On November 16, 2023 LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma-delta T cell engagers, reported recent corporate highlights and financial results for the quarter ended September 30, 2023 (Press release, Lava Therapeutics, NOV 16, 2023, View Source [SID1234637737]).

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"We continue to advance our lead program, LAVA-1207, in patients with mCRPC in our Phase 1/2a escalation study," said Steve Hurly, president and chief executive officer of LAVA. "Our Gammabody platform continues to receive the support of investigators and patients and enrollment remains on track. We are also pleased with the progress of our partnered programs, particularly the initiation of the Phase 1 study of SGN-EGFRd2 (LAVA-1223) in advanced solid tumors which provides additional validation of our platform. With an expected cash runway into 2026, LAVA remains well-positioned to bring meaningful benefits to patients in areas of high unmet need and to deliver shareholder value."

LAVA-1207

Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with metastatic castration-resistant prostate cancer (mCRPC). The safety, tolerability, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-1207 in patients with mCRPC are being evaluated in an ongoing dose escalation phase 1/2a, first-in-human study.

● Trial enrollment is progressing across 10 clinical trial sites in Europe and the United States.
● The Company expects to report additional data for the dose escalation phase of the trial in the third quarter of 2024, which if positive, we expect these results to allow us to rapidly design and enter into a dose expansion study to support a potential pivotal future trial.
Partnered Programs

Seagen- SGN-EGFRd2 (LAVA-1223)

● During the third quarter, Seagen began recruitment in a Phase 1 study evaluating the safety and tolerability of SGN-EGFRd2 (LAVA-1223) as a monotherapy administered intravenously in advanced solid tumors. The study design has three parts: Parts A and B of the study will identify dosage for SGN-EGFRd2 and Part C will use the findings in Parts A and B for a dose to determine safety and efficacy of SGN-EGFRd2. Eligible patients for Part A include patients with colorectal cancer, non-small cell lung cancer or head and neck squamous cancer that is relapsed, refractory, or be intolerant to standard of care therapies. For more information, please refer to clinicaltrials.gov (NCT05983133).

Janssen Biotech – Undisclosed Candidate

● Earlier this year, Janssen selected a lead candidate aimed at an undisclosed tumor-associated antigen for further development towards a phase 1 clinical trial. A milestone payment was received in July 2023.

Third Quarter 2023 Financial Results

The financial information provided below reflects changes made to previously issued consolidated financial statements to revise immaterial prior-period misstatements. Further information regarding the revision is included in LAVA’s consolidated financial statements, "Note 12 — Revision of Immaterial Misstatements," included in Exhibit 99.1 to the report on Form 6-K to be filed with the SEC on the date hereof.

● As of September 30, 2023, LAVA had cash, cash equivalents and investments totaling $104.6 million compared to cash, cash equivalents and investments of $132.9 million as of December 31, 2022. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2026.
● Revenue from contracts with customers was less than $0.1 million and $15.3 million for the quarters ended September 30, 2023 and 2022, respectively, and $3.1 million and $16.8 million for the nine months ended September 30, 2023 and 2022, respectively. In connection with the license agreement with Seagen, we recognized less than $0.1 million in revenue for the three months ended September 30, 2023, related to reimbursement for research activities and initial supply related stability studies. Revenue from contracts with customers was $15.3 million for the three months ended September 30, 2022, related to the Seagen Agreement. Of that amount, $15.2 million related to the nonrefundable upfront payment and $0.1 million related to reimbursement for research activities.
● Cost of providing services and sales of goods was less than $0.1 million and zero for the quarters ended September 30, 2023 and 2022, respectively, and $3.3 million and zero for the nine months ended September 30, 2023 and 2022, respectively. The increase in cost was due to the cost of the initial supply delivery to Seagen and related stability studies.
● Research and development expenses were $7.9 million and $13.7 million for the quarters ended September 30, 2023 and 2022, respectively, and $30.5 million and $29.6 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease was primarily due to reduced manufacturing scale-up costs and clinical trial activities due to the discontinuation of the activities for LAVA-051, announced in June 2023.
● General and administrative expenses were $2.9 million and $3.1 million for the quarters ended September 30, 2023 and 2022, respectively, and $10.4 million and $10.5 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease for both periods was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount.
● Net loss was $8.8 million and net profit was $0.9 million for the quarters ended September 30, 2023 and 2022, respectively, or $0.34 net loss and $0.04 net profit per share for the quarters ended September 30, 2023 and 2022, respectively. Net losses were $35.5 million and $17 million for the nine months ended September 30, 2023 and 2022, respectively, or $1.35 and $0.66 net loss per share for the nine months ended September 30, 2023 and 2022, respectively.

On November 16, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that the company will be participating in the 35th Annual Piper Sandler Healthcare Conference, which is taking place in New York City, November 28-30, 2023 (Press release, ImmunityBio, NOV 16, 2023, View Source [SID1234637736]).

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Details of the presentation can be found below.

Piper Sandler Healthcare Conference

Date

Thursday, November 30, 2023

Time:

10:30 am EST

Format:

Fireside chat with Director and Senior Research Analyst Joseph Catanzaro, Ph.D.

Webcast Link: View Source;tp_key=54f83a05b0

A replay of the presentation will be available by visiting the "Events" section of the ImmunityBio website and will be archived for 90 days.

On November 16, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it has granted non-statutory stock options to purchase an aggregate of 438,950 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, NOV 16, 2023, View Source [SID1234637735]).

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The stock options were granted on November 15, 2023 at an exercise price of $1.94 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 423,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 15,950 shares have a 10- year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

On November 16, 2023 Curium, a world leader in nuclear medicine, reported that in partnership with its exclusive distributor SYN Innovation Laboratories in Greece, the first patients in Greece have been injected with PYLCLARI (INN: Piflufolastat (18F) also known as (18 F)-DCFPyL, indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings (Press release, Curium, NOV 16, 2023, View Source [SID1234637734]):

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Primary staging of patients with high-risk PCa prior to initial curative therapy
To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "We are thrilled that patients in Europe are finally able to benefit from PYLCLARI, and in particular those patients in Greece via our strong partnership with SYN Innovation Laboratories. As a world leader in nuclear medicine, Curium is pleased to be improving the choice of diagnostic tools available to physicians in Greece to diagnose prostate cancer – ultimately for the benefit of prostate cancer patients."

Savvas Thalasselis, Managing Director, SYN Innovation Laboratories SA commented: "Today’s announcement of the first dose of PYLCLARI in Greece is an important milestone for the detection of prostate cancer, in particular for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy. Our long-term partnership with Curium has demonstrated our commitment to diagnosing patients with cancer, and we look forward to further supporting Curium with their future pipeline of diagnostic and therapeutic products."

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union. SYN Innovation Laboratories has been a partner with Curium since 2017, with exclusive manufacturing and distribution rights for Curium’s wide range of positron emission tomography products in Greece. SYN Innovation Laboratories will manufacture PYLCLARI at its facilities in Athens, Greece.

On November 16, 2023 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, reported that it has entered into a collaboration with Georgetown University as part of a collaborative research support agreement with Janssen Scientific Affairs, LLC (Janssen) and a drug supply agreement with Bristol Myers Squibb (BMS) to test its drug candidate TG01 in combination with daratumumab (anti-CD38) and nivolumab (anti-PD1) in patients with RAS-mutated pancreatic cancer and patients with non-small cell lung cancer (NSCLC) (Press release, Circio, NOV 16, 2023, View Source [SID1234637733]).

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Mutations in the RAS-family of genes are a major cause of cancer and found in over 90% of pancreatic and 30% of NSCLC cancer patients. RAS-mutated cancers typically have poor prognosis, and few targeted treatment options exist. The only approved RAS-targeting pharmaceuticals are small molecule inhibitors of the specific G12C KRAS mutation, which covers around 40% of RAS-mutated lung cancers, and the medical need for novel treatment alternatives for mutant RAS cancer remains high. Furthermore, anti-PD1 resistance is emerging as a major problem in immunotherapy, and more than 80% of patients with advanced tumors still do not respond to such treatment.

To further study this unmet medical need, Georgetown University is pursuing a phase 2 study to test the combination of daratumumab provided by Janssen, nivolumab provided by BMS, and TG01 provided by Circio in immunotherapy-naïve pancreatic cancer and in anti-PD1 resistant NSCLC. The scientific hypothesis behind the study is based on ground-breaking research led and published by Prof. Samir Khleif and colleagues, demonstrating that elimination of dysfunctional CD8 T-cells by anti-CD38, followed by priming of new effector T-cells by a cancer vaccine, reinstated and strengthened efficacy of PD1 checkpoint blockade in pre-clinical models.

Prof. Samir Khleif, Georgetown University, said: "Resistance to checkpoint blockade remains one of the most challenging problems in treating cancer patients and represents a significant unmet medical need. We are very pleased to have established this collaboration to test a novel immunotherapy combination regimen with the intention of overcoming immunotherapy resistance. The combination of anti-CD38, anti-PD1 and a cancer vaccine has demonstrated highly potent in preclinical in vivo models, and we are eager to evaluate how these findings will translate in the clinic."

The trial will be led by Georgetown University in Washington D.C, USA. The triple therapy combination will be tested in 54 patients in total, 27 immunotherapy-naïve KRAS-mutated patients with pancreatic cancer and 27 KRAS-mutated patients with NSCLC who have progressed on prior anti-PD1 therapy.

Dr. Erik Digman Wiklund, Chief Executive Officer of Circio Holding ASA, added: "We continue to see increasing interest in our mutant KRAS program, and the Georgetown phase 2 study will be the third investigator-sponsored clinical trial with the enhanced TG01 vaccine. This will be the first time TG01 is tested in lung and non-resectable pancreatic cancer, potentially opening up new indications for future development. Collaborations such as this is at the core of the TG01 development strategy, and shows that we are continuing to execute on our strategy of advancing our KRAS program through external development in multiple settings and geographies."

Circio has been awarded two prestigious research grants from Innovation Norway (IN) and the Norwegian Research Council (NRC) to advance the TG program in several clinical studies. This phase 2 trial at Georgetown will be the first study where TG01 is combined with anti-CD38 and anti-PD1, and the first time the vaccine is tested in NSCLC. Circio will be responsible for TG01 drug supply and scientific support towards specific KRAS-related immunological assays, supported through the IN and NRC research grants. Janssen will contribute with funding for the study and daratumumab supply, and BMS will provide supply of nivolumab. The study protocol has been approved by the US FDA, and it is anticipated that the first patient will be enrolled at Georgetown before the end of 2023.