On October 3, 2022 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 that interim Phase 2 data evaluating the safety and efficacy of suprachoroidal (SC) administration using its first VDC product candidate, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (IL/CM)), were presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting held September 30-October 3, 2022, in Chicago, IL (Press release, Aura Biosciences, OCT 3, 2022, View Source [SID1234621632]).

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"The Phase 2 interim safety and efficacy data that was presented at AAO is very encouraging for patients with primary choroidal melanoma, as the majority of patients are diagnosed with early-stage disease and have no vision-preserving treatment options. Interim data showed a statistically significant reduction in tumor growth rate and a robust tumor control response with a high rate of visual acuity preservation at the therapeutic regimen," said Dr. Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear. "Belzupacap sarotalocan offers a favorable safety profile supporting the potential to become the first vision-preserving treatment for early-stage choroidal melanoma, where patients have had to rely on radiotherapy for the last few decades."

"Preliminary analysis of the data from the Phase 2 trial using suprachoroidal administration supports tolerability up to three cycles of therapy and shows a dose-dependent anti-tumor response. The results provide further clinical evidence to support the potential use of belzupacap sarotalocan as a novel targeted therapy in patients with early-stage disease with this targeted route using suprachoroidal administration," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "We believe that the data to date provides proof of concept for an additional intraocular route of administration and further supports belzupacap sarotalocan’s target product profile."

The presentation can be accessed on the Company’s website: link

Interim Safety and Efficacy Data from the Ongoing Phase 2 Trial with SC Administration

This Phase 2 trial (NCT04417530) is assessing the safety and preliminary efficacy of single- and multiple ascending-doses of belzupacap sarotalocan up to three cycles of treatment via SC administration for the first-line treatment of early-stage choroidal melanoma (IL/CM). A total of 20 adult patients have been enrolled in the trial including the single dose Cohorts 1-3 (n=6) and multiple dose escalation Cohorts 4-6 (n=14). Cohorts 5 and 6 received up to three cycles of therapy, which was considered the therapeutic regimen for evaluation. One patient in Cohort 5 (n=3) received two cycles of therapy and two patients in Cohort 5 received three cycles of therapy (40 µg/dose). All patients from Cohort 6 (n=8) received three cycles of therapy at the highest dose (80 µg/dose). One patient from Cohort 6, who discontinued after

one cycle due to unrelated serious adverse events (SAEs), is not included. All patients in Cohorts 5 and 6 had active growth at study entry, as an enrichment strategy to evaluate preliminary efficacy. This group of patients with active growth treated at the therapeutic regimen of three cycles was evaluated for tumor growth rate, tumor control, and visual acuity preservation as the defined clinical endpoints to evaluate preliminary efficacy. These endpoints have been discussed with the U.S. Food and Drug Administration and are planned to be used in the pivotal program. The results, with an average of six months follow up in patients that received three cycles of therapy in Cohorts 5 and 6, showed a statistically significant reduction in the tumor growth rate (-0.296 mm/yr, p = 0.0007) compared to each patient’s documented growth rate at study entry, and an 88.9% (8/9) tumor control rate. In addition, the visual acuity preservation rate was 88.9% (8/9) 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 safety profile of belzupacap sarotalocan was generally favorable, with no dose-limiting toxicities or treatment-related SAEs reported as of August 19, 2022. There was no posterior inflammation and only mild anterior inflammation (Grade 1) in 20% of the patients. Treatment-related AEs were predominantly mild and resolved without sequalae. We believe these interim results indicate that belzupacap sarotalocan may offer a targeted vision preserving therapy for the first-line treatment of primary CM, where 80% of patients are diagnosed early and have no approved therapies to date.

Details for the Virtual Investor Day:

The Company will host a virtual Investor Day today at 11:30 a.m. Eastern Time to discuss belzupacap sarotalocan, its first VDC product candidate, for the first-line treatment of patients with early-stage choroidal melanoma. The Company’s executive management team will be joined by three distinguished ocular oncology thought leaders:

Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University (USA)

Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear & Associate Professor of Ophthalmology, Harvard Medical School (USA)

Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden University (Netherlands) & Past President of the International Society of Ocular Oncology and the Association for Research in Vision and Ophthalmology

To access the virtual Investor Day, please dial (888) 660-6585 (U.S. and Canada) or (929) 203-0858 (international) at least 10 minutes prior to the start time and refer to conference ID 9748492. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be available on the corporate website at the conclusion of the call.

On October 3, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for the company’s investigational mTORC 1/2 inhibitor sapanisertib (CB-228) for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors have a mutation in nuclear factor erythroid 2-related factor (NFE2L2, also called NRF2) and who have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy (Press release, Calithera Biosciences, OCT 3, 2022, View Source [SID1234621631]).

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"While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer. In addition, we know that patients with lung cancers that harbor mutations in the NRF2/KEAP1 pathway typically have poorer outcomes than those whose tumors do not have these mutations," said Susan Molineaux, chief executive officer of Calithera. "This Fast Track designation allows for a variety of benefits, including the possibility of priority review of sapanisertib as we seek to provide a first-in-class treatment option that may help address the major unmet need in this patient population."

NRF2 mutations are found across multiple solid tumor types, with these mutations occurring in approximately 15% of sqNSCLC patients. Sapanisertib targets a key survival mechanism in NRF2-mutated tumor cells. In a recent investigator-initiated Phase 2 trial, the compound was well-tolerated and demonstrated durable single-agent activity with a 27% (or 3/11) confirmed overall response rate (ORR) and median progression free survival (PFS) of 8.9 months (95% CI: 7 months, not reached) in heavily pretreated patients with NRF2-mutated sqNSCLC.1

Calithera’s ongoing Phase 2 trial (NCT05275673) is a multi-center, open-label study of sapanisertib monotherapy in patients with NRF2-mutated sqNSCLC whose disease has progressed on or after platinum-doublet chemotherapy and immune checkpoint inhibitor therapy (anti-PD/L1) with or without anti-CTLA-4. The study is evaluating sapanisertib 2 mg twice a day or 3 mg once a day in patients with sqNSCLC harboring either wild-type (WT) or mutated NRF2, as detected by next-generation sequencing. The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to WT tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Secondary endpoints include duration of response, progression-free survival and overall survival. Calithera plans to share data from this study by the first quarter of 2023. Data generated from this open-label study could position the company to initiate a study with registrational intent in biomarker specific sqNSCLC populations.

The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with potential pathways for expedited approval that have the objective of getting important new therapies to patients more quickly.

On October 3, 2022, Tyra Biosciences, Inc. (the "Company") reported that entered into an ATM Sales Agreement (the "Sales Agreement") with Virtu Americas LLC (the "Agent"), under which the Company may, from time to time, sell shares of the Company’s common stock having an aggregate offering price of up to $150.0 million in "at the market" offerings through or to the Agent, as sales agent or principal (Filing, 8-K, Tyra Biosciences, OCT 3, 2022, View Source [SID1234621629]). Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.

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The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. No assurance can be given that the Company will sell any shares of common stock under the Sales Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sales Agreement, the Company agreed to indemnify the Agent against certain liabilities, including under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, or to contribute to payments that the Agent may be required to make because of such liabilities. The Company and the Agent may each terminate the Sales Agreement at any time upon specified prior written notice.

The shares will be issued pursuant to the Company’s shelf registration statement on Form S-3, including the Sales Agreement prospectus contained therein, filed with the Securities and Exchange Commission (the "SEC") on October 3, 2022 (the "Registration Statement"), once the Registration Statement is declared effective by the SEC. A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement.

On October 3, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting its Investigational New Drug (IND) application for a Phase 1/2 dose escalation study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B cell non-Hodgkin’s lymphoma (B NHL), including those who have failed previous CD19 CAR T treatment (Press release, Oncternal Therapeutics, OCT 3, 2022, View Source [SID1234621628]).

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"We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody zilovertamab, announced last week. ROR1 is an exciting and promising target that is highly expressed in a wide range of cancers and is an ideal candidate for cell therapy applications due to its highly specific tumor expression, and association with tumor survival mechanisms. Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today. We expect to initiate the study in the coming months and to present interim results at a scientific conference in 2023."

On October 3, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in upcoming investor conferences (Press release, Zymeworks, OCT 3, 2022, View Source [SID1234621627]):

Stifel 2022 Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 16th in New York, NY.

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Jefferies London Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 17th in London, United Kingdom.

In addition, Zymeworks will present an update on its preclinical research programs at an Early R&D day on October 20th, 2022, in New York, NY. At this event, led by Paul Moore, PhD, Zymeworks’ Chief Scientific Officer, we plan to present data from multiple preclinical product candidates built upon our industry-leading multispecific and next-generation TOPO1i based ADC platforms as well as an update to our future scientific vision.

All presentations and webcasts will be available on Zymeworks’ website at View Source