On March 28, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported their participation in upcoming investor conferences and invites investors to participate in one-on-one meetings (Press release, ERYtech Pharma, MAR 28, 2022, View Source [SID1234611127]):

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Investor Access Event

Link to the event

Date: Monday, April 4th and Tuesday, April 5th
Place: Paris (France)
Participant: Eric SOYER (CFO-COO)

Kempen 14th Life Sciences Conference

Link to the event

Date: Thursday, April 21st
Place: Amsterdam (Netherlands)
Participants: Gil BEYEN (CEO) and Eric SOYER (CFO-COO)

If you are interested in arranging a one-on-one meeting, please contact your conference representative.

On March 28, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the fourth quarter of 2021 (Press release, Molecular Templates, MAR 28, 2022, View Source [SID1234611108]).

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"2022 is off to a very promising start, following a number of important developments across our pipeline of ETBs in 2021," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "We continue to see differentiated pharmacodynamic effects and evidence of antigen seeding with MT-6402 with additional data expected throughout 2022. We continue dose finding for the MT-5111 and MT-0169 programs with clinical data expected this year. We plan to file an IND in 2H22 for our CTLA-4 program and are moving forward with our earlier stage pipeline of ETBs in preclinical development targeting TIGIT, TROP-2, and BCMA."

Company Highlights and Upcoming Milestones

Corporate

MTEM expects to provide periodic updates on MT-6402, MT-5111, and MT-0169 throughout 2022.
MTEM has had six abstracts accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting 2022, taking place from April 8-13, 2022.
Gabriela Gruia, M.D. appointed to the Board of Directors.
Megan Filoon promoted to General Counsel.
MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

MTEM continues to enroll patients in the Phase 1 study of MT-6402 which began in July 2021. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of approved checkpoint inhibitors.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment are eligible for enrollment.
The 16 mcg/kg cohort (cohort 1) was completed with no DLTs observed in the six patients treated. One patient in cohort 1 with non-small cell lung cancer (NSCLC) had evaluable-only multiple sites of bone disease that appeared to have resolved on bone scan with only one remaining site which showed decreased uptake. This patient remained on MT-6402 up to cycle 8 when increased uptake was noted on bone scan and treatment was discontinued.
Six patients have been treated in the 24 mcg/kg cohort (cohort 2). One DLT, a grade 3 dermatitis of two days duration, occurred six days after the first dose in cohort 2 in one patient. The patient was treated with systemic steroids and treatment with MT-6402 was held until cycle 2, dose 1, at which time the patient was re-challenged at the same dose without development of recurrent dermatitis.
Following a review of the safety data from cohort 2 (24 mcg/kg), patient enrollment in cohort 3 initiated at a dose of 32 mcg/kg.
MTEM continues to observe pharmacodynamic (PD) effects including monocyte depletion and T cell activation in the 24 mcg/kg cohort. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg generally showing a more rapid and profound PD effect.
Six patients remain on study with five patients awaiting their first efficacy assessment. Dose escalation continues as planned and following determination of the maximum tolerated dose (MTD), expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and PD-L1 positive basket tumor cohorts.
In 2021, MT-6402 was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of patients with advanced NSCLC expressing PD-L1.
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated in November 2021 at a dose of 10 mcg/kg.
As of January 2022, 30 patients had been treated with MT-5111 across eight dose escalation cohorts ranging from 0.5 mcg/kg to 13 mcg/kg without any DLTs.
There have been no signs of capillary leak syndrome (CLS) or significant cardiotoxicity observed to date with MT-5111.
Enrollment has initiated for the next cohort at 17 mcg/kg. Dose escalation will continue to determine the MTD, while the breast cancer expansion cohort collects efficacy and safety data.
MT-0169 (CD38 ETB)

In August 2021, MTEM assumed full rights to MT-0169 from its former co-development partner, Takeda, including full control of MT-0169 clinical development, per the terms of the terminated collaboration agreement with Takeda. Upon approval of a revised protocol, MTEM will continue to conduct the ongoing Phase 1 study for MT-0169 in relapsed/refractory multiple myeloma and non-Hodgkin’s lymphoma and plans to open new sites for the Phase I study.
A more rapid and complete elimination of CD38+ NK cells (a known PD marker for CD38-targeting therapeutics) was observed in the first five patients than had been predicted from in vitro and in vivo models, suggesting that the starting dose of 50 mcg/kg is higher than required.
A revised protocol was submitted to explore a lower dose of MT-0169 to reduce the risk of adverse events observed at the initial dose and to enable patients to continue MT-0169 therapy for a longer duration that may drive tumor benefit. Importantly, the robust and rapid NK cell depletion that was observed at the starting dose is expected to be observed at lower doses.
Research

MTEM continues to advance its pipeline of next-generation ETBs targeting CTLA-4, TIGIT, TROP2, BCMA, SLAMF-7, and CD45.
IND filing of an ETB in the CTLA-4 program is expected in 2H22.
Lead selection for TIGIT, TROP-2, and BCMA is ongoing.
MTEM plans to present preclinical data on its ETB candidates at AACR (Free AACR Whitepaper) in April 2022 and expects to present further preclinical data throughout the year at medical and scientific conferences.
Financial Results for the Fourth Quarter of 2021

The net loss attributable to common shareholders for the fourth quarter of 2021 was $10.2 million, or $0.18 per basic and diluted share. This compares with a net loss attributable to common shareholders of $28.4 million, or $0.57 per basic and diluted share, for the same period in 2020.

Revenues for the fourth quarter of 2021 were $18.0 million, compared to $3.5 million for the same period in 2020. Revenues for the fourth quarter of 2021 were comprised of revenues from collaborative research and development agreements with Vertex and Bristol Myers Squibb. Total research and development expenses for the fourth quarter of 2021 were $19.3 million, compared with $22.3 million for the same period in 2020. Total general and administrative expenses for the fourth quarter of 2021 were $7.9 million, compared with $7.1 million for the same period in 2020.

As of December 31, 2021, MTEM’s cash and investments totaled $152.0 million. MTEM’s current cash and investments are expected to fund operations into the fourth quarter of 2023.

On March 28, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it has entered into a definitive agreement to divest Sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA), to Axsome Therapeutics (Nasdaq: AXSM) (Press release, Jazz Pharmaceuticals, MAR 28, 2022, View Source [SID1234611080]). Under the terms of the agreement, Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. Jazz will receive attractive financial terms including an upfront payment of $53 million, a high single-digit royalty on Axsome’s U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S. net sales of Sunosi in future indications.

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The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi’s consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition.

Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine.

"This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion. Through our development and launch of Sunosi, the Jazz team has laid the foundation for Axsome to continue supporting people who may benefit from this much-needed treatment. As a leader in sleep medicine and rare epilepsies, with a growing oncology franchise, Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025."

"We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization platform with three complimentary assets," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics.

Sunosi is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA. More information about Sunosi, including Full Prescribing Information and Medication Guide, is available View Source." target="_blank" title="View Source." rel="nofollow">View Source

Closing Conditions

The respective obligations of Jazz and Axsome to consummate the transactions contemplated by the definitive agreement are subject to the satisfaction or waiver of a number of customary conditions, including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR Act).

The transaction is structured to be completed in sequential closings for the U.S. and ex-U.S. territories. Subject to the satisfaction or waiver of the closing conditions, the companies expect the U.S. transaction to close in the second quarter of 2022 and the ex-U.S. transaction close to occur within 60 days following the close of the U.S. transaction.

Guggenheim Securities acted as financial advisor and Cooley LLP acted as legal counsel to Jazz.

About Sunosi (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.

Important Safety Information for Sunosi

SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:

have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol

have had a heart attack or a stroke

have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction

are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby

are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.

What are the possible side effects of SUNOSI?

SUNOSI may cause serious side effects, including:

Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.

Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.

The most common side effects of SUNOSI include:

headache

decreased appetite

problems sleeping

nausea

anxiety

These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please find full prescribing information here: View Source

On March 28, 2022 Loki Therapeutics, a company developing next-generation therapeutics that leverage vaccination recall antigens to enhance longevity and treat immune-system related diseases, including cancer, reported the publications of research in the journal, "Science Translational Medicine", demonstrating the potential of AWAKE-LM-TT in the treatment of pancreatic cancer (Press release, Loki Therapeutics, MAR 28, 2022, View Source [SID1234611075]). AWAKE-LM-TT, which was developed by Claudia Gravekamp, Ph.D., Loki’s Co-Founder and Associated Professor of Microbiology & Immunology at Albert Einstein School of Medicine, capitalizes on the childhood vaccination for tetanus to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens.

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The manuscript titled, "Listeria Delivers Tetanus Toxoid Protein to Pancreatic Tumors and Induces Cancer Cell Death in Mice," and co-authored by Dr. Gravekamp, Ph.D., describes research involving a novel approach to treating pancreatic cancer whereby Listeria monocytogenes are used to deliver highly immunogenic tetanus toxoid (TT) proteins directly into tumor cells. This delivery, Listeria-TT, was demonstrated to elicit an immune response, activating tetanus toxoid–specific memory T cells to kill pancreatic ductal adenocarcinoma (PDAC) tumor cells in mice. When combined with gemcitabine (Listeria-TT + GEM), researchers observed an 80% reduction of PDAC tumor burden and an 87% reduction of metastases with an increased survival by 40% compared to nontreated mice, suggesting that Listeria-delivered recall antigens could be an alternative to neoantigen-mediated cancer immunotherapy.

Loki Co-founder and CEO Chris Bradley said, "This study is just the tip of the iceberg when it comes to identifying and finding effective therapeutics to treat difficult cancers. Pancreatic cancer is difficult to identify at an early stage, which makes finding a treatment even more challenging, since it is usually detected at an advanced or late stage. This research demonstrates the significant potential of Loki’s AWAKE-LM-TT as a novel treatment for pancreatic cancer given its ability to harness the childhood vaccination for tetanus toxoid to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens."

Dr. Gravekamp commented, "Because of this research, we have a new strategy that can not only be a successful immunotherapy in treating pancreatic cancer, but other cancers as well. Pancreatic tumors are very challenging to treat in that, to the immune system, these tumors do not appear sufficiently ‘foreign’ to attract the immune system’s attention and can usually suppress any immune responses that does occur. Our approach essentially makes these immunologically ‘cold’ tumors hot enough for the immune system to attack and destroy."

Loki is preparing to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration for a first-in-human clinical program investigating AWAKE-LM-TT in the treatment of pancreatic cancer. Upon receiving FDA clearance for the IND, Loki anticipates initiating a Phase 1 clinical trial in the second half of 2022.

On March 28, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported positive preliminary efficacy and safety results from a phase 1 clinical trial for their lead drug candidate, Silmitasertib (CX-4945), in patients with advanced Basal Cell Carcinoma (Press release, Senhwa Biosciences, MAR 28, 2022, View Source [SID1234611074]). These findings were presented within an e-poster on March 27 at the 2022 annual meeting of the American Academy of Dermatology (AAD) held in Boston, Massachusetts, from March 25-29, 2022.

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The American Academy of Dermatology is the largest, most influential, and representative dermatology group in the United States. The poster features preliminary findings on disease control from a phase 1 study, evaluating the safety and efficacy of Silmitasertib in patients with advanced BCC.

"We are very pleased with the preliminary results of this phase 1 study and we look forward to the final results at the conclusion of the study," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

BCC is the most common type of skin cancer. Most basal cell carcinomas can be surgically removed; however, for unresectable tumors there are two approved targeted drugs and both are characterized as smoothened inhibitors (SMOi). SMOi target the Hedgehog (Hh) pathway and have been approved for the treatment of patients with locally advanced BCC (laBCC) or metastatic BCC (mBCC).

Unfortunately, drug resistance to SMOi is common but targeting the signaling cascade downstream of SMOi could avoid this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting GLI-1 stability and GLI-1’s interaction with target genes. Given the interplay between CK2 and GLI-1 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered due to its oral formulation. Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase I/II studies of Silmitasertib.

The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.