On November 19, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported that data from a Phase I Dose Escalation Study of its lead candidate PT-112, an immunogenic cell death (ICD) inducer, in patients with relapsed or refractory multiple myeloma will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020 (Press release, Phosplatin, NOV 19, 2020, View Source [SID1234571451]).

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!

Title:

A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma

Abstract availability:

Saturday, December 5 through Monday, December 7, 2020, from 7:00 a.m. to 3:30 p.m. (Pacific Time), on the ASH (Free ASH Whitepaper) Annual Meeting and Exposition site and the Phosplatin Therapeutics web site

Session:

653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I

Lead Author:

Taxiarchis Kourelis, M.D., Division of Hematology, Assistant Professor of Medicine, Mayo Clinic College of Medicine Rochester, Minnesota

Under this year’s virtual meeting format, Dr. Kourelis will present a pre-recorded, narrated slide presentation on the multi-center dose escalation study of PT-112 in multiple myeloma patients who are relapsed or refractory to available therapy (NCT03288480). The study was designed and launched following non-clinical work conducted in the Cancer Genetics Laboratory of P. Leif Bergsagel, M.D. at the Mayo Clinic in Scottsdale, Arizona.

About PT-112

PT-112 is a novel small molecule conjugate of pyrophosphate that possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents the best-in-class small molecule inducer of this immunological form of cancer cell death and is currently under Phase II development. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase Ib study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase I study in patients with relapsed or refractory multiple myeloma to be presented at ASH (Free ASH Whitepaper) is the third completed Phase I study of PT-112.

On November 19, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported positive new interim data from its ongoing ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, PLUS THERAPEUTICS, NOV 19, 2020, View Source [SID1234572301]). These results were presented in an electronic poster entitled, "Safety and Feasibility of Rhenium-186 Nanoliposomes (RNL) in Recurrent GBM: the ReSPECT Phase 1 Trial," at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is taking place virtually November 19-21, 2020.

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 interim data set shows that intratumoral RNL can successfully deliver up to fifteen times the absorbed dose of radiation administered by standard external beam radiation therapy (EBRT) without significant toxicity. These data support progression to the ReSPECT trial’s sixth dose escalation cohort.

"The results we have seen thus far from ReSPECT are encouraging and support the continued development of RNL as a potential new option for recurrent GBM patients," said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the study. "With limited therapeutic options for these patients, we remain committed to advancing this clinical program to further investigate the therapeutic potential of RNL."

"Treatment for glioblastoma remains a significant challenge as current therapies have exhibited limited efficacy," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "RNL’s novel design allows the drug to be targeted directly into the tumor using a small catheter and enabling greater control of radiation dosing. These encouraging data reinforce RNL’s potential to deliver targeted high-dose radiation in a safe, effective, and convenient manner."

Key R esults from the I nterim A nalysis

All 15 patients in the first five of six planned cohorts have completed treatment.
RNL treatment volume and radiation dose increased successfully from 0.66 milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi, respectively.
Cohort 5 patients received an RNL average absorbed radiation dose of 423 Gray (Gy).
RNL has been well-tolerated, and no dose-limiting toxicity has been observed despite markedly higher absorbed doses of radiation compared to EBRT.
Most adverse events (AEs) were considered causally unrelated to RNL except scalp discomfort, which was considered related to the surgical procedure. Neither the incidence nor severity of AEs appeared to increase with increasing doses of RNL.
Four serious adverse events (SAEs) were reported, none of the SAEs were considered causally related to RNL.
Median survival duration in patients that previously received bevacizumab (n=7) was 4.8 months, while median and mean survival durations in patients that were bevacizumab-naïve (n=8) are currently 11.0 months (range 3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with four patients still alive.
Two patients survived greater than 30 months after therapy with RNL.
The sixth dose escalation cohort of the ReSPECT trial is underway and one patient has thus far been treated. The sixth cohort is expected to fully enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration (FDA) granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webinar details

The Company will host a webinar today, Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data. In addition, a patient with recurrent GBM from the ReSPECT trial will provide their treatment experience with RNL.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.

On November 19, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that it has entered into a research agreement with Genmab A/S (Nasdaq: GMAB), an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, ImmunoPrecise Antibodies, NOV 19, 2020, View Source [SID1234571420]). IPA will generate novel bispecific antibody combinations using Genmab’s proprietary DuoBody platform and IPA’s proprietary antibodies in the field of infectious disease. The development of IPA’s proprietary antibodies into DuoBody constructs enables additional, novel formulations as the Company investigates a series of combinations in parallel.

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!

"Partnering with Genmab aligns with IPA’s mission to develop safe and effective therapies for patients, in this case, specifically pertaining to the growing demand in infectious disease," said Dr. Jennifer Bath, Chief Executive Officer of ImmunoPrecise Antibodies. "This agreement further complements our strategy to ensure that the full potential of our infectious disease programs is realized, which includes establishing productive partnerships to increase opportunities for ideal formulations with the highest safety and efficacy profiles."

The DuoBody technology is a proprietary platform of Genmab applied in the discovery and development of bispecific antibodies across several therapeutic areas including cancer, hemophilia, autoimmune, infectious, and central nervous system diseases. DuoBody technology has been successfully used in many Genmab internal or partnered investigational clinical therapies.

As a part of the partnership, Genmab and IPA will negotiate in good faith an agreement for the commercial use of resulting DuoBody products.

On November 19, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the Phase 1b study of AFM13, a CD30/CD16A innate cell engager (ICE), in combination with KEYTRUDA was published in Blood, the renowned Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Affimed, NOV 19, 2020, View Source [SID1234571436]). The results demonstrate promising signs of efficacy including an objective response rate (ORR) of 88% at the highest treatment dose, as well as a complete CR of 46%. As a monotherapy, KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.

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!

"We showed for the first time that the combination of an ICE with a PD-1 checkpoint inhibitor can be safely administered with manageable side effects," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "The high objective response rate and complete response rate seen in this proof-of-concept study of AFM13 combined with KEYTRUDA are very encouraging and indicate that the activation of innate immunity could improve upon current therapies."

The study assessed the safety and efficacy of AFM13 in combination with KEYTRUDA in 30 heavily pre-treated patients with R/R Hodgkin lymphoma. The safety profile for the combination was described as well-tolerated and similar to the known profiles for each agent alone. Most adverse events were low grade and remained manageable with standard-of-care therapies.

AFM13 presents a novel approach of activating innate immunity through CD16A-directed tumor-cell killing by NK cells and macrophages. The phase 1b study supports the notion that in combination with an established therapy such as an immune checkpoint inhibitor, that releases the brakes on adaptive immune responses, the ICE AFM13 complements the PD-1 checkpoint inhibitor, thereby triggering both arms of the immune system against tumors.

Dr. Nancy Bartlett, a medical oncologist and Koman Chair in Medical Oncology at Washington University School of Medicine in St. Louis and lead author on the publication, said, "There is an unmet need for patients with Hodgkin lymphoma who have relapsed or are refractory to current therapies. For these patients, there are no therapies that show durable efficacy. The combination of AFM13 with KEYTRUDA was well tolerated and showed an 88% response rate with a very encouraging 46% complete metabolic response rate in a heavily pretreated patient population. This exciting data shows that there are potential treatments on the horizon for patients with limited options."

"Engagement of the innate immune system to kill tumors is novel. The studies of AFM13 and KEYTRUDA in Hodgkin lymphoma, as well as AFM13 in patients with T-cell lymphoma, present exciting approaches to controlling blood cancers that could significantly benefit patients," said Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS), which supported Affimed’s clinical study of AFM13 through its Therapy Acceleration Program (TAP), LLS’s strategic venture philanthropy funding initiative.

More details about the Phase 1b of AFM13 in combination with KEYTRUDA study can be found at www.clinicaltrials.gov using the identifier NCT02665650. The article published in Blood, Volume 136, Number 21 can be found here https://bit.ly/2KiL293 .

About AFM13
AFM13 is a first-in-class innate cell engager that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed’s most advanced ICE clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331. Affimed is currently studying AFM13 in combination with cord blood-derived allogeneic natural killer cells in cooperation with the MD Anderson Cancer Center in Houston. The investigator-sponsored Phase 1 study is preparing to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells, the study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

On November 19, 2020 NeoDynamics AB reported that (publ) Third Quarter 2020 (Press release, NeoDynamics, NOV 19, 2020, View Source [SID1234571452])

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 proposed financing strengthens NeoDynamics ahead of pivotal period

Third quarter 2020

There were no sales during the period. Revenue amounted to SEK 2.643 m (4.581 m) including capitalized costs of SEK 2.051 m (4.469 m).
Loss after tax amounted to SEK -6.731 m (-4.416 m).
Loss per share amounted to SEK -0.19 (-0.29).
9 months 2020

There were no sales during the period. Revenue amounted to SEK 15.175 m (16.329 m), whereof capitalized costs SEK 14.140 m (16 214 m).
Costs for product development contuned to be higher than expected.
Loss after tax amounted to SEK -18.011 m (-12.498 m).
Loss per share amounted to SEK -0.71 (-0.82).
Equity per share was SEK 2.52 (3.63 at year-end).
Equity ratio was 94 (60 per cent at year-end)
Significant events during the third quarter

Reference centers established in Germany to support the introduction of the new pulse biopsy system NeoNavia and optimize the diagnosis of breast cancer.
An Extraordinary General Meeting on 13 August resolved on an incentive program for employees with a maximum of 1,021,900 warrants, where each warrant entitles to subscribe to one new share at SEK 4.71 per share during the period 1 Aug – 30 Sep 2023.
The directed share issue of 2,561,339 shares, SEK 7,684,017 announced in April, was registered with the Swedish Companies Registration Office in September. Hence, the share capital is SEK 3,600,695.10 distributed on 36,006,951 shares.
In September, the NeoNavia biopsy system was very well received at the international senology congresses in Vienna and Lucerne, and for the first time, physicians gained practical experience of the finished product.
Significant events after the period

An Extraordinary General Meeting on November 19 will resolve on a directed share issue to a limited group of investors. The subscription price in the share issue is proposed to be SEK 3.71 per share and was determined through an accelerated bookbuilding procedure. The share issue can provide the company with close to SEK 90 million before transaction costs.
On November 2, the company announced that its CFO, Jörgen Vrenning, has decided to leave the company after eight years to retire. Jörgen will continue in an advisory role until the end of May 2021 to ensure a smooth transition.
The company joined a scientific partnership to evaluate the NeoNavia pulse biopsy system for knee and bone tissue sampling in a new potential indication, osteoarthritis.
Neodynamics gets first order for the pulse biopsy system NeoNavia from the Buckinghamshire Healthcare NHS Trust, London.
CEO’s comments

Proposed new financing strengthens NeoDynamics ahead of pivotal period

During the autumn, the Board discussed various ways to strengthen the company’s cash flow in order to be able to carry out the forthcoming market introduction of NeoNavia in a successful manner. These discussions, which have also involved the company’s main owners, led to the Board’s proposal for a directed issue of approximately SEK 90 million. The company’s owners will decide on the matter at an extraordinary general meeting on 19 November. The share issue provides much-needed room for manoeuvre to create value. The Board’s assessment is that the funding benefits both old and new shareholders.Through the proposed raising of capital, the ownership circle will be expanded with competence and experience in MedTech, a significant stamp of quality for a company such as NeoDynamics The Dutch investment firm Nyenburgh and Swedish Cardeon Futuring Finance have thoroughly analysed the company prior to investing in NeoDynamics. Both appreciate the solid preparation for the launch of NeoNavia, and state it as one of the most important reasons why they have chosen to invest in NeoDynamics.

First order

NeoNavia is now launched in the UK, Germany and Sweden, somewhat delayed compared to plan as the announced product development dragged on and the pandemic further delayed the project in the critical verification and validation phase. Covid-19 currently also limits the possibility of physical meetings on site with radiologists, but many activities are now underway thanks to our specialist sales staff in the UK, Germany and Sweden.It is gratifying to note that after a short introduction, the first centre in the UK was able to place an order. A strong symbolism that we are now up and running. Other centres will want to follow suit.The cancer area remains a priority in hospitals and there is a backlog when it comes to caring for breast cancer patients. Our studies have familiarized doctors with our product and built knowledge on how to use it. This provides benefits when NeoNavia now becomes commercially available.Due to the pandemic, the study in the UK has not been able to be conducted normally and therefore we are expanding with more centres for faster results that can be used in sales work.

The United States is the next step

Work on our registration application to the Federal Drug Administration (FDA) is ongoing, as is the dialogue with the authority. We expect to submit the documentation at the beginning of 2021, in order to get the go-ahead to start selling NeoNavia in the USA during the year as well. Covid-19 has led to the closure of several states where we have planned user tests with American physiciansThe work in the USA also lays the foundation for the regulative application in China, which is next on the agenda. We will also perform a local study in China to get a strong basis, both in the dialogue with the authority and with future customers in the Chinese market.

Scale up of production

The company works continuously to optimize its production processes to keep manufacturing costs at a level that enables a long-term good profit margin. We have been collaborating for just over a year with a well-established FDA-approved Thai manufacturer who, together with us, is preparing the transfer of our disposable probes (needles) to serial / commercial production. The first delivery is expected to take place in mid-2021. Until then, the company’s Swedish partner Sanmina in Örnsköldsvik will be used, which will continue to manufacture the reusable system parts (base unit and driver) which are built with a significantly larger technical content.Finally, we have recently started an international research collaboration to evaluate the NeoNavia pulse biopsy system for knee and bone tissue sampling in osteoarthritis, which is also a large indication. Here we collaborate with William Hunter Revisited, a research consortium consisting of six universities as well as academic hospitals, which specialize in osteoarthritis. We know that our pulse technology is attractive to develop in other indications as well, which we have confirmed by being approached by this research team

NeoDynamics is finally on its way to the market. We look forward to in-depth relationships with cancer clinics in Europe, to roll out NeoNavia in the US and to receive feedback on how the products will be received by doctors and patients.

CEO Anna Eriksrud

The information was submitted for publication through the agency of the contact person set out below, at 08:55 CET on November 19, 2020