On May 31, 2023 Asieris Pharmaceuticals (688176)， a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported the phase I clinical data of ANTICIPATE Study was published for the first time at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago (e16607) (Press release, Asieris Pharmaceuticals, MAY 31, 2023, View Source [SID1234632309]). This is a study of taking oral APL-1202 in combination with BeiGene’s tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC).

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A total of 9 subjects were enrolled In the Phase I stage of the trial, and the clinical data showed oral APL-1202 in combination with tislelizumab was well tolerated. No dose-limiting toxicities were observed at either 375 mg, 750 mg, or 1125 mg daily dose of APL-1202 and the recommended phase II dose (RP2D) was identified as 1125 mg daily dose. Treatment-related adverse events (TRAE) were observed in 6 patients. All AEs were grade 1, except 1 case of CTCAE grade 2 T wave abnormality on ECG and 1 case of CTCAE grade 3 liver dysfunctions. No grade 4 or 5 related AEs were observed. None of these events resulted in treatment interruptions, dose reductions, or delays in radical cystectomy. Preliminary efficacy signals were observed and pathological downstaging to

The clinical trial of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in MIBC has completed the Phase I dose-escalation stage and entered into Phase II stage in November 2022. The trial is actively recruiting for Phase II with the first patient enrolled in December 2022. In addition, APL-1202 is currently undergoing two pivotal Phase II/III clinical trials：APL-1202 in combination with intravesical chemotherapy in chemo-relapsed intermediate-to-high risk non-muscle-invasive bladder cancer (NMIBC), and APL-1202 monotherapy for untreated intermediate-risk NMIBC.

"ASCO Annual Meeting is the largest international conference in the field of cancer treatment globally." said Dr. Linda Wu, Chief Development Officer of Asieris, "Bladder cancer is one of the focused areas of Asieris Pharmaceuticals. The successful selection of our clinical research demonstrates our research and development capabilities in this focused area and showcases the growing influence of China in the international oncology community. In the future, Asieris will continue to prioritize patient-centered innovation and research, strive to develop more new drugs and bring greater benefits to patients in China and around the world."

On May 31, 2023 QBiotics Group Limited (QBiotics), a clinical stage life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals reported that Richard Godfrey will present to potential partners and investors at the Sachs 9th Annual Immuno-Oncology Innovation Forum and the BIO International Convention, both being held in the US through June 2023 (Press release, QBiotics, MAY 31, 2023, View Source [SID1234632307]).

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Mr Godfrey, representing QBiotics in Business Development, Licensing and Partnerships, will provide an update on the Company’s human and veterinary programmes in oncology and wound healing. The presentations will include recent phase I safety and efficacy data with Tigilanol tiglate (TT) in cancer patients and details of two ongoing phase II studies in later stage patients with Head and Neck cancer and Soft Tissue Sarcoma, being treated with TT.

The Sachs 9th Annual Immuno-Oncology Innovation Forum for Business Development, Licensing and investment is at the Waldorf Astoria Chicago Hotel, USA

Presentation time: 2 June 2023, at 11:40 AM Central Daylight Time (GMT-5)).

Venue: The Faulkner Room

Recorded sessions will also be added to the event portal as available on demand during the virtual week, which takes place from 13 – 15 June EDT.

The BIO International Convention takes place at the Boston Convention & Exhibition Center, USA on 5 – 8 June 2023.

Presentation time: 5 June at 12:30 PM Eastern Daylight Time (EDT).

Venue: Session Room 103

Dr Victoria Gordon, CEO of QBiotics commented, "It is an important part of QBiotics’ partner and investor engagement strategy to attend ASCO (Free ASCO Whitepaper) and present at the high-profile satellite SACHS immune oncology forum, as well as presenting our company at the BIO International Convention. We look forward to discussing our lead assets, tigilanol tiglate in the human and veterinary oncology space, and also sharing more information on our second pipeline candidate EBC-1013, which has shown compelling early promise in wound healing."

Any potential partners or investors interested in engaging around QBiotics and its programmes are invited to reach out directly or via the one-on-one conference partnering systems.

On May 31, 2023 KAHR, a clinical-stage biotech company developing DSP107, a novel, bi-specific CD47x4-1BB targeting immunotherapy that activates innate and adaptive immunity to treat solid tumors and blood cancers, reported positive results from the dose escalation Phase I study of DSP107 in combination with atezolizumab (anti-PD-L1) in patients with advanced solid tumors (Press release, KAHR Medical, MAY 31, 2023, View Source [SID1234632306]). The results will be presented as a poster in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, to be held June 2-6, in Chicago, IL.

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Yaron Pereg, Ph.D., Chief Executive Officer of KAHR said, "We are extremely encouraged by the dose escalation data, showing significant tumor shrinkage and durable responses to DSP107 in combination with atezolizumab in patients with microsatellite stable colorectal cancer (MSS-CRC), which is considered a ‘cold’ tumor that usually does not elicit an efficient immune response. The highest dose of DSP107 (10 mg/kg) in the dose escalation phase was selected for the Phase II expansion cohorts in 3rd line MSS-CRC patients and 2nd/3rd line non-small cell lung carcinoma (NSCLC) patients. In light of DSP107’s latest and previously demonstrated favorable safety profile, and the deep and long-lasting responses seen in the combination therapy dose escalation stage of the trial, we believe that DSP107 has the potential to benefit patients who are non-responsive or refractory to existing cancer treatments."

Results of the completed dose escalation part of the study show that DSP107 in combination with atezolizumab was well tolerated (n=19) with no dose limiting toxicities (DLT’s) and no hematological or hepato-toxicities up to and including the highest dose tested (10 mg/kg).

At the highest dose (10 mg/kg) of DSP107, which was selected for the expansion cohorts, the combined treatment demonstrated a disease control rate (DCR) of 57% (4/7 patients with objective response or stable disease). Deep and durable objective responses were observed in 2 of 3 patients with MSS-CRC, with target lesion shrinkage of 73% and 83% including disappearance of pulmonary and hepatic target lesions in one patient and response durability currently standing at 10 and 9 months, respectively. The third MSS-CRC patient achieved stable disease (16% target lesion shrinkage) lasting for 6.5 months until progression. Another patient with adrenal carcinoma from the highest dose cohort also remains stable on treatment after 11 months.

The combination therapy dose escalation phase of the study was an open label, multi-center trial (NCT04440735) that enrolled 19 patients with advanced solid tumors, with a median of 3 prior lines of therapy. Patients were treated weekly with 1, 3 or 10 mg/kg DSP107 infusions and atezolizumab (1200 mg) every three weeks, until disease progression. The primary objective was to determine the safety and tolerability of DSP107 in combination with atezolizumab. The secondary objective was to assess the preliminary efficacy of DSP107 in combination with atezolizumab.

Presentation information
Date: June 3rd, 2023, 8:00 am-4:00 pm
Session: Developmental Therapeutics – Immunotherapy
Abstract #2632
Poster #474

Abstract available on the ASCO (Free ASCO Whitepaper) website.

About DSP107

DSP107 is a dual-targeting fusion protein that activates innate and adaptive immunity by blocking CD47 on cancer cells and utilizing 4-1BB conditional co-stimulatory activation of T-cells. By binding both cancer cells and immune cells, DSP107 combines checkpoint inhibition with tumor localized immune cell activation to bolster anti tumor immunity. DSP107 binds to and inhibits CD47, an immune checkpoint protein overexpressed in many cancers that enables the tumor to evade immune recognition and attack by macrophages. Simultaneously, when anchored to the tumor, DSP107 binds 4-1BB, a co-stimulatory receptor expressed on T-cells, recruits them to the tumor microenvironment and stimulates their activation. These activities result in targeted macrophage and T-cell mediated immune activation and tumor destruction.

DSP107’s phase I monotherapy dose escalation data demonstrated an excellent safety profile (n=23), with no binding to red blood cells and no dose limiting toxicities (DLT’s), hematological or hepato-toxicities in all tested doses up to and including 10 mg/kg. Paired biopsies data demonstrated biological activity including immune cell infiltration in the tumor compartment following DSP107 treatment and 50% disease control rates (11/22) in advanced solid tumor patients.

DSP107 is also being tested in combination with standard of care therapies (azacytidine and azacytidine with venetoclax) for relapsed/refractory AML and MDS patients in a Phase 1b study.

On May 31, 2023 Tavanta Therapeutics, a clinical-stage specialty pharmaceutical company, reported that it will present new data from its metastatic prostate cancer program during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago, as well as from its anal fissure program during the upcoming American Society of Colon and Rectal Surgeons (ASCRS) Annual Meeting being held June 3-6 in Seattle (Press release, Tavanta Therapeutics, MAY 31, 2023, View Source [SID1234632304]).

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"At ASCO (Free ASCO Whitepaper), we will present detailed Phase 3 results for TAVT-45 that further demonstrate its potential to become the first FDA-approved oral suspension formulation of abiraterone acetate for patients with metastatic prostate cancer and provide a much-needed alternative for patients with dysphagia," said Andreas Maetzel, M.D., Ph.D., Chief Medical Officer of Tavanta Therapeutics. "At ASCRS, we are excited to present the first data from our Phase 2 study of TAVT-119 in people with anal fissure. Currently, non-surgical options to treat anal fissures include topical nitrates (which are limited by headache/tolerability) and topical calcium channel blockers (which are only available via compounding pharmacies as none are FDA-approved for anal fissure). Based on the data that will be presented, we believe that TAVT-119 has the potential to offer patients a therapeutic option that is safe, efficacious and accessible."

"We are pleased to highlight these promising new data, which reflect the significant progress of our clinical development programs," said Lynne Powell, Chief Executive Officer of Tavanta Therapeutics.

Details of presentations are as follows:

ASCO Presentation

Poster: A Novel Abiraterone Acetate Oral Suspension for Patients with Metastatic Prostate Cancer: An Open-Label, Phase 3, Randomized Trial
Poster Number: 146
Date: Saturday, June 3, 2023
Poster Session Time: The poster will be presented from 8:00 – 11:00 a.m. CDT, during the "Genitourinary Cancer—Prostate, Testicular, and Penile" poster session

The Company’s abstract, which has been made available on the ASCO (Free ASCO Whitepaper) website can be viewed here. For more information about ASCO (Free ASCO Whitepaper) visit View Source

ASCRS Presentation

Poster: Phase 2 Study of TAVT-119 (amlodipine besylate) Gel in Patients with Chronic Anal Fissure
Poster Number: eP600
Date: Monday, June 5, 2023
Poster Session Time: An oral presentation of the ePoster will occur from 11:25 – 11:30 a.m. PDT, during the "ePoster Monitor 16 Benign Anorectal Disease" session

The Company’s abstract will be made available after the presentation on Tavanta’s website. For more information about ASCRS visit View Source

About Prostate Cancer and TAVT-45 Granules for Oral Suspension

Prostate cancer is the second leading cause of cancer in men.1 TAVT-45 (abiraterone acetate) Granules for Oral Suspension ("TAVT-45"), is an enhanced formulation of abiraterone acetate, an androgen biosynthesis inhibitor. Abiraterone acetate is currently marketed in the U.S. and EU as Zytiga tablets for the treatment of metastatic prostate cancer. When reconstituted with water or juice to yield an oral suspension, TAVT-45 may provide an alternative for 20 to 30 percent of patients who suffer from dysphagia or have difficulty swallowing tablets. Other limitations of the commercially available abiraterone tablets include the requirement to be taken on an empty stomach and the high variability in systemic exposure. This high variability in systemic exposure can result in patients with low abiraterone plasma concentrations and exposure, which can lead to suboptimal clinical outcomes.2,3 It is anticipated that TAVT-45 may be taken regardless of food consumption and may result in fewer patients with sub-optimal abiraterone trough plasma concentrations.

About Anal Fissures and TAVT-119 Gel

Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms, and are quite common in the general population.4 TAVT-119 is a novel topical formulation of amlodipine, a long-acting calcium channel blocker (CCB) that can relax smooth muscle and improve vasodilation. Amlodipine is currently marketed in the U.S. and EU as Norvasc tablets for treating hypertension and coronary artery disease. TAVT-119 gel is under development for treating moderate to severe pain associated with anal fissure. Current non-surgical treatment options for anal fissure include topical nitrates and CCBs. However, topical nitrates are associated with side effects such as severe headaches, while CCBs are not approved in the U.S. to treat anal fissures and are often used off-label via compounding pharmacies.4,5 TAVT-119 has the potential to become the first FDA-approved CCB for anal fissure, which could overcome access/availability issues of compounded agents, with fewer adverse events expected compared to topical nitrates.

On May 31, 2023 Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as ‘Lynk Pharmaceuticals’), an innovative clinical stage company, reported the successful completion of a RMB 200 million Series C1 financing round (Press release, Lynk Pharmaceuticals, MAY 31, 2023, View Source [SID1234632303]). There was joint participation by China Grand Prosperity Investment, Tailong Capital and Liando Investment. The proceeds from this round of financing will be primarily used to accelerate the clinical development of Lynk Pharmaceuticals’ core products.

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Founded in 2018 and headquartered in Hangzhou, China, Lynk Pharmaceuticals is a global innovative leader in the pharmaceutical industry dedicated to the development of small molecule FIC and BIC drugs for oncology and autoimmune diseases. The company’s core team has deep knowledge in medicinal chemistry, biology, clinical and commercial development, with an average of more than 20 years of experience in new drug research and development or related disciplines in the pharmaceutical industry. The company emphasizes innovation and differentiation in its pipeline, with a focus on the development of highly selective second-generation and tissue-restricted third-generation JAK inhibitors while exploring drug development with novel targets. Currently, the company has 4 Phase II clinical trials for four indications with promising clinical data. Among these, a few programs are expected to enter Phase III clinical trials in the near future. Additional pipeline candidates have shown promising clinical and preclinical data and have the potentials to become BIC/FIC drugs for several indications. Recognizing the significant medical needs in the market of autoimmune diseases and oncology, the company sees great potential for commercialization of its products.

Autoimmune diseases are emerging as the second largest therapeutic area after oncology. There are huge unmet needs for autoimmune related diseases which has led to the creation of a few "blockbuster" drugs. JAK inhibitors are gradually becoming the preferred choice for clinicians and patients around the world due to their validated therapeutic effects and convenience of use. In addition to multiple intrinsic advantages associated with small molecules over biologics, the JAK inhibitors are well known for favorable efficacy and fast onset. According to Frost & Sullivan, the total market size of JAK1 inhibitors alone will reach $30.5 billion by 2030.

Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, said, "We are grateful for the trust and support from China Grand Prosperity Investment, Tailong Capital and Liando Investment. Lynk Pharmaceuticals is committed to developing globally competitive and differentiated FIC/BIC innovative drugs for autoimmune and oncology diseases. In this period of rapid growth, we will take this opportunity to further strengthen our research and development in autoimmune and oncology diseases and to increase the investment in our R&D team as well as our technology platform. Lynk will continue to look for opportunities to accelerate the development and launch of innovative drugs in the hope of providing more effective and safer treatment options for patients worldwide. HaoYue Capital acted as the exclusive financial advisor for this financing. We are sincerely thankful for their professionalism and support."