On March 29, 2023 Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, reported financial results for the fourth quarter and full year ending December 31, 2022 and provided a business update (Press release, Synlogic, MAR 29, 2023, View Source [SID1234629504]).

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"Last year was a tremendous year for Synlogic and our Synthetic Biotic platform given our three positive clinical readouts in three different diseases in the fourth quarter alone," said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. "We are on track to initiate Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU, our lead program, and we were thrilled to present three data presentations – including Phase 2 PKU data as a platform presentation – at the SIMD Annual Meeting."

Fourth Quarter 2022 and Recent Highlights

Received positive opinion on orphan designation from the European Medicines Agency (EMA) for SYNB1934 for PKU
Presentation of data from both the Phase 2 Synpheny-1 study in PKU and the Phase 1 study with SYNB1353 for HCU at the Society for Inherited Metabolic Disorders (SIMD) 44th Annual Meeting
Received Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) for both:
SYNB1934 for PKU
SYNB1353 for HCU
Announced positive top-line Phase 2 data for PKU; advancing SYNB1934 to Phase 3
Demonstrated proof of mechanism for SYNB1353 for HCU, based on a top-line data from a Phase 1 study using a methionine meal challenge in healthy volunteers
Proof of concept achieved with Phase 1b top-line data for SYNB8802 for enteric hyperoxaluria
Anticipated Upcoming Milestones

Initiation of Phase 3 clinical trial of SYNB1934 for PKU in the first half of 2023
Advancing SYNB1353 to Phase 2 study in patients with HCU
Presentation of data from Phase 1b studies of SYNB8802, in development for enteric hyperoxaluria
Progression of preclinical pipeline programs, including partnerships
Corporate Updates

In January 2023, the company announced the appointment of Dr. Dave Hava as Head of Research and Development. Through the integration of the company’s research and development teams, Dr. Hava oversees the advancement of clinical stage programs in addition to progressing our collaboration with Roche and select preclinical programs. Dr. Hava joined Synlogic in 2020, as Chief Scientific Officer, and continues to assume this position within the company.

Fourth Quarter 2022 Financial Results

As of December 31, 2022, Synlogic had cash, cash equivalents, and short-term marketable securities of $77.6 million.

Revenue was $0.1 million for the three months ended December 31, 2022, compared to $0.6 million for the corresponding period in 2021. Revenue in both periods was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD.

Research and development expenses were $13.6 million for the three months ended December 31, 2022, compared to $11.9 million for the corresponding period in 2021.

General and administrative expenses for the three months ended December 31, 2022 were $3.8 million compared to $3.9 million for the corresponding period in 2021.

For the three months ended December 31, 2022, Synlogic reported a consolidated net loss of $16.7 million, or $0.24 per share, compared to a consolidated net loss of $15.1 million, or $0.21 per share, for the corresponding period in 2021.

Full Year 2022 Financial Results

Revenues were $1.2 million for the year ended December 31, 2022, compared to $1.8 million for the same period in 2021. Revenue in both periods was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. Operating expenses were $68.6 million for the year ended December 31, 2022, compared to $62.5 million for the same period in 2021. For the year ended December 31, 2022, consolidated net loss was $66.1 million, or $0.92 per share, compared to a consolidated net loss of $60.6 million, or $1.09 per share, for the year ended December 31, 2021.

Financial Outlook

Based upon its current operating plan and balance sheet as of December 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into the second half of 2024.

On March 29, 2023 CVS Health (NYSE: CVS) reported that it has completed its acquisition of Signify Health (Press release, Signify Health, MAR 29, 2023, View Source [SID1234629503]).

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Signify Health is a leading technology and services company, focused on provider enablement and bringing clinicians into the home to identify chronic conditions, close gaps in care, and address social determinants of health. Signify has a network of more than 10,000 clinicians in all 50 states, who spend an average of 2.5 times longer with a member during home visits than an average visit with a primary care provider.

"This transaction advances our value-based care strategy by enhancing our presence in the home," said CVS Health President and CEO Karen S. Lynch. "Our expanded capabilities will bring us closer to the consumer as we continue to redefine how people access and experience care that is more affordable, convenient and connected."

The combined company will work to improve care delivery capabilities, lower costs, improve levels of engagement and enable broad access to high-quality care, especially for Medicare Advantage customers. Signify clinicians can have an even greater impact by engaging with CVS Health’s unique collection of assets and connecting consumers to care how and when they need it.

"Our mission has always been to build trusted relationships to make people healthier," said Kyle Armbrester, who will continue to lead Signify Health. "As part of CVS Health, we will be uniquely positioned as a payor-agnostic business to support a more proactive, preventive and holistic approach to patient care.

"We’re excited to welcome the Signify team to CVS Health," said Lynch. "I’m confident our shared values and complementary capabilities will work together to better address patient needs."

Under the terms of the transaction, each outstanding share of Signify Health common stock is being exchanged for $30.50 in cash, representing a total transaction value of approximately $8 billion. CVS Health funded the transaction price with existing cash and available resources and is committed to maintaining its current credit ratings.

On March 29, 2023 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the fiscal year ended December 31, 2022, and provided a business update (Press release, Pieris Pharmaceuticals, MAR 29, 2023, View Source [SID1234629502]).

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"Pieris continues to advance potentially transformative clinical and preclinical programs, while remaining committed to cost-effective operations. Our top priority is to obtain data from the elarekibep Phase 2a study in asthma. We are pleased that our partner and study sponsor, AstraZeneca, is significantly increasing operational resources to complete the trial. As an inhaled therapeutic, elarekibep offers the promise of a superior product profile compared to currently available injectable drugs and further validation of our broader respiratory franchise," said Stephen S. Yoder, President and CEO of Pieris. "Respiratory diseases such as asthma, IPF and chronic obstructive pulmonary disease are underserved by the biopharma industry despite high mortality rates, impaired quality of life, and a significant burden on the healthcare system. We believe Pieris is well positioned to develop differentiated inhaled biologics medicines that could fundamentally alter how respiratory diseases are managed.

"Alongside our lead program, elarekibep, Pieris is advancing additional clinical and preclinical programs that could result in meaningful new medicines. We are evaluating opportunities to support the long-term development of these promising therapeutic candidates."

Respiratory Pipeline:

Elarekibep and AstraZeneca Collaboration: Enrollment is ongoing in the multi-center, placebo-controlled Phase 2a study of dry powder inhaler-formulated elarekibep, an IL-4 receptor alpha (IL-4Rα) inhibitor being developed for the treatment of moderate-to-severe asthma. Topline results measuring placebo-adjusted FEV1 improvement at four weeks are now expected to be reported by the middle of 2024 based on AstraZeneca’s most recent projections. AstraZeneca has communicated to the Company that completion of the Phase 2a study remains an important priority and that additional resources have been provided to achieve study completion, including a commitment to adding several new countries and a significant number of additional clinical sites, bringing the total number to more than 100 sites.

Elarekibep is validated by dupilumab, an FDA-approved inhibitor of IL-4Rα, that has demonstrated reduced levels of fractional exhaled nitric oxide (FeNO) and clinical efficacy in uncontrolled, moderate-to-severe asthma. Furthermore, recently reported dupilumab Phase 3 study results have shown efficacy in chronic obstructive pulmonary disease (COPD). Previously reported elarekibep Phase 1 results demonstrated reduced FeNO levels in mild asthma patients, and a favorable safety profile.

Pieris retains co-development and U.S. co-commercialization rights for elarekibep, exercisable following completion of the ongoing Phase 2a study. Beyond elarekibep, Pieris continues to develop two preclinical programs with AstraZeneca for which it also retains co-development and U.S. co-commercialization options.
PRS-220: Pieris continues the development of an inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of IPF and other fibrotic lung diseases. In preclinical models, PRS-220 demonstrated superior on-target potency compared to pamrevlumab, an intravenously infused CTGF antagonist in late-stage clinical development. The Company believes that the inhaled route of administration allows for superior lung exposure. These attributes, combined with the convenience of at-home administration via inhalation, result in PRS-220 having best-in-class potential.

The Company is currently dosing healthy volunteers in a Phase 1 study of PRS-220 and expects to report results in the second half of this year. Pieris continues to benefit from a meaningful grant from the Bavarian government, which supports early-stage development of this program.
PRS-400: Pieris continues to advance PRS-400, an inhaled anti-Jagged-1 Anticalin therapeutic program with potential in a wide range of respiratory diseases driven by mucus hypersecretion. PRS-400 is designed to exert clinical activity by disrupting mucus-mediated pathology in the airways, while avoiding inhibition of healthy mucus production outside of the lungs. Previously presented preclinical data demonstrate that PRS-400 potently inhibits Jagged-1-induced Notch 2 signaling in relevant tissue in the lung. In patients with muco-obstructive respiratory diseases, such as those living with inadequately controlled COPD with chronic bronchitis, PRS-400 has potential to improve clinical outcomes and improve quality of life. PRS-400 is advancing toward development candidate nomination later this year.
Immuno-Oncology Pipeline:

Pieris’s immuno-oncology pipeline continues to progress in a cost-efficient manner with the benefit of its partners. The Company believes that multiple opportunities exist to generate value from this portfolio based on promising preclinical and clinical data.

PRS-344/S095012 and Servier Collaboration: Pieris and Servier continue to enroll the escalation portion of the Phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific MabcalinTM (antibody-Anticalin protein) compound for the treatment of solid tumors, for which Pieris holds full U.S. rights and will receive development milestones and royalties on ex-U.S. sales by Servier. Additionally, Servier discontinued development of PRS-352/S095025, an PD-L1/OX40 bispecific Mabcalin compound, for strategic reasons.
Seagen Collaboration: In January 2023, Seagen initiated a Phase 1 study for SGN-BB228 (also known as PRS-346), triggering a $5 million milestone payment to Pieris. SGN-BB228 is a first-in-class CD228/4-1BB bispecific antibody-Anticalin compound designed to provide a potent costimulatory bridge between tumor-specific T cells and CD228-expressing tumor cells. Pieris and Seagen continue to collaborate on two other undisclosed bispecific programs.
PRS-342/BOS-342: Boston Pharmaceuticals continues to advance PRS-342/BOS-342, a 4-1BB/GPC3 bispecific Mabcalin compound, toward the clinic, with Phase 1 expected to begin in the coming months.
Fiscal Year End Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $59.2 million for the year ended December 31, 2022, compared to a cash and cash equivalents balance of $117.8 million for the year ended December 31, 2021. The decrease was due to funding operations in 2022. The Company believes operations are sufficiently funded for more than the next 12 months.

R&D Expense – R&D expenses were $53.0 million for the year ended December 31, 2022, compared to $66.7 million for the year ended December 31, 2021. The decrease was due to lower overall program costs for both elarekibep and cinrebafusp alfa, lower manufacturing costs across other later-stage respiratory and immuno-oncology programs, lower license fees and lower consulting costs. These lower costs were partially offset by higher clinical costs for PRS-220 and PRS-344/S095012, higher pre-clinical costs for PRS-400, and an increase in personnel and travel costs.

G&A Expense – G&A expenses were $16.4 million for the year ended December 31, 2022, compared to $16.6 million for the year ended December 31, 2021. The period-over-period decrease was driven primarily by lower personnel, facilities and audit and tax costs, partially offset by higher business development, travel and amortization of deferred costs related to revenue recognition.

Other Income – For the year ended December 31, 2022, $8.2 million of grant income was recorded with respect to PRS-220, compared to $3.7 million for the year ended December 31, 2021. The increase was due to higher overall costs incurred on PRS-220 as the program progressed into a Phase 1 clinical study.

Net Loss – Net loss was $33.3 million or $(0.45) per share for the year ended December 31, 2022, compared to a net loss of $45.7 million or $(0.71) per share for the year ended December 31, 2021.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, March 29, 2023, to discuss the full-year financial results and provide a corporate update. Individuals can join the call by dialing 877-407-8920 (Toll Free US & Canada) or +1 412-902-1010 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

On March 29, 2023 Oxford Vacmedix reported completion of Phase 1a in clinical trial of novel cancer vaccine OVM-200 (Press release, Oxford Vacmedix, MAR 29, 2023, View Source;utm_medium=rss&utm_campaign=completion-of-phase-1a-in-clinical-trial-of-ovm-200 [SID1234629501]).

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Oxford Vacmedix (OVM), the UK-based biopharma company focused on the development of vaccines to treat cancer announced today the successful completion of a Phase 1 trial of its lead cancer vaccine; OVM-200 is a cancer vaccine developed using OVM’s novel recombinant overlapping peptide (ROP) platform. It targets survivin, a protein overexpressed by cancer cells that allow unregulated growth, and stimulates an immune response. This trial is both the first time OVM-200 has been used in people and also the first time any ROP based vaccine has been tested in the clinic.

The Phase I trial of OVM-200 is focused on safety and on establishing an immune response in patients with three tumour types – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. Patients have been treated at four sites in the UK; University College London Hospital (UCLH), the cancer hospital of the Oxford University Hospitals Foundation Trust (OUHFT), the Christie NHS Foundation Trust in Manchester and the Sarah Cannon Research Institute in London. The Chief Investigator for the trial is Professor Martin Forster, based at UCLH. To date twelve patients have been treated at four dose levels in Phase 1a, the dose escalation part of the trial. A further 24 patients will be treated in Phase 1b.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

"We are very pleased to have reached this important milestone in the first trial of any vaccine using the ROP technology and also very pleased with the safety and immune response results to date. As the trial is ongoing, we can only share these initial results under confidentiality with potential investors. We are currently in discussion with a number of investors interested in participating in our Series B, to fund the company going forward."

Professor Martin Forster, Chief Investigator based at University College London Hospital added;

"It is a privilege to work with the team at Oxford Vacmedix on this innovative vaccine programme for patients with lung, prostate and ovarian cancer. As clinical investigators we are very excited by the Phase 1a results and look forward to being able to complete this trial of OVM-200. We strongly believe that vaccine treatments will play a major role in future cancer treatments, potentially in combination with immune -oncology agents"

On March 29, 2023 NETRIS Pharma, a clinical-stage private biopharmaceutical company developing a new class of drugs based on dependence receptor biology, reported dosing of the first patients in a multicenter, prospective, single arm, proof-of-concept trial of the anti-netrin-1 antibody, NP137, in combination with mFOLFIRINOX in first line patients with locally advanced pancreatic ductal adenocarcinoma (Press release, Netris Pharma, MAR 29, 2023, View Source [SID1234629500]). Called Lap-NET1 (NCT05546853), the study will enroll 43 to 52 patients and consists of two parts: a safety lead-in phase, with 3-12 patients, and an expansion phase of 40 patients, where efficacy endpoints including best overall objective response rate (ORR) will be measured.

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"The start of the Lap-NET1 trial is a new important clinical milestone for NETRIS Pharma, and our fourth clinical trial currently recruiting. Pancreatic cancer is very complex to treat. However, in close collaboration with US colleagues, we demonstrated that netrin-1 is a key regulator of pancreatic cancer progression. Our lead drug candidate NP137, that targets netrin-1, is effective in controlling disease progression in a variety of preclinical models, and when combined with chemotherapies, has been shown to alleviate the cancer’s resistance to these conventional treatments. There is thus a strong interest to investigate the potential of combining NP137 with mFOLFIRINOX, currently used as a first-line treatment for pancreatic cancers,", said Patrick Mehlen, CEO of NETRIS Pharma.

LapNET-1 is an investigator initiated trial led by Gael Roth as Principal Investigator from Centre Hospitalier Universitaire Grenoble Alpes (CHUGA), with participation of 10 other clinical centers, part of the PRODIGE Group.

"Although pancreatic cancer patient care is improving, primarily given the earlier detection or tumors, and the benefit of mFOLFIRINOX as standard of care in Western Europe, this difficult to treat disease is on the rise with incidence prediction studies suggesting that it will eventually represent the 2nd leading cause of cancer-related death in Western countries," said Gael Roth, clinical oncologist at CHUGA and Principal Investigator of LapNET-1. « I Look forward to lead this clinical trial, given the strong scientific rationale of combining NP137 with mFOLFIRINOX ».