Synlogic Announces Participation in Upcoming Investor and Industry Conferences

On January 24, 2023 Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, reported it will participate in the following upcoming investor and industry conferences (Press release, Synlogic, JAN 24, 2023, View Source [SID1234626551]):

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BIO CEO & Investor Conference: Molly Harper, Chief Business Officer, and Michael Jensen, Chief Financial Officer, will participate in-person and virtually at the BIO CEO & Investor Conference 2023 being held February 6-9, 2023, in New York City. Ms. Harper will present in-person at 4:15 p.m. ET on Monday, February 6. In addition, an on-demand video presentation will be available for conference participants during the event, and for approximately 30 days after the event.
SVB Securities Global Biopharma Conference: The Synlogic management team will participate in the SVB Securities Global Biopharma Conference 2023, being held virtually February 14-16, 2023. Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer, will present virtually at 12 p.m. ET on Thursday, February 16. Register for her presentation here.
Recorded presentations, if available, can be found on the Events section of the Synlogic website. Archived versions of webcasts will also be available after the presentations on the Synlogic website.

Ocean Biomedical Provides Corporate Update and Company Summary

On January 24, 2023 Ocean Biomedical ("Ocean"), a next-generation biopharma company, and Aesther Healthcare Acquisition Corp (Press release, Ocean Biomedical, JAN 24, 2023, View Source [SID1234626546]). (NASDAQ: AEHA), a publicly traded special purpose acquisition company (SPAC), reported an update on key company activities. Built on Ocean Biomedical’s expertise in technology transfer, a unique business model was created to bridge the ‘bench-to-bedside’ gap and accelerate the commercialization of novel assets from leading research universities and medical centers. Ocean Biomedical is expected to become a publicly traded company on NASDAQ under the symbols "OCEA" and "OCEAW" following the expected closing of a Business Combination with Aesther Corporation.

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Key Upcoming Dates

Ocean Biomedical and Aesther would like to call attention to the following upcoming important dates and events:

Shareholder vote: Friday, February 3, 2023

Expected close of business combination between Ocean Biomedical and Aesther Healthcare Acquisition Corp: Tuesday, February 7, 2023

Expected first day of trading on the Nasdaq Stock Exchange for Ocean Biomedical: Wednesday, February 8, 2023

Notable Investment Activity

Ocean and Aesther have partnered with some of the premier investment institutions in the health care space. This has led to a secure and growing runway to continue Ocean’s important innovations, with funding including:

$123.9 million in past and ongoing grants, in use to enable first-in-class drug and vaccine candidates that make up Ocean’s initial core portfolio in oncology, fibrosis, and infectious disease, all based on new target discoveries

A $40 million committed backstop by Vellar Opportunity Fund SPV LLC – Series 3

A Common Stock Purchase Agreement with White Lion Capital LLC, which provides that White Lion Capital is committed to purchase the company’s Common Stock with an aggregate gross purchase price of up to $75 million

Pro forma enterprise value of the combined company is expected to be approximately $345 million, assuming no redemptions of current Aesther public stockholders.

Management Comments

"The scientific and operational progress Ocean Biomedical has had to date, even without access to the public markets, is astounding – the company is at an inflection point, with multiple ways to win. The combination of the company’s close ties to innovation coming out of the world’s top research institutions with the anticipated advantages of being a publicly-traded company would produce unprecedented value," said Suren Ajjarapu, Chairman and CEO of Aesther. "With a world-class board and leadership team, Ocean’s trajectory is unmatched. This is a once-in-a-lifetime kind of company, and from an investment standpoint, is in a category of its own."

"Ocean Biomedical acts as the parent of three distinct biotech companies and is ultimately responsible for a total of three platform assets and a diversified pipeline that addresses high-value and high-impact indications. Each of these assets are progressing towards the next stage of their development pipelines," said Dr. Chirinjeev Kathuria, Ocean Biomedical co-founder and Executive Chairman of the Board of Directors. "Ocean has the vision and now, the tools, to concretely change the course of humanity for the better. First and foremost, our founders are dedicated to serving patients with some of the most devastating illnesses we face as humans today. That’s why we created Ocean Biomedical, which will be our most important legacy."

Ocean Will Address Areas of Great Unmet Need Through Novel Scientific Breakthroughs

A key component of Ocean Biomedical’s model is to elevate the efforts of scientists at premier institutions such as Brown University, Harvard University, Yale University and Stanford University to ensure their discoveries advance through clinical development with urgency in order to reach the hands of doctors and patients who need them. Currently, the company’s portfolio is focused on three critical areas: oncology, pulmonary fibrosis, and infectious disease.

Oncology

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death and second most diagnosed cancer in the United States, affecting approximately 460,000 people in the U.S. alone.

Glioblastoma multiforme (GBM) is a lethal type of brain tumor with a single-digit five-year survival rate. It affects approximately 28,000 people in the U.S. alone.

CHI3L1 is a novel target and pathway discovery, the master checkpoint inhibitor, uncovered by the Ocean team. This novel, bispecific antibody approach generates strong anti-tumor response in lung cancer and brain cancer, whether used in combination or as a monotherapy. Ocean Biomedical’s novel approach to tumor suppression, focused on controlling Chitinase 3-like-1 (CHI3LI), other immune checkpoint inhibitors, and T-cell co-stimulators, could control important pathways pan-cancer and has potential application for tumor suppression across multiple cancer pathways.

Pulmonary Fibrosis

Idiopathic pulmonary fibrosis is a progressive disease that results in the irreversible loss of lung function with high morbidity and mortality rates. Its prevalence in the U.S. has been reported to range from 10-60 cases per 100,000 people, while in Europe it ranges from 1.3-32.5 cases per 100,000.

Hermansky-Pudlak Syndrome (HPS) is a rare, genetic disease with high prevalence occurring in Puerto Rico, with 1 case every 1,800 people.

Ocean has identified a novel target and pathway discovery called Chitinase 1 (Chit1), as well as a potential inhibitor of this pathway called OCF-203. OCF-203 has been evaluated in multiple models of pulmonary fibrosis with impressive reductions in fibrosis. These discoveries hold potential for growth into other fibrotic diseases, including scleroderma, alcoholic liver disease, and NASH.

Malaria

Malaria is a deadly disease with over 3 billion people at risk of infection annually worldwide. 200-300 million people are infected worldwide each year. It is the number one killer of children under five years old, with over 500,000 children under five killed each year.

Ocean’s proprietary platform for infectious diseases has yielded promising vaccine and therapeutic candidates for malaria, including the discovery of PfSEA-1 and PfGARP. These targets enable a promising new strategy for combating the disease. Moreover, the company’s drug target discovery platform has the potential to discover targets against other infectious diseases, like tuberculosis or another pandemic-type virus.

For more information, please visit www.oceanbiomedical.com. The company’s latest investor presentation as filed with the SEC can be found here.

Advisors
EF Hutton, division of Benchmark Investments, LLC, serves as capital markets advisor to Aesther Healthcare Acquisition Corp. Nelson Mullins Riley & Scarborough LLP serves as legal counsel to Aesther Healthcare Acquisition Corp. and Malone Bailey, LLP serves as auditors to Aesther Healthcare Acquisition Corp. Dykema Gossett PLLC serves as legal counsel to Ocean Biomedical, Inc. and Deloitte & Touche LLP serves as auditors to Ocean Biomedical, Inc.

Gritstone bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On January 24, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 28,000 shares of its common stock with an exercise price of $3.67, which is equal to the closing price of Gritstone’s common stock on January 9, 2023, the date of the grant (Press release, Gritstone Bio, JAN 24, 2023, View Source [SID1234626540]). These stock options are part of an inducement material to each of the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

Entry Into Definitive Investment Agreements

On January 24, 2023 AnPac Bio-Medical Science Co., Ltd. (the "Company") signed definitive investment agreements with several third party investors, where the investors agreed to purchase 29,714,279 newly issued Class A ordinary shares (1,485,714 American Depositary Shares or "ADSs") of the Company at a price of US$0.175 per ordinary share or US$3.5 per ADS (1:20 ADS-to-share ratio), for a total purchase price of $5.2 million (Filing, 6-K, Anpac Bio, JAN 24, 2023, View Source [SID1234626538]). Concurrently, for each Class A ordinary share purchased, the investors will receive from the Company two warrants with each warrant to purchase one Class A ordinary share at an exercise price of $0.21 per ordinary share (2,971,428 ADS an at exercise price of $4.20 per ADS). The warrants are exercisable within 2 years from the date of issuance. The closing is expected to take place within 30 days after signing.

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This Report on Form 6-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company.

AskGene Presents Encouraging Clinical Results on ASKB589 at ASCO-GI 2023

On January 24, 2023 AskGene Pharma Inc. reported encouraging clinical results for ASKB589, an anti-CLDN18.2 antibody, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium (ASCO-GI 2023) in San Francisco on January 19-21, 2023 (Press release, AskGene Pharmaceuticals, JAN 24, 2023, View Source [SID1234626531]).

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The results were from clinical trial NCT04632108, a Phase I/II, two-part, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 monotherapy (Part A) and in combination with chemotherapy (Part B) in patients with advanced solid tumors. In Part A, patients with heavily pre-treated solid tumors received ASKB589 at doses ranging between 0.3 and 20 mg/kg every 3 weeks (Q3W). In Part B, doses of ASKB589 ranging from 3 to 15 mg/kg were given in combination with chemotherapy Q3W. The majority of the enrolled patients had gastric or gastroesophageal junction (G/GEJ) cancer (77.5% for Part A; 91.1% for Part B).

As of January 04, 2023, a total of 85 patients were treated with ASKB589 (40 patients received monotherapy and 45 patients received ASKB589 in combination with capecitabine and oxaliplatin (CAPOX)). The highest dose of monotherapy tested was 20 mg/kg, and the highest dose of ASKB589 in combination with chemotherapy was 15 mg/kg. ASKB589 was safe and well tolerated both as monotherapy and in combination with chemotherapy. No dose-limiting toxicity was observed during the escalation phase of the study in Part A or Part B. A maximum tolerated dose (MTD) was therefore not identified for either monotherapy or combination therapy. The majority of adverse events were of mild severity (grade 1 or 2). The most common adverse events were gastrointestinal related events, including nausea (50% for monotherapy; 64.4% for combination therapy) and vomiting (45% for monotherapy and 73.3% for combination therapy), which were generally resolved within one week.

Among the 21 patients with CLDN 18.2-positive G/GEJ cancer who received ≥ 10 mg/kg ASKB589 monotherapy, two (2) patients had partial response (PR). One of these patients has continued in PR at 35 weeks. Among the 24 patients with CLDN 18.2-positive G/GEJ cancer who received ≥ 6 mg/kg ASKB589 combined with CAPOX chemotherapy as first-line treatment for metastatic or unresectable advanced disease, the objective response rate (ORR) was 75% (18 PR patients), and the disease control rate (DCR) was 100%.

In summary, ASKB589 was well-tolerated with manageable safety and good tolerability both as monotherapy and in combination with chemotherapy. ASKB589 combined with CAPOX regimen as first-line treatment for patients with CLDN 18.2-positive gastric or gastroesophageal junction cancer showed deep and durable antitumor activity at dose levels ≥ 6 mg/kg.

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene, commented: "Claudin 18.2 has recently been validated as the first new molecular target that demonstrates the potential for clinical benefit for patients with gastric and gastroesophageal cancer in quite some time. This clinical trial shows that ASKB589, particularly in combination with chemotherapy, can be administered safely in patients with these types of cancer and results in a high rate of deep and durable responses, as well as a remarkable disease control rate. We are planning to initiate a registrational trial in claudin 18.2 selected G/GEJ patients in 2023. "

Presentation Details

Title: Safety and Anti-Tumor Activity of a Phase I/II Study of ASKB589, an Anti-Claudin 18.2 (CLDN18.2) Monoclonal Antibody as a Monotherapy and in Combination with Chemotherapy in Patients with Solid Tumors
First Author: Miao Zhang, Peking University Cancer Hospital
Presenter: Barbara Hickingbottom, AskGene
Abstract #: 397
Poster #: G19
About NCT04632108

The NCT04632108 study is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 monotherapy and combination chemotherapy in patients with advanced solid tumors. The study includes ASKB589 monotherapy dose escalation and expansion study (Part A) and dose escalation and expansion study of ASKB589 combined with chemotherapy (Part B). The patients in the dose escalation studies were enrolled regardless of the expression of CLDN18.2, while only the patients who test positive for CLDN18.2 by the central lab have been enrolled in the dose expansion study.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin 18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. ASKB589 is intended for use in gastric and gastroesophageal junction cancers and pancreatic cancers. The multi-center Phase I/II clinical trial in China is led by Professor Shen Lin from Peking University Cancer Hospital.