On July 11, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported its preliminary unaudited financial results for fiscal year ended April 30, 2022 (Press release, PharmaCyte Biotech, JUL 11, 2022, View Source [SID1234616586]).

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Cash Position

PharmaCyte had $85.4 million in cash and cash equivalents as of April 30, 2022.

Preliminary (Unaudited) 2022 Fiscal Year End Financial Results

PharmaCyte expects to report operating expenses of approximately $4.4 million, compared to $3.6 million in the prior fiscal year. This increase is primarily due to expenses associated with PharmaCyte listing on Nasdaq and two capital raises totaling approximately $90 million.

Net loss for fiscal year 2022 is expected to be approximately $4.2 million or approximately $0.27 per share, compared with a net loss of $3.6 million, or $2.45 per share, for the prior fiscal year.

Management Commentary

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "During fiscal year 2022, our team focused on fulfilling the long list of requests from the FDA in order to have the clinical hold lifted on our planned phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). To date, we have completed almost two dozen studies with only a few remaining. Shortly, we expect to begin our two-phase pig study. This is the last major study required by the FDA.

"Our team has made considerable progress during the year, while controlling costs despite the worldwide supply chain challenges. Our progress through a challenging year demonstrates the value of our experienced and proven team of scientific and medical professionals who have played key roles in helping to get some of the world’s most successful drugs through the clinic.

"We believe the market opportunity to develop cellular therapies for cancer, diabetes and malignant ascites using our signature live-cell encapsulation technology, Cell-in-a-Box, is significant. With our enhanced cash position and recent uplisting to Nasdaq, we are positioned to methodically scale the business and further enhance our already strong scientific team as well as adding complementary capital markets experience to our Board of Directors. We are in the process of thoroughly vetting candidates to ensure that the best people are in place to help us seize the opportunities presented by the strength of our technology, therapies, and cash position.

"We are motivated not just by the market opportunity for our Company, but by the groundbreaking implications for patients. We are frustrated by the value of our stock, which like many biotech companies today, is trading below cash value. That said, we remain intent on continuing to drive our clinical progress toward a solution that we believe can revolutionize our treatment for cancer, diabetes, and malignant ascites and, in turn, create long-term shareholder value."

Recent Highlights

On July 5, 2022, the Company announced it has fulfilled another item from the list of required FDA tasks for its pancreatic cancer product candidate. This was done through the completion of a study that confirmed the qRT-PCR can be successfully implemented for testing. It also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps both before and after encapsulation in the cGMP batches.
On June 2, 2022, PharmaCyte’s Board of Directors authorized a share repurchase program to repurchase up to $10 million of PharmaCyte’s outstanding shares of common stock. The share repurchase will begin shortly after issuance of our preliminary year-end financial results in this press release.
On May 23, 2022, PharmaCyte announced that it has initiated the first in a new series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites. This is the eighth and final preclinical study that may lead to a Phase 1 clinical trial. Such a clinical trial may allow us to validate the technology much faster than PharmaCyte’s planned Phase 2b clinical trial in LAPC.
On April 19, 2022, PharmaCyte reported positive results to satisfy FDA requirements related to the empty capsule material that comprises its pancreatic cancer clinical trial product candidate.
On April 13, 2022, the Company announced that it would accelerate preparations for the start of its Phase 2b clinical trial in LAPC by working parallel paths to have the clinical hold lifted and enroll the first patient in the clinical trial for LAPC.
On April 5, 2022, PharmaCyte announced the appointment of Dr. Matthias Löhr to its Board of Directors. Dr. Löhr is Professor of Gastroenterology and Hepatology at the famed Karolinska Institute in Stockholm, Sweden, and leads the Pancreatic Team at Karolinska University Hospital. He has held dozens of leadership roles in learned societies, cancer research centers, universities and governmental agencies.
On March 22, 2022, PharmaCyte announced it had successfully completed a 24-month product stability study required by the FDA for its pancreatic cancer clinical trial product candidate. This demonstrates that CypCaps has now proven it has a shelf life of at least 24 months when stored at -80 degrees Celsius.
Cautionary Statement

The financial data contained in this press release are preliminary and unaudited, based upon PharmaCyte’s good faith estimates and subject to completion of PharmaCyte’s financial closing procedures. While PharmaCyte expects that its final financial results for its fiscal year and quarter ended April 30, 2022, following the completion of its financial closing procedures, will generally be consistent with the amounts provided in this press release. PharmaCyte’s actual results may differ materially from these estimates as a result of the completion of its financial closing procedures, as well as final adjustments and other developments that may arise between now and the time that its financial results for the fiscal year and quarter ended April 30, 2022, are finalized.

The results provided in this press release are preliminary and subject to completion and audit of PharmaCyte’s financial statements.

On July 11, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported it has formed a strategic partnership with MD Anderson Cancer Center Foundation Spain, a non-profit organization whose objectives are to beat cancer and to increase accessibility of early phase oncology clinical trials (Press release, LabCorp, JUL 11, 2022, View Source [SID1234616585]). Through this collaboration, oncology clinical trials managed by Labcorp Drug Development will be prioritized and conducted at MD Anderson Cancer Center Foundation Spain, representing a new model for future trials.

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"This collaboration will help accelerate the discovery and development of cancer therapies worldwide," said Prasanth Reddy, M.D., MPH, FACP, senior vice president and oncology head at Labcorp. "Early phase clinical research in people with cancer is the first step in the regulatory approval process for new therapies, and this collaboration meets the growing demand for oncology clinical trials throughout Spain."

Early phase clinical trials of experimental oncology drugs, often referred to as Phase I or Phase Ib trials, are designed to identify the safety profile, recommended dose, schedule of administration and pharmacologic behavior of new agents or new combinations of agents.

"Having access to drugs in early development is an opportunity for patients with cancer that has metastasized to be able to benefit from the most innovative mechanisms of action in oncology, said Dr. Enrique Grande, head of MD Anderson Madrid Medical Oncology Service and head of clinical research at MD Anderson Foundation Spain. "The agreement with Labcorp allows studies of high scientific value to be concentrated at our center, thus contributing to the consolidation of the MD Anderson Cancer Center Foundation Spain and MD Anderson Madrid hospital as a European reference in the treatment of cancer patients."

The research team at MD Anderson Cancer Center Foundation Spain designs and develops clinical trials to find the best ways to prevent, diagnose and treat cancer. The Phase I Clinical Trials Unit in Madrid was established in October 2021 as a subsidiary of the prestigious MD Anderson Cancer Center in Houston, Texas. Cancer centers running these types of clinical trials can provide more potential treatment options to patients, an indicator of the quality of care available. The new unit, the largest research unit dedicated to Phase I in Spain, is staffed with highly qualified personnel to be able to offer innovative treatments in a unified, multidisciplinary facility enabling enhanced quality services and patient care.

Labcorp Drug Development offers end-to-end capabilities in oncology from research and discovery through commercialization. During the past five years, the company has been involved in 1,035 oncology studies globally involving 125,500 patients in 83 countries. This includes 444 early phase oncology clinical trials with more than 25,000 patients. Spain is the third leading country for early phase oncology trials behind the United States and the United Kingdom.

On July 11, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, reported that its Board of Directors has suspended the Company’s previously announced share repurchase program (Press release, Greenwich LifeSciences, JUL 11, 2022, View Source [SID1234616584]).

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Under the now suspended share repurchase program, the Company repurchased approximately 520,000 shares of common stock for an aggregate purchase price of approximately $7.5 million. Following these repurchases, the Company had approximately 12.8 million shares of common stock outstanding.

On July 11, 2022 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported the successful enrollment of the first patient in its first Proof-of-Concept (POC) Phase I clinical trial (Press release, Evogene, JUL 11, 2022, View Source [SID1234616583]).

The trial is designed primarily to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti PD-1 agent), in patients with either non-small cell lung cancer, melanoma or renal cell carcinoma. Bristol Myers Squibb’s Opdivo is the immune checkpoint inhibitor in the trial.

It has been previously reported that treatment with Biomica’s BMC128 in combination with ICI immunotherapy significantly enhanced anti-tumor activity in various preclinical models. Response to BMC128 was correlated with a desired anti-tumor immunological profile and led to a stimulation of the immune system shifting cold-tumors into hot-tumors.

BMC128 is a rationally designed consortium of microbes, which was identified and selected through a detailed functional microbiome analysis using PRISM, a high-resolution microbiome analysis platform powered by Evogene’s ‘MicroBoost AI’ tech engine and Big-Data platform.

Dr. Elran Haber, CEO of Biomica, stated: "We are very excited with our first patient in, under our first in-human, proof-of-concept trial. ICIs are a revolutionary treatment and have demonstrated their efficacy in prolonged survival rates of cancer patients. However, many patients are resistant to ICI, and it has been shown that the gut microbiome plays an important role in this resistance. Based on the compelling pre-clinical results that Biomica has achieved to-date, we are excited to evaluate BMC128 in a clinical setting for the first time. Our goal is to provide patients with a meaningful recovery, improved outcome and long-term response to treatment. We are thrilled in reaching this milestone and we look forward to embarking on the next phase of our clinical development process."

About BMC128:

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BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s ‘MicroBoost AI’ platform.

Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

On July 11, 2022 Sanofi reported the launch of its new investment fund, dubbed Impact, to support the distribution of 30 Sanofi medicines in 40 lower-income countries (Press release, EVERSANA, JUL 11, 2022, View Source [SID1234616582]). Launched under an entirely new brand, the fund will see standard of care medicines produced by Sanofi for disease areas such as diabetes, cardiovascular disease, tuberculosis, malaria and cancer, dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries . At the same time, the French pharma giant also announced the beginning of a fund, also under the brand of Impact, that will support startup companies and other innovators that can deliver "scalable solutions for sustainable healthcare in underserved regions," including business financing and technical assistance.

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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 German Ministry of Health has published an updated draft version of the "Financial Stabilisation of the Statutory Health Insurance System" (GKV-Finanzstabilisierungsgesetz) bill. The current draft, which replaces the premature release in March that caused uproar across the pharma industry, became public at the beginning of this week but has not been made available on the Ministry’s website. The new draft has been slightly amended from its previous incarnation but still contains some of the "most problematic provisions," suggested Alexander Natz, General Secretary of EUCOPE in a statement emailed to EVERSANA. In Natz’s eyes, the new draft also contains "further measures which negatively affect the pharmaceutical industry."

With a newly released revised proposal, Democrats are hoping to finally unleash a dormant economic package this summer, at the earliest, to lower the prices of drugs for seniors. The revisions come after Senate Majority Leader Charles E. Schumer (D-New York) spent weeks speaking privately with Senator Joe Manchin (D-West Virginia) who had reservations about a past bill called the Build Back Better Act. Manchin resisted the $2 trillion Build Back Better Act over concerns that it would add too much federal debt and further drive inflation. The proposal aims to give the federal government the authority to negotiate prices of certain drugs covered by Medicare, limit drug costs for Medicare beneficiaries to $2,000 per annum and penalize companies that pad drug prices at a faster rate than inflation.

THE DETAILS

COVID-19

The European Medicines Agency (EMA) has stated that regulators worldwide have agreed on fundamental principles for adapting vaccines to tackle COVID-19 variants. According to EMA, International Coalition of Medicines Regulatory Authorities (ICMRA) members and the World Health Organization (WHO) agreed that authorized COVID-19 vaccines continue to offer protection against severe disease, hospitalization, and death and encouraged their use, where available, both as primary series and as booster doses.

Novavax is expecting to provide a COVID-19 vaccine targeting Omicron in Q4 2022 as it accelerates the development of shots to protect against the BA.4 and BA.5 subvariants. The company said it is already "well underway" in its variant program and will focus on Omicron BA.4/5, as recommended by the U.S. Food and Drug Administration’s (FDA) independent experts on the Vaccines and Related Biological Products Advisory Committee in their guidance on June 30.

The U.S. Food and Drug Administration has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to enable state-licensed pharmacists to prescribe the pill. "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19," said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research.

The Africa Centres for Disease Control and Prevention (CDC) announced it inked a memorandum of understanding with Pfizer for the supply of Paxlovid (nirmatrelvir and ritonavir), an antiviral pill for the treatment of COVID-19. The Memorandum of Understanding (MOU) will enable members of the African Union to access Paxlovid at cost, according to Ahmed Ogwell Ouma, acting director of the CDC.

POLICY

With a newly released revised proposal, Democrats are hoping to finally unleash a dormant economic package this summer, at the earliest, to lower the prices of drugs for seniors. The revisions come after Senate Majority Leader Charles E. Schumer (D-New York) spent weeks speaking privately with Senator Joe Manchin (D-West Virginia) who had reservations about a past bill called the Build Back Better Act. Manchin resisted the $2 trillion Build Back Better Act over concerns that it would add too much federal debt and further drive inflation. The proposal aims to give the federal government the authority to negotiate prices of certain drugs covered by Medicare, limit drug costs for Medicare beneficiaries to $2,000 per annum and penalize companies that pad drug prices at a faster rate than inflation.

The German Ministry of Health has published an updated draft version of the "Financial Stabilisation of the Statutory Health Insurance System" (GKV-Finanzstabilisierungsgesetz) bill. The current draft, which replaces the premature release in March that caused uproar across the pharma industry, became public at the beginning of this week but has not been made available on the Ministry’s website. The new draft has been slightly amended from its previous incarnation but still contains some of the "most problematic provisions," suggested Alexander Natz, General Secretary of EUCOPE in a statement emailed to EVERSANA. In Natz’ eyes, the new draft also contains "further measures which negatively affect the pharmaceutical industry."

Medicines for Europe has suggested a number of policy reforms to help strengthen European health systems’ use of off-patent medicines. Speaking at the Medicines for Europe annual conference, the group suggested that when revising the EU pharmaceutical legislation, the EU must encourage the use of generic, biosimilar and value-added medicines to increase patient access to medicines and ensure budgetary sustainability, among other initiatives.

The Netherlands’ House of Representatives has voted on seven motions submitted in response to a debate held on pharmaceuticals policy on June 9. The majority of the House voted in favor of a motion by the Den Haan faction, which calls on the cabinet to accelerate the authorization of medicines in the Netherlands.

HTA

EUnetHTA has issued a statement notifying that the public consultations for Applicability of Evidence; Validity of clinical studies and Guidance for JCA Submission Dossier Template are now open. The three deliverables, known as D4.5, D4.6 and D5.1 are now open until August 2, 2022 at midnight. In its release, EUnetHTA 21 specified that comments received from organizations outside EU/EEA countries are welcome but may not be considered by EUnetHTA 21 if the organization is not directly impacted by the regulation (HTAR). In addition, only one consolidated comment form per organization is accepted. If multiple are submitted, the first will be considered the intended submission.

The Italian Medicines Agency (AIFA) has confirmed Zolgensma’s (onasemnogene abeparvovec) requirement for therapeutic innovation following a re-evaluation after one year, for the treatment of spinal muscular atrophy (SMA) 5q in patients weighing up to 13.5 kg.

Economist Impact and Roche have released a report on the "Value of Real-World Evidence in Health Technology Assessment (HTA)," exploring the value that Real-World Evidence (RWE) can add for assessing relative treatment effects during the first HTA of innovative new medicines. The researchers also found that positive language was only used in two of the assessments – Evrysdi and Zolgensma – in one or more final HTA reports about the impact of RWE for decision making. More often than not, RWE was either not cited, considered but disregarded, or discussed "but in a neutral or ambiguous manner."

PRICING & REIMBURSEMENT

Sanofi has announced the launch of its new investment fund, dubbed Impact, to support the distribution of 30 Sanofi medicines in 40 lower-income countries. Launched under an entirely new brand, the fund will see standard of care medicines produced by Sanofi for disease areas such as diabetes, cardiovascular disease, tuberculosis, malaria and cancer, dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries. At the same time, the French pharma giant also announced the beginning of a fund, also under the brand of Impact, that will support startup companies and other innovators that can deliver "scalable solutions for sustainable healthcare in underserved regions," including business financing and technical assistance.

The High Health Authority (HAS) of France has published a favorable opinion for reimbursing Amgen’s Lumykras (sotorasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, whose disease has progressed after at least one line of prior systemic treatment.

France’s High Authority for Health (HAS) has published a favorable opinion for maintaining reimbursement of Kymriah (tisagenlecleucel) to treat diffuse large B-cell lymphoma (DLBCL).

The National Institute for Health and Care Excellence (NICE) has recommended Janssen’s Tremfya (guselkumab), either alone or with methotrexate, for the treatment of active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. The cost of a 100 mg prefilled disposable injection of Tremfya is £2,250.00, but Janssen has agreed to both a simple discount patient access scheme and a complex patient access scheme that make the therapy available to the NHS with a discount.

The Italian Medicines Agency (AIFA) has amended the Yescarta (axicabtagene ciloleucel) register to allow treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and refractory or relapsed primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy up to 75 years of age.

DRUG APPROVAL

The European Commission has approved Sanofi’s Nexviadyme (avalglucosidase alfa) for the treatment of both late-onset and infantile-onset Pompe disease. The enzyme replacement therapy (ERT) is now the first approved medicine for the rare, progressive, and debilitating muscle disorder since 2006 – since Myozyme (alglucosidase alfa) was greenlit.

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Phanes’ PT886 for the treatment of pancreatic cancer.

Health Canada has approved Pfizer’s Cibinqo (abrocitinib) for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, announced the company.

The U.S. Food and Drug Administration (FDA) has accepted Eiasai and Biogen’s Biologics License Application (BLA) under the accelerated approval pathway for lecanemab, the companies’ Alzheimer’s candidate.

The U.S. Food and Drug Administration (FDA) has accepted Roche and Genentech’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

GlaxoSmithKline (GSK) has announced that Health Canada has accepted its New Drug Submission (NDS) for daprodustat for the potential treatment of patients with anemia of chronic kidney disease (CKD).