On July 21, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that DEP HER2-zirconium, its HER2-targeted radiodiagnostic candidate, has demonstrated a favourable biodistribution profile, with excellent imaging contrast between tumour and normal tissues, as well as rapid uptake and high levels of tumour accumulation in a HER+ breast cancer model (Press release, Starpharma, JUL 21, 2023, View Source;mc_eid=bf52dd3418 [SID1234633338]). These are important features for a radiodiagnostic product for accurate diagnosis and monitoring of tumour lesions using PET-CT imaging. The study details and results are reported below.

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Starpharma’s DEP HER2-zirconium is a radiodiagnostic product that belongs to the rapidly growing "radiotheranostic" category – which includes both radiodiagnostic and radiotherapeutic products. DEP HER2-zirconium is designed to specifically diagnose, stage, and monitor HER2+ cancers with greater sensitivity, meaning that patients suffering from these cancers could be diagnosed earlier, more accurately, and monitored more closely during cancer treatment.

The study results are very encouraging as they confirm the optimised binding properties of DEP HER2-zirconium for targeted delivery and preferential uptake by cancer cells, and support a precision medicine approach for cancer patients. The combined effect of the novel pharmacological properties of DEP HER2-zirconium gives it an advantage in the promotion of selective tumour cell entry and support its targeted delivery mechanism to tumour cells, leaving normal cells relatively untouched.

Commenting on the significance of these findings, Clinical Pharmacology and Oncology specialist, Dr Paul Wabnitz, (MD, FRACP)3, said:

"Translated clinically, this technology has the potential to detect cancer cells at very low levels and better guide therapeutic decisions at earlier stages and at levels that were previously undetectable by current radiological methods. This has several advantages, including dose optimisation and better identifying the minimal dose level for an efficacious response, thereby minimising toxicity and promoting the quality of life and care of cancer patients undergoing therapy."

Dr Jackie Fairley, CEO of Starpharma, commented:

"Radiotheranostics and HER2 therapeutics are both rapidly growing categories with a number of highly successful product launches in recent years. The application of Starpharma’s DEP technology in the radiotheranostic area presents a substantial opportunity to expand the commercial opportunity for DEP. The DEP platform offers greater flexibility which allows a wide range of radioisotopes to be utilised."

HER2 and radiotheranostics market

The global radiotheranostics market was US$1.8 billion in 2022 and is expected to grow by over 10% annually to US$4.2 billion by 2030. There are already several successful marketed radiodiagnostics, such as Pylarify and Illuccix, which detect prostate cancer through PET-CT scans, with others in development.

HER2-based antibody products had total sales of ~US$11 billion in 2022, which included Herceptin (or trastuzumab), marketed by Roche/Genentech and the highly successful AstraZeneca product, Enhertu.

DEP HER2-zirconium study details and results

DEP HER2-zirconium utilises a novel single-domain antibody (sdAb), or nanobody, which is smaller than a full mAb, to target and bind to HER2+ tumour cells. The study assessed the biodistribution and imaging (diagnostic) performance of DEP HER2-zirconium compared with a HER2-targeted full antibody (trastuzumab/Herceptin), labelled with zirconium-89. Zirconium-89 is a radioisotope used for PET-CT imaging in cancer patients.

A HER2+ human breast cancer cell line (BT474) was grown as a tumour subcutaneously in mice. Biodistribution was measured by in vivo PET-CT imaging and quantitative ex vivo gamma counting at time points ranging from 4 hours to 120 hours after dosing with either DEP HER2-zirconium or trastuzumab-zirconium, with a target radioactivity of 3 MBq (megabecquerel) per dose.

In this study, DEP HER2-zirconium:

Showed significant accumulation in tumour (>25% of the injected dose per gram [ID/g] of tumour);
Was cleared more rapidly from the blood, and highly perfused organs such as heart and lung, than HER2 mAb trastuzumab-zirconium (see Figure 1);
Demonstrated a significantly higher tumour-to-blood ratio than trastuzumab-zirconium; and
Resulted in high tumour-to-organ ratios, delivering excellent specificity in imaging the HER2+ breast cancer model (see Figure 2).
Figure 1. Injected dose in blood over time, demonstrating more rapid clearance of DEP HER2-zirconium versus trastuzumab-zirconium.

In summary, the data reported here for DEP HER2-zirconium highlight its promise in radiotheranostics, due to its efficiency of tumour delivery and favourable PK and biodistribution characteristics. The study results demonstrate positive characteristics that are relevant to both radiodiagnostic and radiotherapeutic DEP-based products.

On July 20, 2023 EpiBiologics, a biotechnology company advancing a next-generation antibody-based protein degradation platform and pipeline for membrane and extracellular drug targets, reported that Ann Lee-Karlon, Ph.D., will join as Chief Executive Officer, President, and member of the Board of Directors (Press release, EpiBiologics, JUL 20, 2023, View Source [SID1234643976]). Dr. Lee-Karlon will focus on expanding EpiBiologics’ proprietary EpiTAC platform, establishing value-driven collaborations, and building the company’s pipeline of bispecific antibody protein degrader therapeutics.

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"I had the pleasure of working with Ann at Genentech and am confident her deep experience building therapeutic pipelines and leading strategic collaborations will be invaluable as EpiBiologics progresses novel protein degrader therapeutics toward the clinic," said David Schenkein, MD, general partner at GV. "We would like to thank Rami Hannoush for his leadership as co-founder and interim CEO and look forward to an exciting next stage of growth for EpiBiologics under Ann’s leadership."

Prior to EpiBiologics, Dr. Lee-Karlon served as Chief Operating Officer of Altos Labs. She joined Altos at its initiation in 2021 and was instrumental in building the foundation for rapid growth to 500 employees across three global sites. Before Altos, Dr. Lee-Karlon spent over 18 years at Genentech, most recently as Senior Vice President. During her tenure at Genentech, she led portfolio strategy and operations and had project leadership oversight for over 80 drug development teams from research and development through FDA approval and global launch. She led major corporate partnerships and programs, including Ocrevus for multiple sclerosis and Rituxan in immunology. Dr. Lee-Karlon holds a B.S. in bioengineering from UC Berkeley, an MBA from Stanford University, and a Ph.D. in bioengineering from UC San Diego, where she was a National Science Foundation Fellow.

"EpiBiologics has developed a groundbreaking platform to target membrane and extracellular proteins, leveraging a novel atlas of tissue-specific degrader antibodies," said Dr. Lee-Karlon, CEO of EpiBiologics. "Targeted extracellular protein degradation represents a new therapeutic modality with a wide range of applications including cancer, immunology, and neurological diseases. I’m excited to work with the outstanding scientific team, advisors, and leaders to deliver new and important treatment options for patients in need."

EpiBiologics also announced that the company brought the total series A round to $73 million with the addition of $23 million from new investors Digitalis Ventures, Taiho Ventures, and existing investor Codon Capital. In March, EpiBiologics launched with its $50 million series A financing with participation from Mubadala Capital, Polaris Partners, Vivo Capital, and GV.

EpiBiologics welcomes new members to its board of directors, including Samuel Bjork, partner at Digitalis Ventures, and Seiji Miyahara, Ph.D., senior investment director at Taiho Ventures. Board member Mitchell Mutz, Ph.D., of Vivo Capital, who led the company’s efforts to close the series A extension, will continue in his role as the CFO of EpiBiologics.

"EpiBiologics has made tremendous progress with its leading-edge EpiTAC platform, which will unravel the underlying intricacies of disease biology to build precision therapeutics," said Mr. Bjork. "We are excited to work closely with Ann as the new CEO and the entire EpiBiologics team to bring the next generation of medicines to patients."

"With Ann’s strong track record in the biopharma industry, we are thrilled to join EpiBiologics’ syndicate of investors," said Dr. Miyahara. "We look forward to helping EpiBiologics continue to develop its novel bispecific antibody platform towards important treatments for a broad range of diseases."

On July 20, 2023 ADC Therapeutics reported that it plans to discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, JUL 20, 2023, View Source [SID1234634579]). Given the challenges of defining the addressable segment of the difficult-to-treat unfit or frail DLBCL patient population, including many patients with significant active underlying co-morbidities, the benefit-risk profile does not support continuation of the LOTIS-9 trial.

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Following a meeting yesterday, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trial for new patient enrollment but will allow patients already on therapy who are deriving clinical benefit to remain on therapy after being reconsented. Following treatment of any reconsenting patients, the Company will conduct the necessary steps to conclude the trial and does not plan to continue studying this regimen in the unfit or frail previously untreated DLBCL patient population.

About (loncastuximab tesirine-lpyl)

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

On July 20, 2023, Propanc Biopharma, Inc. (the "Company") reported to have entered into a common stock purchase agreement (the "Equity Line Agreement") with an institutional investor (the "Investor") providing for an equity financing facility, pursuant to which Company has the option to request that the Investor commit to purchase up to $5,000,000 of the Company’s shares (the "Shares") of common stock, par value $0.001 per share (the "Common Stock"), over a 24-month term commencing on the date on which a registration statement filed by the Company to register the offer and resale of the Shares by the Investor (the "Registration Statement") is declared effective by the U.S. Securities and Exchange Commission (the "SEC"). Pursuant to the Equity Line Agreement, the Company has the option to exercise this right by providing a notice (a "Drawdown Notice") from the Company to the Investor setting forth the number of Shares that the Investor will purchase. The Company has agreed to use the proceeds from such issuances for the purpose of financing its research and product development activities, finished product manufacture for clinical studies, working capital requirements and general corporate purposes.

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Pursuant to the Equity Line Agreement, purchases of Shares cannot occur unless and until certain conditions are met, including but not limited to, the SEC declaring the Registration Statement effective, and the maximum number of Shares that may be purchased pursuant to a Drawdown Notice cannot exceed the lesser of (i) 200% of the average daily traded value of the Common Stock during the five (5) business days immediately preceding a Drawdown Notice or (ii) $200,000; provided that in no event may a Drawdown Notice be for less than $5,000, exceed 52,500,000 Shares or cause the Investor’s ownership to exceed 4.99% of the outstanding number of shares of Common Stock immediately prior to the issuance of such Shares. The actual amount of proceeds that the Company will receive in connection with each Drawdown Notice is determined under the Equity Line Agreement by multiplying the number of Shares to be sold by the applicable purchase price per share, which is equal to 85% of the lowest traded price of the Common Stock during the 7 business days immediately following the Clearing Date, less Clearing Costs (as each such term is defined in the Equity Line Agreement).

Additionally, in connection with the Equity Line Agreement, the Company and the Investor entered into a registration rights agreement, dated July 20, 2023 (the "Registration Rights Agreement"), pursuant to which the Company agreed to register the maximum number of Shares within 45 days of the date of the Registration Rights Agreement, subject to any comments from the SEC and applicable laws, rules and regulations.

The foregoing descriptions of each of the Equity Line Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of each of the Equity Line Agreement and the Registration Rights Agreement, copies of which are attached to this Current Report on Form 8-K (this "Report") as Exhibits 10.1 and 10.2.

On July 20, 2023 DURECT Corporation (Nasdaq: DRRX) ("DURECT"), a biopharmaceutical company focused on developing its epigenetic regulator program for the treatment of acute organ injury and chronic liver diseases, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 2,991,027 shares of common stock and accompanying warrants to purchase up to 2,991,027 shares of common stock in a registered direct offering (the "Offering") priced at-the-market under Nasdaq rules (Press release, DURECT, JUL 20, 2023, View Source [SID1234633357]). The shares of common stock and accompanying warrants are being sold at a combined purchase price of $5.015 per share and accompanying warrant. The warrants will have an exercise price of $4.89 per share, will be immediately exercisable and will expire five years from the date of issuance.

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The closing of the Offering is expected to occur on or about July 21, 2023, subject to customary closing conditions. The gross proceeds from the Offering are expected to be approximately $15 million, before deducting fees to the placement agents and other estimated offering expenses payable by DURECT. DURECT intends to use the net proceeds of the Offering for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, selling, general and administrative costs, facilities expansion, and to meet working capital needs.

H.C. Wainwright & Co. is acting as exclusive placement agent for the Offering.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-258333) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on July 30, 2021 and declared effective by the SEC on August 16, 2021. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to, and describing the terms of, the Offering will be filed with the SEC. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the prospectus supplement and accompanying prospectus can be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.