On March 31, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, reported that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval (Press release, Guided Therapeutics, MAR 31, 2022, View Source [SID1234611315]). The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval shortly thereafter.

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!

In addition, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable.

"We are pleased to hear that LuViva has performed well and as expected in the first clinical trials in China," said Gene Cartwright, CEO of Guided Therapeutics. "We look forward to a speedy conclusion and filing of study results with the Chinese regulatory authorities."

On March 31, 2022 Fresenius Kabi reported that it has agreed to acquire a stake of 55% of mAbxience Holding S.L. ("mAbxience") (Press release, Fresenius, MAR 31, 2022, View Source [SID1234611221]). The purchase price will be a combination of €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets. The contractual provisions also include a put / call option scheme regarding the current owners’ remaining shares in mAbxience (45%).

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!

mAbxience is a leading international biopharmaceutical company, focused on the rapidly developing biosimilars market. The company was founded in 2010 by Dr. Hugo Sigman and Dr. Silvia Gold as the biotechnology division of Insud Pharma S.L. mAbxience has established itself as a leader in the development and manufacturing of biological drugs, with two commercialized biosimilar products (Rituximab and Bevacizumab) and a mid-single-digit number of molecules across immunology and oncology expected to be launched globally in the years 2024 to 2029. This is supported by internal R&D laboratories and state-of-the-art manufacturing facilities in Spain and Argentina. In addition to highly competitive production costs for the internal programs, the manufacturing platform allows mAbxience to offer third party biological CDMO services, including a recent contract with AstraZeneca to produce the drug substance for its COVID-19 vaccine in Latin America. The company currently employs approximately 600 staff and generated sales of approx. €255 million in 2021.

The acquisition of a majority stake in mAbxience follows Fresenius Kabi’s recently unveiled Vision 2026 strategy, delivering on one of the core growth vectors – to "Broaden Biopharma" – by expanding along the value chain and further enhancing the existing Fresenius Kabi biosimilars pipeline.

Fresenius Kabi expects, through its in-house biosimilars programs and through its investment in mAbxience, to capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market. Fresenius Kabi’s footprint in biopharmaceuticals will be significantly strengthened by broadening its biosimilars portfolio and by gaining access to the distinctive manufacturing capabilities of mAbxience. It will also allow Fresenius Kabi to provide end-to-end integrated biopharmaceutical solutions for customers from its state-of-the-art facilities.

mAbxience operates three state-of-the-art facilities for the production of biologic drug substance. This addresses a critical gap in Fresenius Kabi’s value chain, adding flexible, single-use biologic drug substance capacity that can be leveraged to provide competitive cost of production for the enlarged biosimilars portfolio. This manufacturing capability also offers end-to-end integrated biopharmaceutical solutions for customers and thus establishes a strategic foothold for Fresenius Kabi in the fast-growing biologic CDMO sector, complementing the existing small molecule API and fill & finish operations.

Once completed, the transaction is expected to deliver material operating and cost synergies for Fresenius Kabi, primarily driven by leveraging mAbxience’s manufacturing capabilities for Fresenius Kabi’s existing biosimilars business.

The transaction remains subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.

Ivenix strengthens Fresenius Kabi’s MedTech business and accelerates growth

Delivers on core growth vector "Expand MedTech" of Vision 2026
Provides next-generation infusion therapy platform for U.S. market
Complements Fresenius Kabi’s global infusion therapy offering
Provides Fresenius Kabi with key capabilities in hospital connectivity and creates new options for growth of MedTech business
Significant scale and growth synergies expected
Fresenius Kabi announced today that it has agreed to acquire Ivenix, Inc. („Ivenix"), a specialized infusion therapy company. The purchase price will be a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

Ivenix is a privately held company based in North Andover, Massachusetts, USA. The company has developed the technologically most advanced infusion system including a large volume pump ("LVP") with administration sets, infusion management software tools, applications and analytics to inform care and advance efficiency. The Ivenix Infusion System’s innovative design and architecture sets a new standard in infusion safety, simplicity and interoperability. The system is centred around the patient and clinician and is designed to reduce infusion-related errors and drive down the total cost of ownership. After having received the U.S. Food and Drug Administration’s (FDA) approval, the Ivenix Infusion System was successfully launched in late 2021.

Ivenix’ Infusion System provides access to attractive growth potential for Fresenius Kabi in the large and growing infusion therapy market. The combination of Ivenix’ leading hardware and software products with Fresenius Kabi’s offerings in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space.

The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.

Financing and implications on Group financials

mAbxience is expected to be accretive to Group cash earnings per share (earnings before amortization and integration costs) right after closing. Ivenix is expected to be neutral to Group cash earnings per share in 2025 and accretive from 2026 onwards.

Combined, these acquisitions are expected to be broadly neutral to Group cash earnings per share in 2022 and accretive as of 2023.

The transactions are currently expected to be financed by cash flow and available liquidity.

Conference Call

A telephone conference on the acquisition of a majority stake in mAbxience Holding S.L. and the acquisition of Ivenix, Inc. will be held on March 31, 2022 at 1:30 p.m. CEST (7:30 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

On March 31, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported its financial results for the year ended December 31, 2021 (Press release, PDS Biotechnology, MAR 31, 2022, View Source [SID1234611243]).

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!

"I’m very pleased to report that we have undergone a 12-month period of incredible productivity here at PDS Biotech," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. "We’ve made significant clinical progress on our lead oncology candidate, PDS0101, and presented at leading oncology conferences on the promising efficacy and safety results of PDS0101 from two of our ongoing Phase 2 clinical trials. Another phase 2 clinical study of PDS0101 to be led by Mayo Clinic was initiated this month, to evaluate PDS0101 as a potential first-line neo-adjuvant treatment for patients with oropharyngeal cancer prior to transoral robotic surgery. We also recently announced encouraging pre-clinical data from our NIAID-funded universal flu vaccine program. We continue to leverage our unique T-cell activating platforms to advance additional pre-clinical oncology and infectious disease candidates."

Dr. Bedu-Addo continued: "Over the past year, we completed two licensing transactions and secured additional intellectual property for our expanding pipeline. We also received approval of a US composition of matter and use patent for PDS0101. We strengthened our scientific advisory and leadership teams by adding distinguished immuno-oncology experts to our scientific advisory board and welcomed Matthew Hill as our Chief Financial Officer. We also added more than $52 million to our balance sheet in 2021, significantly extending our cash runway and ability to continue to advance our clinical and pre-clinical programs. We look forward to an equally productive 2022, during which we expect to announce additional data from our ongoing Phase 2 oncology trials for PDS0101, as well as plan to progress at least one of our preclinical programs, PDS0103 into the clinic."

Fourth Quarter 2021 and Recent Business Highlights:

Achieved several milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA (pembrolizumab) for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:

Presented preliminary safety data on a total of 18 checkpoint inhibitor naïve patients at the 2022 Multidisciplinary Head and Neck Cancers Symposium. Highlights from the presentation include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or any significant immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA (range 1-13).

Achieved preliminary objective response benchmarks that enabled us to advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.

Initiated enrollment in the checkpoint inhibitor-refractory cohort.

Announced initiation of an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence. The trial will evaluate PDS0101 as monotherapy and in combination with KEYTRUDA.

Announced encouraging preclinical data for the universal flu vaccine that demonstrated a potent neutralization response against multiple strains of the influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of influenza in preclinical animal subjects.

Granted U.S. Patent Application by the United States Patent and Trademark Office for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.

Achieved enrollment objective of 30 patients in the checkpoint inhibitor refractory arm of the NCI-led triple combination trial in March 2022.

Achieved median overall survival at December 31, 2021 of 12 months for 30 HPV16-positive patients who had received at least one evaluation in the NCI-led triple combination trial. Approximately 73% of the patients had failed 3 prior treatment regimens including checkpoint inhibitor therapy.

Full-Year 2021 Financial Results

For the year ended December 31, 2021, the net loss was approximately $16.9 million, or $0.66 per basic share and diluted share, compared to a net loss of approximately $14.8 million, or $0.89 per basic share and diluted share for the year ended December 31, 2020.

For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million and personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million.

For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7.0 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1.0 million, non-cash stock-based compensation of $2.5 million, and facilities costs of $0.1 million, partially offset by a decrease in professional fees of $0.4 million.

Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to total operating expenses of approximately $14.9 million for the year ended December 31, 2020.

The Company’s cash balance as of December 31, 2021 was $65.2 million. Based on the Company’s available cash resources and cash flow projections, the Company believes this balance is sufficient to fund Company operations and research and development programs through the end of 2023.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am EDT on Thursday, March 31, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com. After the live webcast, the event will be archived on PDS Biotech’s website for six months.

On March 31, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported results of a retrospective, observational study describing the substantial burden of myelosuppression and its impact on healthcare resource utilization (HCRU) in 3,277 patients being treated with chemotherapy for extensive-stage small-cell lung cancer (ES-SCLC) (Press release, G1 Therapeutics, MAR 31, 2022, View Source [SID1234611282]). The study also described patient outcomes from 21 patients receiving trilaciclib prior to chemotherapy; of these, 17 received commercial trilaciclib in the real-world setting, and four received trilaciclib in clinical trials.

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!

Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events (HAE) in at least one blood cell lineage and a 74% reduction in the percent of all-cause hospitalizations (days 1 to 21 after treatment), compared to patients who received chemotherapy alone. The analyses were derived using structured, real-world, de-identified clinical patient level data from the Integra Connect oncology warehouse. Findings are being presented in a poster session at the Annual Conference of the National Comprehensive Cancer Network (NCCN), held from March 31 to April 2, 2022.

The poster titled, "Burden of Myelosuppression Among Patients with Extensive-Stage Small Cell Lung Cancer Treated with Chemotherapy in a Community Oncology Setting" is available in the scientific publications section of G1’s website.

"The real-world burden of myelosuppressive hematologic adverse events among patients receiving chemotherapy, and the resulting hospitalizations, are routinely underestimated in the community oncology setting," said Jeffrey Scott, M.D., Chief Medical Officer of Integra Connect and lead author of the study. "In this retrospective analysis, nearly 60% of patients receiving chemotherapy alone had a grade ≥ 3 myelosuppressive HAE in at least one lineage, with a sizeable proportion having multilineage (≥ 2 lineages) myelosuppression. Importantly, these data also capture the first real-world experience of using trilaciclib prior to chemotherapy. Among those patients, the use of trilaciclib nearly eliminated not only grade ≥ 3 HAEs associated with multilineage myelosuppression but also all-cause hospitalizations."

In the study, the researchers conducted a primary analysis of 3,277 patients who received chemotherapy alone and a secondary analysis from 21 patients who received trilaciclib prior to chemotherapy, including 17 who received commercial trilaciclib in the real-world setting. Utilizing data from the Integra Connect Database, the researchers quantified the prevalence and frequency of grade ≥ 3 myelosuppressive HAEs and associated healthcare resource utilization (including supportive care such as G-CSFs, ESAs, and blood transfusions), and all-cause hospitalizations.

Key findings included:

Myelosuppressive HAEs

Grade ≥ 3 myelosuppressive HAEs were observed across all regimens in chemotherapy-treated patients (no trilaciclib) with ES-SCLC
Patients treated with chemotherapy alone (no trilaciclib):
57.4% had at least one grade ≥ 3 myelosuppressive HAE
33.3% had grade ≥ 3 thrombocytopenia, 34.0% had grade ≥ 3 anemia, and 44.6% had grade ≥ 3 neutropenia
19.6% had both grade ≥ 3 anemia and grade ≥ 3 thrombocytopenia
20.3% had both grade ≥ 3 neutropenia and grade ≥ 3 anemia
23.0% had both grade ≥ 3 neutropenia and grade ≥ 3 thrombocytopenia
14.5% had grade ≥ 3 HAEs in all three lineages
Patients treated with trilaciclib prior to chemotherapy:
28.6% had at least one grade ≥ 3 myelosuppressive HAE
4.8% had grade ≥ 3 thrombocytopenia, 14.3% had grade ≥ 3 anemia, and 19.0% had grade ≥ 3 neutropenia
0% had both grade ≥ 3 anemia and grade ≥ 3 thrombocytopenia
4.8% had both grade ≥ 3 neutropenia and grade ≥ 3 anemia
4.8% had both grade ≥ 3 neutropenia and grade ≥ 3 thrombocytopenia
No patients had grade ≥ 3 HAEs in all three lineages
Healthcare Resource Utilization (HCRU) for HAE Management:

Patients treated with chemotherapy alone (no trilaciclib):
7.4% were hospitalized between days 8 and 16 after initiation of chemotherapy, and 18.8% were hospitalized between days 1 and 21 after initiation
83.9% received a G-CSF (61.1% within three days after treatment), 10.7% received RBC transfusions, and 2.4% received platelet transfusions at any time after initiation
Patients treated with trilaciclib prior to chemotherapy:
No patients were hospitalized between days 8 and 16 after initiation of chemotherapy, and one was hospitalized between days 1 and 21 after initiation
71.4% received a G-CSF (47.6% within three days after treatment), 4.8% received RBC transfusions, and none received platelet transfusions at any time after initiation

The researchers noted that future studies using data from larger patient populations are recommended to enable a more robust comparison between patients treated with trilaciclib prior to chemotherapy and patients treated with chemotherapy without trilaciclib.

"The myelotoxic impacts of chemotherapy in patients with ES-SCLC — including ≥ grade 3 neutropenia, anemia, and thrombocytopenia — pose a considerable burden to both patients and to the healthcare system at large in terms of associated healthcare resources required to treat them," said Huan Huang, Director of Health Economics and Outcomes Research at G1 Therapeutics and co-author of the study. "While the numbers in the trilaciclib dataset are small, these new data add to a growing body of real-world data cataloguing the extent of this burden in patients with ES-SCLC and the need for innovative therapies, such as trilaciclib, to reduce them."

The results add to data recently published in the Journal of Medical Economics showing the use of trilaciclib prior to first-line chemotherapy resulted in cost savings due to fewer myelosuppressive adverse events and their associated treatment costs in patients with extensive-stage small-cell lung cancer. The data showed that the use of trilaciclib in this setting resulted in a 78% overall reduction in the number of myelosuppressive adverse events and an estimated cost savings per patient were $18,840 from a U.S. payer perspective compared to chemotherapy alone. The findings were derived from a cost-effectiveness analysis based on published literature on myelosuppression and data from the pivotal Phase 2 trilaciclib trial. This manuscript is also available in the scientific publications section of the G1’s website.

On March 31, 2022 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported its financial results for the full year ended December 31, 2021, and provided a business update (Press release, Enveric Biosciences, MAR 31, 2022, View Source [SID1234611298]).

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!

"2021 was a foundational year that set the stage for Enveric to execute on its strategy in the future," said Dr. Joseph Tucker, Enveric’s Chief Executive Officer. "With the acquisition of MagicMed in September 2021, we immediately began moving forward with the clinical development strategy of our next-generation treatments and therapies for mental health. We find ourselves strategically positioned with an experienced team of industry professionals, collaborative partners including the University of Calgary, a growing intellectual property portfolio, and a robust Central Nervous System pipeline of promising drug candidates. As we build upon the three core pillars of our success, Drug Development, Drug Discovery, and Intellectual Property, we are focused on creating effective mental health medicines."

Corporate Updates During and Subsequent to the Fourth Quarter 2021:

Clinical Trials

Announced collaboration with the University of Calgary on a groundbreaking clinical trial for EVM-201 in cancer-related distress. A clinical trial, expected to launch in 2023, of EVM-201, a second-generation psychedelic treatment, for Cancer Related Distress will be led by HBI researcher, Dr. Valerie Taylor, Head of the Department of Psychiatry, in Calgary, Canada.
Announced positive preclinical data for EV102 radiodermatitis drug candidate. EV102 has demonstrated a significant and meaningful reduction in dermatitis severity, skin redness, and duration in a preclinical rodent model.
PsyAITM, an artificial intelligence platform, successfully identified viable psychedelic molecules for further drug discovery from Enveric’s initial list of 500 psychedelic molecular compounds within its "Psybrary." We believe it is a first of its kind to employ this machine-learning technology against an extensive psychedelic molecule library to evaluate higher-likelihood molecules that treat conditions that include cancer-related distress, PTSD, and other central nervous system (CNS) indications.
IP Portfolio

Filed and published four patent applications for psychedelic-inspired drug candidates by the World Intellectual Property Organization (WIPO). The four patent applications are focused on the tryptamine family of novel molecules.
Filed its 10th Patent Cooperation Treaty (PCT) patent application directed to tryptamine-based derivative molecules, completing the Company’s broad series of PCT applications covering this family of compounds.
Successfully synthesized and filed a provisional patent for EV104, the Company’s cannabinoid, and celecoxib conjugate. EV104a and EV104b are the Company’s new molecular conjugates for Osteoarthritis ("OA") and other pain indications.
Filed an additional provisional patent application based on new discoveries by the company. The patent application and claimed drug candidates fall into the Company’s EVM201 second-generation, psychedelic-derived drug development program.
Leadership Team

Appointed Bob Dagher, MD, as Chief Medical Officer. Dr. Dagher is a Board-certified neurology and psychiatry physician, bringing over 15 years of clinical experience and extensive therapeutic knowledge in the neuroscience space.
Capital Markets

Closed a $10 million public offering. The Company intends to use the net proceeds from this offering for working capital and to fund other general corporate purposes.
Included in the new AdvisorShares Psychedelics ETF, trading under the ticker symbol "PSIL" on the NYSE Arca exchange. PSIL is an ETF that focuses on investments in biotechnology, pharmaceutical, and life sciences companies that are leading the nascent but advancing psychedelic industry.
Financial Results for the Full Year Ended December 31, 2021:

Comprehensive net loss was $48.8 million for the year ended December 31, 2021, including $36.3 million in net non-cash expenses, with basic and diluted loss per share of $2.07, as compared to a comprehensive net loss of $7.0 million with basic and diluted loss per share of $1.19 per share for the year ended December 31, 2020.

Net cash used in operations for the year ended December 31, 2021, was $11.5 million consisting of the net loss, adjusted by a net of $36.3 million in non-cash expenses and changes in asset and liability balances of $1.2 million.

As of December 31, 2021, the Company had cash and cash equivalents of $17.4 million and working capital of $15.3 million. Subsequent to December 31, 2021, the Company raised an additional $10 million and expects to use the funds to help advance its new drug discovery platform, robust IP portfolio, and a growing pipeline of promising drug candidates.