On March 15, 2023 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, and Grünenthal, an international science-driven pharmaceutical company and a global leader in pain research and management, reported their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in Grünenthal’s pipeline (Press release, Catalent, MAR 15, 2023, https://www.catalent.com/catalent-news/catalent-and-grunenthal-announce-successful-collaboration/ [SID1234628779]).

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Positive preclinical results from the molecule have allowed Grünenthal to progress its development program to first-in-human studies. In this phase, Catalent supported Grünenthal with the development of a bioavailability enhanced formulation, which, moving forward, enables expedited clinical development timelines.

The two companies have been working together on this program since 2021. Catalent has assisted Grünenthal in reformulating the molecule using a lipid-based drug delivery system formulated in softgel technology to improve its bioavailability. Scientific experts at Catalent’s facilities in Beinheim, France, and Nottingham, U.K., carried out this development work using its OptiForm Solution Suite platform, which allowed the rapid characterization and screening of dose forms and formulation technologies to optimize dose design.

Phase 1 studies of the molecule will be supported by scientists from Beinheim using the Catalent Xpress Pharmaceutics platform, which provides rapid development of clinical formulations and on-demand manufacturing of dose forms at the clinical research organization undertaking the trials. Trials will be run for both single ascending dose (SAD) and multiple ascending dose (MAD) studies based on the real-time results of the adaptive study protocol.

"The OptiForm Solution Suite provides an efficient approach to expedite innovative candidates into first-in-human studies. It does this through assessing a broad range of technical solutions to identify the most suitable formulation for the specific candidate," said Stephan Bulat, Head of Chemistry, Manufacturing and Controls at Grünenthal. "The Catalent Xpress Pharmaceutics platform provides the flexibility to efficiently manage our candidates through early clinical development studies, supporting our ambition to achieve best-in-class development timelines."

"With innovators demanding shortened drug development timeframes, Catalent offers a number of integrated solutions to ensure programs can be accelerated to, and through, clinical phases as quickly and safely as possible, while providing design and delivery technology support to give molecules the greatest chance of success," said Ricky Hopson, President, Division Head for Clinical Development and Supply, Catalent. "Working with Grünenthal, we have been able to leverage multiple services that have not only reduced Phase 1 development timelines substantially, but have done so using a formulation and delivery technology that is scalable for future clinical and commercial needs as the program progresses."

Grünenthal is dedicated to creating innovative non-opioid pain treatments that address unmet medical needs. For R&D, Grünenthal executes a distinctive therapeutic area strategy and focuses on four key pain indications: peripheral neuropathic pain, chronic post-surgical pain, chronic low back pain, and osteoarthritis. Grünenthal seeks collaborations in these areas to develop life-changing treatments for patients, independent of the modality and their stage of development. To date, the company has launched six treatment options for patients suffering from pain.

On March 15, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported that it will release its audited financial results for the year ended December 31, 2022 on Wednesday, March 22, 2023, before the U.S. markets open (Press release, BioLineRx, MAR 15, 2023, View Source [SID1234628778]).

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The Company will host a conference call on Wednesday, March 22, 2023 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 24, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On March 15, 2023 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the fourth quarter and year ended December 31, 2022, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAR 15, 2023, View Source [SID1234628777]).

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"2023 is off to a strong start with positive interim Phase 2 safety and efficacy data with suprachoroidal administration in early-stage choroidal melanoma. In February, at the Macula Society’s 46th Annual Meeting, we presented average nine-month interim data which strongly supports the assumptions for the success of the global Phase 3 trial, which is on track to dose the first patient in the first half of this year," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are also excited to initiate clinical development in our second ocular oncology indication, choroidal metastasis, and to report early Phase 1 data in our non-muscle invasive bladder cancer program in the second half of this year. Our recently strengthened balance sheet positions us well to execute and advance our pipeline to meaningful clinical milestones across ocular and urologic oncology."

"We are excited that bel-sar was granted Fast Track Designation for choroidal metastasis. There is an important opportunity to develop a new standard of care as we see a large number of patients with this type of metastasis," said Dr. Cadmus Rich, Chief Medical Officer of Aura Biosciences. "This is the second Fast Track Designation bel-sar has obtained for an ocular oncology indication, which highlights the need for vision preserving treatment options."

Recent Pipeline Developments

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Bel-sar is being developed for the first-line treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies

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Positive interim Phase 2 data evaluating suprachoroidal (SC) administration of bel-sar for the first-line treatment of adult patients with early-stage CM was presented at the Macula Society 46th Annual Meeting. The results reported as of January 10, 2023, with an average of nine months of follow up in patients similar to the planned Phase 3 population, who received three cycles of therapy (n=8), showed a statistically significant reduction in the tumor growth rate (-0.289 mm/yr, p = <0.0001) compared to each patient’s documented growth rate at study entry, and a 100% tumor control rate. In addition, only one patient lost visual acuity in these cohorts, with the majority of patients being at high-risk for vision loss with tumors close to fovea or optic disk. The overall tolerability profile of bel-sar was generally favorable, with no dose-limiting toxicities, treatment-related serious adverse effects (SAEs) or significant adverse events (AEs). There was no posterior inflammation and mild anterior inflammation (Grade 1) in 25% of the patients. Treatment-related AEs were predominantly mild and resolved without sequalae. We believe these interim results indicate that bel-sar may offer a targeted, vision preserving therapy for the first-line treatment of early-stage CM, where 80% of patients are diagnosed early and have no approved therapies to date.

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Aura finalized the global Phase 3 trial design in alignment with regulatory agencies and selected SC route of administration to evaluate the efficacy and safety of bel-sar in early-stage CM. The global Phase 3 trial is randomized and masked and will include three arms, where the primary endpoint will be a time to event composite endpoint that will compare the tumor control and visual acuity of the intervention group with high dose of bel-sar to sham. Aura is planning to enroll approximately 85 adult patients with early-stage CM, including patients with indeterminate lesions and small choroidal melanoma. Patients with documented growth will be enrolled as an enrichment strategy intended to increase the efficiency of the trial, which will also include an adaptive design to further increase the probability of success.

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Aura is enrolling a Phase 1 clinical trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC). This represents an area of high unmet need with approximately 80,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

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The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 23 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 clinical trial is the incidence and severity of treatment-related AEs and SAEs and the incidence of dose-limiting toxicities. The goal of this study is to demonstrate distribution, local necrosis and evidence of immune activation. Aura expects to report initial Phase 1 data in the second half of 2023.

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Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with an unmet medical need and no approved therapies, as the second ocular oncology indication. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in February 2023, and the Investigational Drug application was opened in January 2023

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Nonclinical data supporting bel-sar’s broad tumor targeting potential and immune mediated mechanism of action was presented at the 22nd EURETINA Congress. Preclinical results highlighted bel-sar’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid, supporting its potential use for the treatment of choroidal metastasis, a key second ocular oncology indication. The presentation also included nonclinical data that supported the activity of bel-sar as a single agent as well as in combination with checkpoint inhibitors, highlighting the possibility to treat not only primary tumors in the eye but also potentially distant metastases by an abscopal effect.

Recent Corporate Events

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Raised Gross Proceeds of $92.5 Million in Oversubscribed Follow-on Public Offering. In December 2022, Aura announced the closing of an oversubscribed underwritten follow-on public offering yielding aggregate gross proceeds of approximately $92.5 million. All of the shares in the offering were offered by Aura.

Full Year and Fourth Quarter 2022 Financial Results

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As of December 31, 2022, Aura had cash and cash equivalents and marketable securities totaling $188.8 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2025.

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Research and development expenses increased to $13.2 million and $42.2 million for the three months and full year ended December 31, 2022, respectively, from $8.0 million and $25.2 million for the three months and full year ended December 31, 2021, respectively, primarily due to ongoing clinical costs associated with the progression of Aura’s Phase 2 study and clinical research organization costs associated with the start of Aura’s Phase 3 global trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

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General and administrative expenses increased to $4.5 million and $18.1 million for the three months and full year ended December 31, 2022, respectively, from $3.6 million and $10.1 million for the three months and full year ended December 31, 2021, respectively. General and administrative expenses include $1.1 million and $0.9 million of stock-based compensation for the three months ended December 31, 2022 and 2021, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to a full year of operating as a public company.

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Net loss for the three months and full year ended December 31, 2022, was $16.6 million and $58.8 million, respectively, compared to $11.6 million and $35.3 million for the three months and full year ended December 31, 2021, respectively.

On March 15, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported fourth quarter and full year ended December 31, 2022 financial results and provided corporate updates (Press release, Aravive, MAR 15, 2023, View Source [SID1234628776]).

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"As we reflect on a productive 2022, Aravive remains committed to driving progress across all aspects of our business," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We are on track with development activities around our PROC Phase 3 program, and we anticipate delivering topline results in mid-2023. Our trials in both clear cell renal cell carcinoma and pancreatic cancer continue to yield meaningful and encouraging data, further underscoring the potential of batiraxcept in multiple indications. Furthermore, we are pleased to have secured the funding needed to advance all of our programs beyond the PROC readout and progressing our clinical activities, with strong support from a respected syndicate of leading biotech investors. With a strengthened management team and a continued focus on scientific excellence, we are excited to build on our momentum and make significant strides in the year ahead. We look forward to updating you on our progress throughout the year as our clinical programs advance."

Recent Corporate Highlights

The Phase 3 AXLerate-OC Trial in PROC Completed Enrollment
The registration-directed Phase 3 trial of batiraxcept plus paclitaxel for PROC completed enrollment in January 2023. The trial planned to enroll 350 patients with platinum resistant, high-grade serous ovarian cancer who have received 1-4 prior lines of therapy. CMC work remains on track and the Company expects to report topline data from the trial by mid-2023. If those results are positive, the Company plans on submitting a Biologics License Application (BLA) to FDA by year-end 2023. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with paclitaxel versus placebo in combination with paclitaxel.
Advancement of PROC trial in China Results in Milestone Payment
The Company’s partner in China, 3D Medicines enrolled patients into the Phase 3 PROC trial, which effectively begins their Phase 3 clinical activity towards their goal of ultimate approval in China. The Company received the $6 million payment related to achievement of this milestone in October 2022, the third milestone payment received since the Company entered into an agreement with 3D Medicines in November 2020.
Batiraxcept Granted Fast Track Designation for ccRCC Program
In November 2022, FDA granted Fast Track designation to batiraxcept for treatment of patients with advanced or metastatic ccRCC who have progressed after 1 or 2 prior lines of systemic therapy that include both IO-based and VEGF-TKI-based therapies (either in combination or sequentially). FDA’s designation was based on new Phase 1b data showing an Objective Response Rate (ORR) of 57% and median Progression-Free Survival (PFS) of 11.4 months in patients with advanced or metastatic ccRCC who have progressed after 1 or 2 prior lines of immuno-oncology (IO)- and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies.
Updated ccRCC Data Presented at the 2023 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium
The Company presented a poster at the 2023 ASCO (Free ASCO Whitepaper) GU Cancers Symposium in February 2023 featuring updated results from its ongoing Phase 1b/2 trial of batiraxcept in ccRCC. As of January 17, 2023, safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of 15 mg/kg and 20 mg/kg batiraxcept in combination with 60 mg cabozantinib were evaluated in 26 patients with 2L+ ccRCC. In addition, one of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline serum soluble AXL (sAXL)/GAS6 (biomarker) with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. There were no dose limiting toxicities observed at either dose of batiraxcept. The best response of partial response was observed in 42% (11/26) of the overall population 57% (8/14) of the prior VEGF-TKI-treated group and 55% (11/20) of the biomarker high (sAXL/GAS6) group. The 9-month progression-free survival (PFS) rate was 65% in the overall population, 69% in the biomarker high group (n=20) and 75% in the prior VEGF-TKI, biomarker high group (n=11). Eighty-five percent of patients (22/26) had a reduction in target lesions at the 8-week response assessment, and 58% (15/26) of the total population achieved a better response on batiraxcept plus cabozantinib than they did on prior therapy. The Company has discussed a registrational path with the US FDA that includes use of the sAXL/GAS6 ratio as a potential basis for an accelerated approval.

The open-label Phase 2 portion of the clinical trial initiated January 31, 2022 and is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate 15 mg/kg batiraxcept in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate 15 mg/kg batiraxcept in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate 15 mg/kg batiraxcept monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

The Company expects to report additional data from the P1b portion and preliminary data from the P2 portion of the ccRCC trial mid-2023.
Batiraxcept Granted FDA Orphan Drug Designation in Pancreatic Cancer; Phase 1b/2 Trial in PDAC is Advancing
In February 2023, the Company announced that the U.S. Food and Drug Administration (FDA) granted batiraxcept Orphan Drug Designation (ODD) for the treatment of pancreatic cancer. The Company provided an update on the Phase 1b pancreatic study on September 27, 2022 for 18 patients who had been treated with 15 mg/kg batiraxcept (Days 1 & 15) plus nab-paclitaxel (125 mg/m2 on Days 1, 8, & 15) and gemcitabine (1000 mg/m2 on Days 1, 8, & 15) and have pharmacokinetic data. Consistent with other Phase 1b cancer studies with batiraxcept, there is a relationship between batiraxcept exposures and clinical activity such that 5 of 9 patients in the PDAC study whose batiraxcept levels exceeded the minimum efficacious concentration (MEC) of batiraxcept had a response versus 1 of 9 patients in the low MEC group. Similarly, the mPFS in the high MEC group was 5.6 months (95% CI 2.1, not evaluable) versus 2.7 months (95% CI 1.1, 5.4) in the low MEC group. In May 2022, the Company had reported that batiraxcept was generally well-tolerated in combination with gemcitabine and nab-paclitaxel with no unexpected safety signals. Based on these data, the Company intends to dose an additional 6-18 patients at higher doses (20 mg/kg and potentially 25 mg/kg) to assess whether a higher dose will increase the proportion of patients who will achieve high MEC and increase the clinical activity of batiraxcept in combination with gemcitabine plus nab-paclitaxel. Preliminary data from the 20 mg/kg cohort is expected in the second half of 2023.
Strengthened Balance Sheet, Adding Funding to Support Operations Beyond PROC Readout
In January 2022, Aravive raised approximately $9.9 million in net proceeds from the sale of a pre-funded warrant to purchase 4,545,455 shares of the company’s common stock to Eshelman Ventures, LLC at a price of $2.20 per share, which was the consolidated closing bid price of the company’s common stock on The Nasdaq Global Select Market on December 31, 2021, the date of execution of the stock purchase agreement. Additionally, Fred Eshelman, Pharm.D., was appointed the Executive Chairman of Aravive, having served as the Non-Executive Chairman of the board since April 2020. In March 2022, the Company raised an additional approximately $9.3 million in net proceeds from the sale of common stock and a pre-funded warrant for an aggregate of a combination of 4,850,241 shares of the company’s common stock and pre-funded warrants to a single healthcare-focused institutional investor and Eshelman Ventures, LLC and issued warrants to purchase an additional aggregate of 4,850,241 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In October 2022, the Company raised approximately $40 million in net proceeds from a private placement offering from new biotechnology investors, existing investors and certain of the Company’s management and directors. Combined, the additional capital infusions strengthen the Company’s financial position and fund operations as currently planned into the fourth quarter of 2023, beyond the readout on our Phase 3 PROC trial.
Strengthened Leadership Team with Experienced Industry Experts
Throughout 2022, the Company built upon its strong leadership with the appointments of Scott Dove, Ph.D. as Chief Operating Officer, Rudy Howard as Chief Financial Officer and Robert B. Geller, M.D. as Chief Medical Officer.
Fourth Quarter and Full Year 2022 Financial Results
Revenues for the three and twelve months ended December 31, 2022 were approximately $1.5 million and $9.1 million, respectively, compared with approximately $1.0 million and $7.4 million, respectively, for the three and twelve months ended December 31, 2021. Revenues for 2022 and 2021 were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020, to develop and commercialize batiraxcept in oncology indications in China. Revenues represent 1) a portion of initial signing and milestone recorded from 3D Medicines that is recognized at the time it is probable the milestone will be met and 2) a portion of the milestone that is deferred and recognized over the PROC trial period. The increase in revenue for fiscal year 2022 compared to 2021 was driven primarily by increased expenditures related to the PROC trial, which drives the recognition of deferred revenue over the PROC trial period.

Total operating expenses for the three and twelve months ended December 31, 2022 were approximately $21.3 million and $80.0 million, respectively, compared with approximately $14.6 million and $48.1 million, respectively, for the three and twelve months ended December 31, 2021. Research and development expenses for the three and twelve months ended December 31, 2022 were approximately $18.0 million and $66.9 million, respectively, compared with approximately $12.2 million and $37.5 million, respectively, for the three and twelve months ended December 31, 2021. The increase in research and development expense in 2022 compared to the same periods in 2021 is driven by the continued advancement of our clinical trials and increases in CMC-related costs. General and administrative expenses for the three and twelve months ended December 31, 2022 were approximately $3.4 million and $13.0 million, respectively, compared with approximately $2.4 million and $10.6 million, respectively, for the three and twelve months ended December 31, 2021. The increase in general and administrative expense was primarily driven by higher salary expense, higher stock-based compensation expense, higher severance expense, and increased consulting fees.

For the three and twelve months ended December 31, 2022, Aravive reported a net loss of approximately $29.1 million and $76.3 million, or $0.46 per share and $2.10 per share, respectively compared to a net loss of approximately $13.0 million and $39.2 million, or $0.62 per share and $1.95 per share, respectively, for the three and twelve months ended December 31, 2021.

Cash Position
As of December 31, 2022, cash and cash equivalents were approximately $53.7 million, compared to approximately $27.9 million as of September 30, 2022. During October 2022, the Company received a $6 million milestone payment from the Company’s licensee, 3D Medicines, Inc. and raised approximately $40 million in net proceeds from a private placement offering. The Company believes that its existing cash and cash equivalents will be sufficient to sustain operations into the fourth quarter of 2023.

On March 15, 2023 Almac Sciences, a member of the Almac Group, reported that it has been awarded the highest grade of "outstanding" by the Knowledge Transfer Partnership (KTP) grading panel following the successful completion of a three year project in collaboration with Queen’s University Belfast (QUB) (Press release, Almac, MAR 15, 2023, View Source [SID1234628775]).

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The project which looked at the development of highly innovative continuous flow processes with a key focus on high pressure hydrogenations received the highest accolade after successfully meeting all of the KTP’s objectives.

The Innovate UK-funded KTP aimed to embed flow technologies to ensure long term security of supply for key raw materials through development of a continuous flow platform technology. Continuous flow approaches are impacting the drive to ensure novel, improved technologies strengthen supply chain resilience, contribute to Net Zero Impact and support continued growth of the manufacturing sector.

Dr. Megan Smyth, Team Leader and UKRI Future Leaders Fellow, Almac Sciences commented: "The KTP project has been a huge success which has embedded new technology capacity and knowledge into Almac. As a CDMO, having a wide range of synthetic capabilities is essential to deliver on the complex target chemical structures that our customers contract us to manufacture."

The main achievements from this KTP partnership include the build and installation of flow rigs within Almac Sciences and the successful delivery of multiple projects at 100’s of kgs scale. Project success has been disseminated through peer reviewed publications, multiple conference presentations, poster prizes and retention of the KTP associate in a full-time employment within the company.

Dr. Scott Wharry, Custom and Flow Chemistry Manager, Almac Sciences, commented: "Congratulations to the whole team on the successful completion of the KTP. Receiving the highest accolade is testament to the hard work throughout the project. The flexibility and resilience demonstrated by both the KTP associate, Academic supervisor and Company supervisors during the pandemic was admirable as they worked tirelessly to ensure project delivery and managed change to deliver with a business-centric focus."

#ENDS#