On October 6, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported it received validating written feedback on October 4, 2022 from the FDA pursuant to its Type B Pre-IND meeting request regarding its Deltacel development strategy (Press release, Kiromic, OCT 6, 2022, View Source [SID1234621786]).

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The purpose of the Pre-IND meeting request was to seek alignment with and to obtain FDA guidance on Kiromic’s proposed development strategy about the chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plan for Deltacel/KB-GDT for treating subjects with Non-Small Cell Lung Cancer (NSCLC). Kiromic will leverage this FDA Pre-IND written confirmatory feedback and recommendations into a robust IND submission package for a projected clinical trial launch in Q1 2023.

"We are delighted to receive this very productive feedback about Deltacel/KB-GDT from the FDA, confirming our development strategy for this therapeutic candidate," stated Pietro Bersani, Chief Executive Officer of Kiromic. "It was a strategic decision to focus on metastatic stage 4 lung cancer as our first indication in addressing solid malignancies, and we are very heartened to be continuing to fulfill our mission to address solid malignancies, which represent more than 90% of all cancers."

Further reiterating Management’s focus on executing the Deltacel-aligned development strategy, the Company has streamlined its operations and aligned key resources to advance its Deltacel product candidate while maintaining its other product candidates Procel and Isocel. As part of that aligned strategy and following a thorough evaluation to maximize operational efficiencies, Kiromic’s management made the difficult yet necessary decision to eliminate 20 positions or approximately 29% of its workforce. The Company believes these key actions and overall strategy align with financing options it is actively pursuing.

"Deltacel is our most advanced therapeutic candidate, and its use of allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT) is a next-generation solution for patients. As such, this prioritization also mitigates supply-chain challenges associated with a virus-based approach. We believe these advantages will allow us to efficiently establish the platform’s safety and tolerability and build upon Deltacel’s previously demonstrated preclinical efficacy across multiple indications. With the FDA guidance in hand, we believe we’ve further strengthened our case to align operations with Deltacel and deliver value sooner to our shareholders," commented Bersani.

On October 6, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has executed a binding Term Sheet ("Term Sheet" or "Agreement") with Procare Health Iberia, S.L. ("Procare Health"), of Barcelona, Spain ("Procare Health"), for exclusive marketing and distribution in the United States of Procare Health’s leading patented product, Papilocare, the world’s first and only vaginal gel product with clinical evidences to prevent and treat HPV-dependent cervical lesions, and for Immunocaps, an oral over-the-counter nutritional supplement that supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions (Press release, BioVaxys Technology, OCT 6, 2022, View Source [SID1234621784]). As Immunocaps is an OTC supplement, BioVaxys anticipates that regulatory approval is not required, allowing the rapid build out of sales channels and revenue generation from the product.

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In addition, the agreement gives BioVaxys right-of-refusal in the United States for Ovosicare and Libicare, Procare Health’s over-the-counter supplements to support fertility enhancement for late maternity or IVF processes and Menopausal symptoms improvements which includes low libido among women suffering menopausal changes.

Financial terms include milestone payments and royalties on sales. The companies have agreed to complete an initial ten-year duration exclusive supply and distribution agreement ("Distribution Agreement") by December for Papilocare Gel (packs of 7 and 21 5ml cannulas), 2x40ml and applicators, packs of 1x5ml samples, and 30 capsule packs of Immunocaps. Manufacturing will remain in Spain under Procare Health.

Founded in 2012, Procare Health is a leading privately-held pharmaceuticals company in the women’s health field based in Spain with several affiliates in Europe including France, Portugal and the UK, with marketed products including Papilocare, Libicare, Palomacare, Idracare, Pronolis HD and Ovosicare. Procare Health commercializes its products within more than 60 countries in the world via distribution agreements with well-known and established pharmaceuticals company within the Women’s Health field.

The Agreement follows the Letter of Intent ("LOI") signed last year outlining several collaborations between the two companies, including Papilocare and the clinical development of BioVaxys’ BVX-0918 for late-stage ovarian cancer. Whereas the LOI had originally granted BioVaxys right of first refusal for Papilocare, today’s agreement grants BioVaxys exclusive right to market and distribute the brand in the United States and establishes marketing support from Procare Health for Papilocare and Immunocaps.

Left untreated, HPV infection can lead up to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). In Procare Health’s PALOMA PhaseIIb clinical trial for Papilocare, which results were recently published into the Journal of Lower Genital Tract Disease, which is affiliated with the American Society of Cervical Pathologies (ASCCP), showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population, with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.1 Papilocare has a CE mark valid for the entire EU and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, and Romania. A "CE mark" indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

Under the Term Sheet, BioVaxys will have responsibility for US regulatory approval for Papilocare and anticipates US registration as a Class II medical device.

James Passin, the CEO of BioVaxys, stated, "We are honored to expand the terms of our partnership with Procare Health, one of Europe’s leading innovators in women’s healthcare, further strengthening our women’s healthcare product pipeline."

On October 6, 2022 Seagen Inc. (Nasdaq: SGEN) reported that it will report its third quarter 2022 financial results on Thursday, October 27, 2022 after the close of U.S. financial markets (Press release, Seagen, OCT 6, 2022, View Source [SID1234621783]). Following the announcement, Company management will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update.

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On October 6, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the Independent Data Monitoring Committee for the ENVASARC Phase 2 pivotal trial has recommended that the trial proceed as planned following the review of 12 week safety data from patients enrolled into the trial as of June 30, 2022 (Press release, Tracon Pharmaceuticals, OCT 6, 2022, View Source [SID1234621782]). The safety data reviewed included data from more than 10 patients enrolled into cohort C of treatment with single agent envafolimab at 600 mg administered subcutaneously every three weeks and more than 10 patients enrolled into cohort D of treatment with envafolimab at 600 mg administered subcutaneously every three weeks in combination with Yervoy (ipilimumab) given intravenously.

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"Envafolimab at the 600 mg dose has been well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial. Accrual continues to exceed projections and we remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year," said James Freddo, M.D., TRACON’s Chief Medical Officer.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. In September 2022, TRACON received fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On October 6, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it has scheduled a conference call for Tuesday, Nov. 1, 2022, at 8 a.m. (ET) its third quarter 2022 financial results for the period ending Sept. 30, 2022 (Press release, Leidos, OCT 6, 2022, View Source [SID1234621781]). The company plans to issue its quarterly earnings press release before the conference call on Nov. 1, 2022.

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The company offers a live and replay audio broadcast of the conference call with corresponding press release, presentation materials, and supplemental information at View Source

A telephone playback of the third quarter 2022 earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on Nov. 1, 2022, through 11:59 p.m. (ET) on Nov. 8, 2022. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415) and entering conference ID 13733461.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source