, the trial aims to develop novel therapeutic approaches.

"We are thrilled to be able to move this important research forward on a larger scale," said Dr. Giselle Sholler, division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine and chairperson of the Beat Childhood Cancer Research Consortium. "The insights gained from this trial will help not only local patients and their families but can lead to new therapies that can help children throughout the US and internationally."

With the College of Medicine serving as its home, the Beat Childhood Cancer Research Consortium is a worldwide network of more than 50 universities and children’s hospitals focused on saving lives and helping the Children’s Hospital make a lasting difference around the world. Funding for this clinical trial is provided by the Beat Childhood Cancer Foundation and the Little Warrior Foundation. Funding for Behura’s research which led to the clinical trial was provided by Four Diamonds.

"This is the culmination of the work of many people over the years," said Suzanne Graney, executive director of Four Diamonds. "Without the dedication of our physician-scientists and the generosity of our donors and community, this kind of essential work to improve treatments with an ultimate goal of curing cancer would not be possible."

The pediatric cancer care specialists at Beat Childhood Cancer Research Consortium hospitals and researchers at the College of Medicine are dedicated to turning groundbreaking discoveries into lifesaving treatments for childhood cancer.

"By expanding our research and increasing clinical trials, we are exploring immunotherapy, cellular therapy and precision medicine to deliver the most optimized care to each unique patient," said Dr. Dr. Yatin Vyas, pediatrician-in-chief and chair of the Department of Pediatrics at the Children’s Hospital.

"We are greatly honored to collaborate with the Penn State College of Medicine and Beat Childhood Cancer Research Consortium, which have been diligently fighting childhood cancers by infusing invaluable resources from over 50 universities and children’s hospitals across the United States for the clinical study," said Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc. "We appreciate for having the opportunity of providing Silmitasertib as a potential effective treatment and look forward to realizing its therapeutic value in this urgently needed field for childhood cancers though this study".