On October 6, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported it has successfully imaged its first participant in the US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with PSMA-negative prostate cancer (Press release, Clarity Pharmaceuticals, OCT 6, 2022, View Source [SID1234621758]).

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SABRE (Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, commented, "We are very excited to have recruited and imaged the first participant in this trial which will explore the clinical benefits of the novel SAR-Bombesin agent. Based on the promising preclinical and clinical data to date, SAR-Bombesin shows great potential for improving the diagnosis and treatment for not only patients with prostate cancer that are PSMA negative, but also across broader prostate cancer indications.

"SABRE is the third trial with Clarity’s Targeted Copper Theranostics (TCTs) that GURN is recruiting into. This momentum is underpinned by our belief that the TCTs are the next-generation products that will enable the radiopharmaceutical field to overcome the manufacturing and supply chain challenges associated with the current products in the market and facilitate the expansion of radiopharmaceuticals into the large global oncology market. We look forward to generating data from the trial to validate the potential clinical benefits for large patient populations and improve patient care."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to progress the SABRE trial in the United States as we are already seeing an improved treatment paradigm in the management of PSMA-negative disease for patients with SAR-Bombesin who were imaged under the Therapeutic Goods Agency’s Special Access Scheme in Australia2.

"Given the data to date indicates the potential diagnostic and therapeutic benefits of SAR-Bombesin, we look forward to generating further evidence as we accelerate the product to market. Subject to the outcome of the SABRE trial, Clarity is planning to launch a pivotal Phase III diagnostic trial for first product approvals in the US. We are also preparing to run a theranostic trial with an Investigational New Drug (IND) application scheduled for submission to the US Food and Drug Administration (FDA) later this year. We look forward to progressing our SAR-Bombesin program and potentially providing a large patient population with accurate and precise detection and treatment of their prostate cancer," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)3-7. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide8. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease9.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative10-13. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.

On October 5, 2022 Biohaven reported the company officially launched as a newly independent company, spun out of its former parent as part of Pfizer’s $11.6 billion acquisition, which closed on Oct. 3 (Press release, Biohaven Pharmaceutical, OCT 5, 2022, View Source [SID1234643836]). Led by the same CEO, Vlad Coric, and publicly traded under the same stock ticker, the new Biohaven retains a pipeline of experimental medicines for a range of neurological disorders, four of which are already in clinical testing. It holds nearly $258 million in cash to fund its operations and no debt.

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"I am enthusiastic about continuing to lead our team in new, exciting directions as we strive to bring best-in-class therapies to patients for a broad range of diseases with few or no treatment options," said Coric in an Oct. 4 statement. "If past is prologue, this proven team will continue to succeed in achieving its mission for patients, shareholders and employees."

So far, investors appear to be giving Coric and his team some credit. Biohaven’s shares, which opened trading on Tuesday at a reset value of $7.30 per share, rose to more than $10 apiece by mid-morning on Wednesday, equating to a market value north of $700 million.

The new Biohaven’s most advanced drug candidate is a medicine called troriluzole, which is in late-stage testing for obsessive compulsive disorder and a genetic condition known as spinocerebellar ataxia, or SCA. In the latter condition, however, Phase 3 clinical trial results released in May showed the drug did not perform significantly better than placebo on the study’s main measure. The drug has previously failed studies in Alzheimer’s disease and in severe anxiety.

Biohaven isn’t giving up on SCA yet, focusing on a subset of patients who might benefit and signaling plans to continue regulatory discussions. But it’s focusing more on another drug, dubbed BHV-7000 and acquired via a $100 million deal earlier this year. That medicine is in testing for epilepsy as well as mood and pain disorders.

The company also has a drug for spinal muscular atrophy in Phase 3 testing, a multiple myeloma treatment in a Phase 1 study and half a dozen other discovery-stage programs.

On October 5, 2022 AIGEN Sciences, an artificial intelligence (AI)-based new drug development company, reported that it had completed attracting 4.2 billion won in investment through pre-Series A (Press release, AIGEN Sciences, OCT 5, 2022, View Source [SID1234643559]).

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Partners Investment, Blue Point Partners, Medytox Venture Investment, Quad Asset Management, and Korea University Technology Holdings participated in this investment.

Eisen Science will use this investment to advance artificial intelligence technology by expanding the virtual transcriptome map and to build an integrated platform including transcriptome/structure-based linked molecular design technology. In addition, the company plans to accelerate the development of its own anticancer drug and rare disease pipeline and recruit additional artificial intelligence, synthesis, and pharmacology/bio research personnel.

Eisen Science is an artificial intelligence (AI)-based new drug development company founded by Professor Jae-Woo Kang of Korea University in April last year. Eisen Science’s core new drug development artificial intelligence platform is an artificial intelligence technology based on transcriptome data, which can be used to screen and design drugs with new structures that induce transcriptome changes similar to knock down expression of disease targets. .

The company explained that transcriptome change-inducing drugs have the advantage of minimizing side effects caused by off-target effects of drugs, and can be applied to the development of treatments for intractable diseases for which the disease target is unknown by using the patient’s transcriptome information. am.

Jaewoo Kang, CEO of Eisen Science, said, "Through this investment, we plan to accelerate the development of our own new drug pipeline," adding, "We will develop lead substances in at least three pipelines by 2023 and create business development results with domestic and foreign pharmaceutical companies." "It is planned," he said.

Meanwhile, Igen Science has Vice President (CSO) Gwang-Ok Lee, who has been conducting research for 27 years at domestic pharmaceutical companies such as Hanmi Pharmaceutical, Bukwang Pharmaceutical, and Youngjin Pharmaceutical, and is in charge of planning, business development, and strategic partnerships for over 20 years at pharmaceutical companies such as SK Biopharmaceuticals, Chong Kun Dang, and Boryung. Vice President Kim Jong-ho (CBO) and others were recruited.

On October 5, 2022 Aptamer Science reported on the 5th that it decided to issue convertible bonds (CB) worth 16.5 billion won to secure clinical costs for developing innovative new drugs (Press release, Aptamer Sciences, OCT 5, 2022, View Source;idx=229 [SID1234641612]).

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The day before, Aptamer Science decided to issue the first bearer-type unsecured private convertible bond with interest. Both the coupon interest rate and the maturity interest rate are 0.0%, and the refixing (conversion price adjustment) condition is not included.

The company commented, "Despite the continuation of the high interest rate era, including the recent increase in the base interest rate, the market’s evaluation of the growth strategy appears to be positive, considering the fact that the interest rate is 0% and there is no refixing clause."

The company said, "Generally, in the case of convertible bonds (CB) issued in the KOSDAQ market, conditions for adjusting the conversion price according to the decline in the stock price are included," adding, "The exclusion of the refixing condition means that

"It can be interpreted that the possibility of stock conversion gains due to the rise in stock prices was highly evaluated," he emphasized.

Aptamer Science plans to use the funds raised this time to develop innovative new drugs, such as clinical trials for an anticancer drug (AST-201) for solid tumors and a follow-up pipeline immunotherapy drug (CD-25).

With the existing public offering funds, we plan to conduct large-scale prospective confirmatory clinical trials of a lung cancer early diagnosis kit based on blood protein biomarkers and target Asian markets such as Singapore through LDT (Laboratory Developed Test).

An Aptamer Science official explained, "Regarding the development of an innovative new drug, the anticancer drug (AST-201) was significantly delayed from the originally planned schedule due to problems such as securing raw materials due to the spread of COVID-19."

He continued, "Currently, a CDMO company is producing clinical samples, and as we aim to apply for an clinical trial (IND) in the second quarter of 2023, we plan to secure funds preemptively to accelerate the process."

Go to article: Aptamer Science attracts investment of 16.5 billion won… "We will speed up the development of new drugs"

On October 5, 2022 Aesther Healthcare Acquisition Corp (NASDAQ: AEHA) ("Aesther"), a special purpose acquisition company ("SPAC") and Ocean Biomedical, Inc. ("Ocean"), a next-generation biopharma company reported that Aesther has entered into two separate Backstop Agreements for a total of up to $80 million, with the addition of up to $40 million from Meteora Special Opportunity Fund I, LP, Meteora Select Trading Opportunities Master, LP, and Meteora Capital Partners, LP (collectively, "Meteora") in connection with its proposed business combination (the "Business Combination" or the "Transaction") with Ocean (Press release, Ocean Biomedical, OCT 5, 2022, View Source [SID1234622465]). Previously, Aesther had executed and announced an up to $40 million Backstop Agreement with Vellar Opportunity Fund SPV LLC-Series 3.

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Upon the closing of the Business Combination, Ocean will be a wholly owned subsidiary of Aesther, Aesther will change its name to Ocean Biomedical, Inc., and its common stock and warrants are expected to be listed on Nasdaq, under the symbols "OCEA" and "OCEAW," respectively.

The combined company will work to accelerate the development of Ocean’s core assets in oncology, fibrosis, and infectious diseases, all based on new target discoveries enabling first-in-class drug and vaccine candidates and developed through past and ongoing grants totaling $123.9 million.

Suren Ajjarapu, Chairman and CEO of Aesther, commented, "We are pleased to announce the execution of an up to $40 million Backstop Agreement with Meteora."

"Non-small cell lung cancer is the leading cause of cancer death and second most diagnosed cancer in the United States. Glioblastoma multiforme is a lethal type of brain tumor that affects approximately 28,000 people in the US, with a median survival time of about 15 months. The execution of up to $80 million in Backstop Agreements will help advance our cancer, fibrosis, and malaria discoveries into their Phase 1 trials, and has the potential to alleviate suffering and save thousands of lives," said Dr. Chirinjeev Kathuria, co-founder and Executive Chairman.