On March 28, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported business highlights and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Aileron Therapeutics, MAR 28, 2022, View Source [SID1234611053]).

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"We’re incredibly proud of the progress we’ve made to date advancing our mission to develop a targeted drug that prevents chemotherapy-induced side effects in patients with p53-mutated cancer," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron Therapeutics. "Given proof of concept of ALRN-6924’s ability to protect against chemotherapy-induced bone marrow toxicities and its potential to also protect against multiple other chemotherapy-induced toxicities, our vision is to redefine care for millions of cancer patients, regardless of the type of p53-mutated cancer they have or the type of chemotherapy they receive. We look forward to several anticipated catalysts in 2022 that could further propel us toward this vision."

Aileron is developing ALRN-6924 to protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron is pioneering a precision medicine-based approach known as selective chemoprotection to exclusively treat patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without interfering with chemotherapy’s effects on cancer cells. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and thus expected to improve efficacy of chemotherapy.

2021 and Recent Highlights

NSCLC clinical trial start and blinded safety evaluation.
Initiated a Phase 1b randomized, double-blind, placebo-controlled clinical trial to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated NSCLC undergoing first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors.
Conducted a blinded safety evaluation of the first ten patients enrolled in the trial who completed the first cycle of treatment with ALRN-6924 and chemotherapy. The evaluation did not identify any safety concern, consistent with ALRN-6924’s previously demonstrated safety and tolerability profile.
The Phase 1b trial is anticipated to enroll 60 patients. Patients are randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles.
Upcoming breast cancer clinical trial. Announced plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 against chemotherapy-induced bone marrow and other toxicities in patients with p53-mutated ER+/HER2- breast cancer treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial is anticipated to enroll up to 30 patients in a parallel group design trial with a dose expansion cohort.

Small cell lung cancer (SCLC) clinical trial final data presentation. Presented final results from a completed Phase 1b trial in patients with p53-mutated SCLC receiving second-line topotecan. Following interim proof-of-concept data presented in October 2020 from this trial, the final results reinforced ALRN-6924’s ‘triple-play’ reduction in chemotherapy-induced neutropenia, thrombocytopenia and anemia.

Healthy volunteer study mechanism of action (MOA) data presentation. Presented initial data from company’s ongoing Phase 1 pharmacology study, which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The presented data confirmed ALRN-6924’s novel p53 biomarker-driven MOA, as well as its pharmacodynamic effects, including time to onset, magnitude and duration.

Patent portfolio expansion. Aileron was issued seven new international patents and four U.S. patents, including a new patent for ALRN-6924 in China. The newly issued patents support Aileron’s robust intellectual property portfolio, which includes nearly 160 U.S. and foreign patents, with more than 40 additional applications in prosecution.
2022 Anticipated Milestones

Ongoing NSCLC Clinical Trial

2Q22: Announce results from an interim analysis of the first 20 patients enrolled in the NSCLC trial. The interim analysis will include an initial evaluation of the total number of completed treatment cycles free of hematological toxicity and free of chemotherapy or immunochemotherapy dose reductions, dose delays, use of growth factors and transfusions for the treatment arm compared to placebo. We expect these interim data will determine a refinement to the primary and secondary endpoints for the study.

4Q22: Announce topline results of full anticipated trial enrollment of 60 patients.
Planned Breast Cancer Clinical Trial

1H22: Initiate enrollment of patients with p53-mutated, ER+/HER2- breast cancer; provide more details on the planned neoadjuvant breast cancer trial design at time of trial initiation.
4Q22: Announce interim results from breast cancer trial.
Phase 1 Pharmacology Study in Healthy Volunteers

2H22: Report additional findings from healthy volunteer study.
CMC Activities

Advance validation studies for ALRN-6924 drug substance and drug product manufacturing processes to support a potential future NDA filing for ALRN-6924.
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: As of December 31, 2021, cash, cash equivalents and investments were $45.9 million, compared to $13.8 million as of December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the fourth quarter of 2023.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were $4.6 million, compared to $1.9 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to clinical activities related to our NSCLC trial and our healthy volunteer study and increased spend on CMC development for ALRN-6924 in 2021 as compared to 2020. R&D expenses for the full-year 2021 were $17.0 million, compared to $11.2 million for the prior year.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $2.3 million, compared to $2.3 million for the fourth quarter of 2020. G&A expenses for the full-year 2021 were $9.6 million, compared to $9.3 million for the prior year.

Net Loss: Net loss for the fourth quarter of 2021 was $6.8 million, compared to $4.9 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $26.2 million, compared to a net loss of $21.2 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2021 was $0.08 compared to $0.12 for the fourth quarter of 2020. The basic and diluted net loss per share for the full-year 2021 was $0.29 compared to $0.61 for the full-year 2020.

On March 28, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid", the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported a business update for the company and presented preliminary financial results for the year ended December 2021 (Press release, Lucid Diagnostics, MAR 28, 2022, View Source [SID1234611068]).

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Conference Call and Webcast

A conference call and webcast for today’s business update and fourth quarter and year ended December 31, 2021, financial results will take place at 4:30 PM EDT. To access the conference call, listeners should dial 877-407-0789 toll-free in the U.S. or 201-689-8562 and ask to join the "Lucid Diagnostics Business Update Conference Call". The conference call will be available live via a webcast and for replay at the investor relations section of the Company’s website at www.luciddx.com. Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing 844-512-2921 toll-free in the U.S. or 412-317-6671, followed by the PIN number: 13727145.

Business Update Highlights

"I am happy to report that Lucid Diagnostics is firing on all cylinders," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "Our rapidly growing team is making excellent progress on all fronts and is laying a solid foundation for us to continue driving our long-term growth strategy. This includes EsoGuard commercialization, the rollout of our Lucid Test Center network, expansion of our sales infrastructure and operations, our laboratory operations, and clinical trial work. Our strong balance sheet provides us with the resources to execute on this strategy."

The Company reported solid EsoGuard commercialization progress with excellent traction and robust growth in EsoGuard testing volume. Lucid processed 303 commercial EsoGuard tests in the fourth quarter of 2021, which represents an approximately 50% increase sequentially from the third quarter and a nearly 200% increase annually from the fourth quarter of 2020. This growth has continued into the new year, both in referrals to Lucid Test Centers and tests performed at gastroenterology and foregut surgeon practices.
The Lucid Test Center program has completed its first stage, having advanced from a pilot program in Phoenix, launched in the third quarter of 2021, to a regional Southwest and Pacific Northwest program also covering Denver, Salt Lake City, Las Vegas, Seattle, Portland, and Boise. The Company reported that its experience with the test centers over the past six months has validated the test center model as a key driver of EsoGuard testing volume by simplifying the engagement of its sales reps with primary care physicians. Lucid is now in the process of launching the next stage of its Lucid Test Center program, with accelerated expansion into larger states across the nation. It has hired an experienced Director or Clinical Services who will oversee this expansion. The Company is also continuing the pilot of its EsoGuard Telemedicine Program, operated in partnership with independent third-party telemedicine provider UpScript, which launched in December 2021. It has pursued a direct-to-consumer advertising program on a limited pilot basis in Phoenix.
The Company reported significant expansion of its sales infrastructure and operations during the fourth quarter and recent months. The team, led by its national VP of sales, now consists of three area directors covering the East, Central and West respectively, six market development managers, ten sales representatives, and several sales operations staff. The company expects the overall sales team to double in size and the number of sales reps to triple by the end of the calendar year. The company also reported substantial progress in honing its data and analytics driven sales process and intensive sales training to drive commercial success.
Last month the Company announced that LucidDx Labs, a wholly-owned subsidiary of Lucid, had acquired certain licenses and other related assets from its long time CLIA laboratory partner, Research Dx, which allowed it to operate own new CLIA-certified, CAP-accredited clinical laboratory in Lake Forest, CA. The Laboratory has completed the necessary assay validations to process clinical samples as a Laboratory Developed Test (LDT), completed a College of American Pathologists (CAP) audit, and begun performing EsoGuard testing at the new facility.
In conjunction with it taking over the laboratory and fully controlling the EsoGuard billings and collection process, the Company has been able to upgrade our revenue cycle management provider and simplify the billing and collections process it had to utilize as a partner of a third-party commercial laboratory. It is now in position to start submitting Medicare claims using the effective $1938 Medicare payment rate. The Company continues to wait for Medicare Administrative Contractor Palmetto GBA’s MolDx program to issue a draft local coverage determination (LCD) following an encouraging Contractor Advisory Committee (CAC) meeting in the fall.
The laboratory has been submitting claims to private payors and is encouraged that it has been receiving approximately $1,150 per test representing approximately 60% out-of-network coverage. It reported that is reaching critical threshold of submitted and processed claims in certain locales which will allow it to begin having meaningful conversations with select private payors in these locales on in-network payment and coverage. It is expanding its market access team and collecting the critical clinical utility data to allow it to fully engage in these negotiations.
In March 2022, both the PAVmed and Lucid board of directors approved entering into an intercompany license between PAVmed and Lucid such that Lucid will be granted the rights to commercialize EsoCure for the endoscopic treatment of late esophageal precancer (dysplastic Barrett’s Esophagus), including a royalty arrangement whereby Lucid will pay PAVmed a 5% royalty on all EsoCure sales up to $100 million per calendar year, and 8% above that threshold.
In March 2022, both the PAVmed and Lucid board of directors approved entering into a purchase and sale of the CapNostics, LLC assets, including the EsophaCap non-endoscopic sponge-based esophageal cell collection device, from PAVmed to Lucid as well as transferring the consulting agreement with the principal owner of CapNostics, LLC prior to the purchase by PAVmed on October 5, 2021.
Preliminary Financial Results

For the fourth quarter of 2021, EsoGuard related revenues were $0.3 million, while for the year ended December 31, 2021, revenues were $0.5 million. Fourth-quarter and full-year 2021 operating expenses were approximately $11.1 million and $27.3 million, respectively, which include stock-based compensation expenses of $3.2 million and $9.6 million, respectively. GAAP net loss attributable to common stockholders for the fourth quarter and full-year 2021 were approximately $11.3 million and $28.1 million, or $(0.32) and $(1.51) per common share.
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the fourth quarter and year ended December 31, 2021, were approximately $7.7 million and $17.8 million or $(0.22) and $(0.96) per common share.
Lucid had cash and cash equivalents of $53.7 million as of December 31, 2021, compared to $0.1 million as of December 31, 2020.
On March 28, 2022, the Company entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with CF Principal Investments LLC ("Cantor"), an affiliate of Cantor Fitzgerald, relating to a committed equity facility (the "Facility"). Pursuant to the Purchase Agreement, the Company has the right to sell to Cantor up to $50.0 million of its common shares (the "Shares"), subject to certain conditions and limitations set forth in the Purchase Agreement. While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at a price related to the current market price.
Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, the Company will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be 96% of the volume-weighted average price of the Shares on such trading day.
The unaudited financial results for the year ended December 31, 2021, will be filed with the SEC on Form 10-K in the coming days and will be available at www.luciddx.com or www.sec.gov.
Lucid Non-GAAP Measures

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.
Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.
Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.
A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the fourth quarter and year ended December 31, 2021, and 2020 is as follows

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On March 28, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported it has entered into a credit facility with Oxford Finance LLC for up to $150 million that is designed to primarily support the continued development, commercial preparation and potential launches of VS-6766 and defactinib (Press release, Verastem, MAR 28, 2022, View Source [SID1234611032]).

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"The term loan facility with Oxford is an ideal non-dilutive opportunity for Verastem. Combined with our strong cash position and expected future payments from Secura Bio related to the 2020 sale of COPIKTRA (duvelisib), we believe we have significant financial optionality to advance our current development and commercial objectives," said Rob Gagnon, Chief Business and Financial Officer of Verastem Oncology. "The strengthened balance sheet will allow us to build on our breakthrough therapy designation for VS-6766 and defactinib in low-grade serous ovarian cancer and prepare for potential launches in both low-grade serous ovarian cancer and KRAS-mutant non-small cell lung cancer."

Under the terms of the loan agreement with Oxford Finance LLC, Verastem drew an initial $25 million term loan at closing. The Company has the ability to access up to an additional $125 million in a series of tranches, $75 million of which are based on certain pre-determined milestones and $50 million at the lender’s discretion. The loans carry an interest-only period up to 48 months and will bear interest at a floating rate which is subject to both a floor and a cap.

The Company had cash, cash equivalents, and investment balance of $100.3 million as of December 31, 2021. Taking into account the initial drawdown of $25.0 million at closing, the Company would have had pro-forma cash, cash equivalents, and investment balance of $125.3 million as of December 31, 2021 and an expected cash runway through 2025.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to currently available MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.1

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

On March 28, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported it will host a conference call on Thursday March 31, 08.00a.m. Eastern time to discuss its financial and operating results for the full fiscal year 2021, in addition to providing a business update (Press release, VolitionRX, MAR 28, 2022, View Source [SID1234611054]).

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Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in 2021, and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until April 14, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13728406.

On March 28, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the first patient dosing for its proprietary recombinant bispecific antibody targeting Claudin18.2 and CD3 (R&D code: IBI389) in a Phase I clinical trial for the treatment of advanced malignancies (Press release, Innovent Biologics, MAR 28, 2022, View Source [SID1234611069]).

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The study (NCT05164458) is an open, multicenter Phase 1a/1b study evaluating the safety, tolerability and efficacy of IBI389 monotherapy or combination therapy in the treatment of advanced solid tumors.

CD3-targeted bispecific antibodies (CD3-BsAbs) or T Cell Engager (TCE) are emerging novel therapeutic modalities in cancer immunotherapy in recent years. TCE redirects T cells to tumor cells by simultaneously binding tumor-associated antigen (TAA) expressed on tumor cells and CD3 expressed on T cells, thus inducing T cell killing of tumor cells. Differentiated from conventional immunotherapies, CD3-BsAbs provoke a stronger immune response through CD3-activated T cells without the binding of the T cell receptor (TCR) to the major histocompatibility complex (MHC)-peptide complex, and also do not rely on T cell-activated co-stimulatory signals.IBI389 has the potential to efficiently and selectively kill CLDN18.2-expressing tumor cells, increasing lymphocytic tumor infiltration and enhancing tumor immune response, while possessing a low risk of CRS (cytokine release syndrome). Preclinical results showed that IBI389 exhibited significant antitumor effects and could bound to tumor cells even in cell lines with low CLDN18.2 expression, and is promising to treat patient populations with low to moderate CLDN18.2 expression where conventional antibodies are found limited response.

The principal investigator of the study, Professor Feng Bi, Director of the Department of Abdominal Oncology and Director of the Molecular Targeted Therapy Research Unit at West China Hospital of Sichuan University, pointed out: "In recent years, CLDN18.2 has become one of the most topical R&D areas in molecular biology, and preliminary efficacy results in some clinical studies demonstrated encouraging druggablity of this target. IBI389 bispecific antibody distinguishes itself from traditional monoclonal antibodies by encouraging T-cell infiltration and killing of tumors, thus enhancing the antitumor effect as a single agent. We are looking forward to the positive results of IBI389 in patients with CLDN18.2-expressing solid tumors."

Dr. Hui Zhou, Senior Vice President of Innovent, said: " IBI389 marks an exciting start for Innovent in the TCE field. The scientists of Innovent Academy has accomplished sophisticated research, screen and design work in drug discovery stage, and the results of preclinical studies show that IBI389 has a potent anti-tumor effect with a good safety profile. We believe that as a differentiated molecule targeting CLDN18.2, IBI389 will bring benefits to patients with advanced gastric cancer and pancreatic cancer even with low CLDN18.2 expression."

About IBI389

IBI389 is an anti-CLDN18.2/CD3 bispecific antibody discovered and developed by Innovent. It induces immune synapse formations by linking CD3 molecules in T-cell receptor complexes and CLDN18.2 antigens on the surfaces of tumor cells. Therefore IBI389 stimulates T-cell activation, resulting in cytolytic protein production, inflammatory cytokine release and further T-cell proliferation, which eventually leads to durable anti-tumor effects.

About Claudin 18.2

Claudin protein is a critical component of tight junction complex molecules which play an important role in the life activities of the human body. Claudin18.2 is a member of the Claudin protein family, which is a highly tissue-specific protein expressed only in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer such as gastric cancer, pancreatic cancer, esophageal adenocarcinoma, and colorectalcancer. The unique feature of limited expression in normal tissues and highly specific expression in cancer makes Claudin18.2 an ideal target for developing the immunotherapeutic for solid tumors. Globally, there are many candidate therapies in clinical development. The drug modalities under development include monoclonal antibodies, bispecific antibodies, antibody-conjugated drugs and CAR-T cell products. However, currently no drug targeting Claudin18.2 has been approved.

About Gastric and Pancreatic adenocarcinoma

Gastric and pancreatic cancer are both malignant tumors of the digestive system that seriously endanger human life and health. The latest global cancer statistics show that there will be about 1.089 million new cases of gastric cancer worldwide in 2020, accounting for 5.6% of the global cancer incidence, and about 768,000 deaths, accounting for 7.7% of the global cancer deaths. There are about 495,000 new cases of pancreatic cancer, accounting for 2.6% of the global cancer incidence, and about 466,000 deaths, accounting for 4.7% of the global cancer deaths. According to the national cancer statistics released by the National Cancer Center of China in 2019, the incidence of gastric cancer in China in 2015 was about 403,000, accounting for 10.26% of the total cancer incidence, second only to lung cancer at 20.03%, with an incidence rate of 29.31/100,000 people, and about 291,000 deaths, accounting for 12.45% of the total cancer deaths, behind lung and liver cancer, with a mortality rate of 21.16/100,000 people. In 2015, the number of cases and deaths of pancreatic cancer nationwide were 95,000 and 85,000 respectively, ranking the 10th and 6th in the incidence and mortality of malignant tumors. The mortality ratio of pancreatic cancer was 0.89, making it a true "King of Cancer". Despite the treatment progress in recent years, drug resistance, recurrence and metastasis are still inevitable. The 5-year survival rate of patients with advanced gastric cancer is about 5-20%, and the median survival rate is about 10 months. Pancreatic cancer has a worse prognosis, with a 5-year survival rate of only 6 to 8%.