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.

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"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.

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"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])

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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

On November 19, 2020 Laminar Pharma, a biotech company based in the Balearic Islands, reported that it is getting closer and closer to its IPO (Press release, Laminar Pharma, NOV 19, 2020, View Source [SID1234572013]). It launched a funding round this month to increase its investment in research staff and advance the development of clinical trials.

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This operation aims to raise 1.2 million euros

The financing round was launched on October 30 with the aim of raising 1.2 million euros and is currently available on the Fellow Funders Crowd Investment platform. In the first two weeks, thanks to the trust of numerous investors, more than one million euros have been raised, which is equivalent to 92% of the target set. As there are still another two weeks left, everything suggests that the target will be met. In addition to this main source of financing, which is private investment, Laminar Pharma has received support from the Spanish government, Spain’s regional governments and the European Commission.

Pablo Escribá, CEO of the biopharmaceutical company, has a positive outlook: "We are optimistic about exceeding the planned target, as we did in the round at the end of last year. Currently at Laminar Pharma we hold patents for 8% of all drugs under development by Spanish biotechnology companies in our country, according to the pipeline of the Spanish Association of Bio-companies (ASEBIO) and we hope to grow in valuation as we advance in the clinical research stages of our drugs undergoing development. The company plans to request marketing authorization from regulatory agencies in two years, with the aim of announcing our first market launch in 2023."

Fellow Funders partner Mariano Colmenar is satisfied with the operation, which is run by his own collective financing platform, authorized and supervised by the National Securities Market Commission (CNMV) since 2016. "We have shown that investors see a promising future in the biotechnology sector, anticipating good benefits. The pharmaceutical market is a long-term market, since years of research and clinical trials are necessary before the products can safely be launched to market."

On November 19, 2020 MercachemSyncom reported that it will change its name and operate under the registered trade name of Symeres (Press release, Mercachem, NOV 19, 2020, View Source [SID1234584204]).

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The new name reflects the strategic evolution of the company, with the growth of integrated drug discovery and development services, which complement the company’s strong reputation in synthetic discovery and development chemistry. Recent examples of this evolution include the acquisition of ADME-Tox provider Admescope in November 2020 and strategic alliances integrating our services with high-quality CROs in the fields of in vitro biology, biophysics, and structural biology.

The name Symeres (derived from Sy-ncom Me-rcachem res-research) and accompanying tagline "making molecules matter" are derived from the experience and success of the Syncom and Mercachem legacy organizations and their core strengths in innovative research.

Dr. Eelco Ebbers, CEO of Symeres, added, "The evolution of MercachemSyncom into Symeres is representative of the continuing expansion of the organization and our move into integrated solutions for drug discovery and development services, alongside our strong chemistry-centric services. The most recent example being our acquisition of Admescope. We look forward to continuing our journey with our clients around the world under our new identity, without forgetting the core values of quality, integrity, transparency, and innovation that got us to where we are today."