On April 28, 2022 Peak Bio Co., Ltd. ("Peak Bio"), a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory diseases, and Ignyte Acquisition Corp. (Nasdaq: IGNY) ("Ignyte"), a special purpose acquisition company ("SPAC"), reported they have entered into a definitive business combination agreement (Press release, Peak Bio, APR 28, 2022, View Source [SID1234613192]). Upon closing of the transaction, Ignyte will be renamed Peak Bio, Inc. (the "Combined Company") and will be led by Hoyoung Huh, MD, Ph.D., Chief Executive Officer of Peak Bio. The Combined Company expects to list its stock on Nasdaq under the ticker symbol "PKBO".

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A group of healthcare investors including existing Peak Bio stockholders and Palo Alto Investors have committed to participate in the transaction through a $25 million common stock PIPE at a purchase price of $10.00 per share. Gross proceeds of the transaction available to the Combined Company at closing will approximate $82.5 million (assuming no redemptions from Ignyte’s trust account and before transaction expenses).

Dr. Huh stated that "We are excited about our differentiated inflammation and oncology pipeline and look forward to partnering with Ignyte and advancing our pipeline of potential blockbuster candidates. We believe we will have several near-term catalysts that can be achieved with our cash at closing. Much of our work is the culmination of our efforts at our Korean and US research sites which captured the best of pan pacific financing alternatives, diverse and highly talented scientific acumen, all the while creating a novel mechanism to bring valuable assets to bear into the U.S. NASDAQ market."

David Rosenberg, Chairman and co-CEO of Ignyte Acquisition Corp., commented, "We are excited to partner with the Peak team in this first of its kind transaction, taking an exciting South Korean biotechnology company public on Nasdaq via a SPAC. Dr. Huh’s reputation as a serial founder and entrepreneur of multiple public and private biotech companies made Peak the perfect merger target for Ignyte. We look forward to helping Peak execute on its compelling therapeutic pipeline in both oncology and rare inflammatory disease in order to not only drive shareholder value, but to improve quality of life for those impacted by Peak Bio’s targeted diseases."

Peak Bio Overview

Peak Bio’s pipeline is focused on developing drugs to treat oncology and inflammatory diseases. The company’s pipeline of inflammatory therapeutic candidates is led by PHP-303, which is currently Phase II ready in AATD and works by inhibiting a bioactive form of Neutrophil Elastase. The company’s pipeline also includes an antibody drug conjugate platform focused on developing therapies for oncology indications.

PHP-303 – 5th Generation Best-In-Class Neutrophil Elastase (NE) Inhibitor: PHP-303, is an oral QD, reversible and highly selective small molecule addressing toxicity and efficacy shortfalls from previous generation Neutrophil Elastase Inhibitors by inhibiting the bioactive form of enzyme.
PHP-303 was acquired from Bayer and improved to be an ideal solution for conditions involving NE imbalance with well-demonstrated tolerability and safety / PK data.
PHP-303 is a best-in-class Phase II ready NE Inhibitor targeting AATD and ARDS diseases where chronic inflammatory imbalance and NE are important determinants in disease progression
Antibody Drug Conjugate (ADC) Platform: Unlike competitors, Peak Bio’s approach to ADCs engages the immune system to enhance tumoricidal activity reducing the number of treatment cycles and improving toxicity with a proprietary approach towards the generation of novel toxins.
Peak Bio’s most advanced ADC candidate targeting Trop2 has shown superior linker stability and in vivo activity compared to an FDA-approved competitor with superior specificity to cancer cells and a unique ability to generate neoepitopes and synergize with I/O therapies.
De-risking steps such as the manufacturability assessment have revealed no liability that may impede the manufacturing of the Peak Bio Trop2 antibody and safety studies have demonstrated that our ADC was safely tolerated in repeat-dose preclinical primate studies.
We are working to validate other solid tumor targets to partner with our current toxin and other novel toxins to further solidify our oncology portfolio.
Planned Milestones and Uses of Proceeds:

Proceeds from the PIPE and merger transaction are expected to provide Peak Bio with capital to further develop its clinical-stage programs and ADC platform technology, including:
Initiate and fund a Phase II AATD Adaptive Design study in 2022 with a data readout expected in the first half of 2024
Submission to DoD for Phase II grant of PHP-303 in ARDS and an IND submission in the first half of 2023
Fund ADC toxin studies in lead program targeting Trop2 leading toward an IND submission in the second half of 2023 and begin Phase Ia initiation in 2024
Conduct research and development to identify new ADC toxins
Summary of Transaction

The transaction values the combined company at a pro forma equity value of $278 million, assuming a $10.00 per share price and no shareholder redemptions. As a result of the transaction, the combined company is expected to have more than $82.5 million in gross proceeds from a combination of approximately $57.5 million in cash held in Ignyte’s trust account (assuming no Ignyte stockholders exercise their redemption rights at closing) and more than $25 million, at $10.00 per share, from a fully committed PIPE.

The PIPE includes participation from leading healthcare institutional investor, Palo Alto Investors and insiders.

The transaction, which has been approved by each of Ignyte’s Board of Directors, Peak Bio’s Board of Directors and Peak Bio’s shareholders is expected to be completed in the third quarter of 2022, subject to approval by Ignyte’s shareholders and satisfaction, or the waiver of, customary closing conditions identified in the business combination agreement.

Chardan and Ladenburg Thalmann & Co. Inc. are serving as the financial advisors to Ignyte and Peak Bio. DLA Piper LLP (US) is serving as legal advisor to Ignyte. Bae, Kim & Lee LLC and B C Burr McCabe Law are serving as legal advisors to Peak Bio.

Additional information about the transaction, including copies of certain documents related to the transaction, including the investor presentation, will be provided in a Current Report on Form 8-K to be filed by Ignyte with the Securities and Exchange Commission (the "SEC") and available at www.sec.gov and on the Ignyte website at View Source In addition, Ignyte intends to file a proxy statement with the SEC, which will include additional information regarding the transaction (the "Proxy Statement"), and will file other documents regarding the transaction with the SEC.

On April 28, 2022 Lytix Biopharma AS (Lytix), a clinical-stage company with an in situ vaccination technology platform targeting cancer indications, reported that its abstract has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago June 3-7, 2022 (Press release, Lytix Biopharma, APR 28, 2022, View Source [SID1234613191]).

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Title: LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes in patients with metastatic soft tissue sarcoma.
Presenter: Morten Nielsen, MD | National Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, Herlev, Denmark

On April 28, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharma company committed to deliver innovative and impactful therapeutics to address severe unmet medical needs, reported the financial results for the first quarter of 2022 (Press release, HanAll Biopharma, APR 28, 2022, View Source [SID1234613190]).

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"In the first quarter, our team focused on enhancing our R&D capabilities by appointing Almira Chabi, an acknowledged industry leader, as our Chief Medical Officer and Chief Development Officer. In addition, we are seeking open collaboration opportunities to expand our areas of focus by investing in Turn Biotechnologies." said Sean Jeong, M.D., CEO of HanAll Biopharma.

"HanAll is primed to accelerate clinical studies on late-stage pipeline assets by further expanding R&D investment to serve our patients." he continued. "We are expecting to initiate a Phase 3 trial of HL161 (INN: batoclimab) in myasthenia gravis (MG) in Japan as well as presenting topline results from a second Phase 3 in the U.S., later this year. We also plan to expand the indication of HL036 (INN: tanfanercept) into new inflammatory eye disorders and advance HL187, an immuno-oncology antibody therapy targeting TIGIT, into first-in human studies by 2023."

FIRST QUARTER 2022 BUSINESS UPDATE

HL161 (INN: batoclimab): A novel, fully human, anti-FcRn antibody developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies. It is being developed in the US and China respectively by global license partners Immunovant and Harbour BioMed.

Harbour BioMed is developing batoclimab in six autoimmune indications including myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica spectrum disorder (NMOSD), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and pemphigus vulgaris (PV). Harbour is undergoing a pivotal Phase 3 trial in MG, and is progressing towards Biologics License Application (BLA) submission. The clinical trial on TED is currently in its Phase 2 study.

Immunovant announced plans for a Phase 3 trial in myasthenia gravis (MG) as well as for other clinical trial plans for 2022, through its quarterly reports revealed on February this year. The Phase 3 in MG is planned to be initiated in the first half of 2022, and two additional pivotal clinical trials are expected in 2022. Moreover, with the addition of two new indication programs, HL161 is planned to be developed in five autoimmune diseases in the US and Europe.

HanAll Biopharma plans to initiate Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the second half of the year.

HL036 (INN: tanfanercept): A novel, topical anti-TNF biologic therapy for dry eye disease jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, tanfanercept aims to treat inflammatory eye diseases by inhibiting TNF, which is critical in ocular inflammation.

November 2021, the first patient first dose in the second Phase 3 clinical trial (study name: VELOS-3) has started in the US and the trial is currently progressing. The VELOS-3 clinical trial aims to replicate the efficacy seen in VELOS-2 (the first Phase 3 trial), and is proceeding at nine clinical sites in the US with patients who have moderate to severe dry eye disease.

HanAll’s partner for Chinese market Harbour BioMed is currently conducting a pivotal Phase 3 trial of tanfanercept (also referred to as HBM9036) for dry eye disease and is progressing towards BLA submission.

HL187/ HL186: Novel immuno-oncology antibodies that respectively target TIM-3 and TIGIT, being developed in collaboration with Daewoong Pharmaceutical.

HL187 has an enhanced mechanism of action that reinforces the effector function of the antibody, which activates the immune cells to fight cancer by inhibiting the action of regulatory T cells.

Last year HL187 was nominated as participant of government-led R&D support program, by Korea Drug Development Fund (KDDF), and is proceeding toxicity study. HanAll plans to initiate Phase 1 clinical trial in 2023.

HL186 targeting TIM-3, is currently under its pre-clinical study.

Tanfanercept new indication programs: HanAll Biopharma is exploring the options to expand the indications of tanfanercept to new inflammatory eye disorders and finalize a new indications development plan in 2022.

Sales in Pharmaceuticals division remained a strong sales driver, with double digit sales growth on major products such as Normix, an antibiotic for gastrointestinal infection, Eligard, a prostate cancer treatment, and Biotop, a probiotics product. The total sales in Q1 2022 has been reduced by the base effect from the one-time license and collaboration revenue in Q1 2021.

Research and development investment was up by 24.9 percent compared to the same period last year to 3.1 billion won for the three months ended March 31, 2022. The year-on-year increase reflected higher costs related to clinical studies including VELOS-3 and clinical research.

Net Loss recorded 83 million won for three months ended March 31, 2022, due to an increase in COGS and R&D expenses. The increase in COGS was due to an extraordinary cost incurred by manufacturing suspension from December 2021 to February 2022. The rise in COGS is temporary and is expected to decrease in Q2 2022.

On April 28, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it has received approval from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority and from the CElm Provincial de Sevilla Ethics Committee in Spain for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer (Press release, CNS Pharmaceuticals, APR 28, 2022, View Source [SID1234613189]).

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"We continue to build momentum in our potentially pivotal study of Berubicin, and importantly advance toward bringing a much needed treatment option to patients. We have significantly bolstered our international presence and we are grateful to Spain for joining us in support of this trial. We are committed to driving this development program forward and are executing on all fronts to build momentum," commented John Climaco, CEO of CNS Pharmaceuticals.

Dr. Juan M Sepúlveda Sánchez, MD, 12 de Octubre University Hospital, Madrid, added, "There remains a significant unmet medical need for patients with GBM. We are pleased to bring this important clinical program to Spain and help to further evaluate Berubicin’s potential to meet that need. I look forward to working alongside the rest of the clinical team to advance CNS Pharmaceuticals’ potentially pivotal study and importantly, progress Berubicin through the clinic with the hope of bringing a valuable treatment options to patients and physicians."

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On April 28, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, reported that recommended use of its Oncotype DX Breast Recurrence Score test in early-stage breast cancer patients has been expanded by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in its 2022 Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer guideline update (Press release, Exact Sciences, APR 28, 2022, View Source [SID1234613188]).i

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The test is now recommended for use in postmenopausal patients with up to three positive axillary lymph nodes and is the only test recommended for use in premenopausal patients with node-negative disease. Importantly, the test is recommended irrespective of clinical risk, and Oncotype DX is the most strongly recommended with the highest evidence quality of all multigene tests included in the guidelines.

"We are pleased that the updated ASCO (Free ASCO Whitepaper) guidelines recognize the strength of the data supporting Oncotype DX and expand the recommended use of the test based on findings from the RxPONDER study," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "The Oncotype DX test has been used to guide the treatment decisions for more than one million women around the world, and the updated guidelines provide even greater clarity and confidence to physicians in individualizing the discussion of the risks and benefits of chemotherapy with their patients."

The updated guidelines incorporate results from the RxPONDER trial published in The New England Journal of Medicine.ii The study demonstrated that the test identifies a majority of early-stage breast cancer patients with one to three positive nodes who may be spared chemotherapy. Postmenopausal women with Oncotype DX Breast Recurrence Score results of 0 to 25 did not show benefit from the addition of chemotherapy to hormone therapy. Premenopausal women with a Recurrence Score result of 0 to 25 received a 2.4% benefit from chemotherapy in terms of distant recurrence at five years.iii

Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes.iv The vast majority of these patients currently receive chemotherapy[v] even though approximately 85% of them have Recurrence Score results of 0 to 25.vi In addition, about two out of three early-stage breast cancer patients are postmenopausal.vii

About the Oncotype DX and Oncotype MAP Portfolio of Tests
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/