On November 30, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) ( "IPA") (NASDAQ: IPA), an advanced biotherapeutic research and technology company, reported that BioStrand BV ("BioStrand"), an AI in silico discovery subsidiary of IPA, has entered into a research collaboration and license agreement (the "Agreement") with BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer (Press release, ImmunoPrecise Antibodies, NOV 30, 2022, View Source [SID1234624603]).

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 collaboration will leverage BioStrand’s LENSai software, built upon IPA’s proprietary HYFT Universal Fingerprint technologies, and will focus on in silico antibody discovery to generate relevant clinical molecules for potential development. Under the terms of the Agreement, BioStrand and BriaCell will collaborate on the design, discovery, and development of anti-cancer antibodies. Upon successful antibody discovery, BioStrand will receive an upfront payment of US$500,000, and will be eligible to receive future success-based development milestones, including those for the submission of Investigational New Drugs (INDs), clinical milestone payments, and commercial royalties on net sales of products. Further terms are not disclosed.

"We are very excited to begin this program with BriaCell and apply our technology to the development of biologics that may have a huge clinical impact," stated Dr. Ingrid Brands, General Manager and co-founder of BioStrand. "Shortening timelines, while also integrating as much information as possible upstream to improve the efficiency of the process, is extremely important in the development of highly targeted therapies. It is a step towards realizing our long-term vision of significantly advancing precision medicine."

"We believe that BioStrand’s revolutionary AI-powered technology, combined with its cutting-edge protein engineering platform, will allow us to design and discover potent anti-cancer therapeutics," stated Miguel A. Lopez-Lago, PhD, Chief Scientific Officer of BriaCell. "This approach would complement BriaCell’s current immunotherapy pipeline of innovative anti-cancer therapeutics."

On November 30, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that the first participant has been dosed in an investigator-sponsored Phase 1 study of bomedemstat, an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor, in combination with venetoclax (Venclexa) in patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Imago BioSciences, NOV 30, 2022, View Source [SID1234624602]). Venetoclax is a BCL-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of several hematologic cancers, including in combination with azacytidine for elderly patients with AML unable to tolerate the standard of care.

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 Phase 1 open-label study is being conducted at the University of Miami, led by Terrence J. Bradley, M.D. It will enroll approximately 18 adult participants diagnosed with AML who have failed at least one standard, front-line therapy and will assess the safety and efficacy of bomedemstat in combination with venetoclax (VenBom therapy). This combination regimen consists of once daily, oral administration of both bomedemstat and venetoclax. Participants will receive three cycles of the treatment, and may continue to receive treatment as long as they experience clinical benefit or until disease progression.

"This study is the first clinical study grounded on the pre-clinical work by Dr. Sheng Cai demonstrating that this combination had the potential to offer a unique benefit to patients with AML who have limited treatment options," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "We are very pleased that such an experienced team as that at the University of Miami has initiated this trial."

In ongoing Phase 2 studies, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with myelofibrosis and essential thrombocythemia. Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05597306.

On November 30, 2022 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing IV administered, self-amplifying RNA to transform outcomes for cancer patients, reported that it is reprioritizing its pipeline to focus on its lead viral RNA (vRNA) immunotherapy product candidate, ONCR-021 (Press release, Oncorus, NOV 30, 2022, View Source [SID1234624601]). In addition, the company is discontinuing the development of ONCR-177, reducing its workforce and burn rate and reiterating guidance for its cash runway into early 2024.

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!

"Oncorus’ mission is now focused on realizing the full promise of IV-administered, self-amplifying RNA medicines to transform outcomes for cancer patients through our lead program, ONCR-021, which we plan to evaluate in patients with non-small cell lung and other cancers," said Theodore (Ted) Ashburn, M.D., Ph.D., President, and Chief Executive Officer of Oncorus. "As part of this reprioritization, we are discontinuing the Phase 1 trial of ONCR-177 to focus our resources on ONCR-021. We would like to express our deep gratitude to all the patients and their families, investigators and collaborators who participated in the ONCR-177 study. We believe that we are now well positioned to execute on our goals and progress our novel, first-of-its-kind self-amplifying vRNA immunotherapy candidate, ONCR-021, into the clinic for cancer patients."

Oncorus will present the results of the Phase 1 study of ONCR-177 in patients with advanced disease in conjunction with a scientific congress in 2023. In addition, Oncorus has reduced its workforce by 20%, with its remaining workforce solely focused on the clinical development of ONCR-021, its first self-amplifying RNA product candidate. With this re-prioritization and workforce realignment, Oncorus has reduced its burn rate and continues to expect its current cash, cash equivalents and investments will be sufficient to fund its operating expenses into early 2024.

ONCR-021 Program Highlights and Upcoming Milestones

ONCR-021 is Oncorus’ lead candidate from its self-amplifying RNA platform intended to allow for intravenous (IV) administration. ONCR-021 is comprised of vRNA encoding for the genome of an optimized strain of the Coxsackievirus A21 (CVA21) formulated in a proprietary lipid nanoparticle (LNP). This technology enables RNA self-amplification via multiple transcription cycles in tumor cells and further amplification via viral spread to neighboring tumor cells. The company is planning to submit an investigational new drug application (IND) for this program in mid-2023 to evaluate ONCR-021 in patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), melanoma and hepatocellular carcinoma (HCC).

In October 2022, Oncorus published preclinical data in Nature Communications highlighting the potential of its self-amplifying RNA platform as a novel approach to treating cancer by enabling repeat IV administration. The data demonstrate that the delivery of RNA encoding for the genome of a replication competent virus encapsulated in an LNP enables selective replication, virus assembly, spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of virus neutralizing antibodies in the bloodstream. These RNA constructs were well-tolerated in preclinical models and elicited tumor-specific in situ production of oncolytic virions, broad immune cell recruitment and tumor destruction. Efficacy was observed across multiple cancer models, including xenografts, PDX, GEMM and syngeneic models, with survival benefit observed in an orthotopic small cell lung cancer (SCLC) tumor model. Overall, these constructs were well-tolerated after a single or multiple IV doses in both mice and non-human primates. These results support the potential of this modality to safely and effectively kill tumor cells while stimulating multiple arms of the immune system to better fight cancer.

Additional Development Programs

Further development of ONCR-788, the company’s second self-amplifying RNA product candidate, which encodes for a modified genome of the Seneca Valley Virus (SVV) for the treatment of small cell lung cancer (SCLC), neuroendocrine prostate cancer and other neuroendocrine tumors, and ONCR-719, an armed HSV-1 engineered for viral entry via the EGFR receptor for the treatment of glioblastoma multiforme, is dependent on additional financing.

Conference Call and Webcast Information

Oncorus will host a live conference and webcast today, November 30, 2022, at 8:00 a.m. ET to discuss these company updates. To access the conference call, please register here. The live webcast can be accessed under the "Events & Presentations" section of Oncorus’ website at www.oncorus.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

On November 30 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the virtual JMP Securities Hematology and Oncology Summit on Wednesday, December 7, 2022 at 12:00 pm ET / 9:00 am PT (Press release, Exelixis, NOV 30, 2022, View Source [SID1234624600]).

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!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for at least 30 days.

On November 30, 2022 Eli Lilly and Company (NYSE: LLY) and Akouos, Inc. (NASDAQ: AKUS) reported that the tender offer to purchase all of the issued and outstanding shares ("Shares") of Akouos’s common stock in exchange for (a) $12.50 per Share, net to the stockholder in cash, without interest and less any applicable tax withholding, plus (b) one non-tradable contingent value right ("CVR") per Share, which represents the contractual right to receive contingent payments of up to $3.00 per CVR, net to the stockholder in cash, without interest and less any applicable tax withholding, upon the achievement of certain specified milestones (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on Nov. 29, 2022 and was not extended (such date and time, the "Expiration Time") (Press release, Eli Lilly, NOV 30, 2022, View Source [SID1234624599]).

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!

Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Lilly that, as of the Expiration Time, 29,992,668 Shares were validly tendered and not validly withdrawn in the Offer, representing 81.1% of the issued and outstanding Shares as of the Expiration Time. Accordingly, all conditions to the Offer have been satisfied. Lilly and Kearny Acquisition Corporation, a wholly owned subsidiary of Lilly (the "Purchaser"), have accepted for payment, and will promptly pay for, all shares validly tendered and not validly withdrawn in the Offer.

The parties expect to consummate the acquisition on Dec. 1, 2022, in accordance with, and subject to the terms of, the definitive agreement for the proposed acquisition.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Akouos, Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel and Centerview Partners LLC as sole financial advisor.