On November 10, 2022 Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, reported financial results for the third quarter ended September 30, 2022, along with an update on the Company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, NOV 10, 2022, View Source [SID1234624021]).

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"Rain continues to execute on our milademetan franchise with encouraging early interim data from our Phase 2 MANTRA-2 trial and anticipated near-term topline data from our Phase 3 registrational MANTRA trial next quarter," said Avanish Vellanki, co-founder and chief executive officer of Rain. "The preliminary observations of monotherapy activity of milademetan in the MANTRA-2 trial demonstrates encouraging data in a novel biomarker-based tumor agnostic strategy and supporting potential in additional MDM2-dependent cancers."

Dr. Robert Doebele, MD, PhD, president and chief scientific officer of Rain continued, "Preliminary data from the MANTRA-2 trial exhibited activity with two unconfirmed partial responses (PRs) at their first scan and promising tumor regression activity in two additional patients following milademetan monotherapy. We are very encouraged to see proof of concept activity using a genetic selection strategy across a diverse set of solid tumor types in heavily pre-treated patients, and those that possess multiple genetic co-alterations including strong oncogenic driver mutations. We believe the early activity suggests reactivation of p53 in MDM2-dependent cancers and may represent a sound therapeutic strategy with single-agent milademetan, and possibly through combination regimens as well."

Dr. Richard Bryce, MBChB, chief medical officer of Rain continued, "We have also observed this promising activity from the MANTRA-2 trial in patients with MDM2 copy number above 8. Hence, we plan to revise the protocol to include patients tested locally for MDM2 copy number of 8 and greater and anticipate this will further enhance the pace of enrollment to expedite completion of the 65-patient trial. We plan to initiate the MANTRA-4 trial next quarter and remain very excited about this second tumor agnostic basket strategy."

Key Corporate Updates and Upcoming Milestones

$50.0 Million Registered Offering of Common Stock
Completed a $50.0 million registered offering of common stock and non-voting common stock on November 8, 2022
End of third quarter cash balance of $90.7 million excludes the $50.0 million registered offering
Phase 3 MANTRA Trial of Milademetan in Dedifferentiated Liposarcoma
Topline data now anticipated in the first quarter of 2023
Phase 2 Preliminary Interim Data for the MANTRA-2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors
As of October 26, 2022, ten patients were efficacy-evaluable with CN ≥8 by central testing
Two unconfirmed PRs were observed with tumor regression of 34% and 30% (pancreatic and lung cancer, respectively)
The patient with pancreatic cancer is pending response confirmation and ongoing treatment
The patient with lung cancer is deceased due to COVID-19
Two patients exhibited promising activity with tumor regression of 29% and 27% (biliary tract and breast cancer, respectively) and the patients are continuing with the investigational therapy
Observed rapid anti-tumor effect of milademetan in heavily pretreated, refractory patients, with a median of four prior therapies
Safety profile to date is preliminarily consistent with prior Phase 1 milademetan trial
Phase 2 MANTRA-3 Trial in Merkel Cell Carcinoma Deprioritized
MANTRA-3 is deprioritized to rationalize use of financial and personnel resources
Phase 1/2 MANTRA-4 Basket Trial in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene
Commencement of MANTRA-4, the trial to evaluate the combination of milademetan with Roche’s FDA-approved IO therapy, atezolizumab, planned for first quarter of 2023
Recent addition to our Scientific Advisory Board, Nicholas A. Saccomano, Ph.D. in September 2022
Dr. Saccomano is the former Chief Scientific Officer of Array Biopharma, and a seasoned leader and mentor with over 30 years of experience in pharmaceutical and biotechnology research and development
Our updated corporate presentation includes details of the preliminary interim data for MANTRA-2 and is available at the "Corporate Presentation" section of the Rain website.

Third Quarter Financial Results
For the three and nine months ended September 30, 2022, Rain reported a net loss of $18.0 million and $53.0 million, respectively, as compared to a net loss of $18.4 million and $33.4 million for the same periods in 2021, respectively.

Research and development (R&D) expenses were $14.5 million and $42.3 million for the three and nine months ended September 30, 2022, respectively, as compared to $15.3 million and $26.1 million for the same periods in 2021, respectively. The decrease for the three months ended September 30, 2022 as compared to the prior period was primarily due to the milestone fees to Daiichi Sankyo of $5.5 million incurred during the prior period, partially offset by various R&D costs for milademetan, as well as higher payroll-related costs for Rain’s R&D personnel. The increase for the nine-months ended September 30, 2022 as compared to the prior period was primarily driven by the ongoing MANTRA Phase 3 trial in liposarcoma and Phase 2 tumor-agnostic basket trial (MANTRA-2), as well as personnel costs and various other R&D costs for milademetan. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.7 million and $2.8 million in the three and nine months ended September 30, 2022, respectively, as compared to $0.7 million and $1.4 million in the same periods in 2021, respectively.

General and administrative (G&A) expenses were $3.9 million and $11.3 million for the three and nine months ended September 30, 2022, respectively, as compared to $3.2 million and $7.3 million for the same periods in 2021, respectively. The increases were primarily due to higher payroll-related costs for Rain’s G&A personnel, outside consulting, legal costs and various third-party G&A costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.2 million and $0.8 million for the three and nine months ended September 30, 2022, as compared to $0.2 million and $0.4 million for each of the same periods in 2021.

Total non-cash stock-based compensation expense were approximately $0.9 million and $3.6 million for the three and nine months ended September 30, 2022, respectively, as compared to $0.9 million and $1.8 million for the same periods in 2021, respectively.

As of September 30, 2022, Rain had $90.7 million in cash, cash equivalents and short-term investments as compared to $140.2 million at December 31, 2021. On November 8, 2022, Rain completed a $50.0 million registered offering of common stock and non-voting common stock, and together with the cash balance as of September 30, 2022 provides cash runway into 2025.

As of September 30, 2022, Rain had approximately 26.6 million shares of common stock outstanding.

Third Quarter 2022 Results Conference Call and Webcast Details
The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2022 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here. The conference call can be accessed by dialing 1 (877) 704-4453 (U.S. Toll Free) / 1 (201) 389-0920 (International). The passcode for the conference call is 13733093.

Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

About MANTRA-2

The MANTRA-2 trial is designed to evaluate the safety and efficacy of milademetan monotherapy in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy and that exhibit wild-type p53 and a prespecified minimum MDM2 gene copy number. Approximately 65 patients are anticipated to be enrolled to receive milademetan. As of the latest data cutoff on October 26, 2022, 17 patients have been enrolled. The primary endpoint of the trial is objective response rate as measured by RECIST criteria. Secondary endpoints include duration of response, disease control rate progression-free survival by investigator assessment, overall survival and growth modulation index.

About Milademetan

Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53.Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of MDM2 inhibition. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS, and is evaluating milademetan in a Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in the first quarter of 2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.

On November 10, 2022 Ionis Pharmaceuticals, Inc. (the "Company") reported that it entered into a collaboration and license agreement (the "Agreement") with Metagenomi, Inc. ("Metagenomi") to research, develop and commercialize investigational medicines for up to eight potential genetic targets using gene editing technologies (Filing, 8-K, Ionis Pharmaceuticals, NOV 10, 2022, View Source [SID1234623925]).

Under the terms of the Agreement, the Company and Metagenomi will collaborate to discover investigational medicines for up to four initial genetic targets selected by the Company, and, upon the achievement of certain development milestones, four additional genetic targets selected by the Company. The Company will have the exclusive, worldwide right to develop and commercialize products discovered pursuant to the parties’ drug discovery collaboration ("Products"), subject to a limited option exercisable by Metagenomi to co-develop and co-commercialize Products directed to a limited number of genetic targets ("Co-Co Products"). For each option exercised by Metagenomi, Metagenomi will pay the Company a license fee and the parties will negotiate a co-development and co-commercialization agreement.

In addition, each party agreed not to, independently or with any third party, develop or commercialize any product that targets the genetic targets selected by the Company and uses certain gene editing modalities for specified periods of time under the Agreement.

As payment for the grant of rights to the Company under the Agreement, the Company paid an $80 million upfront fee. The Company will also pay Metagenomi certain fees for the selection of genetic targets, and contingent on the achievement of certain development, regulatory and sales events, milestone payments and royalties. In addition, the Company will reimburse Metagenomi for certain of its costs in conducting its research and drug discovery activities under the collaboration.

The Agreement continues (a) with respect to Products on a Product-by-Product and country-by-country basis until the expiration of the last to expire royalty term with respect to a Product in the applicable country, and (b) with respect to Co-Co Products until the parties cease all exploitation of such Co-Co Products.

The foregoing summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2022.

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On November 10, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that the ongoing Phase 2 clinical studies of RXC004 will open enrolment into the combination arms, where RXC004 will be combined with immune checkpoint inhibitors (ICIs) (Press release, Redx Pharma, NOV 10, 2022, View Source [SID1234623897]). The PORCUPINE study of RXC004 in genetically selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) will open a combination arm with nivolumab (OPDIVO – Bristol Myers Squibb, an anti-PD-1 antibody) and PORCUPINE 2 in patients with biliary tract cancer will open a combination arm with pembrolizumab (KEYTRUDA – MSD International Business GmbH, an anti-PD-1 antibody). The recommended RXC004 dose for both combination arms is 1.5mg once daily. Results from these open label Phase 2 studies are expected from H1 2023.

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The poster, presented today, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (8- 12 Nov Boston, MA, USA) provided encouraging data from the combination module ("Module 2") of the Phase 1 clinical study of RXC004 with nivolumab. Results from the monotherapy module ("Module 1") of the study were previously presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2021[1].

Tumour-derived Wnt-ligand signalling is implicated in reduced intrinsic and adaptive resistance to ICI therapy in multiple cancers[2][3][4]. Inhibition of Wnt-ligand signalling can enhance ICI efficacy by reversing dendritic cell tolerisation, decreasing Treg cells, and reducing the recruitment of myeloid-derived suppressor cells[5]. RXC004 can reverse immune evasion in mouse tumour models and has potential for clinical synergy with anti-PD-1 therapies[6].

Lisa Anson, Chief Executive Officer of Redx Pharma, said: "The poster presented today shows RXC004 to have a manageable tolerability profile in combination with nivolumab for Wnt-ligand dependent tumours, and a PK profile supporting once daily dosing. We are pleased that the data support our decision to open the combination arms of the Phase 2 proof-of-concept studies to understand the potential efficacy of RXC004 in combination with PD-1 inhibitors., This is an exciting development, which may open up new treatment options for patients with a very poor prognosis. We look forward to reporting initial headline data from our Phase 2 programme from H1 2023."

Dr Natalie Cook, Lead Investigator of the Study, from the University of Manchester and Christie NHS Trust, commented: "The Phase 1 study results from RXC004 in combination with a standard dose of the PD-1 inhibitor, nivolumab, presented today at SITC (Free SITC Whitepaper) are consistent with the previously presented Phase 1 results of RXC004 as monotherapy. Together, these data support the continued clinical development of RXC004 – both as monotherapy and in combination with checkpoint inhibitors – as a potential targeted treatment in selected patients with Wnt-ligand dependent cancers."

The Phase 1 trial (clinicaltrials.gov NCT03447470) evaluated RXC004, a highly potent, selective and orally active Porcupine inhibitor as a monotherapy (Module 1), and in combination with the approved dose of nivolumab (Module 2), in unselected patients with advanced solid tumours for whom no standard therapy is available. The primary objective of the open label, ‘3+3’ dose escalation Phase 1 study was to assess the safety and tolerability of RXC004 with additional endpoints including pharmacokinetics (PK), pharmacodynamic effects on peripheral immune cells and preliminary anti-tumour activity, as measured by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). The data presented at the SITC (Free SITC Whitepaper) conference were from 13 patients who completed Module 2, up to 18 October 2022. Previously 25 patients completed Module 1 and the results, which were reported at ESMO (Free ESMO Whitepaper) 2021, supported commencement of the ongoing monotherapy arms of the Phase 2 Programme.

Key results presented at the SITC (Free SITC Whitepaper) conference highlighted:

RXC004 at doses of 1mg and 1.5mg once daily in combination with standard dose nivolumab had a manageable tolerability profile, with a pharmacokinetic profile supporting once daily dosing. The treatment related adverse event profile reported for Module 2 was similar to that previously reported from Module 1, with fatigue, nausea, dysgeusia (‘altered taste’) and decreased appetite being reported most frequently. While the per-protocol Phase 2 dose for RXC004 monotherapy is 2mg, RXC004 doses higher than 1.5mg were not explored in Module 2 because of the potential for overlapping toxicity of colitis, which was reported in Module 1, and is a known adverse effect of immune checkpoint inhibitors. As in Module 1, the treatment combination was administered alongside denosumab prophylaxis which, together with the low dose of this potent molecule, averted the bone toxicity traditionally associated with Wnt pathway inhibition.

Preliminary efficacy data from Module 2 supports continued investigation of combination of RXC004 at 1.5mg dose once daily with checkpoint inhibitors. At the cut-off date, 10 out of the 13 unselected patients in Module 2 had RECIST-evaluable disease. Of these, 4/6 patients[7] in the 1.5mg RXC004 cohort had RECIST stable disease as best response. Analysis of blood samples from some patients on treatment indicated changes in peripheral immune cell compartments consistent with those seen in preclinical models and were suggestive of an anti-tumour immune response. Of note, CD8+ T-cell proliferation increased in some patients and was more pronounced in patients with stable disease. This observation is reported to correlate with improved response to immune checkpoint inhibitors[8]. This effect will be further investigated in the Phase 2 programme in recurrent MSS mCRC and biliary tract cancers, where immune checkpoint inhibitors alone are ineffective.

About the Phase 2 programme for RXC004

RXC004 entered Phase 2 clinical trials in November 2021. The first study in the Phase 2 programme, PORCUPINE, (clinicaltrials.gov NCT04907539) is focused on patients with advanced MSS mCRC who have progressed following treatment with standard of care and is evaluating preliminary efficacy and safety of RXC004 in genetically selected patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, advanced MSS mCRC. Given the dual mechanism of action of RXC004, which preclinically was shown to inhibit tumour growth and immune evasion, there is a strong rationale for immune therapy combination in the MSS mCRC setting, and the second module of the trial will evaluate RXC004 in combination with nivolumab, a PD-1 inhibitor. This combination module is now approved by the FDA, which will allow patient recruitment to commence in US trial centres. A second Phase 2 study of RXC004, PORCUPINE2, (clinicaltrials.gov NCT04907851), as a monotherapy for genetically selected pancreatic cancer and unselected biliary cancer, a highly Wnt-ligand dependent cancer, commenced in January 2022, and a second arm of the biliary cancer module will evaluate RXC004 in combination with pembrolizumab, a PD-1 inhibitor. Redx expects to report topline data readouts from the Phase 2 programme starting in the first half of 2023.

Additional data presented at SITC (Free SITC Whitepaper) by the Garvan Institute of Medical Research

In addition, a second poster on RXC004 was presented at SITC (Free SITC Whitepaper) by Redx’s collaboration partner, Associate Professor Marina Pajic of the Garvan Institute of Medical Research in New South Wales, Australia. The poster was titled, "Effective Co-targeting of Fibrotic and Immune Microenvironments to Improve the Overall Anti-tumour Response in Models of Advanced Pancreatic Cancer" and demonstrated the therapeutic potential of RXC004 (PORCUPINE inhibitor) and a ROCK2 selective inhibitor, in targeting fibrosis associated with pancreatic cancer. The data showed an increased survival in mouse models and highlights the potential of RXC004 to modulate the tumour immune environment of pancreatic cancers.

On November 10, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company and Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, reported that data from preclinical studies of Imugene’s onCARlytics (CF33-CD19) oncolytic virus in combination with Celularity’s placental-derived off-the-shelf allogeneic CYCART-19 T cells was presented at the renowned Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held in Boston, USA on 8-12 November 2022 (Press release, Imugene, NOV 10, 2022, View Source [SID1234623879]).

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Dr Anthony Park from Dr Saul Priceman’s lab at City of Hope presented the poster, "CF33-CD19t oncolytic virus (onCARlytics) in combination with off-the-shelf allogeneic CYCART-19 T-cells targeting de novo CD19t expressing tumors."

Key findings of the presentation are as follows:

onCARlytics can target triple-negative breast cancer cell line MDA-MB-468 to express CD19t as a CAR T cell target in a virus dose-dependent manner.
CYCART-19 demonstrated efficacy in preclinical models against MDA-MB-468 expressing CD19t following onCARlytics infection.
There was an increase in CYCART-19 activation and IL-2 production in a virus dose-dependent manner.
Allogeneic CYCART-19 T cells produced less IFN-γ compared to autologous CD19-CAR T cells after CD19t-expressing tumor killing.
CD19t expression was detected in tumors following onCARlytics infection in vivo.
CYCART-19 treatment 7 days post onCARlytics infection showed significant tumor regression compared to onCARlytics or T cells alone in a mouse xenograft model of triple-negative breast cancer.
The poster is available on Imugene’s website, View Source and Celularity’s website, View Source

Imugene CEO/MD Leslie Chong said "When we embarked on the partnership with Celularity we were eager to investigate the combination of the cutting-edge technologies, Imugene’s onCARlytics and Celularity’s placental-derived allogeneic CAR-T (CYCART-19). The results presented at SITC (Free SITC Whitepaper) further build our confidence as to the potential benefit to patients from these technologies and provide an excellent platform for further clinical development."

Celularity Founder, Chairman and CEO Bob Hariri added, "We are encouraged by the potent cytolytic activity observed in the CYCART-19 preclinical models when combining Imugene’s onCARlytics product with our placentally derived CYCART-19 cells. The cytokine secretion profile demonstrated by the CYCART-19 cells suggests this combination may elicit reduced CRS potential in patients compared to PBMC derived CAR-T products."

About CYCART-19 T cells combination with onCARlytics

Autologous chimeric antigen receptor (CAR) T cell therapy has shown impressive clinical responses against CD19+ B-Cell hematological malignancies and is being actively explored in the treatment of solid tumors. However, several barriers have precluded therapeutic responses in solid tumors, including limited tumor-restricted CAR targets and the immunosuppressive tumor microenvironment. We have recently reported the successful combination immunotherapy using a novel chimeric vaccinia-based oncolytic virus (OV), called onCARlytics (Imugene Limited) that is engineered to express a non-signaling truncated CD19 (CD19t) antigen for tumor-selective delivery, enabling de novo targeting of tumor cells by autologous CD19-CAR T cell1. One of the field’s unanswered questions is whether treatment-naïve allogeneic CAR T cells are superior to cancer patient-derived T cells for product manufacturing to improve overall responses against solid tumors.

This combination strategy was evaluated using two allogeneic CAR T cell products generated from peripheral blood mononuclear cells (PBMC) and placental T cells, respectively. PBMC-derived CAR T cells were manufactured from normal healthy donors. CYCART-19 (Celularity Inc.) cells were derived from postpartum human placental T cells that are genetically modified to express the CD19 CAR followed by CRISPR-Cas9-mediated knockout of the endogenous t cell receptor (TCR) and expanded to produce multiple doses of allogeneic "off-the-shelf" treatment.

CYCART-19 T cells induced potent cytolytic activity against solid tumor cells infected with onCARlytics. Interestingly, while we observed comparable anti-tumor activity between PBMC-derived CD19-CAR T cells and CYCART-19, differences in cytokine secretion were detected. This warrants the possibility that the placenta-derived CAR T product may elicit reduced cytokine release syndrome (CRS) potential in patients with maintained or improved efficacy. This combination approach demonstrated in vivo anti-tumor response in human tumor xenograft models. In summary, our results have demonstrated that further development of this combination immunotherapy for the potential treatment of a wide array of solid tumors is warranted.

References
¹ Warner SG, Kim SI, Chaurasiya S, O’Leary MP, Lu J, Sivanandam V, Woo Y, Chen NG, Fong Y. A Novel Chimeric Poxvirus Encoding hNIS Is Tumor-Tropic, Imageable, and Synergistic with Radioiodine to Sustain Colon Cancer Regression. Mol Ther Oncolytics. 2019 Apr 11;13:82-92. doi: 10.1016/j.omto.2019.04.001. PMID: 31061881; PMCID: PMC6495072.

On November 10, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that it will publish its results for the third quarter and first nine months 2022 results on November 16, 2022 at 10:00 pm CET (9:00 pm GMT; 4:00 pm EST) (Press release, MorphoSys, NOV 10, 2022, View Source [SID1234623877]).

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MorphoSys’ Management team will host a conference call and webcast on November 17, 2022 at 2:00 pm CET (1:00 pm GMT; 8:00 am EST) to present the third quarter and first nine months financial results 2022 and provide an outlook for 2022.

The conference call will start with a presentation by the Management team followed by a Q&A session.

A live webcast and slides will be made available at the Investors section on MorphoSys’ website, www.morphosys.com.

To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website:

View Source;linkSecurityString=5f6d0a600

Please dial in 10 minutes before the beginning of the conference.

A replay of the conference will also be available at the corporate website following the live event.