On March 16, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release full year 2022 results and corporate update on Thursday, March 23, 2023. The Company will host a conference call at 8:30 a.m. EDT / 13:30 CET (Press release, Affimed, MAR 16, 2023, View Source,Thursday%2C%20March%2023%2C%202023. [SID1234628945]).

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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

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The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link https://register.vevent.com/register/BIbfecf0c35a2946dc88d3ae439cb5d3e2, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

On March 16, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an early stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported that it will present a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (AACR) (Free AACR Whitepaper) 2023 being held on April 14-19, 2023 (Press release, MediGene, MAR 16, 2023, View Source [SID1234628944]).

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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

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The work to be presented shows that T cells carrying a NY-ESO-1-specific T cell receptor (TCR) combined with a chimeric PD1-41BB switch receptor, have significantly increased TCR-T cell proliferation, functionality and anti-tumor activity, compared to T cells expressing the TCR alone. A potential mechanism associated with this enhanced functionality is the greater release of multiple different effector cytokines.

The abstract for this research has been published online at View Source!/10828/presentation/3341 and posters will be available online on April 18, 2023.

Poster details

4057/9: T cells co-expressing a highly potent NY-ESO-1-specific TCR and a chimeric PD1-41BB co-stimulatory switch receptor show a favorable polyfunctional profile for the treatment of solid tumors

Andrea Coluccio, Stefanie Tippmer, Petra Prinz, Maja Buerdek, Kathrin Mutze, Barbara Loesch, Kathrin Davari, Giulia Longinotti, Dolores J. Schendel.

Session details: Adoptive Cell and Natural Killer Cell Therapy

On March 16, 2023 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, and Bhami Research Laboratory (BRL), reported a licensing agreement that will provide Catalent with access to BRL’s formulation technology to help enable the subcutaneous delivery of high-concentration biologic therapies (Press release, Catalent, MAR 16, 2023, https://www.catalent.com/catalent-news/catalent-and-bhami-research-laboratory-enter-into-licensing-agreement/ [SID1234628943]).

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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

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Under the terms of the agreement, financial details of which have not been disclosed, Catalent is authorized to collaborate with its customers to evaluate BRL’s formulation technology to reduce viscosity and deliver high-concentration biologic products. The technology is applicable to a wide range of monoclonal antibodies and fusion proteins, and successful programs could be integrated into Catalent’s formulation and manufacturing services at scale. Small volume and low viscosity biotherapeutics delivered subcutaneously provide superior patient benefits over traditional intravenous injections including improved access to healthcare, reduced need for hospitalization and overall treatment cost, and the opportunity to employ new delivery technologies such as auto-injectors.

"We are delighted to be expanding the reach of our exciting subcutaneous protein delivery platform to customers through this collaboration with Catalent, a global CDMO of repute," said Dr. Surya Pai, Co-founder and Chief Executive Officer of BRL. Dr. Bhami Shenoy, Co-founder and Chief Scientific Officer of BRL added, "The patented, high-concentration, low-viscosity protein drug delivery platform has been designed to make patient care convenient, affordable and safe."

"This agreement allows Catalent Biologics to offer its customers a novel patented formulation that may be evaluated for enabling the delivery of high-concentration therapies by reducing viscosity," said Julien Meissonnier, Catalent’s Chief Scientific Officer. "The potential for maintaining the stability of a drug with the convenience of a pre-filled syringe or auto-injector could have a significant impact on reducing the barriers to subcutaneous delivery of therapies and improving the patient experience."

NOTES FOR EDITORS
BHAMI RESEARCH LABORATORY
Bhami Research Laboratory Pvt. Ltd. (BRL) is an eight-year-old biotech based out of India, with core expertise in protein and peptide drug delivery. BRL aims to enhance the delivery of biologics therapeutics through its proprietary high concentration subcutaneous protein delivery technology. Additionally, BRL also focuses on oral delivery of peptides through its novel proprietary technology. For more information, www.bhamilab.com.

On March 16, 2023 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has acquired TAETSoftware Corp ("TAETCo"), a Vancouver-based clinical studies management company engaged in the development and commercialization of the Trial Adverse Events Tracker ("TAET") technology platform, a proprietary software application which will enable clinical study subjects to record and submit clinical trial Adverse Drug Events ("ADE") reports to study sponsors in real time (Press release, BioVaxys Technology, MAR 16, 2023, https://biovaxys.com/2023/03/16/biovaxys-acquires-clinical-study-management-company-and-completes-private-placement/ [SID1234628942]). In exchange for all of the issued and outstanding shares of TAETCo, the company issued the TAETCo shareholders 24,500,000 common shares, with an additional 2,500,000 common shares payable upon the successful testing of the beta version of the application.

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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

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Trial Adverse Events Tracker ("TAET") is an innovative software application designed to enhance and improve tracking of adverse events and/or side effects of subjects enrolled in clinical studies. TAET provides a secure and private link for study subjects to instantly update investigators with adverse events they are experiencing onto an online database for real-time evaluation by study investigators. With customizable fields for ADE’s, study subject demographics and disease data, and other study-related variables, TAET provides a high degree of data recording flexibility with the inherent benefit of real-time data submission, and the ability for study subjects and investigators to direct message each other if necessary.

Paper-based reporting has long been the primary method for recording ADEs, but can be limited by under-reporting, poorly documented reporting, and reporting delays. As a web-based or mobile app for reporting ADEs, TAET offers added value compared to conventional reporting tools.1 Furthermore, BioVaxys intends to explore the potential of offering blinded demographic and disease data to companies with an interest in healthcare analytics and data mining.

James Passin, BioVaxys CEO, stated, "The acquisition of TAETCO provides BioVaxys with a third low-risk near-term revenue generating product, supporting our core business in cancer and viral vaccine development. In addition to providing a fee-based product for recording clinical study ADE’s for CROs and study sponsors, BioVaxys will seek to leverage recent breakthroughs in artificial intelligence by collaborating with one or more players in healthcare data mining to develop insights into correlations between demographics and other factors and ADEs."

Jay Dhaliwal, the Founder and CEO of TAETCo and developer of the TAET application, is a registered pharmacist with capital markets experience. He holds a Bachelor of Pharmacy from the University of British Columbia, a Bachelor of Science in Biology from the University of Victoria. Mr. Dhaliwal has agreed to act as consultant to BioVaxys to assist with the commercial development of TAET.

In addition, BioVaxys is pleased to announce that it has also closed a private placement consisting of 5,360,000 common shares at a price of $0.125 per share for gross proceeds of $670,000. All common shares issued pursuant to the private placement will be subject to a statutory hold period of four months and one day. The Company intends to use the proceeds for the private placement of working capital.

1) Fukushima, A., Iessa, N., Balakrishnan, M.R. et al. Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience. BMC Med Inform Decis Mak 22, 118 (2022).

On March 16, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the twelve months ended December 31, 2022, and provided a business update (Press release, Onconova, MAR 16, 2023, View Source [SID1234628941]).

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Highlights for the fourth quarter of 2022 and recent weeks include:

· Based upon encouraging safety findings from its ongoing Phase 1 program, Onconova intends to administer narazaciclib orally with a continuous daily dosing schedule in upcoming clinical trials. Results from the Phase 1 solid tumor trial evaluating a continuous daily dosing regimen of narazaciclib showed that the maximum tolerated dose was not reached through the fifth dose escalation cohort. The Phase 1 trial will advance to its sixth dose escalation cohort, which will evaluate a dose of 240 mg orally on a continuous daily schedule.

· The Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC) is expected to open for enrollment in the first quarter of 2023. The trial remains on track for a preliminary data readout from its Phase 1 portion in the fourth quarter of 2023.

· Two abstracts describing the results of preclinical studies of narazaciclib were recently accepted for poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The abstracts, which are available on the AACR (Free AACR Whitepaper) website, are titled "Differential targets engaged by narazaciclib in comparison to the approved CDK4/6 inhibitors contribute to enhanced inhibition of tumor cell growth" and "Synergistic activity of the CDK4/6 antagonist narazaciclib (ON123300) with irreversible BTK inhibition in ibrutinib-resistant mantle cell lymphoma."

· The investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) continues to progress and remains open for enrollment. The second of two evaluable participants in the program recently achieved a complete clinical response of all cancerous skin lesions following four treatment cycles of oral rigosertib. The program’s first evaluable participant previously achieved a complete response. Both participants remain on therapy and have maintained their response to therapy to-date. Onconova intends to review the program’s initial data with regulators to gain insight on the optimal regulatory path for rigosertib in RDEB-associated SCC, an ultra-rare and invariably fatal condition.

· Rigosertib’s additional investigator-sponsored trials also continue to progress. The Phase 1/2a trial evaluating rigosertib in combination with nivolumab in KRAS-mutated (KRAS+) non-small cell lung cancer (NSCLC) continues to enroll patients in its dose-expansion cohort, with additional data from the trial expected in the second quarter of 2023. A Phase 2 trial of rigosertib in combination with pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is expected to open for enrollment later this quarter.

· Data from cell-based and in vitro assays characterizing rigosertib’s multi-faceted mechanism of action were recently featured in a poster presentation at the AACR (Free AACR Whitepaper) Targeting RAS Conference.

Management Commentary

"We recently received IRB approval at New York University Langone Health for our Phase 1/2a trial of narazaciclib plus letrozole in recurrent LGEEC, which is on track for an important preliminary readout later this year," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "Prior preclinical data as well as single arm and randomized Phase 2 clinical data provide strong proof-of-concept for narazaciclib’s mechanism of action in LGEEC and demonstrate its potential to overcome the numerous shortcomings of the CDK 4/6 inhibitors that are currently used off-label in combination with letrozole in this indication. We look forward to building on these datasets in our upcoming trial, which we believe will further highlight the advantages of narazaciclib’s differentiated kinase inhibitory profile."

Dr. Fruchtman continued, "Recent progress in rigosertib’s investigator-sponsored trials was highlighted by data from our RDEB-associated SCC program. With both of the program’s evaluable participants achieving a complete clinical response of all cancerous skin lesions with rigosertib monotherapy, we now intend to engage with regulators to identify the most expeditious path to a potential approval in this ultra-orphan indication. In addition, trials of rigosertib combined with checkpoint inhibition continue to advance, with a Phase 2 study in checkpoint-inhibitor refractory melanoma expected to open for enrollment later this quarter and additional data from a Phase 1/2a trial in KRAS-mutated NSCLC expected next quarter. Looking forward, we expect the continued progress of these investigator-sponsored trials to provide an important source of value to complement our lead narazaciclib program, which remains our primary focus."

Full Year Financial Results

Cash and cash equivalents as of December 31, 2022, were $38.8 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2024.

Research and development expenses were $11.4 million for 2022, compared with $7.3 million for 2021. The increase was primarily related to the narazaciclib development program and drug manufacturing.

General and administrative expenses were $8.4 million for 2022, compared with $9.4 million for 2021. The decrease was primarily related to lower costs for our annual general meeting than in the 2021 period.

Net loss for 2022 was $19.0 million, or $0.91 per share on 20.9 million weighted average shares outstanding, compared with a net loss of $16.2 million, or $0.96 per share for 2021 based on 16.8 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the full year 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 715-9871 (domestic callers) or (646) 307-1963 (international callers) and using conference ID 3097517.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.