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Data from Medivir’s MIV-818 phase 1b study to be presented at the ESMO Congress

On August 5, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that an e-poster entitled "Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM)" will be presented by Dr Debashis Sarker, King´s College London, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress (Press release, Medivir, AUG 5, 2021, View Source [SID1234586040]).

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The Abstract will be released on the ESMO (Free ESMO Whitepaper) website 13 September 00.05 CEST (View Source). The results from the completed phase 1b monotherapy dose escalation part of the study (e-poster presentation number 527P) is scheduled for presentation during the ESMO (Free ESMO Whitepaper) congress 16-21 September.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse aetiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Pharmaxis Cancer Drug Decreases Tumour Burden in Pre Clinical Liver Cancer Model

On August 5, 2021 Pharmaxis Ltd (ASX: PXS) reported the first public presentation of data from a preclinical study of PXS-5505 in the liver cancer, cholangiocarcinoma (CCA) at the Americas Hepato-Pancreato-Biliary Association (AHBPA) conference in Miami, USA (Press release, Pharmaxis, AUG 5, 2021, View Source [SID1234586039]).

Under the guidance of Dr Roberto Hernandez-Alejandro, MD (Chief Division of Transplantation / Hepatobiliary Surgery), a research team at the University of Rochester Medical Center, New York State, has been investigating the role of lysyl oxidase enzymes in liver cancer and whether Pharmaxis cancer drug PXS-5505 can improve the efficacy of current chemotherapy drugs by inhibiting these enzymes.

CCA is the second most frequently diagnosed primary liver malignancy and has nearly doubled in incidence over the last decade. A prominent feature of CCA is the presence of highly fibrotic tissue that increases tumour stiffness, and decreases drug perfusion.

The oral presentation by Dr Paul Burchard, MD at today’s meeting covered two main aspects of the team’s research.

Firstly, they examined tumour tissue specimens collected from patients at their institution over a 10-year period and found that LOX enzymes are significantly elevated in human CCA and correlate with poor prognosis.
Secondly, they examined the effect of PXS-5505 with or without chemotherapy treatment in a pre-clinical model of CCA and found that the combination of PXS-5505 and chemotherapy significantly improves survival, delays tumor growth, and reduces intratumoral pressure.
Finally, they propose that PXS-5505 in combination with standard chemotherapy represents an innovative therapeutic strategy with potential for clinical translation in primary liver malignancy
Pharmaxis CEO Gary Phillips said, "The role of LOX enzymes in fibrosis is well established and there is a growing body of evidence that in cancers such as those of the liver and pancreas, the poor outcomes experienced with current chemotherapy regimens is due to fibrotic tissue restricting drug access and stimulating tumour growth. Pharmaxis is working with a number of independent research groups globally on different tumour types with our anti fibrotic cancer drug PXS-5505 and I’m very encouraged by the results presented today by Dr Burchard that show a potential disease modifying role for our drug in liver cancer.

"PXS-5505 is currently progressing well through a phase 1c/2 clinical trial looking for evidence of disease modifying effects in bone cancer myelofibrosis as a monotherapy. Exploring the potential of PXS-5505 to address liver cancers such as cholangiocarcinoma or other cancers where fibrosis is limiting the clinical benefit of current chemotherapy is something we will continue to assess with our scientific and clinical collaborators."

The phase 1c/2a trial MF-101 in myelofibrosis, cleared by the FDA under the Investigational New Drug (IND) scheme, aims to demonstrate that PXS-5505 is safe and effective as a monotherapy in myelofibrosis patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs. An effective pan-LOX inhibitor for myelofibrosis would open a market that is conservatively estimated at US$1 billion per annum.

Second Genome Announces Collaboration with Arena Pharmaceuticals to Identify Gastrointestinal Biomarkers

On August 5, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4-sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, reported they are entering a strategic collaboration with Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) to identify microbiome biomarkers associated with clinical response for their lead program in gastroenterology, etrasimod (Press release, Second Genome, AUG 5, 2021, View Source [SID1234586037]).

Under the terms of the agreement, Second Genome will utilize its proprietary sg-4-sight discovery engine to identify microbiome biomarkers associated with clinical benefit or adverse effects observed within data from the CULTIVATE clinical trial. Arena’s CULTIVATE trial is a Phase 2/3 clinical trial evaluating the efficacy and safety of etrasimod, a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator, in patients with moderately-to-severely active Crohn’s disease. This work will help inform patient stratification and optimize potential treatments for patients in the future.

"The multi-disciplinary capabilities of our sg-4-sight platform and our team’s deep expertise enable Second Genome to collaborate with partners as we continue to advance our own pipeline of precision therapeutics and biomarkers," said Karim Dabbagh, Ph.D., President and Chief Executive Officer of Second Genome. "Arena shares our commitment to unlocking innovative ways to improve human health. We look forward to working with Arena and applying our sg-4-sight platform to discover microbiome signals in Crohn’s disease patients."

"There is substantial evidence that gut microbiome is intricately involved in therapy response in gastrointestinal diseases," said Amit D. Munshi, President and Chief Executive Officer of Arena Pharmaceuticals. "We are pleased to collaborate with Second Genome to discover microbiome biomarkers predictive of clinical response as we continue to progress our CULTIVATE clinical trial."

Cytocom Inc. Provides Update on Completed Merger with Cleveland BioLabs

On August 5, 2021 Cytocom Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported shareholders with an update regarding its recent merger with Cleveland BioLabs (Press release, Cleveland BioLabs, AUG 5, 2021, https://www.prnewswire.com/news-releases/cytocom-inc-provides-update-on-completed-merger-with-cleveland-biolabs-301349236.html [SID1234586036]). The all-stock transaction, first announced in October 2020, was formally completed on July 27, 2021.

"With the Cleveland BioLabs merger completed and Cytocom now operating as a publicly-traded company, the management team at Cytocom is in the process of integrating both companies as we are rapidly advancing our late-stage clinical programs and expanding our toll-like receptor platforms," stated Michael K. Handley, President and CEO of Cytocom Inc. "Furthermore, we believe, through the combination of the two companies, we have created one of the most compelling platforms in the immunotherapy space with 21 programs utilizing eight different assets."

Mr. Handley continued, "We expect to achieve a number of financial and developmental milestones over the next 12 to 18 months that support our goal of becoming a recognized leader in immune-modulating treatments including neutropenia/anemia, emergent viruses, cancer, and autoimmune diseases. We intend to showcase the power of our drug development platform and further generate shareholder value."

Additional information related to the merger close can be found in the Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on July 28, 2021, including the exchange ratio of private Cytocom stock to the new public stock. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of public Cytocom common stock in accordance with the exchange ratio. Continental Transfer & Trust is in the process of completing these activities and will then initiate communication directly to shareholders to provide the necessary forms for former shareholders to receive their new registered freely tradable shares of common Cytocom Inc. stock.

Cytocom acquired ImQuest Life Sciences in an all-stock deal, first announced on July 20, 2020, and completed on June 23, 2021. Pursuant to the terms of the acquisition agreement, Cytocom escrowed stock that is accounted for in the current public company’s capital structure that will be used to provide an aggregate of $12 million in value of Cytocom shares based on the volume-weighted-average trading price of such shares over the period beginning 30 trading days following the closing of such merger. Continental Stock Transfer & Trust is responsible for implementing the issuance of shares of Cytocom common stock to former shareholders of ImQuest in accordance with the exchange ratio.

All other aspects related to merger integration and stock conversion are proceeding as expected. Management will provide a detailed update of the post-merger activities on the company’s quarterly earnings call later this month. All questions regarding the distribution of Cytocom common stock should be directed to Continental Stock Transfer & Trust. Continental Stock Transfer & Trust may be contacted by mail at 1 State St., 30th Floor, New York, NY, 10004-1561 or by phone at (212) 509-4000.

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2021

On August 5, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, Lipocine, AUG 5, 2021, View Source [SID1234586034]).

Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
36-week biopsy data from the LiFT clinical study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Clinical data from the LiFT clinical study were presented at The International Liver Congress 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021
Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
The U.S. Food and Drug Administration ("FDA") cleared the Company’s Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021
Second Quarter Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

Research and development expenses were $1.5 million for the second quarter ended June 30 2021, compared with $2.3 million for the second quarter ended June 30, 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a decrease in personnel expense, which was mainly due to a decrease in stock compensation and bonus expense. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $1.5 million for the second quarter ended June 30, 2021, compared with $2.0 million for the second quarter ended June 30, 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs, which was mainly due to a decrease in stock compensation and bonus expense, and a decrease in legal expenses. These decreases were offset by increases in corporate insurance and other general and administrative expenses.

As of June 30, 2021, the Company had $46.6 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.

Six Months Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $10.2 million, or ($0.12) per diluted share, for the six months ended June 30, 2021, compared with a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020.

Research and development expenses were $3.0 million for the six months ended June 30, 2021, compared with $4.8 million for the six months ended June 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, which was mainly due to a decrease in stock compensation expense offset by increases in salaries. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $3.1 million for the six months ended June 30, 2021, compared with $4.0 million for the six months ended June 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs, mainly due a reduction in stock compensation expense. These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses.