On May 25, 2021 Clarus Therapeutics Inc. ("Clarus"), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, and HavaH Therapeutics ("HavaH"), an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease and certain forms of breast cancer by using the innate breast-tissue-specific hormone/immune interface, reported a licensing agreement whereby Clarus will acquire the exclusive worldwide (excluding Australia) development and commercialization rights for HAVAH T+Ai (CLAR-121) (Press release, clarus therapeutics inc, MAY 25, 2021, View Source [SID1234580587]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women. If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease, including inflammatory periductal mastitis (PDM) and estrogen receptor-positive (ER+) breast cancer. Clarus’s initial clinical development target is PDM — a destructive autoimmune inflammatory process of the retro-areolar milk ducts that results in multiple fistulae and inevitably results in disfiguring surgery and a high risk of recurrence. There is no known treatment for this condition apart from surgery, which has significant limitations.1 Due to the low prevalence of PDM in the U.S., Clarus anticipates this disease could qualify for orphan drug designation by the U.S. Food and Drug Administration and plans to petition the agency for that status for CLAR-121.

If approved, CLAR-121 would be the first T treatment of its kind for inflammatory breast disease.

HavaH has extensive clinical experience with CLAR-121 in more than 1,000 Australian women (more than 6,200 implants) with breast disease, and Clarus expects that access to HavaH’s pharmacokinetics, safety and early efficacy data in PDM will expedite progression to Phase 2/3 clinical studies in the U.S. Clarus estimates that the annual U.S. market size for PDM exceeds $400 million.2,3,4 With this new pipeline asset, Clarus may also pursue, alone or in partnership, future indications in ER+ breast cancer, macromastia, granulomatous mastitis, and autoimmune induced breast pain.

"This licensing agreement marks the beginning of an exciting new partnership with HavaH. Their experience coupled with the significant amount of clinical data generated in Australia will benefit Clarus greatly as we begin our development activities in the U.S.," said Dr. Robert Dudley, Clarus’s founder, president and CEO. "CLAR-121 allows us to leverage our expertise in androgen biology, as exemplified by JATENZO, a testosterone replacement therapy (TRT) for male hypogonadism and Clarus’s first commercial product, and expands our development pipeline with an initial focus on PDM in women — a debilitating, painful disease with very limited treatment options, short of invasive surgery. This treatment, if approved, has the potential to be life-changing for women who suffer from PDM, and its development fits well with our mantra: ‘good is never good enough’. Our goal is to provide treatment options that not only produce a positive clinical outcome, but also provide a positive therapeutic experience for patients."

Under the terms of the licensing agreement, Clarus will be responsible for future global development and regulatory activities for CLAR-121, excluding Australia. Clarus will pay HavaH an upfront payment of $500,000 upon signing and HavaH may be eligible for up to $10.75 million in potential development and regulatory milestone payments. HavaH will retain the right to promote HAVAH T+Ai in Australia. Additionally, HavaH would be eligible for a modest royalty and up to $30 million in potential commercial milestones.

"We developed HAVAH T+Ai to address a significant unmet need in women’s health, and our partnership with Clarus will enable us to advance this therapeutic approach not only for inflammatory breast disease but, more widely we hope, for ER+ breast cancer where data now unambiguously demonstrates that the androgen receptor has an important tumor suppressor role in this form of breast cancer,"5 said Stephen Birrell, MD, PhD, HavaH founder, chairman and chief medical officer.

"In Clarus, we found a partner who understands and appreciates the potentially profound importance of androgen action in the context of inflammatory breast disease, as well as its role as an adjunctive endocrine therapy for certain forms of breast cancer," said Kathy Harrison, HavaH CEO.

Reedland Capital Partners, acting through Weild & Co., member FINRA/SIPC, served as financial advisor to HavaH in connection with this transaction. For more information, please visit www.reedland.com.

On May 25, 2021 Alloy Therapeutics ("Alloy") and Pyxis Oncology ("Pyxis") reported the formation of a joint venture named Kyma Therapeutics to develop immune-modulating antibodies for novel targets in cancer and autoimmune diseases (Press release, Pyxis Oncology, MAY 25, 2021, View Source [SID1234580586]). Kyma Therapeutics will advance programs directed to immune-modulating targets identified by Pyxis. Alloy Discovery Services will generate therapeutic candidates using Alloy’s broad suite of human antibody discovery technologies, including the ATX-Gx mouse platform while Pyxis will develop assays and perform ex-vivo and in-vivo studies on the therapeutic candidates.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Pyxis and Alloy intend to collaboratively fund and perform services for Kyma Therapeutics to rapidly develop programs to a value-inflection point with the objective that the programs will have the potential for independent financing and partnering. Pyxis and Alloy will retain certain rights to participate in the development and commercialization of products originating from Kyma Therapeutics.

"We are excited to partner with Pyxis on the formation of Kyma Therapeutics to advance novel biologics for cancer and autoimmune disease," said Errik Anderson, Chief Executive Officer and Founder of Alloy. "This joint venture combines Pyxis’ proprietary target discovery technology and expertise with Alloy’s high throughput antibody discovery engine, enabling the rapid development of high-impact immune-modulating therapeutics for underserved patient populations."

Lara Sullivan, M.D., Chief Executive Officer of Pyxis, added, "Kyma Therapeutics represents the successful execution of Pyxis’ and Alloy’s corporate strategies to bring new treatment options to patients with the highest capital efficiency. We look forward to working with Alloy to further advance these compelling treatments for patients with cancer and autoimmune diseases."

Chris Pacheco, Venture Partner at 82VS, Alloy’s affiliated venture studio, added, "Kyma Therapeutics embraces a new approach to streamline biotechnology company creation and the drug discovery process, alongside leading scientific entrepreneurs and target-rich companies. We are thrilled to advance this important pipeline in partnership with Pyxis, which will ultimately be for the benefit of patients."

The announcement follows in the footsteps of Broadwing Bio, a partnership between Alloy and Maze Therapeutics, which was formed in December 2020. Each year, 82VS is expected to launch five to ten new asset-centric companies such as Kyma and Broadwing, through partnerships with leading scientific entrepreneurs, large biopharma companies, and other target-rich venture-backed companies.

On May 25, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that initial promising data from the Archer-1 Phase 1b trial investigating Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, MAY 25, 2021, View Source [SID1234580585]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The preliminary results show clinical activity with seven out of seven patients achieving a response, including 5 complete responses and 2 partial responses. All responses are currently ongoing, 5 of them 2 years after Betalutin administration.

Across this patient group, Betalutin with RTX showed a very good safety profile, comparable to that of single agent Betalutin, with no dose limiting toxicities observed.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of CD37-targeted Betalutin in combination with CD20-targeted RTX in patients with relapsed/refractory FL who have received one or more prior therapies.

The starting doses of Betalutin and lilotomab were 10MBq/kg and 40mg, respectively, which was escalated to Betalutin 15MBq/kg and lilotomab 40mg in the second cohort. Following Betalutin dosing, patients received four weekly doses of RTX (375mg/m2) on days 7, 14, 21 and 28. Patients who did not progress (including CR, PR, SD) were scheduled to receive RTX maintenance for 2 years.

The primary objective of the study was to evaluate the safety and tolerability of Betalutin in combination with RTX, the secondary objective to evaluate the preliminary anti-tumour activity of combination treatment.

The rationale for Archer-1 was provided by earlier preclinical data showing Betalutin can up-regulate CD20 expression in different rituximab-sensitive NHL cell lines and act synergistically with rituximab in a rituximab-sensitive NHL animal model and, more recently, that Betalutin has the potential to counteract resistance to rituximab in non-Hodgkin’s lymphoma models.

Peter Braun, Nordic Nanovector CEO, commented: "We are encouraged by the results in this small Phase I study in second line FL patients. Both the overall safety of this combination and the preliminary signs of efficacy are promising. We look at this study as an additional building block in our overall strategy to develop Betalutin for difficult to treat hematological tumors. Our near-term focus remains very much on completing PARADIGME in 3L FL and delivering top line 3-month data by the end of 2021.

On May 25, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, MAY 25, 2021, View Source [SID1234580584]). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results will be presented at a webcast on May 25, 2021, at 11:00 (CET), log in details is available below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Following the accelerated approval of Pepaxto in the U.S. earlier this year, the positive topline results from the OCEAN study marks another major milestone for Oncopeptides. It is very exciting news for patients and indicates that melflufen has the potential to become part of the standard of care in relapsed refractory multiple myeloma", says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "By demonstrating that melflufen is at least as efficacious as pomalidomide, we pave the way for a potential use of melflufen in earlier lines of therapy in a substantially larger patient population".

The PFS, as assessed by the independent review committee, demonstrated a Hazard Ratio* favoring melflufen of 0.817 (95% CI: 0.659-1.012, p=0.0640) for the primary endpoint and shows that melflufen is non-inferior to pomalidomide. The Hazard Ratio for PFS as per investigator assessment was 0.790 (95% CI: 0.639-0.976). In both assessments, the median PFS for the melflufen arm was more than 40% higher than for the pomalidomide arm. The Overall Response Rate for melflufen was 32.1% vs. 26.5% for pomalidomide.

"The efficacy and safety data from the OCEAN study are very encouraging, and the results will be of importance in physicians´ treatment decisions for patients with relapsed and refractory multiple myeloma", says Pieter Sonneveld, MD, PhD, Professor of Hematology at the Erasmus University of Rotterdam, and Principal Investigator of the OCEAN study. "Melflufen has a unique mode of action, which in addition with its tolerability profile, makes the drug an attractive treatment option for many patients."

Melflufen and pomalidomide had similar discontinuation rates for adverse events, and the safety profile of melflufen was in line with previous studies and consistent across age subgroups. The Company expects to present complete OCEAN data at an upcoming scientific congress.

"The outcome from the phase 3 OCEAN study is very good news for patients with relapsed refractory multiple myeloma", says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer at Oncopeptides. "This head-to-head-comparison was a bold study with an optimal design for demonstrating melflufen’s true isolated treatment effects. I am truly looking forward to sharing these data with a broader audience, as the OCEAN data clearly show that melflufen may be an important therapeutic option for the increasing number of patients who need more treatment alternatives."

Based on these data, Oncopeptides intends to submit a supplementary New Drug Application to the US Food and Drug Administration FDA, in Q4 2021.

Pepaxto (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Melflufen is evaluated in a comprehensive clinical study program. In addition to the phase 3 OCEAN study, Oncopeptides is currently enrolling patients in the phase 3 LIGHTHOUSE study, with the aim to establish the efficacy and safety of a combination therapy with melflufen plus daratumumab compared to daratumumab, based on the successful results from the ANCHOR study, presented at American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on May 25, 2021, at 07:00 (CET).

Webcast for investors, analysts, and the media

The Company will host a webcast on May 25, 2021, at 11:00 (CET), including presentations by CEO Marty J Duvall, CSO Jakob Lindberg, CMO Klaas Bakker, and CFO Anders Martin-Löf.

About phase 3 OCEAN study

The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies. The patients have previously been treated with at least an immunomodulator agent, and a proteasome inhibitor. They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma. The study was initiated in 2017 and includes 495 patients from more than 100 hospitals around the world. The primary efficacy endpoint is Progression Free Survival.

On May 25, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that Joseph C. Papa, chairman and chief executive officer; Sam Eldessouky, senior vice president and corporate controller; and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Jefferies Healthcare Conference on June 2, 2021 at 11:00 a.m. ET (Press release, Bausch Health, MAY 25, 2021, View Source [SID1234580583]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast and audio archive of the events will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source