On July 13, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a biotechnology company pioneering innovative medicines to overcome difficult-to-treat cancers and viral infections, and its collaboration partner, Manhattan BioSolutions (together, the "Partners"), reported that promising new preliminary preclinical results for the COVID-19 vaccine candidate now progressing under joint development by the Partners (Press release, Nascent Biotech, JUL 13, 2021, View Source [SID1234584829]).

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Under a research collaboration agreement signed in 2020, Nascent Biotech and Manhattan BioSolutions partnered to discover and develop a safe and affordable COVID-19 vaccination platform based on modifying licensed BCG vaccine technology originally developed for Tuberculosis ("TB"), but with broader utility in protecting against infection from other types of viruses, some of which may have the potential to cause major outbreaks in humans. The vaccine candidate currently in development is based on genetically engineered BCG bacteria, which have been modified by the addition of SARS-CoV-2 protein fragments. Next-generation vaccine candidates, each representing a different combination of a receptor binding domain ("RBD") fragment of a spike protein ("S") and a conserved nucleocapsid ("N") antigen, have been successfully constructed and validated for the expression of viral protein fragments in the BCG bacteria.

In a preclinical murine model, a single subcutaneous immunization of synthetic BCG-S generated cellular immune responses in BALB/c mice. T-cells from splenocytes isolated from BCG-S-immunized mice showed statistically significant antigen-specific IFN‐γ secretion, according to direct Enzyme-Linked ImmunoSpot ("ELISpot") T-cell analysis.

Based on this promising preliminary data, additional experiments are underway to better understand protective efficacy and other characteristics of the related immune response that follows immunization with the most promising BCG-vectored vaccine candidate demonstrated in mouse models.

Dr. Boris Shor, CEO of Manhattan BioSolutions, commented: "We successfully generated a versatile ‘plug-and-play’ BCG system that allows the expression of a large set of rationally selected SARS-CoV-2 polypeptide fragments previously identified to be immunogenic in a substantial study population. Current vaccine efforts are primarily focused on generation of humoral responses to vaccines. Our BCG-vectored vaccine candidates are designed to generate safe T-cell immunity against SARS-CoV-2, and these initial results are highly encouraging."

Sean Carrick, CEO of Nascent Biotech, added: ‘Published evidence suggests that BCG vaccination is safe and might be associated with a decrease in the incidence of sickness during the COVID-19 pandemic, and lower incidence of extreme fatigue. Through grant funding and additional investments, we are making progress toward building a Viral Infection business platform and providing meaningful treatment for patients. We continue to be excited about our partnership with Manhattan BioSolutions, and we look forward to working together to deliver innovative therapies with the power to improve patient outcomes."

On July 13, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported the first commercial sale in China of ORPATHYS (savolitinib), HUTCHMED’s oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, which occurred on July 12, 2021 (Press release, Hutchison China MediTech, JUL 13, 2021, https://www.hutch-med.com/first-commercial-sale-of-orpathys-milestone-payment/ [SID1234586916]).

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This follows less than three weeks after the June 22, 2021 approval of ORPATHYS in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.

Under the terms of the license and collaboration agreement between HUTCHMED and AstraZeneca ("AstraZeneca") (LSE/STO/Nasdaq: AZN), a US$25 million non-creditable and non-refundable milestone payment is triggered by the first commercial sales of ORPATHYS in China. HUTCHMED is responsible for the clinical development, marketing authorization, manufacturing and supply of ORPATHYS in China, while AstraZeneca is responsible for its commercialization for which it will pay HUTCHMED fixed royalties of 30% based on all China sales.

More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.[i],[ii],[iii] This mutation is more common (13-22%) among patients with pulmonary sarcomatoid carcinoma (PSC), a rare and aggressive subtype of NSCLC usually resistant to chemotherapy.[i],[iv]

About ORPATHYS
ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor ("TKI") that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

ORPATHYS is marketed in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

ORPATHYS development in NSCLC
Phase II study of ORPATHYS monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, ORPATHYS was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May 2020, and updated results were published in The Lancet Respiratory Medicine in June 2021. At a median follow up of 17.6 months, ORPATHYS demonstrated an objective response rate ("ORR") of 42.9% (95% confidence interval [CI] 31.1-55.3) and median progression-free survival ("PFS") of 6.8 months (95% CI 4.2-9.6) in the overall trial population. PFS was clinically meaningful across subgroups, and ORR results were consistent regardless of prior treatment or tumor histology, including in patients with the PSC subtype (40.0%, 95% CI 21.1-61.3) and patients with other NSCLC subtypes (44.4%, 95% CI 29.6-60.0). Disease control rate ("DCR") in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of ORPATHYS was consistent with previous trials, and no new safety signals were identified.

SAVANNAH Phase II study of ORPATHYS in combination with TAGRISSO in patients who have progressed following TAGRISSO due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in epidermal growth factor receptor ("EGFR") mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO, an EGFR TKI owned by AstraZeneca.

Phase III study of ORPATHYS in combination with TAGRISSO in patients who have progressed following EGFR TKI treatment due to MET amplification (in planning) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.

Phase III study of ORPATHYS in combination with TAGRISSO in treatment naïve patients with EGFR mutant positive NSCLC with MET overexpression (in planning) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.

ORPATHYS development in kidney cancer
SAVOIR randomized, controlled study of ORPATHYS monotherapy in MET-driven papillary renal cell carcinoma ("RCC") (NCT03091192) – In May 2020, data from 60 patients in this global study of ORPATHYS monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO (Free ASCO Whitepaper) 2020 Program and published simultaneously in JAMA Oncology. ORPATHYS demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no ORPATHYS responding patients experiencing disease progression at data cut-off, and an encouraging overall survival ("OS") hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.

CALYPSO Phase I/II study of ORPATHYS in combination with IMFINZI PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of ORPATHYS in combination with IMFINZI, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the ORPATHYS/IMFINZI combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, showing a confirmed response rate in 14 MET-driven patients of 57%, with a median duration of response ("DoR") of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.

Phase III in combination with IMFINZI PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we intend to initiate a global Phase III, open-label, randomized, controlled study of ORPATHYS plus IMFINZI versus sunitinib monotherapy versus IMFINZI monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.

ORPATHYS development in other cancer indications
Phase II study of ORPATHYS monotherapy in advanced or metastatic MET amplified gastric cancer ("GC") or adenocarcinoma of the gastroesophageal junction ("GEJ") (NCT04923932) – This Phase II trial is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics ("PK") of ORPATHYS in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy. The primary endpoint is ORR as assessed by an independent review committee. Other endpoints include 12-week and 6-month PFS rates, median PFS, DoR, DCR, median OS, safety, PK and quality of life.

This trial follows multiple Phase II studies that have been conducted in Asia to study ORPATHYS in MET-driven gastric cancer patients, including VIKTORY.[v] VIKTORY is an investigator initiated Phase II umbrella study in gastric cancer in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified gastric cancer. Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

ORPATHYS opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including non-small cell lung cancer, gastric cancer and colorectal cancer.

On July 13, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net revenue of $135.6 million for the second quarter of 2021 (Press release, Pacira Pharmaceuticals, JUL 13, 2021, View Source [SID1234584814]). The company’s total revenues include net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera°, which were $130.1 million and $3.8 million for the second quarter of 2021 and $45.8 million and $1.4 million, respectively, for the month of June 2021. EXPAREL average daily sales were 178% and 120% of the prior year levels for the second quarter and month of June 2021, respectively. The company reports average daily growth rates for EXPAREL to normalize for differences in the number of selling days per reporting period. The number of EXPAREL selling days were 22, 20, and 22 for the months of April, May, and June, respectively, in both 2021 and 2020.

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"We are encouraged by the continued robust growth in EXPAREL sales with the second quarter of 2021 coming in at record levels despite the barrier of COVID-19 for many elective surgery procedures. As conditions normalize in the second half of 2021, we anticipate increasing opportunity for EXPAREL expansion," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The surgical market is accelerating its transition to outpatient settings, facilitated by our wealth of clinical data and experience to support EXPAREL-based regional approaches across a growing number of complex surgical settings. Additionally, interest in iovera° continues to mount with our educational and commercial programs highlighting its ability to deliver drug-free pain control that endures for several months. Throughout the balance of the year, we will continue to build on our established momentum as the industry leader of non-opioid pain management and regenerative health solutions."

The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. EXPAREL sales in the second quarter of 2020 were significantly disrupted when the COVID-19 pandemic was at its peak and elective surgeries were largely prohibited. Elective surgery restrictions began to lift on a state-by-state basis in April 2020 and EXPAREL average daily sales returned to year-over-year growth in June 2020.

In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2021.

On July 13, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, has taken another major step towards leveraging the speed and throughput of its proprietary, plant-based FastPharming Protein Expression System by reported it is adding three anti-cancer targets to its pipeline of therapeutic candidates (Press release, FairJourney Biologics, JUL 13, 2021, https://fjb.pt/collaboration/ibio-enters-into-a-research-services-agreement-with-fairjourney-biologics/ [SID1234584830]). This development establishes the Company’s new drug discovery capabilities announced just a few weeks ago.

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As part of iBio’s efforts to change the drug development paradigm with the FastPharming System by reducing the time and cost to move from initial concept to the clinic, the Company intends to partner with best-in-class technology partners to help achieve that vision. Accordingly, iBio has entered into a research services agreement with FairJourney Biologics S.A. ("FairJourney"), leaders in antibody optimization. Pursuant to the agreement, iBio will gain access to novel display technologies and proprietary antibody libraries.

"We believe combining our ‘speed-to-clinic’ advantages and Glycaneering TechnologiesTM with the antibody optimization technologies provided by FairJourney may enable us to quickly develop differentiated cancer therapeutic antibodies with improved antibody-dependent cell-mediated cytotoxicity, or ADCC," said Martin B. Brenner, DVM, Ph.D., iBio’s Chief Scientific Officer.

António Parada, CEO at FairJourney commented, "Our experience in antibody discovery for use in oncology has grown in recent years, with a number of undisclosed collaborations rapidly moving towards the clinic. We are excited to work with an innovator like iBio, which we believe has the ability to change the bioprocess paradigm, using its proprietary glycosylation technologies to enhance human anti-cancer antibody development."

On July 13, 2021 Sanofi’s ongoing efforts to simplify its Consumer Healthcare portfolio and accelerate its growth trajectory, reported that the company has signed an agreement with HYPERA S.A. ("Hypera Pharma") for the divestiture of eight products commercialized in Latin America (Press release, Sanofi, JUL 13, 2021, View Source [SID1234584867]). The agreement also includes four prescription products from the General Medicine portfolio.

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"As discussed during our Capital Markets Day in February, simplifying the CHC product portfolio is an important part of our strategy to focus our resources and efforts where we can bring the most value, especially to consumers. We are pleased these products will continue to be available for consumers as we focus on becoming a fully integrated standalone business" said Julie Van Ongevalle, Executive Vice-President, Sanofi and Head of Sanofi Consumer Healthcare.

Sanofi does not anticipate any impact of this divestiture to its Latin American-based workforce.

The transaction is expected to close at the end of 2021, subject to approval of relevant regulatory authorities and other customary closing conditions.